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". 

US-Based Ocugen: 

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:

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

COVAXIN Vaccine: 

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.

COVID19 Pandemic:

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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Anonymous said…
At a time when Covid cases & deaths are rapidly dwindling&sero surveys show that >15 Cr people in India have already been infected,& death rates are less than 1/1000, the Govt is rushing through vaccines which have not been properly tested. We saw the Noteban & Lockdown disasters
Riaz Haq said…
India’s Vaccine Nationalism Is a Global Risk
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.
Riaz Haq said…
#India #farmersrprotest | Farmer leaders reject Supreme Court panel as a ‘government ploy’ to reduce pressure on #Modi sarkar. #Sikh #Punjab

“We understand that this committee is a government ploy. It is only meant to divert attention from the protest, and to reduce the pressure on the government,” said Balbir Singh Rajewal, who heads his own faction of the Bharatiya Kisan Union in Punjab.

“All members of this committee are pro-government, and they have been promoting and justifying these laws from the beginning. They have been writing in the newspapers, claiming that these laws are in farmers’ interests,” he said.

One of the proposed committee members, food and agricultural policy expert Pramod Kumar Joshi, told The Hindu he had not yet received any official communication from the Supreme Court, and would not comment until he had seen the committee’s terms of reference. He has previously characterised the farmers’ repeal demand as “bizarre”. Another member, agricultural economist Ashok Gulati, has been a long-time advocate for farm reforms and welcomed the Centre’s announcement of the new laws as “big, bold steps in the right direction which will benefit both farmers and consumers”.


The unions said they intend to show up for the next round of talks with Central Ministers led by Mr. Tomar, scheduled for January 15. In the meanwhile, a full calendar of protest events will continue, starting with plans to burn the three farm laws for the festival of Lohri on Wednesday, which will also mark the 50th day of protest on the borders of Delhi. Women, children and senior citizens will also continue to participate in the protest, despite the Chief Justice’s appeal to send them home.

With regard to their Republic Day plans, union leaders said the Centre was misleading the Supreme Court on the issue. “We are going to protest peacefully. We don’t want to occupy Parliament. We have no plan to go to Lal Qila. On our side, violence will not be tolerated,” said Mr. Rajewal, adding that the tractor parade would take place in Delhi as well as in other locations across the country.

Riaz Haq said…
Up to 1m #Hindus gather in #India as festival goes ahead amid #COVID19 fears. Millions more are expected to descend on Haridwar in the coming weeks for #KumbhMela2021, one of the world’s biggest religious gatherings. #Muslim #Hajj was canceled in 2020.

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?”
Riaz Haq said…
#Pakistan approves #AstraZeneca #COVID #vaccine for emergency use, the first #coronavirus vaccine to get approval. Pak would get vaccine from multiple sources, including "tens of millions" of doses under an agreement with #China's CanSinoBio via @YahooNews

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.
Riaz Haq said…
Modi's vaccine nationalism is risking Indians' lives.

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.
Riaz Haq said…
#Hindu Nationalists attack #AmazonPrime's "Tandav" episode which shows #farmersrprotest & student protests and police killings that have happened in recent months under #Modi. Its title “Dictator” is apparent reference to Modi. #BJP #Hindutva #FreeSpeech

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.
Riaz Haq said…
#Chinese Foreign Minister Wang Yi Speaks with #Pakistani Foreign Minister Shah Mahmood Qureshi on the Phone. #Beijing has decided to assist Pakistan with #Covid19 #vaccine and coordinating with Chinese enterprises to accelerate its export to Pakistan

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.
Riaz Haq said…
Tears and safety fears as #India huge #coronavirus #vaccine campaign falters. Motivated by vaccine nationalism, #Indian made #Covaxin vaccine was hastily approved by #Modi government without completing phase 3 trials - World - DAWN.COM

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”.

WhatsApp worries
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.”

Coronavirus complacency
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.”

Selfie zones
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.

Riaz Haq said…
If Poor Countries Go Unvaccinated, a Study Says, Rich Countries & Global #Economy Will Be Hurt. Sharing #Covid_19 #vaccine with poor nations is not an act of charity. Study says it is in rich countries' self-interest to do so. #Covid_19 #CovidVaccine

A failure to distribute the Covid-19 vaccine in poor nations will worsen economic damage, with half the costs borne by wealthy countries, new research shows.

This is the crucial takeaway from an academic study to be released on Monday. In the most extreme scenario — with wealthy nations fully vaccinated by the middle of this year, and poor countries largely shut out — the study concludes that the global economy would suffer losses exceeding $9 trillion, a sum greater than the annual output of Japan and Germany combined.

Nearly half of those costs would be absorbed by wealthy countries like the United States, Canada and Britain.

In the scenario that researchers term most likely, in which developing countries vaccinate half their populations by the end of the year, the world economy would still absorb a blow of between $1.8 trillion and $3.8 trillion. More than half of the pain would be concentrated in wealthy countries.
Riaz Haq said…
While Pakistan has yet to start a Covid vaccination drive, signs are emerging that it’s going to happen pretty soon. After China’s announcement of ‘gifting’ 500,000 doses of a vaccine to Pakistan by the end of January, another good news on free-of-cost availability of a vaccine has come from the World Health Organization. In a statement last Sunday, the world body has announced signing of an agreement for Pfizer-BioNTech vaccine and another arrangement for AstraZeneca/Oxford University vaccine for procurement of two billion doses by the end of the current year. And 150 million of these doses will be made available in the first quarter of the ongoing month.

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.

Riaz Haq said…
#Israel said to be paying average of $47 per person for #Pfizer, #Moderna #vaccines to get large quantities delivered rapidly. It’s much higher than $19.50 for #US and $14.76 for #EU. #covid19 | The Times of Israel

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.

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