Modi's Vaccine Nationalism: India's Hasty Approval of Homegrown COVID19 Vaccine
Indian drug regulator has approved COVAXIN, a Covid19 vaccine developed by Bharat Biotech. The approval has been granted without completing large-scale phase 3 trials in India, according to media reports. It is India's first indigenous vaccine co-developed with Pennsylvania-based startup Ocugen. Ocugen, led by Indian-American scientists, does not currently sell any products. India is the world's second worst-hit country by the global coronavirus pandemic. Critics say the hasty approval of the homegrown Indian vaccine is motivated by "chest thumping nationalism".
|How COVAXIN Works. Source: NY Times|
Ocugen is a US-based biotech company. It has no track record. It has not developed any drugs and doesn't have any products to sell yet. This lack of experience makes Ocugen a strange choice for an international commercialization partner, according to an investment analysis published in the United States. The Food and Drug Administration has made it clear that it won't authorize a coronavirus vaccine without data from a phase 3 trial conducted in the United States. NASDAQ-listed Ocugen stock has soared since the approval of COVAXIN for use in India.
Bharat Biotech is an Indian biotechnology company based in the South Indian city of Hyderabad.
Dr. Krishna Ella, the Chairman of the Bharat Biotech, has claimed that they are "no way" inferior to Pfizer in terms of coronavirus vaccine. He also said that Bharat Biotech is the only firm to have published five articles on the Covid-19 vaccine process, according to media reports.
Some critics have dismissed COVAXIN approval as a manifestation of "chest thumping nationalism". Bloomberg's Andy Mukherjee has a story entitled "COVAXIN: Science, not pride will help India build trust in this vaccine".
Indian government's decision to authorize COVAXIN has been sharply criticized by public interest groups in India. “The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers and likely will not reinforce faith in our scientific decision-making bodies,” Malini Aisola, of the All India Drug Action Network (AIDAN), an independent collective of healthcare non-profits, said in a statement.
India has been hit hard by the coronavirus pandemic with over 10 million infections, second only to the United States. Indian economy has shrunk by double digits. Tens of millions of daily wage earners who make up the bulk of India's workforce have lost their livelihoods. Prime Minister Narendra's Modi's decision to impose a sudden nationwide lockdown is blamed for it.
COVAXIN is India's first indigenously developed vaccine that has just been approved for emergency use in the country. It has been co-developed with US-based Ocugen. COVAXIN's hasty approval without any phase 3 efficacy data has come under sharp criticism. Some critics have dismissed COVAXIN approval as a manifestation of "chest thumping nationalism". Bloomberg's Andy Mukherjee has a story entitled "COVAXIN: Science, not pride will help India build trust in this vaccine".
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By Andy Mukherjee | Bloomberg
Jan. 4, 2021 at 5:58 p.m. PST
The hasty nod for Bharat Biotech International Ltd.’s Covaxin, developed in collaboration with the Indian Council of Medical Research and National Institute of Virology, has raised eyebrows in the scientific and healthcare communities about a “public rollout of an untested product,” according to a national network of nongovernment organizations.
This is unfortunate. With more than 10 million coronavirus infections, India is the world’s second-worst-affected nation after the U.S. New Delhi’s strategy for vaccinating 1.3 billion people will matter greatly for bringing the global pandemic to a decisive end. The country’s virus-battered economy and its overstretched health systems are also yearning for a reprieve. It will be dangerous to allow political calculations to enter the equation and shake people’s confidence in what’s being offered to them — and on what basis.
That’s just what seems to be happening with the unusual approval for Covaxin, which comes with the odd caveat that its use will be restricted to “public interest as an abundant precaution, in clinical trial mode, especially in the context of mutant strains.” Nobody seems to know what this will mean on the ground. Who’ll get Covishield, and who’ll be given Covaxin? More importantly, who’ll decide? In a country beset by massive inequalities in income, wealth and social status, these aren’t trivial questions.
When opposition leaders raised doubts about the vaccine selection process, a minister in Prime Minister Narendra Modi’s cabinet likened their objections to questioning “the valor of our soldiers.”
To be sure, India is not even in the front row of vaccine nationalism. China and Russia are more desperate to beat the West in saving the world. But as my colleague Clara Ferreira Marques has noted, both countries’ vaccine candidates face a transparency deficit, which could limit their global acceptance.
That’s a risk that India, which manufactures more than 60% of the world’s vaccines, should avoid at all cost. According to media reports, Hyderabad, India-based Bharat Biotech has enlisted 23,000 volunteers for phase three clinical trials. That’s encouraging because another report, published last month, had cited a major New Delhi-based research hospital as saying that it couldn’t find enough subjects for the study. If the drug proves to be effective, introducing it even at a later date should pose no problems. Naming Covaxin as an alternative even in the absence of phase three data could be a commercial tactic to squeeze “better discounts” on bulky Covishield purchase contracts, brokerage Jefferies says. Still, cutting corners with science isn’t exactly the best strategy to negotiate drug prices.
The Kremlin-backed Sputnik V is also undergoing trials in India, in partnership with local manufacturer Dr. Reddy’s Laboratories Ltd. The Ahmedabad-based Cadila Healthcare Ltd. is also in the race to develop an indigenous Covid-19 vaccine. Ultimately, it doesn’t matter whether India’s homegrown shots make the final cut. Serum Institute, the world’s largest producer, has already stockpiled 70 million doses of Covishield. Big parts of the developing world will rely on Indian manufacturers to supply easy-to-administer, affordably priced vaccines in large quantities.
Many religious gatherings across the world have been cancelled or scaled back because of Covid. Only a few thousand Muslims took part in last year’s hajj, the annual pilgrimage to Mecca, compared with more than 2 million in normal years.
The pope celebrated midnight mass on Christmas Eve with fewer than 100 participants instead of the usual 10,000. In nearly all countries, Christians, Muslims, Jews and those of other faiths have curtailed or cancelled events marking religious festivals in the past 10 months.
Most of those walking into the freezing river on Thursday morning were not wearing masks and social distancing was hard to maintain. Senthil Avoodai K Raj, a senior police official, said thousands of security forces were present and fines could be imposed for breaching Covid regulations.
India has recorded more than 10m Covid cases – the second highest number in the world after the US – and has recorded more than 150,000 deaths.
On Saturday, the government will launch a vaccination drive, aiming to inoculate 300 million people by early August. Healthcare and frontline workers will be vaccinated first, followed by people over 50 and those with underlying health conditions.
Some pilgrims in Haridwar dismissed the threat from the virus. “India is not like Europe … when it comes to immunity we are better,” said 50-year-old Sanjay Sharma. “It’s really sad to see people not gathering at Kumbh in the same numbers as they would earlier … The greatest truth on Earth is death. What’s the point of living with fear?”
AstraZeneca's COVID-19 vaccine has been approved for emergency use in Pakistan, the health minister said on Saturday, making it the first coronavirus vaccine to get the green light for use in the South Asian country.
Pakistan, which is seeing rising numbers of coronavirus infections, said its vaccines would be procured from multiple sources.
"DRAP granted emergency use authorisation to AstraZeneca's COVID vaccine," the health minister, Faisal Sultan, told Reuters.
Approval has been given to get more than a million doses of Sinopharm's vaccine from China, he said.
"We are in the process to obtain Western origin and other vaccines both via bilateral purchase agreements as well as via the COVAX facility," he said.
The Chinese vaccine is awaiting approval from the Drug Regulatory Authority of Pakistan (DRAP), which has received and reviewed its data.
Pakistan is speaking to a number of vaccine makers, and Sultan said the country could get "in the range of tens of millions" of vaccine doses under an agreement with China's CanSinoBio.
The vaccine company's Ad5-nCoV COVID-19 candidate is nearing completion of Phase III clinical trials in Pakistan.
Efficacy is a key factor, said Sultan. "We have and are watching the evolving stories around efficacy of a number of vaccines."
Sultan said preliminary results of the Cansino may come in by mid-February. He added that Pakistan was considering to engage with Russia's Sputnik V vaccine.
Pakistan reported 2,432 new coronavirus infections and 45 deaths on Friday, taking the total number of cases to more than 516,000 and deaths close to 11,000.
"Our aim is that the bulk of the population will be covered free," the minister said, adding that private sectors could also be allowed once supply was available to an authorized company.
Sultan added that Pakistan had adequate cold chain facilities for most kinds of vaccines.
He approved a homegrown #COVID vaccine without phase 3 trials.
He has not taken this vaccine himself. Other world leaders have built confidence in their vaccines by getting vaccine shots on camera.
Bollywood once again has fallen into the cross hairs of India’s Hindu nationalist ruling party — and major Western streaming services like Amazon and Netflix increasingly find themselves caught in the middle.
Two separate criminal complaints were filed with the police over the weekend against the makers of “Tandav,” a splashy new big-budget web series on Amazon. The fast-paced political drama, which seems to borrow heavily from India’s political scene, may cut uncomfortably close to current events and the country’s biggest controversies.
The complainants, which include a politician with the ruling Bharatiya Janata Party, have insisted that the government pull the series off the air or take out key scenes. Among other objections, they accused the series of disrespecting Hindu gods, belittling members of individual castes and sullying the office of the prime minister.
If the police find merit to the complaints, Amazon and the show’s promoters could wind up in criminal court.
Ali Abbas Zafar, the director of “Tandav,” on Monday posted a statement on his Instagram account saying the show “is a work of fiction and any resemblance to acts and persons and events is purely coincidental.” However, the statement said, the cast and crew “take cognizance of the concerns expressed by the people and unconditionally apologize if it has unintentionally hurt anybody’s sentiments.”
Officials at Amazon have declined to comment.
Defenders of the show say those complaints are pretexts. The pressure on Amazon to drop the series, they say, is part of an increasingly intolerant atmosphere in India that affects even Bollywood, India’s film and entertainment industry. Actors, comedians, producers, artists and anyone who dares to question the government, even indirectly, can find their careers in peril, they say.
“When you take a stand, you have to pay a price,” said Sushant Singh, a Bollywood actor who has openly campaigned against several of the government’s policies. “One doesn’t even get surprised these days. And one does not know how to react anymore.”
These attitudes complicate the ambitions of both Bollywood studios and major companies to capture a huge Indian audience through their laptops and smartphones. Like the Hollywood film industry, Bollywood has increasingly turned to streaming as pandemic restrictions slam the theater business.
Wang Yi said that fighting the pandemic is a top priority for the international community. President Xi Jinping has repeatedly said that the Chinese COVID-19 vaccines, once developed and put into use, will be global public goods. China has not only made promises, but also taken concrete actions to fulfill them by vigorously promoting vaccine cooperation with other countries, in particular, offering assistance and support to developing countries. Pakistan is China's all-weather strategic cooperative partner, and the two sides enjoy a fine tradition of supporting and helping each other. When one side is in trouble, the other side will always lend a helping hand without hesitation. The Chinese government has decided to assist the Pakistani side on vaccine and actively coordinated with Chinese enterprises to accelerate the export of vaccines to Pakistan. Our phone conversation today and the vaccine cooperation between China and Pakistan will unveil the beginning of the celebration of the 70th anniversary of China-Pakistan diplomatic ties.
