NEW DELHI: One of the two Indian vaccine makers — Serum Institute of India and Bharat Biotech — has presented additional data demanded by the apex drug regulator in response to their application for emergency use authorization of Covid vaccine.
Apart from SII and Bharat Biotech, Pfizer has applied for the EUA so far but the US based pharma major has sought more time to make a detailed presentation before the Covid subject expert committee of the Central Drugs Standards Control Organisation.
SII has reserved 50% of whatever quantity it manufactures for low-and middle-income countries.
After evaluating the applications by the other two companies on December 9, the committee had sought more data related to safety and immunogenicity.
“One of the two companies has now submitted the data and due process will be followed by the drug regulator in assessing it,” said V K Paul, member, health, Niti Aayog who also heads the Covid-19 National Task Force.
Amid fears of a new and highly contagious Covid variant originating from the UK, Paul said the current evidence suggest that the mutated virus is not affecting the severity of the disease.
“The new strain of COVID-19 in the UK has increased transmissibility. This mutation is not affecting the severity of the disease. Case fatality is not affected by this mutation,” said Paul.
He added that the new strain of coronavirus seen in the UK “has not been seen in India, so far.”
The Niti Aayog member added that there was “there is no cause for concern” and appealed the citizens to not panic over the mutation. “We need to stay vigilant.”
To a question on Covid vaccines and their impact on the new variant, Paul said that “as of now, it has no impact on the potential of the emerging vaccines being developed in our country and are available in other countries.”
Union health secretary Rajesh Bhushan, meanwhile, underlined that there has been a sustained decline in Covid cases in India since mid-September.