|  | 


Covid-19: what you need to know today


Rarely do the meetings of the Committee of Experts on the Subject of the Central Organization for the Control of Medicines Standards receive as much attention as the one that met on Wednesday.

Some of the details of the procedure have been reported, but here is a quick summary and why it is important. It is important to note that the SEC does not approve vaccines, as some have suggested. It simply recommends a course of action after looking at the available data. If the data is insufficient, ask for more before deciding what your recommendation should be.

There were four items on the agenda for Wednesday’s meeting.

One was the approval of phase 1/2 pooled trials for one of India’s most promising Covid-19 vaccine candidates, the mRNA being developed by Pune-based Gennova Biopharmaceuticals. This was granted (based on data from animal studies), but with the proviso that the company would present the interim results of the first part of the trial before moving on to the next.

The second was a discussion about Pfizer’s application seeking emergency use approval for its mRNA vaccine, which has been approved in the UK and which the US FDA indicated earlier this week would approve. soon. However, the company requested more time to prepare its presentation to the committee.

The third was Bharat Biotech’s request for the emergency use authorization of its Covaxin Covid-19 vaccine based on data from phase 1/2 trials. Phase 3 trials are currently ongoing and no interim data is expected before the end of the month. As this writer pointed out, Bharat Biotech’s action seemed to be motivated more by a desire to get in on the action (after all, others were requesting approval of their vaccines) than by logic. The results of the company’s Phase 1/2 trials have not been made public or published in a peer-reviewed journal, although they must have been satisfactory, because the Phase 3 trials were approved by the regulator. The SEC did the right thing Wednesday by asking the company to submit data from its Phase 3 trials before its application could be considered.

The fourth was the Serum Institute of India’s request for the emergency use authorization of Covishield, the AstraZeneca / Oxford-developed vaccine that the company is manufacturing. Room 222 wrote in detail about the trial data on the basis of which the company requested approval. In this case, the SEC said it would like to see the safety and immunogenicity data from ongoing Phase 3 trials of the vaccine in India, and also await the decision of the UK drug regulator, which is currently evaluating the application. from AstraZeneca / Oxford, before taking a call.

In all four cases, the committee was not pressured or influenced by circumstances, and its decisions were based solely on logic, data, and science. This speaks well to the drug regulator (regular readers of this column know that I rarely have kind words for anyone) and should reassure anyone who is concerned that the desire to have their own vaccine could short-circuit approval processes. from India.

Postscript: One of the reasons I decided to write this column (in March) was to try to be the voice of reason in all matters related to the pandemic. I’m not sure I’ve done it consistently. However, three people who have done so 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 (it was my first choice as an expert for an HT Leadership Summit discussion on Covid-19). All three have written a book titled Until We Win: India’s Fight Against the Covid-19 Pandemic, which looks at both the macro (public health and policy) and micro (all your pressing Covid questions answered) landscape. 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.

Original source