Serum Institute of India seeks permission for local trials of Novavax vaccine

Serum Institute of India (SII) has applied to the DCGI to conduct a small domestic trial of Novavax’s COVID-19 vaccine, which was found to be 89.3 per cent effective in a UK trial.

Serum expects a decision on an Indian trial of Novavax’s vaccine soon, Adar Poonawalla, CEO of Serum Institute of India told Reuters, hours after the US company reported the efficacy data.

“We have already applied to the drug controller’s office for the bridging trial, a few days ago. So they should also give that approval soon now,” Poonawalla said. “

Novavax’s UK trial, which enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, the EU and other countries.

SII is already bulk producing a vaccine created by Oxford University and AstraZeneca, and Poonawalla told Reuters earlier that his company would manufacture “upwards of 40-50 million doses per month” of the Novavax vaccine from around April.

Indian health officials ask for bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in western nations.

There are, however, provisions under rules introduced in 2019 to waive such trials in certain conditions. Pfizer 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.

The Pfizer vaccine has not been approved in India, whose immunisation campaign is using a homegrown one developed by Bharat Biotech and the Indian Council of Medical Research, and the AstraZeneca/Oxford University vaccine.