By putting the vaccine approval on hold for want of data, DCGI has underscored its priorities

With a single stroke of a pen, the Drugs Controller General of India has put to rest any doubts and concerns that it would rush to grant emergency use approval to COVID-19 vaccines tested and manufactured in India or elsewhere in the absence of supporting data.

With a single stroke of a pen, the Drugs Controller General of India has put to rest any doubts and concerns that it would rush to grant emergency use approval to COVID-19 vaccines tested and manufactured in India or elsewhere in the absence of supporting data.

The greatly reassuring decision to seek additional safety and immunogenicity data from the Pune-based Serum Institute of India and Hyderabad’s Bharat Biotech underlines the regulator’s priorities even for emergency use approval rather than early rollout of vaccines which have not been sufficiently studied.

Regulator true to its name

The decision to seek more evidence would mean a slight delay in locally manufactured vaccines becoming available for use. But it clearly demonstrates that the committee did not misread the recent announcement by Prime Minister Narendra Modi that a vaccine will be available in the next few weeks as a signal to grant approval in haste.

By keeping the approval on hold pending more evidence, the expert committee has done much to gain trust in the regulator’s uncompromising approval process even for emergency use in the midst of the pandemic. However, the two vaccine manufacturers have unfortunately come out as being in a hurry to seek approval without sufficient data to support their case.

Insufficient data submitted for approval

Bharat Biotech’s mad rush to seek approval is particularly concerning as the company had not submitted any data from phase-3 trial but relied entirely on the interim safety and immunogenicity data of phase-1 and phase-2 trials; the company had begun phase-3 trials only in mid-November.

While Serum had submitted interim safety and efficacy data of the Oxford vaccine from the phase-2/3 clinical trials carried out in India and other countries, the safety data of the Indian trial submitted was only till mid-November The phase-3 trials by Serum began on September 21, and since the second dose is administered 28 days after the first, the median follow-up after the second dose would have been for just a few weeks. The U.S. FDA had stipulated at least two months  after completion of the full vaccination regimen to assess a vaccine’s benefit-risk profile for emergency use approval.

With the published data of the interim phase-3 trial of the Oxford vaccine raising some concerns, the committee has rightfully sought immunogenicity data from the UK trial. While the UK has approved the mRNA vaccine from the U.S.-based Pfizer, no country including UK has approved the Oxford vaccine manufactured by London-based AstraZeneca.

Striking difference

In September, nine global vaccine manufacturers had signed a joint pledge that they would not seek premature approval from regulatory authorities and would test COVID-19 vaccines to the highest standards and keep the safety of trial participants as “top priority”. So Indian manufacturers should strive to carry out the trials to the highest ethical standards and submit comprehensive data such that emergency use approval is a sure shot. Any more haste shown in seeking approval for emergency use may turn detrimental and companies may even run the risk of losing public trust.

Even if India approves Pfizer’s vaccine first, there is no reason for companies to rush as there is room for more vaccines as no single company can meet India’s and global demand. Also, the uptake of Pfizer’s mRNA vaccine might not be much as it has a few drawbacks in terms of availability, cost and storage temperature.  

Published in The Hindu on December 11, 2020

One thought

  1. The decision by DCGI appears to be correct, no matter how the mad rush for the vaccine by politicians, particularly those like Trump (USA) and Johnson(UK), just to get their cuts (?). SII should provide the full data on phase III trials in India and not just those in UK. With so many dead already, mostly because of dirty living and habits and deprivation of cleanliness as well as total lack of community responsibilities, we Indians must wait till full clearance. With over 50% false negatives or false positives, Indian pathologist labs have still to learn how to conduct RT-PCR correctly. But, ads in all spheres of life, short-cutting all processes has become a way of life in India, you name them, right from Scientists to teachers, farmers, Businessmen, Industrialists, Engineers, Teachers, and most of all the Politicians! Even journalists cut corners to suit a political philosophy!

Comments are closed.