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Covid-19: What you need to know today
It is important to note that SEC doesn’t approve vaccines, as some have suggested. It just recommends a course of action after looking at the data on hand.
Rarely do meetings of the Subject Expert Committee of the Central Drugs Standards Control Organisation get as much attention as the one that met on Wednesday did.
Some of the details of the proceedings have been reported, but here’s a quick run through — and why it matters. It is important to note that SEC doesn’t approve vaccines, as some have suggested. It just recommends a course of action after looking at the data on hand. If the data is insufficient, it asks for more before deciding what its recommendation should be.
On the agenda of the meeting on Wednesday were four items.
One was the approval of combined Phase 1/2 trials for one of India’s most promising Covid-19 vaccine candidates, the mRNA one being developed by Pune-based Gennova Biopharmaceuticals. This was granted (on the basis of data from animal studies), but with the caveat that the company would submit interim results from the first part of the trial before proceeding to the next.
The second was a discussion on Pfizer’s application seeking emergency use approval of it mRNA vaccine, which has been approved in the UK, and which, the US FDA indicated earlier this this week it would approve shortly. The company, however, asked for more time to prepare for its presentation to the committee.
The third was Bharat Biotech’s application for emergency use authorisation of its Covaxin Covid-19 vaccine based on data from Phase1/2 trials. Phase 3 trials are currently ongoing, and interim data isn’t expected before the end of the month. As this writer pointed out, Bharat Biotech’s action seemed to be prompted more by the desire to get in on the action — others were applying for approval for their vaccines, after all — than by logic. The results of the company’s Phase 1/2 trials have not been released publicly or published in a peer-reviewed journal, although they must have been satisfactory, because the Phase 3 trials were approved by the regulator. SEC did the right thing on Wednesday by asking the company to present data from its Phase 3 trials before its application could be considered.
The fourth was Serum Institute of India’s application for emergency use authorisation of Covishield, the vaccine developed by AstraZeneca/Oxford which the company is manufacturing. Dispatch 222 wrote in detail about the trial data on the basis of which the company sought approval. In this case, SEC said it would like to see safety and immunogenicity data from the ongoing Phase 3 trials of the vaccine in India, and also wait for the decision of the UK drugs regulator, which is currently evaluating AstraZeneca/Oxford’s application, before taking a call.
In all four cases, the committee was not pressured or influenced by the circumstances, and its decisions were based solely on logic, data, and science. This speaks well of the drugs regulator — regular readers of this column know that I rarely have kind words for anyone — and should reassure anyone who is worried that the desire to have its own vaccine could short-circuit India’s approval processes.
Postscript: One of the reasons I decided to write this column (back in March) was to try and be the voice of reason in all matters related to the pandemic. I’m not sure I have done that consistently. However, three people who have are Gagandeep Kang, Randeep Guleria, and Chandrakant Lahariya. Kang and Lahariya are active on Twitter, where they do a very good job of being voices of reason. Guleria has done the same on other platforms (he was my first choice as expert for a HT Leadership Summit discussion on Covid-19). The three of them have written a book called Till We Win: India’s Fight Against The Covid-19 Pandemic, which looks at both the macro picture (public health and policy) and the micro one (all your pressing Covid questions answered). One of the authors was kind enough to send me a copy. Not only is it an easy read, it is an important book driven by science, data, and reason.