On behalf of the Pakistani government and people, Shah Mahmood Qureshi expressed gratitude to the Chinese government for its decision to provide vaccine aid and procurement facilitation to Pakistan. He said Pakistan has approved a vaccine by China's Sinopharm for emergency use and will actively consider granting market access to other China-developed vaccines. He also suggested the two sides strengthen communication to ensure successful celebrations of the 70th anniversary of the bilateral ties and hold the 10th CPEC Joint Cooperation Committee meeting at an early date, so as to push for greater progress in bilateral relations.
India's huge coronavirus vaccination drive is behind schedule, with a third of recipients not showing up for appointments because of safety fears, technical glitches and a belief that the pandemic is ending.
After one week, India has vaccinated 1.4 million people, or 200,000 people per day. It had initially hoped to process 300,000 per day before ramping up the rollout and inoculating 300m by July.
At the Sharda Hospital in Greater Noida near New Delhi, pharma student Khushi Dhingra, 17, hugged a friend and wept as she waited to get her shot.
“I am very afraid. I hate needles and I am worried about side effects,” she told AFP.
“My papa is very worried too. He is calling me again and again to make sure I am okay.”
“There are about 80 students in my batch but only two have opted to get the shot,” said nursing student Sakshi Sharma, 21, in Greater Noida.
“My friends are saying there will be side effects, that you can even get paralysis.”
India is using two shots for its drive.
One is Covishield, a locally produced version of the Oxford-AstraZeneca vaccine, which has been approved and safely used in a number of other countries after completing Phase 3 human trials.
The other — Covaxin — was developed locally by Bharat Biotech and has not yet completed Phase 3 trials, though the government has insisted it is “110 per cent safe”.
Side effects are a common fear, with a few cases of severe reactions — and even deaths — reported widely in the media and circulating wildly on Facebook and WhatsApp.
In the eastern state of West Bengal, health chief Ajoy Chakraborty said that turnout was just under 70pc, calling it “not encouraging”.
“We could have achieved our target if some hadn't backed out after seeing television reports of adverse effects following immunisation,” Chakraborty said.
But Alisha Khan, 20, a nursing student in Greater Noida, said people were also hesitant because of the “rushed” approval of Covaxin.
“Why are they trying to experiment on us? First, they should have completed trials in a proper way,” Khan told AFP. “I am shivering already out of fear.”
Dhingra, in the end, did not get a shot after staff realised she was under 18. She had, however, received a text telling her to come for the vaccination from the IT system managing the mammoth process.
The government says that this and other glitches are being ironed out.
One was that if a person did not show up for vaccination, someone else could not simply take their place.
This led to unfinished vaccine vials — which contain a certain number of doses and have to be used that day — being thrown away.
Also hurting the effort is complacency with the number of coronavirus infections and deaths in India falling sharply in recent months.
“In the beginning when there was lockdown, [villagers] were very scared of the coronavirus,” said Asha Chauhan, 30, who is part of vaccination efforts in rural areas.
“Now that fear has gone because cases have come down. They feel corona has gone from our country now,” she said. “They fear they will die if they take the vaccine.”
Many of the 30m people due for jabs in the first phase are health workers who have seen the deadly pandemic close up — yet many of them are hesitant.
This needs to addressed before the vaccine is rolled out to the wider Indian population, experts say, where vaccine scepticism is already rife.
“They must launch awareness campaigns in every nook and corner of the country,” Anita Yadav, 25, an auxiliary nurse and midwife, told AFP.
The government has attempted to boost participation, even adapting a classic Bollywood song with lyrics telling people not to believe false rumours.
The agreements have come under the WHO-led Covax programme — a global initiative to ensure rapid and equitable access to Covid-19 vaccines for all countries regardless of income level. Covax is an alliance that had been set up in April last year by the Global Alliance for Vaccines and Immunisation, Coalition for Epidemic Preparedness Innovations and WHO. It has pledged free vaccine for 20% of Pakistan’s population.
Of the two billion doses to be procured under the Covax programme, 1.3 billion will be provided to 92 lower-income economies, including Pakistan, says the UN’s health agency. Therefore, chances of Pakistan getting the free doses in the first quarter of the current year seem to have brightened. And this is why the Ministry of National Health Services has termed it a positive development and expressed the hope that vaccination against the coronavirus will start soon.
A cash-strapped Pakistani government has earmarked a meager amount of $150 million for Covid vaccination campaign, with the amount just enough for 0.2% population. The country is thus heavily relying on free procurement of a vaccine in pursuit of vaccinating at least 70 million people to achieve ‘herd immunity’. The government has also rightly allowed import of vaccine by the private sector so as to cut the burden of the affording class. A mix of this all could take us to the pre-Covid normal.
The price tag per person for coronavirus vaccines that Israel has purchased from the Pfizer-BioNtech and Moderna pharmaceutical companies is $47, the Kan public broadcaster reported on Monday evening.
In total the country will pay out NIS 1 billion ($315 million) to the two manufacturers for their two-shot vaccination products, the station reported, without citing sources.
The government has set a goal to inoculate five million of Israel’s 9.9 million citizens by the end of March.
Pfizer, which is providing the vaccines that Israel is already using for its mass vaccination program, will receive NIS 775 million ($245 million). The bulk of vaccines used for the campaign are expected to come from Pfizer.
Moderna, which began supplying its vaccines to the country last week, will receive NIS 320 million ($101 million).
The sum means the average price for each dose of vaccine from both companies is about $23.50, slightly higher than the amount that Pfizer had initially said the shots would cost, according to the report. The higher price is because Israel has pushed to buy large numbers of the vaccines and to have them delivered quickly to keep the vaccination drive in high gear.
Vaccine prices reported by the Washington Post and the BBC in December indicate Israel is paying significantly more for the Pfizer vaccine than either the US or the European Union.
The Washington Post reported at the time that the US was paying Pfizer/BioNTech $19.50 per dose while the EU 27-country bloc was paying $14.76. It cited Moderna vaccine prices as $15 per dose for the US and $18 per dose for the EU.
The figures were based on EU prices that were tweeted — and then deleted — by a Belgian government official as well as calculations from Bernstein Research, an analysis and investment firm.
The BBC reported a day earlier that Pfizer was marketing its vaccines to countries at a price range of $10.65 to $21 per dose, while Moderna’s range was $25 to $37 per dose.
Israel was late joining the line for the Pfizer vaccine behind the US, Canada and Japan.
Kan reported that the total price tag of NIS 1 billion is about the same as the cost to the economy for every two days of Israel’s ongoing lockdown, currently scheduled to end next week. The lockdown, the third the government has ordered since the virus outbreak began early last year, started two weeks ago and then was further tightened at the end of last week.
As the vaccination drive presses on, Prime Minister Benjamin Netanyahu held a meeting Monday with health officials to discuss exactly what rights will be granted in the so-called green passports to be issued to those who have been fully vaccinated, Kan reported. The documents, which will begin to be printed next week, will grant holders access to large gatherings and cultural venues.
Health Ministry sources told the broadcaster that the green passport system will have a significant influence on the lockdown exit strategy, with more benefits being granted as the number of vaccinated citizens increases.
The Foreign Ministry has recently been in contact with several countries to explore the possibility that that Israelis carrying a green passport will be exempt from quarantine when visiting those destinations, the station said
So far Israel has give at least a first dose of the Pfizer vaccine to 1,854,055 million citizens, the Health Ministry said Tuesday — by far the highest vaccination rate in the world, according to the Our World In Data website.
Netanyahu vowed Sunday that Israel would ramp up its vaccine drive further, to a target of administering 170,000 shots a day, as a new batch of hundreds of thousands of doses of Pfizer’s vaccine touched down at Ben Gurion Airport.
China has pledged to donate 500,000 doses of coronavirus vaccine made by the Chinese firm SinoPharm.
Two government sources said the first batch would be flown in on Saturday.]
Pakistan has so far approved two vaccines for emergency use, one made by China National Pharmaceutical Group (SinoPharm) and the other by AstraZeneca.
Russia’s Sputnik V vaccine is also likely to get similar approval, officials say, adding that the authorisations will be reviewed quarterly with regard to safety, efficacy and quality.
Health Minister Faisal Sultan has said Pakistan could get “in the range of tens of millions” of vaccine doses under an agreement with China’s Cansino Biologics Inc.
Cansino’s Ad5-nCoV vaccine candidate is nearing completion of Phase III clinical trials in Pakistan, and preliminary results may be available by mid-February, Sultan said.
The South Asian nation of 220 million people also expects China to donate a further million vaccine doses.
Dr Ghazna Khalid, a member of the government task force on COVID-19, said Pakistan would procure vaccines from various markets.
“There’s going to be an accumulation of vaccines, a consortium available, there’s going to be Chinese vaccines, there’s going to be AstraZeneca,” she said.
“We are the fifth biggest country in the world, and it’s going to be very difficult to immunise.”
Pakistan reported 1,563 new coronavirus infections and 74 deaths in the latest 24-hour period, taking the total number of cases to more than 537,477, with 11,450 deaths.
Besides the healthcare project, the economic body also approved several projects regarding infrastructural and human development, education and water resources worth around Rs209 billion.
Focus on heath amid pandemic
Pakistan is investing in stronger health systems after the coronavirus pandemic unveiled the shortcomings of the country’s health system. The government’s focus is on strengthening the health system and engaging communities to protect people from future health threats. Pakistan government has also allocated $250 million initial funds for the purchase of the COVID-19 vaccine and has announced to provide coronavirus vaccines free of charge to its citizens.
Universal health coverage
Prime Minister Imran Khan has vowed to improve healthcare spending and also announced universal health coverage for all citizens for the first time in Pakistan. The programme, first initiated in Khyber Pakhtunkhwa province in 2020, would soon be extended to other provinces. Under the universal health insurance programme, each family would be entitled to medical treatment of up to Rs1 million ($6,000) a year at over 250 government and private hospitals across Pakistan.
“The development of the Universal Health Coverage benefit Package of Pakistan and its implementation will become the cornerstone of health reforms across Pakistan” believes PM’s Special Assistant on Health Dr. Faisal Sultan.
The government plans to establish 48 nutrition centres under its Ehsaas programme to overcome common health problems like stunting, underweight and overweight in children under five years of age, especially in under-developed and poor areas of the country.
Under this programme, nutrition/health services and conditional cash transfers will be made available to mothers and children. In the beginning, these centres will be set up in 13 districts.
