The Phase III human clinical trials of Covaxin began in mid-November 2020, involving 26,000 volunteers, between 18 and 98 years of age, across 21 sites. It was India’s first and only Phase III study for a COVID-19 vaccine, and the largest Phase III efficacy trial ever conducted here for any vaccine. The study included 2,433 participants over the age of 60 and 4,500 with co-morbidities.
The interim results of the trial released in late April 2021, showed an efficacy of 100 per cent against severe COVID-19 disease; the efficacy of protection from asymptomatic COVID-19 infection was 78 per cent, putting it at par with other global front-runner vaccines. The analysis was on a data set of 127 Covid-positive volunteers.
Data from 25,800 participants, half of whom received the vaccine and the other half a placebo, also showed that the vaccinated candidate was safe and well tolerated. A review of the safety database showed that severe, serious and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. This was again published in The Lancet.
Analysis from the NIV indicated that vaccine-induced antibodies could neutralize the known variants of concern including the delta variant.
This was all excellent news! Those results will always be a matter of great pride to us at the ICMR, which I will cherish for the rest of my life. There were critics who said that we had to complete Phase III before giving the vaccine to humans, before it could be given to the nation. But there is a Gazette notification of 19 March 2019, which is pre-COVID, and it said that in national interest, if a product has successfully undergone the Phase II trial, it can be deployed. In other words, emergency authorization can be given. And that rule was invoked by the Drugs Controller on 2 January 2020, when approval for Covaxin was issued.
The leadership had about, I would say, more than 15 meetings with various chief ministers of different states. And at that point in time, we had to participate and any question that was put forward for the vaccine or for the testing would come to me. So we were all on our toes at every level. But there was no question after the Emergency Use Authorization (EUA) happened. We were only asked how we could help out; the government would help the company to scale it up.
As we battled one challenge after another and found ways to deal with them, and firmed our resolve to have an Indian vaccine, a tiny section of our population—the so-called experts in the media and elsewhere—began to raise doubts on our ability. It was not the first time that an Indian initiative was being ridiculed even before it had the opportunity to succeed. But it was disgraceful that it should happen at a time when our scientists and researchers were showing a steely determination to find a solution to the pandemic.
It was the Macaulay-mindset at work. What had T.B. Macaulay done? He framed India’s education policy. He said that if the East India Company had to rule over this country, we have to systematically destroy its education system, drilling every Indian’s mind that the Indian education system is inferior to that of the British. This was instilled in 1834 in every Indian’s mind. It is this Macaulay mindset which is responsible for every Indian critic in India who feels that anything Indian can never work.
And that’s why I told Bharat Biotech in a lighter vein, that they should name their company after ‘another country’ Biotech not Bharat, for acceptability from the Macaulay-minded people! It was something I mentioned during my depositions before the Department Related Parliamentary Standing Committee on Health and Family Welfare and the parliamentary standing committee on ‘COVID-19 pandemic response, India’s contribution and the way forward’. I would like to put on record that the members of these panels were most supportive and praised the efforts of the ICMR. Cutting across party lines, they were also of the opinion that the work that the ICMR had done was phenomenal.
Once the Phase III clinical results came out, it laid to rest the criticism of the cynics. It is the vaccine which has more than 10 full scientific publications in top international journals, all featuring only Indian authors.
The approvals for Covaxin, contrary to criticism, were purely data-driven. Phase II trials established beyond doubt the immunogenicity of the vaccine. No responsible Subject Expert Committee (SEC) approves vaccines without adequate data, and those involved with the approval were all responsible people. Experts had taken into account the alpha variant of SARS-Cov-2 before granting approval to Covaxin. And because Covaxin is a whole-virus inactivated vaccine, as I mentioned earlier, it is equipped to target all parts of the virus instead of just partially. The virus is known to have undergone mutations in the spike protein also, and drug makers such as Pfizer Inc. have admitted that it needs about four to six weeks to make tweaks to their vaccine to adjust to the new mutations.
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