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Bharat Biotech Seeks Emergency Approval: What Experts Have to Say

What are the ethics of asking for emergency approval without releasing data for public scrutiny? Experts answer.

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  • Are the vaccines applying for approval based on sound data and enough data?
  • Have we reached a level of confidence with the safety and efficacy as these trials are still ongoing?
  • These are based on double-blind trials for Covixin so has the unblinding happened or are these presumptions based on phase 2 since phase 3 is ongoing?
  • Is it too much of a race?

These are some of the questions Dr Anant Bhan, Adjunct Professor & Researcher in Bioethics at Mangaluru’s Yenepoya University, posed as news of Bharat Biotech applying for an emergency approval from the Drugs Controller General of India (DCGI) for their vaccine ‘Covaxin’ hit. Many top vaccine candidates are applying for emergency approval or even beginning to distribute before phase 3 trial results are out for public scrutiny.

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Is this normal? What are the ethics of asking for emergency approval without releasing data for public scrutiny (or peer review)? The last results made public were from Covaxin’s pre-clinical animal trials, but since then there has been no data for the public.

Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University, explains,

“Companies are under no obligation to show data to the public. They only need to show their data to the regulators. Approval is entirely in the realm of the regulator.”
Dr Shahid Jameel, Virologist

What Data Will the Public Know?

Dr Jameel says that if and when a vaccine is approved, it is up to the DCGI to justify their results.

“So far, Pfizer and the Oxford vaccine have released their results via press releases, and these press release efficacies are meant for stock markers and shareholders, not for any serious discussion.”
Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University

So when would the results be available for researchers and serious discussion?

“This is not a requirement. Besides, the DGCI has an external committee to review it and submit recommendations to the DGCI to permit or not permit the drug. So in a sense, it is peer-reviewed by these experts on the board. So far we don’t even know if their dosing is complete but they are not legally obliged to disclose anything to the public.”

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What about ethically? In a time of massive public health mistrust and anti-vax sentiments, how will this lack of transparency further damage public trust? Put simply, why should we use a vaccine if we don’t have the data?

“DGCI needs all the requisite data, no one else. But yes, once it is approved, then we can ask DGCI to justify the approval and ask questions.”
Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University

Dr Bhan adds that a problematic vaccine would become a “PR nightmare and so it is in their best interests to ensure a safe vaccine that has taken the time to get the proper results. This would improve confidence and this same data could be used for other countries too.”

The ICMR Connect

Bharat Biotech is being co-sponsored by the Indian Council of Medical Research (ICMR) - so do they owe the Indian public greater transparency? For example, the Oxford vaccine was partly funded by British tax-payers, and the developers have acknowledged that.

“ICMR is the one setting guidelines so they have to abide by those. As a co-sponsor and government entity, they have to ensure their reputation is intact and so they must ensure everything meets ethics and science standards. Still, the most important player is the regulator - and while not every data has to be released, they need to strongly justify their approval.” says Dr Bhan.

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He adds,

“If approved, there will be many concerns on what basis it was done, who made the decision, what data was examined etc. So hopefully, the regulatory body takes it seriously and makes an informed, transparent decision.”

These would be essential for public trust and trust in the vaccination process. Still, the responsibility of solidifying public trust in vaccines is with the government, and not companies - although it would make great PR sense for companies to go with this as well.

Oxford and Pzfier Vaccines Are Asking for Approval Based on Foreign Trials: Is this Fair for India?

When Pfizer Inc asked for approval in India, they had not collated the results of the tests on the Indian population. They had the results from foreign trials and asked for direct approval without Indian testing.

The Serum Institute of India (SII) did the same for the Oxford-AstraZenca vaccine. Their data from India is still being processed, and they had positive results from the UK and Brazil but went ahead and asked for emergency approval for the drug in India.

Is this fair for India’s population? Dr Jameel says the Oxford-AstraZenca vaccine brings up many questions,

“I don’t know for what trial they have asked for approval - UK or Brazil? Firstly you cannot combine both the results and make it 90 percent efficacy, and 62 percent and together make it 70 percent, I don’t buy this argument. Simply because one, the dosing regime turned out to be different and they were essentially two different trials. And two, because of the different populations so there were two variables. So on what basis have they asked for approval?”
Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University
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What about the need for trials in India? Pfizer is applying to bypass these entirely.

Dr Bhan says, “This is where the regulator needs to come in. It would be good to have local data, as it is not always possible to extrapolate data from another context. Also, this is a new vaccine for a new virus and we will only know how they perform in an Indian setting once we do those studies. To bypass the Indian trials, I would be very surprised if DGCI approves this and it would need very strong transparency and justification.”

Dr Jameel adds that Indian law requires what is called a ‘bridge trial,’ which is a smaller trial than a regular phase 3 trial. “Again, it is in the domain of the regulator to give approval based on an emergency or an unmet need - but it would go with the caution that this vaccine is going in a population in which it has not been sufficiently tested.”

When asked if a pandemic would not count as an “emergency,” Dr Jameel responded by saying:

“I don’t know what is the tearing hurry! What is the emergency situation that a vaccine has to be given in a week and not in 4 weeks? We can wait another month for the results first. Pfizer has really skewed the market with this silly race.”
Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University
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India is an important vaccine market, but Dr Jameel says that Pfizer knows we don't have the storage capacity for the Pfizer vaccine. “I am not clear why they are asking approval since they are only willing to sell to government contacts knowing our situation. Are they asking to sell it in the country to people who can afford to pay 20-30 dollars per dose? If that's the case, then it is highly unethical and not equitable.”

But Dr Jameel tells me that while we wish the company were accountable for these questions, they simply are not legally obliged to be and thus not likely release details to the public. “The company is doing nothing wrong, this is the usual protocol. Companies are in the business of money not charity. Other companies have released it not to the public but to their stakeholders.”

Still, in a pandemic, where lives are at risk, perhaps regulators and public health stakeholders can pressure companies for more transparency.

Dr Jameel admits that he has a “hunch” the DGCI will not approve these vaccines just yet. So far, India stands in good stead with a good supply chain and orders for doses from SII and the Russian vaccine Sputnik V.

(The article was first published in FIT and has been republished with permission)

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Topics:  covid 19   COVID   covid vaccine 

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