Editor’s Pick: more vaccines in the basket

(The Editor's Pick is a new newsletter from The Hindu that provides a snapshot of the most important stories from today's edition of our newspaper, along with a note from our top editors on why we chose to give prominence to these stories.)

In a major shift in vaccine approval policy, precipitated by the record number of new cases that the country is registering day on day, the government has decided to fast track approvals for COVID-19 vaccines that have been developed outside India and have been granted the emergency use authorisation (EUA) by other drug regulatory agencies.

The vaccines that would be eligible for the fast-track approval will include those that have been approved by regulatory agencies in the U.S., the U.K., Europe, Japan or those that find mention in the World Health Organization’s list of approved emergency use vaccines. This would include the Pfizer, Moderna and Johnson and Johnson vaccines.

While so far there have been no tie-ups with Pfizer and Moderna by any vaccine manufacturer in India, Hyderabad-based Biological E (Bio E) has tied up with Johnson and Johnson to test and manufacture the vaccine locally. Since the decision also allows imports of bulk drug material and fill and finish locally, it is likely that India will have access to Johnson and Johnson vaccine at the earliest. The fast-track approval process would mean that local clinical trials or bridging studies as they are called, will take place in parallel to mass vaccination. So far, clinical trials conducted in India were needed before the Indian regulator could approve the vaccine. This was believed to be one of the sticking points when Pfizer had earlier applied for an EUA in India for its vaccine

Bridging trials are critical since a vaccine that is approved in a different country may have untoward effects in another population. However, as The Hindu’s editorial today notes, India is in a crisis, and it is still a mystery why the government did not plan for enough stocks like the U.S and the U.K. did. Now, it seems we are finally learning from their example by conceding that no country can be entirely ‘atmanirbhar’ in vaccinating its population. It is important to remember though that while this move to expand the basket of available vaccines is welcome, it cannot be assumed that choice translates to immediate availability. India must now compete with other global bids for these vaccines to ensure their availability for its adult population. With more vaccines come inevitably more complications associated with adverse events and side effects and that is another area where vigilance must be stepped up. These factors mark this story out as our top pick of the day.

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