This was decided at a meeting of the Ehsaas Nashonuma (nutrition) Steering Committee presided over by Special Assistant to the Prime Minister on Social Protection and Poverty Alleviation Dr Sania Nishtar here on Monday.
The meeting was informed that the programme was being implemented in partnership with the World Food Programme and provincial governments. The participants of the meeting discussed issues related to coordination between the parties which will implement the programme and how to effectively address the issue of undergrowth and malnutrition in the country.
The meeting was informed that it is a three-year programme which delivers conditional cash transfers to vulnerable pregnant women, mothers and children under five and provide them specialised nutritious food, immunisations and health-awareness sessions.
Representatives from the federal and provincial ministries, Foreign Commonwealth and Development Office, World Bank, World Food Programme, World Health Organisation, Asian Development Bank and Unicef attended the meeting. Nutrition under the Ehsaas programme aims to support multi-sectoral strategies through poor-friendly programmes by targeting mothers and children.
The deaths were reported from Uttar Pradesh, Karnataka, Andhra Pradesh, Rajasthan, Telengana, Gurugram and Odisha. The six men and three women who died were between 27 and 56 years old. The deaths took place between 24 hours and five days of taking the vaccines and all have been ascribed to cardiovascular problems or “brain stroke”. The vaccine taken in each case was Covishield.
Here are three key takeaways from the conversation.
Worries about vaccine 'snatching'
The government hopes to begin its COVID-19 vaccine rollout by April at the latest. It will begin with frontline health-care workers. They number about 10 million people. Next will be Pakistan's elderly citizens, a cohort that numbers some 22 million people.
But even at this phase, there's concern that Pakistan's powerful elites could muscle in to obtain the free, government-provided vaccine.
They could do this by pressuring local health officials in charge of vaccinating particular districts to allow them priority access, threatening people administering the vaccine, or pressuring health officials to ensure they are offered the vaccine ahead of others. Elite Pakistanis could offer to pay for the vaccine, which could create a black market that would siphon off doses meant for high-priority people.
And if Pakistans with health vulnerabilities are eligible, that rule could likely favor elites. They are more likely to have access to health services and medical documents to demonstrate they have a condition that puts them at the head of the vaccination line. They also have access to the ears of decision-makers, from managers of health clinics to ministers.
Poor, less literate Pakistanis, particularly women and rural residents, will have far less sway, and so they'll be less likely to be part of the second cohort, unless there's a concerted effort to include them.
The concern that elites could elbow their way to the front of the line was most recently articulated by the former adviser to the prime minister on health.
"In developing countries such as ours, the influential people get vaccines first," said Zafar Mirza at a conference on Jan. 1, as reported by local media."The government, too, should take care that [the vaccine] should be given to those in line of priority, and there should not be any snatching."
There's one idea that could help address this conundrum: letting elites buy their own vaccines. Starting in the summer, the government will allow companies that import vaccines to conduct their own rollout.
"The government will be following its own plan, where they'll be focusing on the elderly and people with co-morbidities. But since the private sector will come in, other people can also get vaccinated," says Hayat.
So far, the government has given one Pakistani company, Sindh Medical Stores permission to import the AstraZeneca vaccine for private sale. Local media describes the company as "one of the biggest importers of vaccines and other pharmaceutical products in Pakistan." The company says it is likely to charge $13 for a dose, which they expect to be made available at large non-governmental hospitals. However, the company says it still has no timeframe on when it will be able to offer the AstraZeneca vaccine for sale because of stiff global competition on orders.
The government's decision to allow private vaccine sales reflects the stages of the rollout of COVID-19 testing. Initially the government was in charge. But weeks into the pandemic, diagnostic labs were given permission by the government to conduct tests for a fee. That appears to have helped boost testing numbers and reduce pressure on the government's free testing services.
Allowing Pakistanis to purchase the vaccine could lead to a similar result – reducing pressure on the government, with its scarce supplies, to vaccinate wealthier citizens.
Sparks fly over ‘water’: Covaxin hits out at critics, says trials 200% honest
Experts pointed out that the government may have acted in haste, and the sentiment was echoed by some Opposition politicians who suggested that the Union government ignored scientific protocols to give the nod to a fully indigenous vaccine because it tied in with the Atmanirbhar Bharat slogan.
Bharat Biotech chairman and managing director, Krishna Ella, on Monday hit out at comments suggesting that its anti-coronavirus disease (Covid-19) vaccine, Covaxin, was “safe like water”, and said that their Phase 3 efficacy data, likely to be out by February or March, will silence all critics.
Though he did not take any names, Ella’s remarks appear to have sparked a rare war of words between vaccine-makers a day after Serum Institute of India’s (SII) CEO, Adar Poonawalla, told NDTV that only three vaccines had passed all the scientific evaluations -- Pfizer-BioNTech, Modera and Oxford-AstraZeneca -- and that while the others were safe, “safe like water”, their effectiveness had not yet been evaluated.
“It is easy to target Indian scientists. I had to tell this because some other company has branded my product as ‘safe like water’. Some local company in press yesterday said that safety is like water of other companies. Only three companies have done efficacy, and other vaccine is like water. I want to deny that. It hurts us as scientists; we work 24 hours and don’t deserve this type of bashing from people,” Ella told a media briefing.
Pakistan has begun importing Covid-19 vaccine for private sale, starting with 50,000 Sputnik V Russian shots.
The consignment will be the first of regular deliveries, officials said, and came as the country braces for a third wave of infections.
Officials have again closed schools and begun locking down hotspot neighbourhoods as the UK variant drives a new spike in cases. Pakistan has appeared to escape the heavy death tolls of many countries, but the coronavirus has again flared up in recent weeks.
Hospital daily admissions and the number of people in critical care were rising fast, said Asad Umar, the minister overseeing the government's Covid-19 response.
He said if compliance with the rules did not improve “we will be forced to place stronger restrictions on activities”.
“Please be very very careful. The new strain spreads faster and is more deadly.”
Pakistan's vaccination programme has until now relied on donations from China and allocations from the World Health Organisation's Covax scheme, which have yet to arrive.
The government last year gave permission for businesses to import vaccines, in a country where private hospitals and clinics fill gaps left by underfunded and overstretched public provision.
“This is the first shipment of 50,000 doses which came last night only,” an official of AG Pharma which imported the vaccine told Reuters. Local media reported another 150,000 doses were on their way.
Pakistan began vaccinating health workers six weeks ago and opened up jabs to the elderly last week. Shots have so far been donations from China, with a tranche of 17m Oxford AstraZeneca shots due from Covax, but currently delayed
It remains unclear how much private clinics will be able to charge for vaccinations. Pakistan had at first agreed that private firms would be able to sell vaccine without price caps, but that decision had been reversed, said health minister Dr Faisal Sultan.
“Now, however, there is a formula, already in vogue, to determine max price,” he said. “So yes, there is a price cap that DRAP (Drug Regulatory Authority of Pakistan) will recommend and get approval for,” he said.
The decision to allow commercial imports of the vaccine with an exemption on upper price caps had sparked criticism that it will create inequality.
Pakistan has a history of vaccine hesitancy and still sees stubbornly high numbers of people refuse to give their children polio shots. Officials fear a nationwide Covid vaccine roll out will be hit by similar scepticism.
But the country of around 220 million is favoured with a very young population and doctors believe they can still give jabs to 40 to 50 million people this year.
For months, the United States and European Union have blocked a proposal at the World Trade Organization that would waive intellectual property rights for Covid-19 vaccines and treatments. The application, put forward by South Africa and India with support from most developing nations, has been bogged down in procedural hearings.
“Every minute we are deadlocked in the negotiating room, people are dying,” said Mustaqeem De Gama, a South African diplomat who is involved in the talks.
Growing numbers of health officials and advocacy groups worldwide are calling for Western governments to use aggressive powers — most of them rarely or never used before — to force companies to publish vaccine recipes, share their know-how and ramp up manufacturing. Public health advocates have pleaded for help, including asking the Biden administration to use its patent to push for broader vaccine access.
Governments have resisted. By partnering with drug companies, Western leaders bought their way to the front of the line. But they also ignored years of warnings — and explicit calls from the World Health Organization — to include contract language that would have guaranteed doses for poor countries or encouraged companies to share their knowledge and the patents they control.
“It was like a run on toilet paper. Everybody was like, ‘Get out of my way. I’m gonna get that last package of Charmin,’” said Gregg Gonsalves, a Yale epidemiologist. “We just ran for the doses.”
In the coming days, a patent will finally be issued on a five-year-old invention, a feat of molecular engineering that is at the heart of at least five major Covid-19 vaccines. And the United States government will control that patent.
The new patent presents an opportunity — and some argue the last best chance — to exact leverage over the drug companies producing the vaccines and pressure them to expand access to less affluent countries.
The question is whether the government will do anything at all.
The rapid development of Covid-19 vaccines, achieved at record speed and financed by massive public funding in the United States, the European Union and Britain, represents a great triumph of the pandemic. Governments partnered with drugmakers, pouring in billions of dollars to procure raw materials, finance clinical trials and retrofit factories. Billions more were committed to buy the finished product.
But this Western success has created stark inequity. Residents of wealthy and middle-income countries have received about 90 percent of the nearly 400 million vaccines delivered so far. Under current projections, many of the rest will have to wait years.
A new "double mutant" variant of the coronavirus has been detected from samples collected in India.
Officials are checking if the variant, where two mutations come together in the same virus, may be more infectious or less affected by vaccines.
Some 10,787 samples from 18 Indian states also showed up 771 cases of known variants - 736 of the UK, 34 of the South African and one Brazilian.
Officials say the variants are not linked to a spike in cases in India.
India reported 47,262 cases and 275 deaths on Wednesday - the sharpest daily rise this year.
The Indian SARS-CoV-2 Consortium on Genomics (INSACOG), a group of 10 national laboratories under India's health ministry, carried out genomic sequencing on the latest samples. Genomic sequencing is a testing process to map the entire genetic code of an organism - in this case, the virus.
The genetic code of the virus works like its instruction manual. Mutations in viruses are common but most of them are insignificant and do not cause any change in its ability to transmit or cause serious infection. But some mutations, like the ones in the UK or South Africa variant lineages, can make the virus more infectious and in some cases even deadlier.
Virologist Shahid Jameel explained that a "double mutation in key areas of the virus's spike protein may increase these risks and allow the virus to escape the immune system".
The spike protein is the part of the virus that it uses to penetrate human cells.
With a Chinese COVID-19 vaccine receiving the first Good Manufacturing Practice (GMP) certificate issued by the Hungarian authorities, Chinese jabs are reportedly a step closer to becoming a global public good.
