From AstraZeneca to Novavax: Serum Institute wins FDA nod to supply new COVID shot to US from India

With an FDA authorization for Novavax’s Nuvaxovid, Serum Institute of India (SII) has scored the go-ahead to finally supply a COVID-19 vaccine to the U.S.

Wednesday’s emergency use authorization for Novavax’s recombinant protein-based vaccine means SII is able to supply the shot, also known as Covovax, to the U.S. from India.

SII has been producing AstraZeneca’s Vaxzevria, but that adenovirus-vectored vaccine isn’t available in the U.S. The Novavax green light now makes SII the first Indian drugmaker to produce a COVID shot for the U.S. market.

All the Novavax shots that are being distributed globally commercially, including the ones that are initially deployed in the U.S., are manufactured by SII at “a single facility,” Novavax chief medical officer Filip Dubovsky said last month, according to Reuters.

The U.S. government had secured an initial 3.2 million doses of the Novavax shot following a positive recommendation from an FDA expert panel. A Novavax spokesperson previously told The Washington Post that some doses had already arrived in the U.S. on July 6.

Before Wednesday’s authorization, there were reports that Novavax had struggled to meet manufacturing standards, mainly around vaccine purity.

Novavax and SII’s belated arrival comes as the global demand for COVID vaccines ebbs. SII CEO Adar Poonawalla recently said the company had stopped making AstraZeneca’s shot after piling up 200 million doses as it couldn’t find any takers even free of charge.

In the U.S., about 90.6 million doses of various COVID vaccine doses have been tossed, The Wall Street Journal reported last week, citing data from the CDC.

Elsewhere, Novavax last May signed an advance purchase agreement with Gavi, the Vaccine Alliance, to supply up to 350 million doses of Nuvaxovid for potential distribution in low-income countries. Those were part of a memorandum of understanding covering a cumulative 1.1 billion doses of the shot, with the remaining supply of the agreement to be covered by SII.

Meanwhile, Novavax and SII are working on an updated omicron-targeted shot as a potential booster. In late May, Novavax launched a phase 3 trial for the omicron-specific vaccine, coded NVX-CoV2515, in Australia in people who had received ether a primary or booster series of an mRNA vaccine.