Novavax's COVID-19 vaccine scores WHO emergency listing, opening up supply to COVAX

Novavax has taken another major step toward expanding the reach of its COVID-19 vaccine, Covovax, despite a filing delay with the U.S. FDA.

The World Health Orgnaization has granted an emergency use listing for Covovax (NVX-CoV2373). The license means Novovax and its manufacturing partner Serum Institute of India (SII) can now start shipping the vaccine to the COVAX program, a global initiative that provides vaccines to low-income countries and other regions.

Before the WHO’s blessing, Novavax and SII have in November won a global-first authorization for the vaccine in Indonesia. But the pair has yet to crack the developed market, with a much-delayed FDA emergency use authorization filing expected by the end of 2021.

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Covovax is a recombinant protein-based vaccine co-formulated with Novavax’s Matrix-M adjuvant to enhance an immune response. In a large-scale phase 3 study conducted in the U.S. and Mexico during the first half of 2021, the vaccine cut the risk to moderate-to-severe COVID by 100% with an overall efficacy against COVID of 90.4%, according to detailed results published Wednesday in the New England Journal of Medicine.

The two-dose vaccine, given intramuscularly 21 days apart, can be stored at 2 to 8 degrees Celsius. That means it can be stored and shipped in normal refrigeration conditions, giving it a logistics edge for utilization in rural areas.

In February, Gavi, the Vaccine Alliance, signed up for 1.1 billion doses of the Novavax shot for supply to COVAX. Novavax has said it expects to have the capacity of 2 billion doses per year starting 2022. It’s not immediately clear how many doses Novavax and SII plan to ship after the WHO authorization. Novavax didn’t respond to a Fierce Pharma request for comment by publication time.

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So far, the majority of COVID vaccines shipped to low- and middle-income countries are provided by a partnership between AstraZeneca and SII and companies in China.

Meanwhile, Novavax is making inroads with higher-income countries. A conditional marketing authorization from the European Medicines Agency could come next week, the Financial Times reported Thursday. In Japan, Novavax’s partner Takeda has filed the vaccine, known as TAK-019 in the country, to local health authorities. Novavax also has submitted regulatory filings in the U.K., Australia and Canada.

But the Maryland-based biotech previously hit a snag with the FDA related to manufacturing issues. In announcing the Japanese filing on Wednesday, Novavax said it still aims to finish the chemistry manufacturing and controls data package with the FDA by the end of the year.