Confidence in Chinese vaccines boosted
The China National Pharmaceutical Group Co., Ltd. (Sinopharm) announced on Saturday that its COVID-19 vaccine has acquired the GMP certificate issued by the Hungarian National Institute of Pharmacy and Nutrition (OGYEI), becoming the first Chinese COVID-19 vaccine to receive such a certificate.
Besides enhancing the competitiveness of Chinese vaccines in Europe, vaccine experts told the Global Times that the issuance of this certificate will boost small European countries' confidence in Chinese vaccines as the continent struggles with the low roll-out and uneven distribution of vaccines.
"This decision made by Hungary can provide a reference for the future approval of Chinese vaccines in other EU countries, which will also lead to more recognition of Chinese vaccines in the EU," Feng Duojia, president of the China Vaccine Industry Association, was quoted by the Global Times as saying.
At least 100 million doses of COVID-19 vaccines from Sinopharm have been supplied around the world.
China is donating COVID-19 vaccines to 80 countries and three international organizations besides exporting them to over 40 countries, Chinese Foreign Ministry spokesperson Hua Chunying said on Tuesday.
Hua said China is also cooperating with over 10 countries in vaccine research, development and production.
In the past week, six new countries received Chinese vaccines and more countries intend to purchase more Chinese vaccines.
Lebanon became the latest Asian country to receive the first batch of Chinese vaccines as the Chinese People's Liberation Army (PLA) delivered a batch of COVID-19 vaccines to the Lebanese army on Sunday at their request.
Georgia, Sri Lanka and Nepal also received their first batches of Chinese vaccines in the past week.
Sri Lankan President Gotabaya Rajapaksa on Wednesday morning welcomed a batch of 600,000 doses of Sinopharm COVID-19 vaccines donated by the Chinese government, tweeting that "Thank you! people of #China for prioritizing #lka in this battle against #COVID19 pandemic."
Ethiopia in east Africa and El Salvador in central America were also the two newest recipients of Chinese vaccines in the past week.
Meanwhile, other countries either began or continued purchasing Chinese vaccines to help them fight the ongoing pandemic.
For example, Mongolia, Azerbaijan, Pakistan and the Philippines received their first batches of purchased Chinese vaccines. Meanwhile, Bolivia and Zimbabwe respectively got their second and third shipments of purchased Chinese
A temporary U.S. ban on exports of critical raw materials could limit the production of coronavirus vaccines by companies such as the Serum Institute of India (SII), its chief executive said in a World Bank panel discussion here on Thursday.
SII, the world’s biggest vaccine maker, has licensed the AstraZeneca/Oxford University product and will soon start bulk-manufacturing the Novavax shot.
“There are a lot of bags, filters and critical items that manufacturers need,” Adar Poonawalla said. “The Novavax vaccine, which we are a major manufacturer of, needs these items from the U.S.”
He said the recent invocation of the U.S. Defence Production Act to preserve vaccine raw materials for its own companies went against the global goal of sharing vaccines equitably.
The White House said this week it had used the act to help drugmaker Merck & Co produce Johnson & Johnson’s COVID-19 vaccine.
“This really needs to be looked at because if they are talking about building capacity all over the world, the sharing of these critical raw materials, which just can’t be replaced in a matter of six months or a year, is going to become a critical limiting factor,” Poonawalla said.
India’s Biological E has tied up with J&J to potentially contract manufacture up to 600 million doses of its vaccine per year. They have signed an initial deal but production volumes have not been agreed upon.
India's most coronavirus-hit state Maharashtra went into a weekend lockdown on Saturday as the country battles exploding infection numbers and vaccine shortages.
Having let its guard down with mass religious festivals, political rallies and spectators at cricket matches, the world's second most populous nation has added more than a million new infections since late March.
After a lockdown a year ago caused widespread misery and hit the economy for six, the central government is desperate to avoid a hugely unpopular second shutdown.
But many states are tightening the screw, in particular the epicentre Maharashtra and its capital Mumbai, where restaurants are shut and public gatherings of more than five people are banned.
Every weekend from Saturday until the end of April the state's 125 million people are confined to their homes unless shopping for food, medicine or travelling.
"I'm not for the lockdown at all but I don't think the government has any other choice," media professional Neha Tyagi, 27, told AFP in Mumbai.
"This lockdown could have been totally avoided if people would take the virus seriously."
Cricket is now played behind closed doors -- including the big-bucks Indian Premier League, which began Friday -- and in many states including in the capital New Delhi a night curfew is in force.
All eight teams in the IPL, which includes the sport's top international stars, are in strict bio-bubbles and four players have so far tested positive.
Raipur district, home to the capital of Chhattisgarh state, is under a 10-day lockdown with no one allowed to enter the area unless performing essential services.
- Short on stocks -
India's drive to vaccinate its 1.3 billion people also looks to be hitting problems, with just 94 million shots provided so far and stocks running low.
In megacity Mumbai, 25 out of 71 private hospitals administering jabs ran out of supplies Thursday, city authorities said.
The situation at government-run inoculation centres was not much better, with a giant 1,000-bed field hospital turning away people arriving for their first dose on Friday morning.
City authorities tweeted that the shortage was "due to non-receipt of stocks" from the national government.
The Times of India reported Friday that states on average had just over five days of stock left, according to health ministry data, with some regions already grappling with severe shortages.
But the central government has accused some states -- run by opposition parties -- of "distract(ing) attention from their failures" and playing politics.
"It is not right to say that there is a vaccine shortage. Vaccines have been made available to all states according to their needs," Home Minister Amit Shah said on Friday.
The CEO of the Serum Institute of India, the world's biggest vaccine maker by volume, has warned that production capacity is "very stressed".
Poorer countries, as well as some rich nations, have relied heavily on Serum for supplies of the AstraZeneca vaccine, but last month New Delhi put the brakes on exports to prioritise domestic needs.
When millions of Indians switched off lights and lit candles and earthen lamps in the early days of the pandemic in solidarity with COVID warriors, many probably though the fight will be over soon, but a year on, the situation has become grimmer.
On April 10 last year, five days after millions responded to Prime Minister Narendra Modi's appeal to show the nation's "collective resolve and solidarity" in the fight against the coronavirus, the number of confirmed infections stood at 6,761, while the death toll was 206.
Cut to the present, India registered a record 1,45,384 fresh COVID-19 cases on Saturday, pushing its infection tally to 1,32,05,926, while the death toll stood at 1,68,436.
Delhi alone recorded over 8,500 new cases on Friday, while Maharashtra reported more than 58,000.
As per the health ministry, 10 states -- Maharashtra, Chhattisgarh, Uttar Pradesh, Delhi, Karnataka, Tamil Nadu, Kerala, Madhya Pradesh, Gujarat and Rajasthan -- are showing a steep rise in daily COVID-19 cases at present.
They accounted for 82.82 per cent of the new infections on Saturday, it said.
The number of active cases has breached the 10-lakh mark again after around six-and-a-half months, and the country recorded 794 more fatalities in a day, the highest since October 18 last year.
India crossed the grim milestone of one crore COVID-19 cases on December 19 last year. The spread of the virus slowed down briefly and there was an improvement in the situation in January 2021.
The country's lowest daily spike of just 8,635 infections was reported on February 2.
But the ebbing did not last long, and the infections began surging again in March 2021.
A large number of healthcare workers have contracted the virus too, including those who have taken both doses of the vaccine.
Over 9.78 crore COVID-19 vaccine doses have been administered in the country so far to healthcare and frontline workers, and people above 45.
India is racing against time to contain the second wave of the coronavirus by again imposing restrictions like night curfews and vaccinating over 20 lakh people daily.
Making matters worse, several more infectious variants of the coronavirus have surfaced, and many experts believe it might be behind the surge of cases in the country.
Three variants of concern have been identified – the UK variant, Brazil variant and the South African variant.
India has also detected a new "double mutant" COVID-19 variant in states like Maharashtra and Delhi, where a surge of cases is being recorded
Nightmare scenes of a country struggling to cope have begun to emerge as doctors speak of a new variant of the virus that appears to be spreading faster than ever before, affecting young people and even children this time around and pushing India’s healthcare system to the brink of collapse. States such as Maharashtra have imposed a weekend lockdown in an attempt to curb infections, while Delhi has introduced a night curfew, with a total lockdown still not ruled out.
Over the weekend bodies piled up outside the government hospital in Raipur, in the state of Chhattisgarh, because the hospital had “not expected so many people to die at once” from coronavirus and could not cremate them fast enough. In Surat, in the state of Gujarat, crematoriums became so overwhelmed with coronavirus victims that families began burning their dead on open ground.
“This sheer tsunami of cases has already overwhelmed the healthcare infrastructure in the state,” said Dr Shashank Joshi, a member of the Mumbai Covid taskforce. “This time we are seeing younger people between 20 and 40 getting seriously affected and even children are now being hospitalised with severe symptoms. The capacity for the healthcare system to hold on is fast dwindling.”
Kshitij Thakur, a local politician in the Vasai-Virar municipality of Maharashtra, made a desperate public plea for help with an “acute” shortage of oxygen in the local government hospital, which had already led to the loss of three lives.
“The supply can run for only three hours,” said Thakur in a tweet directed at the central government and prime minister Narendra Modi. “There are more than 7,000 active cases in the area and more than 3,000 people require oxygen supply daily.”
Though over 108 million people have been vaccinated so far, in a country of 1.3bn it has not been enough to curb the second wave. On Tuesday, the drugs controller general of India (DCGI), Dr VG Somani, approved the Russian Covid-19 vaccine, Sputnik V, for emergency use in India, with distribution likely to begin next month, and also cleared the way for Pfizer, Moderna and Johnson & Johnson to be given approval.
Did Govt invested a rupee in Serum Institute? SII, a private company, was aided by Gates Foundation for upscaling to produce vaccines. BeardBaba snatched the credit for ‘Indian’ vaccine, Vaccine Maitri etc. Then SII asked for ₹3000 crore to boost capacity. Baba eloped.
Problems that have delayed AstraZeneca (AZN.L) supplies to the COVAX vaccine-sharing facility have been resolved, UNICEF told Reuters on Tuesday, saying it should receive 65 million doses by end-May from manufacturers outside India.
The rollout of COVID vaccines has been disrupted by supply shortfalls in many countries, aggravated by a temporary hold on exports of the inoculation made by the Serum Institute of India (SII) as the country battles to contain a surge in infections. read more
"The initial challenges related to release of vaccines due to ramping up a new supply chain and production across different continents have now been resolved," the U.N. agency responsible for distributing vaccines through the programme told Reuters in an email.
"At this point, UNICEF expects around 65 million doses of COVID-19 vaccines from suppliers outside of India will be available for supply through the end of May to 80 countries."
COVAX is also holding talks with New Delhi for SII to resume supplies of the AstraZeneca vaccine, UNICEF said.
