Govt seeks more data for full market clearance to Covishield, Covaxin

Approval for full market authorisation for both Covid-19 vaccines, Covishield and Covaxin, could take longer, with the subject expert committee of the national drugs regulator seeking more data from the manufacturers in its meeting on Friday.

Serum Institute of India (SII) and Bharat Biotech International Ltd, manufacturers of Covishield and Covaxin respectively, separately applied to the central drugs standard control organisation (CDSCO) to seek full market authorisation stating that more than a billion vaccine doses have been administered to beneficiaries under the national Covid-19 immunisation programme.

“The volume of doses administered is large enough, no doubt, but there were some specific queries that the panel had, and has sought additional data in a particular format for that purpose. Like in case of emergency use authorisation, for complete market authorisation also, the review needs to be thorough,” said an official familiar with the development, on condition of anonymity.

Full market authorisation is granted when there is enough data to demonstrate that the vaccine is safe and effective for most people who receive it.

SII locally manufactures the Oxford-AstraZeneca Covid-19 vaccine under the brand name Covishield.

On December 31, last year, SII CEO Adar Poonawalla announced through a tweet that it applied to India’s drugs regulator for full market authorisation to Covishield, citing adequate availability of the required data.

“Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission,” tweeted Poonawalla.

According to people familiar with the development, Bharat Biotech also moved its application for complete market authorisation for Covaxin last week.

Both the vaccines were granted approval for restricted use in emergency situation by the drugs controller general of India, VG Somani, on January 3, last year, and both the vaccines have been the mainstay of India’s covid immunisation programme.