Indian Council of Medical Research (ICMR)’s director general Dr Balram Bhargava, secretary of the department of health research, talks about Covaxin, Bharat Biotech International Limited’s vaccine against the coronavirus disease (Covid-19) that has been developed in collaboration with ICMR, receiving approval from India’s drug regulator for restricted use in an emergency situation. Edited excerpts from an interview:
Ques: Two vaccines against Coronavirus disease (Covid-19) got approval for emergency use in India in a span of 24 hours; were such quick approvals expected?
Ans: The first joint monitoring committee meeting on Covid-19 vaccines happened on January 8, 2020, and in less than a year we have two vaccines in the pipeline that are ready to be used and granted regulatory approvals, which is indeed an extraordinary achievement. It has been a result of a pre-emptive, proactive and scientific approach by the members of the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) who deliberated for over eight hours looking in great deal at all the evidence at hand before recommending that these vaccines be granted emergency use approval.
Ques: Has there been sufficient data for grant of approval, especially in the case of Covaxin by Bharat Biotech that has received criticism for having inadequate trial data?
Ans: These kinds of approvals are purely data-driven, and in both these vaccines Phase 2 immunogenicity has been well established. The question of approving a vaccine without adequate data does not arise as the expert panel minutely scans the national as well international data presented to them before granting an approval. This is one of the best days for humanity as not just one but two of the vaccines have been approved. And this is good news not just for India but also for many low- and middle-income countries.
Ques: What does permission for restricted use in emergency situation in public interest mean that has been said for Covaxin?
Ans: The experts have looked at and taken into account the new UK strain (of Sars-Cov-2) before granting approval to Covaxin as they have kept in mind that Covaxin is a whole-viron inactivated vaccine (the whole virus vaccine) with more potential to target all parts of the virus rather than some parts. This also makes it a more effective tool against the new virus strain found in the United Kingdom. The virus is known to have undergone mutations also in the spike protein, and even Pfizer Inc. recently said that it needs about four to six weeks to make tweaks to their vaccine to adjust to the new mutations having been detected in the virus.
Ques: The data will be updated as the clinical trials progress; is that likely to change the status of approval?
Ans: Clinical trials will obviously continue and rolling review will also continue. It is not a one-off sort of a thing as we will be monitoring everyone who is vaccinated, and the data also gets updated accordingly. But having the option of two vaccines means their stockpile will be large, and the country is comfortably placed in terms of vaccination options.
Ques: How soon is the immunisation likely to start now that the regulatory approvals are in place?
Ans: This is for the Union ministry of health and family welfare to decide