In addition to the 65 million doses expected from outside India, mostly made in South Korea, it also anticipates receiving 50 million doses next month from the SII compared with almost none this month.
COVAX had expected a total of more than 100 million doses from SII between February and May, excluding supplies for India, but has so far received only about 18.2 million.
As India battles its biggest jump in coronavirus infections and opens up vaccinations to all its adults from next month, SII is unlikely to be able to restart major exports soon.
"While discussions on the resumption of SII deliveries continue, COVAX will continue to transmit vaccines from other delivery partners," such as Pfizer (PFE.N)/BioNTech (22UAy.DE) or AstraZeneca outside India, UNICEF said.
"A number of shipments are currently being planned to ensure that all available supplies are put to use without delays following release from the manufacturers. Plans are also being laid to make up lost ground as soon as supply allows."
India this week approved an advance payment of about $400 million for SII, the world's biggest maker of vaccines, for it to expand its monthly capacity to more than 100 million doses by end-May from up to 70 million now.
India has so far administered more than 127 million vaccine doses, 91% of those the SII-made AstraZeneca drug. The other vaccine in use is domestically developed Covaxin.
Faisal Edhi offers help
A day earlier, Faisal Edhi, son of renowned philanthropist Abdul Sattar Edhi and chairman of the Edhi Foundation, penned a letter to Prime Minister Narendra Modi in which he expressed his concern on the Covid-19 crisis underway in India and offered his help in confronting the epidemic.
"We are very sorry to hear about the exceptionally heavy impact that the pandemic has had on your country, where a tremendous number of people are suffering immensely," said Faisal in his letter.
He said the Edhi Foundation sympathised with India during this difficult time and offered help in the form of "a fleet of 50 ambulances along with our services to assist you in addressing, and further circumventing, the current health conditions".
Faisal personally offered to lead and manage the humanitarian team from his organisation, said the letter.
It added that the Edhi Foundation understood the gravity of the situation and "we wish to lend you our full support, without any inconvenience to you, which is why we will arrange all the necessary supplies that our team needs to assist the people of India."
On Saturday, #PakistanstandswithIndia and #Indianeedoxygen remained the top trends on Twitter for the second day as a record number of infections and deaths due to the novel coronavirus created an alarming situation in the neighbouring country.
In the past 24 hours, India reported 2,624 deaths — a new daily record — as well as more than 340,000 new cases. The country's deaths since the start of the pandemic rose to nearly 190,000 while its total cases reached 16.5 million, second only to the United States.
Over the last few days, Twitter has been flooded with Indians sharing harrowing stories of the struggle they faced while trying to find hospital beds and oxygen for their loved ones.
Mainstream media has also covered the desperate situation in several Indian cities where many have died waiting in line to get medical attention as hospitals have reached capacity and medical oxygen remains in short supply. Dozens of Covid positive critical patients have died in the Indian capital alone after hospitals ran out of oxygen.
Reports suggest crematoriums in Delhi have run out of space, forcing people to wait for hours, even days along with the bodies of their loved ones to ensure their final rites are carried out.
Reacting to the situation, Prime Minister Imran Khan expressed Pakistan's solidarity with India, saying: "Our prayers for a speedy recovery go to all those suffering from the pandemic in our neighbourhood & the world."
The premier said "we must fight this global challenge confronting humanity together."
Foreign Minister Shah Mahmood Qureshi too expressed his support to people in India amid the intensifying second wave which he said had hit the South Asian region hard.
"On behalf of the people of Pakistan, I extend our heartfelt sympathies to the affected families in #India," he tweeted.
Qureshi said the pandemic was a reminder that "humanitarian issues require responses beyond political consideration", adding that Pakistan continued to work with Saarc (South Asian Association for Regional Cooperation) to increase cooperation to tackle Covid-19.
Information Minister Fawad Chaudhry said prayers of Pakistani citizens were with the people of India, adding: "May God be kind and may these difficult times get over soon."
Minister for Human Rights Shireen Mazari said it was "painful" to see the suffering of Indian people as they grappled with the coronavirus and oxygen shortages.
"India needs a strong Government. Modi does not matter. I can go back & open a tea stall.But the nation can't suffer anymore"
Time for #Modi to go back to being chai-wala again! #CovidIndia
In recent months, the chief executive of Serum Institute of India, the world’s largest vaccine manufacturer, has come under increasingly intense pressure as both pro-government voices and leaders of the state governments headed by opposition politicians criticized him.
Some accused him for delays in supplying vaccines; some called him a “profiteer” for not offering Covid-19 vaccines to state governments at cost. There were calls for his company to be nationalized.
In an interview with The Times of London published on Saturday, the executive, Adar Poonawalla, described menacing calls from some of the most powerful men in India, creating an environment so ugly that he anticipated being out of the country for an extended period while he made plans to start producing vaccines elsewhere.
“‘Threats’ is an understatement,” Mr. Poonawalla said. “The level of expectation and aggression is really unprecedented.”
The interview reported that he had flown into London to join his wife and children hours before Britain barred travelers from India on April 23.
“I’m staying here an extended time, because I don’t want to go back to that situation,” he added. “Everything falls on my shoulders, but I can’t do it alone.”
The interview set off a storm on social media, with some interpreting his interest in manufacturing outside India as a threat to move his business and others seeing him as having been driven out of the country by the viciousness of his critics.
Within hours, Mr. Poonawalla wrote on Twitter that he would be returning to India “in a few days.”
The New York Times was unable to reach Mr. Poonawalla directly on Saturday, and a request for comment from his company was not immediately returned.
India, the world’s leading producer of vaccines, is struggling to vaccinate itself out of a crisis as a voracious second wave leaves a tableau of death and despair. When cases were relatively low, the country exported more than 60 million shots. On Saturday, India expanded vaccination eligibility to all people over age 18, but many states said that they would not be able to meet the demand because of a shortage of doses.
Less than 2 percent of India’s 940 million adults have been fully vaccinated, according to data compiled from government sources by the Our World in Data project at the University of Oxford. The country’s biggest city, Mumbai, just halted all vaccinations because it essentially ran out, and several states reported vaccine shortages as well.
All that has made Mr. Poonawalla, a 40-year-old billionaire, a focus for public anger.
Last month, Serum Institute wrote a letter to India’s federal home minister asking for security, citing the threats to Mr. Poonawalla. Just a few days ago, the federal government said it had completed a threat assessment and would have the Central Reserve Police Force protect him. On the same day, Mr. Poonawalla announced on Twitter that he was unilaterally lowering the cost of a Covid vaccine to make it more affordable for government purchas
Indians are currently dealing with a humanitarian catastrophe of Modi’s making. New Delhi’s ambitions to be a global power have been dealt a blow. Under Modi, Jaishankar once boasted, diplomacy “is having many balls up in the air at the same time and displaying the confidence and dexterity to drop none.” Now that all the balls are lying on the floor, the country will need humility, honesty, and extraordinary effort to pick them up and start again.
Modi, who has consistently campaigned on virulent nationalism captured by the slogan “Atmanirbhar Bharat” (or self-reliant India), has been forced to abruptly change policy. Last week, with images of people dying on roads without oxygen and crematoriums for pet dogs being used for humans’ last rites as the second wave of the COVID-19 pandemic overwhelmed the country, his government accepted offers of help from nearly 40 other nations. Its diplomats have lobbied with foreign governments for oxygen plants and tankers, the arrival of medicines, and other supplies hailed on social media. “We have given assistance; we are getting assistance,” said Harsh Vardhan Shringla, the country’s top diplomat, to justify the embarrassing U-turn. “It shows an interdependent world. It shows a world that is working with each other.”
The world may be working with each other, but it is not working for Modi in the realm of foreign policy. Rather, this is a moment of reckoning, triggered by the rampaging coronavirus. After seven years as prime minister, Modi’s hyper-nationalistic domestic agenda—including his ambition of making the country a “Vishwaguru” (or master to the world)—now lies in tatters.
India, which has been envisaged since former U.S. President Donald Trump’s administration became the Quadrilateral Security Dialogue’s lynchpin and focused other efforts in the Indo-Pacific strategy to counter China, will have to work harder to justify that role. Meanwhile, China has redoubled its efforts in India’s neighborhood since the second wave began, strengthening its existing ties with South Asian countries and contrasting its strength and reliability with India’s limitations.
In March, when the second wave of the pandemic started unfolding in India, Jaishankar’s ministry was busy issuing official statements and organizing social media storms against popstar Rihanna and climate change activist Greta Thunberg. On Thursday, at the peak of the health crisis, Jaishankar’s focus in a meeting with all the Indian ambassadors to various global capitals was on countering the so-called “one-sided” narrative in international media, which said Modi’s government had failed the country by its “incompetent” handling of the second pandemic wave.
Until recently, Jaishankar was also the most enthusiastic promoter of the government’s Vaccine Maitri (or “Vaccine Friendship”) program, under which New Delhi supplied around 66.4 million doses of the India-made AstraZeneca vaccine to 95 countries in packing boxes marked prominently with large pictures of Modi. These vaccines were either commercially contracted, given as bilateral grants, or transferred under the World Health Organization’s COVID-19 Vaccines Global Access (COVAX) scheme for poorer countries. Meanwhile, India’s own vaccination rollout has been dismal. Around 2 percent of Indians have been fully vaccinated, despite the country being the world’s biggest vaccine manufacturer—a misstep that has emerged as one of the key culprits for India’s uncontrolled second wave.
A month after the second wave of coronavirus infections started sweeping over India, the country is mired in grief, and it could be weeks, even months before the situation improves. On Tuesday, yet another grim milestone was crossed: 20 million cases of COVID-19 registered since the start of the pandemic. About seven million of those were confirmed over the last month alone.
Of the total 222,000 confirmed coronavirus deaths in the country, more than 57,000 have been recorded over the last month. That's about 80 deaths per hour, and as the government's toll only includes COVID deaths registered in hospitals, many believe the real toll is far higher. Even the official death rate has continued to climb. Over the last two weeks, the virus has claimed about 120 lives every hour, on average.
"I have lost all hope," Lily Priyamvada Pant, told CBS News at a crematorium in Delhi on Sunday. She had just watched her 40-year-old son's funeral pyre burn. Her whole family caught the virus, and her husband was still in an intensive care unit, unaware that his eldest son had succumbed to the disease.
"Doctors told me if you tell him, he will not survive," she said. "He is the CEO of a company and director of many companies… but he could help with nothing."
The feeling of helplessness is familiar in India's cities now, and there's no sign yet that the dizzying infection rate is about start falling quickly. The sheer number of people suffering with the disease has crippled the country's health care system, even in its wealthiest mega-cities.
