Here's why India rushed to approve a local vaccine
How can a coronavirus vaccine be authorized for emergency use by millions of vulnerable people in “clinical trial” mode?
No idea, says Dr Gagandeep Kang, one of India's best-known vaccine experts. "Either you are doing a clinical trial or not" . Clinical trials - a three-step process - determine whether the vaccine induces good immune responses and whether it causes unacceptable side effects.
India's drug regulator on Sunday urgently approved a locally produced coronavirus vaccine called Covaxin before trials were completed. The government-backed vaccine was developed by Bharat Biotech, a 24-year-old vaccine maker, which has a portfolio of 16 vaccines and exported to 123 countries.
The regulator said the vaccine had been approved for "restricted use in emergency situations in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection with mutant strains." (The regulator has also approved the AstraZeneca Oxford global jab, which is also produced in India.)
This, despite the fact that the key third phase of Covaxin's clinical trials - the vaccine is given to thousands of people and tested for effectiveness and safety - was underway.
The assurances given by the regulator that the vaccine is "safe and provides a robust immune response" have not appeased most scientists and health experts. The All India Drug Action Network, a watchdog, said it was "baffled to understand the scientific logic" of approving "an incompletely studied vaccine."
Bharat Biotech says it has a stockpile of 20 million doses of Covaxin and aims to manufacture 700 million doses from its four facilities in two cities by the end of the year. “Our vaccine is 200% safe,” says cabinet chairman Dr Krishna Ella.
Dr Ella defended approval. On the one hand, he said, laws Indian clinical trials have allowed "expedited" clearance to use drugs after the second phase of trials for "unmet medical needs of serious and life-threatening illnesses in the country." The fact that its vaccine is based on an inactivated form of coronavirus - a reliable, time-tested platform - has also helped.
Studies in monkeys and hamsters have shown that Covaxin provides sufficient protection against infection, Dr Ella said. Nearly 24 of the 000 volunteers had already participated in the ongoing third phase trials, and the company should have vaccine efficacy data by February, he added.
Scientists are skeptical. “Since there are no data for the third phase of the trials, we don't know how effective this vaccine is. We know it is safe, going through the limited phase two trials. What if we deploy a vaccine with unknown efficacy and later find it only 50% effective? Would it be fair to the people who received it? Dr Shahid Jameel, a leading virologist, told me.
It is still unclear what the regulator meant by saying the vaccine would be administered in a "clinical trial mode". In a conventional trial, volunteers are not told whether they are getting the vaccine or a placebo, and many are excluded from participation due to pre-existing health concerns.
Dr Ella said his company will monitor recipients after they take shots of Covaxin. This will likely add to the logistics of the immunization program.
So did the regulator really mean that Covaxin would be given to people in a “fourth phase of clinical trials” for ongoing studies after the vaccine was approved and marketed? “Give us a little time to figure this out. We don't know if this will be treated as a trial, ”Dr Ella said.
That's not all.
A senior member of the federal Covid-19 task force further muddied the waters, saying that Covaxin would be "like a backup vaccine" in the event of a sharp increase in cases. The epidemiologists I've spoken to say they're baffled. “Does that mean that in the event of an outbreak, some people will receive a vaccine that has not been proven to work? Said a senior epidemiologist.
However, Professor Paul Griffin, an infectious disease expert at the University of Queensland, says it is not uncommon for vaccines to be used in emergency situations in a targeted manner while remaining in a trial setting. clinics. This is usually taken into account if the ongoing trials are robust and if the data from previous trials support the expanded use of the vaccine “both in terms of safety and efficacy,” he told me.
With more than 10 million coronavirus infections, India has the second highest number of reported cases after the United States. The pandemic has damaged its economy. India plans to vaccinate some 300 million people between January and July. But the rollout is also happening at a time when business has slowed down considerably. Bharat Biotech is a well-known vaccine manufacturer with a history of clinical trials in 20 countries, involving over 700 volunteers.
So why couldn't India wait a few more weeks for the end of final trials and approve a vaccine with proven efficacy? Why this haste?
“It's incomprehensible,” Shashi Tharoor, a senior opposition politician and MP, told me.
Mr Tharoor attributes this "unseemly haste" to the BJP government of Narendra Modi "which likes to place slogans on the bottom". In this case, he says, "breathtaking" vaccine nationalism - combined with the Prime Minister's "Autonomous India" campaign - has taken precedence over common sense and a generation of established scientific protocols. Others say "bad science communication" and a lack of transparency on the part of regulators also contributed to the fiasco.
India is a vaccine-manufacturing powerhouse, producing 60% of the world's vaccines. It manages the world's largest vaccination program targeting 55 million people - mostly newborns and pregnant women - who receive some 390 million free doses of vaccines against a dozen diseases each year.
The Covaxin fiasco holds many lessons for India.
As the virus designs ways to become more infectious, a number of vaccines may be needed to counter it and prevent serious illness in those infected.
“Approval of all vaccines must be provided on the basis of adequate evidence of efficacy and safety. Clarity of tested and approved doses as well as dosage regimens is also needed in this context, ”said K Srinath Reddy, President of the Public Health Foundation of India. me.
“It is in the interest of science and the public confidence that all concerns related to any vaccine are adequately addressed. We cannot win this battle if we doubt the weapons that are handed to us, ”he added.
This article appeared first on: https://www.bbc.com/news/world-asia-india-55534902