India's Serum Institute to make Novavax's Covid vaccine for US market

US major Novavax has said its Covid-19 vaccine (NVX-CoV2373) for adults — to be used in the US following an approval from the USFDA — would be manufactured by its Indian partner Serum Institute of India (SII).

According to Reuters, Novavax’s Chief Medical Officer Filip Dubovsky said on Tuesday that all vaccines being distributed commercially across the world “are being made in a single facility by our partners (the Serum Institute in India — SII) that includes the vaccines which are being deployed around the world as well as the ones that will be initially deployed in the US”.

The company has indicated in the first quarter earnings call that it has reached a major milestone in its pathway to an emergency use authorisation from the US Food and Drugs Administration (USFDA), and a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is set for June 7, following “successful completion” of an inspection of the manufacturing site at SII.

On Tuesday, Novavax shares jumped nearly 20 per cent during the day’s trade after the VRBPAC recommended that the USFDA grant emergency use authorisation (EUA) for Novavax’s Covid-19 vaccine for people aged above 18. This brings the firm a step closer to a US launch.

The VRBPAC has voted strongly in favour of the vaccine — 21 to zero, with one abstention — Novavax said on its website.

“In today’s VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organisations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision,” Novavax said.

Meanwhile, SII is getting ready to work with its US partner Novavax on an Omicron variant-specific vaccine for Covid-19 that will be different from the original shot developed by the US major using the Wuhan strain of the Sars-CoV-2 virus. The Pune-based company has also received a nod from the Indian drug regulator’s office to manufacture trial batches of this vaccine for the purpose of testing, sources indicated.

Sources said the Drugs Controller General of India (DCGI) has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for “examination, test, and analysis”. Globally, Novavax is testing this Omicron BA.1-specific vaccine as a booster after two shots of the mRNA vaccine.

Novavax is developing a vaccine using the Omicron strain as the Sars-CoV-2 virus has mutated from the original Wuhan strain. Omicron has hit over 60 countries in the world and is the dominant strain in circulation.

Novavax is planning two types of Omicron vaccines — a monovalent and a bivalent option — and these are expected to be in the clinic (in clinical trials) later this month. Stanley C. Erck, president and CEO of Novavax, said in the first quarter earnings call that they are advancing an Omicron monovalent and bivalent option and it is expected to be in clinic later this month.