There were reports on Tuesday that dozens of U.S. Embassy staff in Delhi were among the latest confirmed infections, but an embassy spokesperson told CBS News that while the health and safety of staff and their families was "among the [State] Department's highest priorities," and that it would "take all necessary measures to safeguard the health and wellbeing of our employees, including offering vaccines," they could not confirm details due to privacy concerns.
Hospital beds, doctors and nurses, ventilators, oxygen and medicines have all been in short supply. Almost a month after CBS News first reported on those shortages — and despite government claims that there is no oxygen shortage, and the fact that tons of foreign medical aid has started to arrive — there has been no meaningful improvement in the supply of these necessities.
But while people continue to die daily for a simple lack of oxygen, experts are increasingly worried about another shortage: vaccines.
A chain is only as strong as its weakest link. The Quadrilateral Security Dialogue process brings together Japan, Australia, India and the United States as an informal grouping of democracies to cooperate around the vast and critical Indo-Pacific maritime space.
India has always been the weakest link in the chain. Its sizable armed forces equipped with nuclear weapons are a bulwark against China’s much superior military might. Still, it’s a very poor country with a per capita income of only 3% to 5% of the other three; a weak state with limited capacity to govern a billion plus population; and a soft state without the political will to make and implement tough decisions.
The second wave of COVID-19 in April and May is India’s biggest national tragedy and international embarrassment since partition in 1947. The national and world press covered this in graphic detail (more than they would in their own countries), with images of people gasping to death on the streets, bodies piled up awaiting last rites and cremation and mass numbers of corpses floating in the Ganges River, many of which having washed up on its banks. Prime Minister Narendra Modi’s carefully cultivated competence bubble has been punctured by the open display of mass ineptitude.
In the wake of this stark and grim reminder of its manifold pathologies and weaknesses, the question must be asked: at which point would India become a liability rather than an asset for the other “Quad” partners? The question is important because the other three are bound together in formal alliances by security treaties and India is not, demonstrating less commitment.
The excitement, expectations and hopes of the Modi government in 2014, with promises of “minimum government, maximum governance” and “sabka sath, sabka viswas, sabka vikash” (with all, with everyone’s trust, development for all), are fading memories. On June 1, India’s official COVID-19 deaths per million was 238 compared to the world average of 457, the U.S. at 1,832, the U.K. at 1,873 and Brazil reporting 2,163.
The crux of the problem thus is not the unmitigated spread of COVID-19 but the lack of a fit-for-purpose public health infrastructure and the availability of medical supplies, equipment and drugs. India is a sobering reminder of why a strong economy is not an optional luxury but an essential requirement for good health.
Modi’s neglect of urgent economic and governance reforms in addition to requirements for a good public health infrastructure — choosing instead to go into a semipermanent campaign mode in every state election and focusing on a Hindu nationalist agenda — further aggravated the COVID-19 misery.
People’s health is vitally dependent on a healthy economy that gives the government the financial wherewithal to create an efficient universal-access public health system. No country achieves better health outcomes by becoming poorer.
The pandemic, for its part, hastened an economic decline that had already begun. According to World Bank figures, India’s annual GDP growth tumbled from 8.3% in 2016 to 4.2% in 2019. It contracted by 7.3% in 2020–2021 and the 2021 GDP forecast has been downgraded by around 17% — the worst among the G20 countries.
India got the worst of both worlds: a smashed economy and a massive COVID-19 toll that peaked in May with the official count recording nearly 400,000 daily new cases and over 4,000 daily new deaths. Recovery will be a long haul on both the disease and the economy front.
Pakistan administered the 10 millionth Covid-19 vaccine dose on Wednesday, with Federal Planning, Development and Special Initiatives Minister Asad Umar announcing that the authorities aimed to inoculate 70 million people by the end of this year.
He said around 300,000 people were registering themselves for vaccination against Covid-19 on a daily basis and urged people to get inoculated so that the government may ease Covid-19 restrictions.
The minister added that precautionary measures taken during the third wave of the pandemic in the country had shown positive results and a visible reduction in Covid-19 positivity rate.
Pakistan's coronavirus positivity rate has been recorded as 2.54 per cent in the past 24 hours — the second day in a row that the positivity rate remained below 3pc. According to the health ministry, 43,900 tests were conducted during the last 24 hours after which 1,118 people tested positive.
Besides, 335,790 people were administered Covid-19 vaccines on Tuesday, according to the National Command and Control Centre (NCOC).
“The more [people] we vaccinate, the better we will be protected [against Covid-19],” Umar said, appealing to people to increasingly participate in the vaccination campaign.
Federal Information and Broadcasting Minister Fawad Chaudhry, who accompanied Umar on the occasion of the administration of the 10 millionth dose, tweeted: "We have reached the milestone of administering the vaccine to 10 million people [sic]."
He also lauded the government, particularly Prime Minister Imran Khan and the NCOC, for the way it battled the pandemic.
A day earlier, Umar had announced that a call centre was being established to contact people who had not been administered the second dose of the vaccine and convince them to complete their vaccination, as reports emerged that around 300,000 recipients of the first dose had never returned to receive their second jab of the Covid-19 vaccine.
Last week 120,000 doses of the locally manufactured PakVac vaccine — produced from the concentrate of Cansino vaccine — were launched in the country.
Announcing the production of PakVac, the government had said in a tweet that three million doses of the vaccine would be manufactured per month.
The PakVac vaccine has been developed by China's state-run pharmaceutical company Cansino and is being brought to Pakistan in a concentrated form, where it is packaged at the National Institute of Health (NIH) in Islamabad. Cansino was the first Chinese vaccine to have undergone clinical trial in Pakistan and was administered to around 18,000 people.
The company's interim efficacy results of a multi-country trial, which included Pakistan, showed the vaccine had a 65.7 per cent efficacy in preventing symptomatic coronavirus cases and a 90.98per cent success rate in stopping severe infections.
In the Pakistani subset, the efficacy of the vaccine at preventing symptomatic cases stood at 74.8per cent and 100per cent at preventing severe disease.
The launch of the first batch of PakVac doses coincided with the Drug Regulatory Authority of Pakistan authorising the use of American Pfizer vaccine for emergency use.
The decision came in the wake of Pakistan receiving the first batch of Pfizer doses in May, when 100,000 doses were delivered under the World Health Organisation's global shared vaccine programme, Covax.
As a deadly second wave raged across India through April and May, the Narendra Modi government made an unprecedented move: It shifted the responsibility of procuring vaccines onto different regional governments in the country.
For decades, India’s vastly successful universal immunization program has relied on the central government procuring vaccines and distributing it to different regional authorities. When the pandemic hit, the expectation was that the country would build on that model.
But on April 21, as India recorded nearly 315,000 coronavirus cases, the Modi government announced it would only buy half the country’s requirement of vaccines. Local governments and private hospitals would have to source the remaining by themselves, within 10 days.
The move left the 36 regional governments shellshocked—with zero notice, they were expected to locate and contact vaccine manufacturers around the world, negotiate prices and secure supplies, even as the country’s hospitals were overwhelmed with those struggling, while cremation sites overflowed with the dead. In doing so, Modi was—wittingly or otherwise—emulating former U,S. President Donald Trump, who in March 2020 passed off the responsibility of buying life-saving ventilators and masks to the governors, insisting that his government was “not a shipping clerk.”
With the Modi government’s announcement, local governments floated global tenders, and even municipalities tried their luck—Mumbai’s authorities wrote to its six international “sister cities,” pleading for vaccines. Nothing worked. Companies like Moderna and Pfizer offered a reality check, insisting that they would only deal with the federal government.
Even the Supreme Court of India, normally shy of crossing paths with the Modi government, came out and called the policy “arbitrary and irrational.”
Stung by the criticism, Modi last week came on television and announced that he was reversing the policy, adding that his government was now taking back responsibility for the country’s vaccination procurement.
But a steep price has already been paid. Six precious weeks were wasted in the race between vaccination and infection. Right now, the country is already opening up again, easing restrictions on everything from marriages to eating out. But with only 3.7 percent of its population vaccinated, the country faces the grim prospect of a being caught in yet another new wave of coronavirus infections.
Much of the blame for this should be shouldered by Modi and his government.
Since the beginning of the pandemic, Modi had made himself the face of the country’s vaccination drive. Quite literally—vaccination certificates issued by the government feature a smiling photo of Modi, possibly the only world leader to do so.
On the country’s Independence Day celebrations in August last year, Modi first broke the news to the country that there were “not one, not two, as many as three coronavirus vaccines” in different stages of testing, assuring citizens that the country was fully prepared to vaccinate the country as quickly as possible with indigenously developed vaccines. A month later, in his speech to the United Nations General Assembly, Modi said he wanted to assurethe global community that “India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis.”
In January this year, he reminded the world againthat India was “ready to save humanity.”
#Brazil probes #Health Ministry deal to buy #India's #Covaxin vaccine at $15 a dose, higher than for other #COVID #vaccines. #Brazilian drug agency had rejected a request to import it for lack of documentation and information on its safety. - ABC News -https://abcnews.go.com/International/wireStory/brazil-probes-health-ministry-deal-buy-covaxin-vaccine-78429303
Brazil's Senate is investigating Brazilian President Bolsonaro's 'Covaxin Deal Scandal.' It is huge news in Brazil, but Indian media is silent.
Of those, five had taken Covishield, a version of the AstraZeneca Plc vaccine made in India, and one had been given Sinopharm, Jude Gedeon, the island nation’s public health commissioner said at a press conference on Thursday. Covishield has mainly been reserved for people over 60 in the Seychelles. All of those who died had serious underlying conditions, he said.
The rise in infections, which surged at the beginning of May and has remained at elevated levels ever since, is likely due to the arrival of the highly-transmissible delta variant, which was first identified in India, Gedeon said.
“It looks like delta came in Seychelles in May which explain the surge at the beginning of May,” Gedeon said. “We presume that the majority of cases we got in May was from that variant.”
The palm-fringed archipelago had rushed to inoculate its 98,000 people so that it could reopen to tourism, the lifeblood of its economy. It had to impose restrictions on gatherings and opening times for bars and restaurants after the initial surge and has maintained those.
“For the last three weeks a team of experts from World Health Organization and Africa Centers for Disease Control have been working with us to evaluate our vaccination rate, data and response,” Gedeon said. “They will produce a report which will help us decide on the strategy to be used moving forward in terms of vaccination, measures etc.”
Frequent genomic studies have been reccomended, he said.
