Modi's Vaccine Nationalism: India's Hasty Approval of Homegrown COVID19 Vaccine

[Riaz Haq]

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. 

Summary:

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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[Riaz Haq]

#Modi #Vaccine Disaster Leaves #India Vulnerable to 3rd #Covid Wave. Modi has made himself the face of country’s #vaccination drive. Quite literally—vaccination certificates issued by govt feature a smiling photo of Modi, the only world leader to do so.

https://foreignpolicy.com/2021/06/16/modi-vaccine-failures-india-co...

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.”

[Riaz Haq]

#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://abcn.ws/3j38g2o

#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...

Brazil's Senate is investigating Brazilian President Bolsonaro's 'Covaxin Deal Scandal.' It is huge news in Brazil, but Indian media is silent.

[Riaz Haq]

#COVID19 kills 6 fully vaccinated people in #Seychelles, despite inoculating a greater proportion of its people than any other nation. Of those, 5 had taken Covishield version of the AstraZeneca #vaccine made in #India, & 1 had received #China's Sinopharm https://www.bloomberg.com/news/articles/2021-07-02/u-k-and-eu-try-t...

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.

[Riaz Haq]

India’s Homegrown Vaccine Gave Lower Protection in Delta Wave Chris Kay Bookmark November 24 2021, 12:30 AM November 24 2021, 10:45 AM (Bloomberg) -- Covaxin, one of the main vaccines used in India’s coronavirus immunization drive, provides only 50% protection against symptomatic Covid-19, according to a real-world study that suggests the shot is less effective than initially thought. As India

https://www.bloombergquint.com/coronavirus-outbreak/covaxin-gave-lo...

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.

[Riaz Haq]

‘Indian homegrown Covid vaccine only 50% effective’
Experts say despite horrible performance of health system, New Delhi hailed indigenous vaccine as a major success



https://tribune.com.pk/story/2331063/indian-homegrown-covid-vaccine...



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.

[Riaz Haq]

Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33–62; p<0·0001). The adjusted effectiveness of two doses administered at least 28 days before testing was 46% (95% CI 22–62) and administered at least 42 days before testing was 57% (21–76). After excluding participants with previous SARS-CoV-2 infections, the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29–61).
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(2100674-5/fulltext
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

[Riaz Haq]

Innovation alone won’t end COVID-19
Tahir Amin

https://www.nature.com/articles/s41562-022-01298-7

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-c...) 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...).

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.

[Riaz Haq]

Seattle #startup claims #India-based drugmaker stole #COVID19 #mRNA #vaccine #tech, seeks $950M https://www.geekwire.com/2022/seattle-startup-claims-india-based-dr... via @GeekWire

(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.

[Riaz Haq]

#India’s drug regulator has ignored red alerts on #COVAXIN, imperiling millions of lives. World #Health Organization warned #UN agencies against procuring Covaxin, India’s indigenously developed & manufactured #COVID19 #vaccine. #Modi #Hindutva #Bharat https://www.statnews.com/2022/04/15/indias-drug-regulator-has-ignor...

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).

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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.

[Riaz Haq]

#India’s speedy approvals of #COVID19 #vaccines come under fire. “It sets a dangerous precedent which could be very damaging for vaccine confidence and uptake down the road.” #Modi #BJP #pandemic #health https://www.science.org/content/article/india-s-speedy-approvals-co...

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.

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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.)