FDA green-lights Novavax vaccine as COVID-19 levels rise

The Food and Drug Administration (FDA) yesterday approved an emergency use authorization (EUA) for the Novavax COVID-19 vaccine, bringing a fourth vaccine to the US market against the backdrop of a BA.5 Omicron subvariant surge and lagging vaccine and booster dose uptake.

Rollout awaits CDC recommendation

The FDA's approval allows distribution of the vaccine to begin, but before health providers can administer it, the Centers for Disease Control and Prevention (CDC) must recommend it. The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to discuss the topic on Jul 19.

In its announcement, the FDA said the vaccine is approved for use as a two-dose primary series in adults (ages 18 and older). The vaccine is made on a more traditional platform, which officials hope will sway more people to become immunized. The vaccine contains the SARS-CoV-2 spike protein produced in insect calls and contains the Matrix-M adjuvant as an immune booster.

The FDA's announcement yesterday came more than a month after its vaccine advisory board recommended EUA approval. Earlier this week, the Biden administration announced the purchase of 3.2 million Novavax doses.

The vaccine is already in use in other parts of the world, including European Union, the United Kingdom, South Korea, and Australia. The World Health Organization has also listed it for emergency use.

In a statement, Novavax said doses were shipped from the Serum Institute of India and are in the United States now.

In a related development, the European Medicines Agency today identified severe allergic reactions as a potential side effect of the Novavax vaccine and said it will also update the product information to include unusual or decreased feeling in the skin, according to Reuters. The US product label includes a warning about administering the vaccine to people who have had allergic reactions to any of the vaccine components.

US markers rising again

The 7-day average for new daily cases yesterday was 130,511, reflecting an increase following a relatively high but stable trend since late May, according to the New York Times tracker. The Times analysis also found that hospitalizations are rising—up 17% since Jul 1.

Nationally, nearly 60% of US counties are at moderate or high community transmission levels, according to the CDC. In Los Angeles County, the health director warned that the county may order an indoor mask mandate later this month if COVID-19 hospitalizations continue to rise, according to the Associated Press.

Booster dose uptake lagging

Earlier this week, top US health officials urged the public to get current with COVID-19 vaccinations, as the more transmissible BA.5 Omicron subvariant—known to evade protection afforded by vaccine and previous infection—is driving surges across the country.

Officials have urged people to get boosters, which are still useful tools for preventing severe illness and death. Only 34.1% of people ages 5 and older, however, have received their first booster dose, according to the CDC. And earlier this week at a White House COVID-19 briefing, CDC Director Rochelle Walensky, MD, MPH, said only 28% of those ages 50 and older have gotten their recommended second booster dose.

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