As India was slammed by its second major Covid wave earlier this year, researchers at the All India Institute of Medical Sciences in Delhi analyzed data from 2,714 of the hospital’s health workers who were showing signs of infection and underwent RT-PCR testing between April 15 and May 15, according to a study published in The Lancet Infectious Diseases journal. At the start of the country’s vacci
At the start of the country’s vaccination campaign in January, staff at AIIMS had exclusively been offered Covaxin, a shot co-developed by India’s state-funded health research agency and local company Bharat Biotech International Ltd. The authors found that two weeks or more after completing a two-dose regime the vaccine’s adjusted effectiveness against symptomatic Covid was lower than the 77.8%
The authors found that two weeks or more after completing a two-dose regime the vaccine’s adjusted effectiveness against symptomatic Covid was lower than the 77.8% that interim results established during final stage tests, a study of which was published in The Lancet earlier this month. High infection rates and virus exposure among the hospital’s employees may have contributed to Covaxin’s weaker
Covaxin’s weaker real-world efficacy, along with the possibility that the then recently emerged delta variant blunted the shot’s protection, the researchers said. “Our study offers a more complete picture of how BBV152 performs in the field and should be considered in the context of Covid-19 surge conditions in India, combined with the possible immune evasive potential of the delta variant,” Mani Soneja, an additional professor of medicine at AIIMS in New Delhi, said in a statement referring to the vaccine’s scientific name. Read more: India’s Covaxin Found 77.8% Effective in Lancet Covid Study While various studies indicate almost all Covid vaccines show reduced effectiveness against the highly infectious delta variant, which began its rampant spread across India in early 2021, the new research on Covaxin may dent the inoculation’s appeal at a time when Bharat Biotech is scaling up manufacturing and as India restarts overseas vaccine shipments. So far more than 130 million doses of Covaxin have been administered in India. Bharat Biotech and India’s government, which has widely promoted the shot, have sought to close the door on controversies involving the vaccine’s early authorization in January before it had completed phase 3 human trials, prompting widespread hesitancy in the country at the time. The World Health Organization’s independent technical panel also took months before granting emergency approval to Covaxin in early November, repeatedly asking Bharat Biotech for further data. Krishna Ella, chairman of the Hyderabad-based vaccine maker, said the WHO green light took as long as it did because of criticism surrounding the shot, which was developed using traditional inactivated-virus technology. The researchers said the AIIMs study didn’t estimate the vaccine’s effectiveness against hospitalization, severe disease and death, while acknowledging that it wasn’t designed to estimate the vaccine’s effectiveness against hospitalization, severe disease and death, while acknowledging that it wasn’t designed to estimate protection over different time intervals. Patients weren’t tested to find if they were symptomatic due to a specific variant and the authors also pointed to the lack of data on comorbidities and prior infections.
Experts say despite horrible performance of health system, New Delhi hailed indigenous vaccine as a major success
India’s homegrown Covid-19 vaccine is only 50 per cent effective against symptomatic infections during the peak of the country’s deadly second wave, according to new research.
The new data analysed over 1,000 Covid-19 cases with a test-negative control case group, matching by age and gender, according to the study published in The Lancet Infectious Diseases journal.
The experts say that India despite the horrible performance of its health system, which totally collapsed during the second wave of Covid-19, celebrated its indigenous vaccine as a major success.
Recently, India also celebrated achieving its one billion vaccination target as a unique milestone, but the recent study has “badly exposed the reality of such claims”.
The Modi government has been promoting the indigenous vaccine among healthcare workers, and so far, 138 million doses have been administered in the country.
However, the vaccine’s rollout was marked by controversy as it was approved in the country before its third trial data was released.
The vaccine, developed by Hyderabad-based Bharat Biotech, was recently approved by the WHO technical committee and was included in the list of acceptable vaccines, but only after a wait of four months.
This is the first real-world assessment of Covaxin, which is one of the two main vaccines being used in India’s inoculation drive.
Also read: Many 'challenges' ahead in India’s coronavirus vaccination program
The real-world study for Covaxin, conducted April 15-May 15, compares with a 77.8% effectiveness rate in a late-stage trial of more than 25,000 participants that was conducted from November 2020 to January 2021.
The study included 2,714 health workers from Delhi’s All India Institute of Medical Sciences, who were showing signs of infection and underwent RT-PCR testing between 15 April and 15 May, the peak of India’s second wave of coronavirus crisis. The study was published in The Lancet medical journal on Nov 24, 2021.
All the medical workers were inoculated with two doses of Covaxin at least 14 days before and had a high risk of exposure to the virus.
The study said that half the participants were found to have symptomatic Covid-19 as confirmed by RT-PCR tests.
Researchers found that the adjusted effectiveness of Covaxin against symptomatic Covid-19 was at 50 per cent overall, lower than the 77.8 per cent that interim tests results. After excluding participants with previous Covid-19 infections, the adjusted effectiveness dropped to 47 per cent.
The analysts are of the view that the report clearly indicates that Indian attempt to boost a false sense of superiority pushed its frontline medical and common citizen towards a medical disaster as witnessed during the catastrophic failure of the Indian medical system.
It has also been reported by Indian media that many of the Indian celebrities, political leaders, and wealthy businessmen and their families got vaccinated from UK and US, as they never trusted the claims of effectiveness of the Indian vaccine.
Ironically, India once again resorted to false claims to project itself as a leader in the pharmaceutical industry endangering its own population.
The vaccine effectiveness estimated in our study is lower than the efficacy announced after completion of the phase 3 trial, despite a similar testing strategy being used (SARS-CoV-2 RT-PCR testing for participants with symptoms suggestive of COVID-19 determined through weekly telephone follow-up).3 Several factors might be responsible for the observation of a lower effectiveness in this study. First, the population included in our study comprised only hospital employees, who might have been exposed to a higher risk of SARS-CoV-2 infection than the general population. The study was conducted during the peak of the second wave of COVID-19 in India, with high test-positivity rates for both hospital employees and residents of Delhi. On April 26, 2021, the test-positivity rate for Delhi was around 35%,7 which was the highest it had been since the beginning of the pandemic. Thus, our results might only reflect the performance of BBV152 under such surge conditions. Second, the prevalence of circulating variants of concern, especially the delta variant, might have contributed to lower effectiveness of BBV152. Although in-vitro studies have shown neutralisation of these variants by both convalescent and post-vaccine sera, the neutralisation titres are several times lesser against variants, particularly the delta variant.8, 9 The phase 3 trial of BBV152 was conducted during a period when the overall test-positivity rate was low, and the prevalence of the delta variant among positive cases was largely unknown. By contrast, at the end of April, 2021, a period during which this study was conducted, the delta variant was the dominant strain, making up more than 80% of all sequenced genomes as per the reports from the Indian SARS-CoV-2 Genome Sequencing Consortia.10
The only way to break this cycle of inequity is to suspend the IP on the vaccines and COVID-19-related treatments, while also compelling pharmaceutical companies to share their know-how to allow other potential manufacturers to scale up supplies. Over a year has passed since South Africa and India submitted a proposal requesting a waiver of IP under the World Trade Organization’s international Agreement on Trade Related Aspects of Intellectual Property Rights (more commonly known as the TRIPS waiver). ...
Market enthusiasts, who are against waiving IP, have made a variety of arguments to justify their reasoning — while simultaneously moving the goalposts as it suits them to deflect any counterarguments and facts. One of the key arguments made by countries and pharmaceutical companies blocking the TRIPS waiver is that there are no other manufacturers in the world that can make the vaccines — in particular, the new mRNA versions. However, thanks to investigative journalism at the New York Times (https://www.nytimes.com/interactive/2021/10/22/science/developing-country-covid-vaccines.html) and extensive research by AccessIBSA and Medicines Sans Frontieres that identified over 100 potential manufactures in the Global South that can potentially make mRNA vaccine, this has been dispelled (https://www.hrw.org/news/2021/12/15/experts-identify-100-plus-firms-make-covid-19-mrna-vaccines).
The ultimate argument that underlies resistance to waiving IP is the belief that doing so will harm innovation and future progress because pharmaceutical companies will be disincentivized to invest in future drug research and development. Here lies the crux of the issue if we are to address not only vaccine inequity, but also future pandemics and crises such as climate change. Western capitalism, and the hyper-financialized version of it we live in today, believes that the IP system is the best way to drive innovation and progress, including economic. It is a Faustian bargain that the system has made, cultivating a culture and belief that innovation and technological progress alone will solve all our problems. Those defending this bargain believe the individual good that the IP system incentivizes will benefit the collective good.
This pandemic has clearly shown us that the current IP system does not benefit the collective good. It only focuses on resolving part of the problem — that of innovation and technological progress. It does not solve the individualistic behaviour of nation states, corporations and humans generally, in terms of being incentivized to serve the collective good, unless there is some power and financial gain to be had. That it has taken this pandemic to see this even when many people in some of the richest countries struggle to pay for their medicines daily shows why vaccine inequity is a symptom of a larger problem within our market-driven global health system.
No amount of innovation and technology will change our morals and selfishness, and we live in a world in which leaders refuse to address this challenge. The idea of rewiring ourselves to think about the collective good is usually met with a shrug that it is our human nature to be selfish. It is time our leaders incentivized the collective good to address this pandemic and other impending crises, rather than clinging to the current system that only serves a few and fuels division. By doing so we may realize that everyone can win and be safe, including the economy — which is what the defenders of the IP system and market enthusiasts care most about.
(Reuters) - Seattle biopharma company HDT Bio Corp has sued Indian generic drugmaker Emcure Pharmaceuticals Ltd in U.S. court for allegedly stealing RNA-delivery technology to use in its COVID-19 vaccine.
HDT's lawsuit, filed Monday in Seattle federal court, also said Emcure was planning to go public in India based on the stolen technology, and misappropriated trade secrets that HDT licensed to an Emcure subsidiary.
The lawsuit adds to a growing number of recent intellectual-property disputes involving Pfizer, Moderna, and others over the use of mRNA technology in COVID-19 vaccines.
HDT requested at least $950 million in damages and a court order permanently banning Emcure from using its secrets.
An Emcure spokesperson said Tuesday that the company was not involved with the license. Emcure "has no connection whatsoever with the matter" and is "initiating steps to have the claims dismissed," the spokesperson said.
HDT did not immediately respond to requests for comment.
HDT said in the lawsuit that is developing a self-amplyifing RNA (saRNA) vaccine for COVID-19. According to HDT, saRNA improves on existing mRNA vaccine technology by reducing the risk of side effects like myocarditis and allowing for shots to be given with lower dosages and kept in standard refrigerators.
The lawsuit said HDT licensed its technology to Emcure subsidiary Gennova Biopharmaceuticals to develop a COVID-19 vaccine in India. However, Emcure allegedly claimed the technology as its own in late 2021.
HDT said it was filing a separate arbitration action against Gennova in London related to the claims.
Emcure applied for two Indian patents on HDT's technology and filed for an IPO in India that falsely describes its "indigenously developed" vaccine with a "proprietary mRNA platform," the lawsuit said.
Gennova allegedly terminated its license agreement with HDT at Emcure's request shortly after its CEO told HDT it would not pay royalties on vaccine sales.
