The Serum Institute of India (SII) has sought governmnet permission to conduct a small local trial of US pharma major Novavax’s Covid-19 vaccine, which was given an efficacy rating of 89.3% in a UK trial.
Serum Institute CEO Adar Poonawalla confirmed that the company submitted the application for the “bridging trial” to the drug controller general of India a few days ago and the approval expected soon.
With Novavax have come out with the successful results of the vaccine, the clearance in India is expected to come through sooner.
Novavax’s UK trial, which enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, and the European Union.
SII, the largest vaccine maker in the world is already producing AstraZeneca-Oxford University vaccine at its factory in Pune with plans to step up the output to 50 million doses a month.
Given the huge demand worldwide a second vaccine would help to add to the capacity.
Indian rule stipulate bridging trials of foreign vaccines to ensure that they are safe and generate an immune response in local citizens whose genetic makeup can be different from people in western countries.
There are, however, provisions under rules introduced in 2019 to waive such trials in certain conditions. Pfizer Inc requested an exception while seeking an emergency-use authorisation for its vaccine developed with German partner BioNTech SE, a request the government has turned down.