The lawsuit said it would be "stunning" if Emcure developed the vaccine on its own, considering it did not have prior experience with RNA vaccines or a record of developing original products.
"Emcure's Cinderella story is a fairy tale spun to lure investors to a generics maker whose prior attempt to go public failed for lack of interest," HDT said.
The case is HDT Bio Corp v. Emcure Pharmaceuticals Ltd, U.S. District Court for the District of Washington, No. 2:22-cv-00334.
Why are CDSCO and others treating Bharat Biotech with kid gloves?
The simple answer is that virtually all of India has thrown its weight behind Bharat Biotech because of Prime Minister Narendra Modi’s AatmaNirbhar policy, which broadly translates into a policy of economic self-reliance. This has meant special regulatory privileges for Covaxin, given its status as a made-in-India vaccine that was developed with the support of the Indian Council of Medical Research (ICMR).
In a shocking turn of events, the World Health Organization warned United Nations agencies against procuring Covaxin, India’s indigenously developed and manufactured Covid-19 vaccine, just five months after granting approval to the made-in-India vaccine. The warning came after a WHO inspection of a manufacturing facility owned by Bharat Biotech International Ltd. revealed “deficiencies in good manufacturing practices.”
The WHO has not revealed the extent or nature of the deficiencies at Bharat Biotech’s facility; but given its recent instructions to U.N. agencies, the deficiency must have been significant from a public health perspective. Violations of current good manufacturing processes is nothing new to the Indian pharmaceutical industry. There is a sordid history of warning letters from the U.S. Food and Drug Administration documenting systematic compliance issues over the last decade. Foreign inspections all but ceased during the pandemic. Agencies such as the WHO rely on national regulatory agencies like the Central Drugs Standard Control Organisation (CDSCO), which regulates the pharmaceutical industry in India, to assess compliance before granting approval for commercial use of a drug.
This is not the first time that a foreign regulator has found problems with the manufacturing facility at Bharat Biotech that produces Covaxin. Exactly one year ago, the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s drug regulator, pointed out serious lapses at Bharat Biotech’s manufacturing facility in India that makes this vaccine. ANVISA inspectors discovered issues with quality control at the facility that are meant to confirm that the live virus at the core of this vaccine has been inactivated.
At the time, the CDSCO remained a mute spectator to the affair and gave no assurances to the Indian public on measures it was taking to ensure that Bharat Biotech fixed these issues. It has followed the same path of silence since the WHO’s recent suspension of Covaxin’s procurement by the United Nations.
As I write this, not a single newspaper in India has been able to identify the exact nature of the deficiency the WHO raised, and few in India seem to be concerned about the implications of the WHO’s action, despite the fact that Covaxin is being administered to children in India.
A COVID-19 vaccine named Corbevax looked like a triumph for India’s burgeoning drug industry. Because its U.S. developers hadn’t claimed a patent on it, an Indian manufacturer named Biological E was able to sell the two-dose protein-based vaccine to the government at the extraordinarily low price of 145 rupees ($1.90) per dose. In March, the country began to give the shots to 12- to 14-year-olds, a group for which India did not yet have a licensed COVID-19 vaccine.
But the celebration was quickly drowned out by questions over whether India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), had properly vetted the vaccine.
In February, CDSCO had authorized the use of Corbevax for adolescents ages 12 to 18. But within weeks, the Indian media outlet The Wire Science revealed that the National Technical Advisory Group on Immunisation (NTAGI), an expert group that advises the health ministry on which vaccines to add to the national immunization program, had questioned whether Biological E had shown the vaccine is effective. In adolescents, who are at a lower risk of severe COVID-19, the benefits of a vaccine should be beyond any doubt, NTAGI member Jayaprakash Muliyil tells Science: “Anytime you vaccinate children, you have to be extremely careful.”
Other CDSCO approvals of COVID-19 vaccines have raised questions as well, both from NTAGI and independent experts. The agency has used “suboptimal” standards on several occasions, says Vineeta Bal, an immunologist at India’s National Institute of Immunology. That has led some scientists to ask whether the agency has the capabilities—and is independent enough—to oversee the quality of medicines for India’s 1.4 billion people. The implications go beyond India, because the country is a major global medicine supplier. The World Health Organization has “prequalified” 54 vaccines produced in India for use elsewhere, and WHO relies on CDSCO to oversee the manufacturers.
CDSCO didn’t respond to questions from Science about the criticism. In May 2020, India’s health ministry appointed a committee to advise it on how to restructure India’s drug regulatory system in line with global best practices, but that committee’s recommendations haven’t been published. It’s unclear whether they will address vaccine regulation.
In January 2021, for example, the agency greenlit Covaxin, an inactivated-virus vaccine produced by Bharat Biotech, without data from large-scale efficacy trials—only phase 2 data about the immune response generated by the vaccine. By the time the company published data showing 78% efficacy against symptomatic COVID-19, 6 months later, millions of Indians had already received the shot.
NTAGI also differed with CDSCO’s assessment when the regulator approved a COVID-19 vaccine named ZyCoV-D for use in both adults and adolescents in August 2021. Produced by Zydus Cadila in Gujarat state, ZyCoV-D is the first DNA vaccine approved by any country for use in humans. CDSCO based its decision on results of a trial in about 28,000 participants over 12 years of age, which found the vaccine 67% efficacious at preventing symptomatic COVID-19.
NTAGI, which does not typically make its advice public, opposed the use in adolescents, Muliyil says; it felt a completely new vaccine platform should only be used in adults at first. Moreover, the phase 3 trial had a single efficacy estimate for all ages, says another NTAGI member who asked not to be identified, even though efficacy can differ by age group. (In Western countries, COVID-19 vaccines for adolescents and children were authorized after separate trials in those age groups.)
The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.
The deaths of dozens of children in The Gambia from kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, the World Health Organization said on Wednesday.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters that the UN agency was conducting an investigation along with Indian regulators and the drugmaker, New Delhi-based Maiden Pharmaceuticals Ltd.
Maiden Pharma declined to comment on the alert, while calls and Reuters messages to the Drugs Controller General of India went unanswered. The Gambia and India’s health ministry also did not immediately respond to a request for comment.
The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.
The products may have been distributed elsewhere through informal markets, but had so far only been identified in The Gambia, the WHO said in its alert.
The alert covers four products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Lab analysis confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic when consumed, the WHO said. The Gambia’s government said last month it has also been investigating the deaths, as a spike in cases of acute kidney injury among children under the age of five was detected in late July.
Medical officers in The Gambia raised the alarm in July, after several children began falling ill with kidney problems three to five days after taking a locally sold paracetamol syrup. By August, 28 had died, but health authorities said the toll would likely rise. Now 66 are dead, WHO said on Wednesday.
The deaths have shaken the tiny West African nation, which is already dealing with multiple health emergencies including measles and malaria.
Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically, as well as exporting it to countries in Asia, Africa and Latin America, according to its website.
These are substantial, undeniable achievements that hubris-filled Hindu nationalists say derive from their greatness as an ancient civilization. But wait! China has done still better. And, though far smaller, many emergent countries of East Asia — Japan, South Korea, Vietnam, and Singapore — also boast of better performance than India’s.
In every case, the secret of success is well-known — strong systems of education that create skills, knowledge, attitudes and social behavior’s suited for modern times. Together with that, a strong work ethic in the labor force. Stated differently, high national achievement springs naturally from the quickness with which a country universalizes or ‘Westernizes’ its education and creates positive attitudes towards work.
Here’s how India grew into the present. Empowered by the scientific and industrial revolutions, Britain colonized India and sought to spread Western education and values. Conservative Hindus emphatically rejected this modernization butsar reformist movements such as Brahmo Samaj under Ram Mohan Roy and others made deep inroads.
By 1947 under Jawaharlal Nehru — an avowed Hindu atheist devoted to the ‘scientific temper’ — India was already intellectually equipped to enter the modern world. For the next 50 years, India’s education sought to create a pluralist, secular, scientifically minded society. It reaps rich harvests to the present day — which the BJP happily appropriates as its own.
But Hindu nationalists now want India’s goals and self-image drastically revised. Modi’s second engine, fueled by febrile imaginations, pushes India towards emulating some kind of Hindu rashtra from an idyllic past. My friend Prof Badri Raina, now retired from Delhi University, says that “this backward engine would have us believe that in ancient times we had knowledge of plastic surgery, aeronautics, satellite vision, even as streams of foaming white milk flowed down our plains, and golden birds perched on the branches of trees”.
The loudest call for reforming Muslim education was that of Sir Syed Ahmad Khan. Madressahs, he said, are entirely unnecessary. Using religious idiom, he passionately argued for science and modernity. While his efforts led to some measure of functionality and to jobs within the colonial system, they were nowhere deep or wide as that of Brahmo Samaj. Conservative backlash limited Sir Syed’s influence.
Thus, by the time Partition came around, there was a massive Hindu-Muslim gap. Nevertheless, for the first few decades, Pakistan’s engine #1 steadily gained strength and was consistently stronger than its second engine. Among other things, Pakistan’s space program (born 1961, now dead) much preceded India’s.
However, a STAT review of documents detailing the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants. Moreover, questionable changes were made to the trial protocols — which are established procedures for testing a vaccine or medicine — to expedite the approval process.
For instance, the number of people enrolled in the Phase 1 portion of the trial differed from what was later published in a medical journal. There were also important changes made to the protocol for Phase 2 testing, when immunogenicity data from the previous Phase 1 stage were not yet available.
In addition, the protocol for Phase 3 was approved while Phase 2 was still underway and the final vaccine candidate was selected without Phase 2 data, according to protocol documents and minutes of meetings held by an expert committee that reported to India’s Central Drugs Standard Control Organization (CDSCO), the national regulator responsible for approving medicines. This was the agency that authorized the vaccine for emergency use in January 2021, two months before Phase 3 results were known.
More controversy erupted last spring. Brazilian authorities raised concerns about Bharat Biotech manufacturing. Then, the WHO, which listed the vaccine for emergency use in November 2021, suspended supplies after an inspection of the facilities found unspecified problems. The decision meant United Nations procurement agencies, such as UNICEF, would no longer be able to supply the shot to other countries. A WHO spokesperson declined to offer an update on the findings.
For now, it remains unclear whether the newly disclosed issues surrounding the clinical trial will trigger still more questions about the willingness of the Indian government to boost its oversight. The CDSCO and the Drugs Controller General of India, which oversees the CDSCO, did not respond to emails seeking comment about the changes made to the Covaxin trial protocols and subsequent government approval.
In reviewing the documents, there was a clear discrepancy in the number of enrollees. In reporting the Phase 1/2 data, the protocol stated 402 participants were given the first dose and 394 got the second dose. But results published in Lancet Infectious Diseases in January 2021 stated 375 people were given a first dose and 368 received a second dose. (See Figure 1 on page 640.)