Novavax offers US a fourth strong COVID-19 vaccine

World
By Editor_1
A participant in the Novavax vaccine trial at Howard University in Washington receives a dose on Jan. 22, 2021. Novavax, a small American company buoyed by lavish support from the US government, announced on Monday, June 14, 2021, the results of a clinical trial of its coronavirus vaccine in the United States and Mexico, finding that its two-shot inoculation provided potent protection against the coronavirus -Kenny Holston/THE NEW YORK TIMES
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By Carl Zimmer

WASHINGTON – Novavax, a small US company buoyed by lavish support from the US government, announced Monday (14) the results of a clinical trial of its COVID-19 vaccine in the United States and Mexico, finding that its two-shot inoculation provides potent protection against the coronavirus.

In the 29,960-person trial, the vaccine demonstrated an overall efficacy of 90.4%, on par with the vaccines made by Pfizer-BioNTech and Moderna, and higher than the one-shot vaccine from Johnson & Johnson. The Novavax vaccine showed an efficacy of 100% at preventing moderate or severe disease.

Despite these impressive results, the vaccine’s US future is uncertain and it might be needed more in other countries. Novavax says it may not seek emergency authorization from the Food and Drug Administration until the end of September. And with a plentiful supply of three other authorized vaccines, it’s possible that the agency may tell Novavax to apply instead for a full licence — a process that could require several extra months.

The company’s CEO, Stanley Erck, acknowledged that Novavax would probably win its first authorization elsewhere. The company is also applying in Britain, the European Union, India and South Korea.

By the time Novavax gets the green light from the US government, it may be too late to contribute to the country’s first wave of vaccinations. But many vaccine experts expect that, with waning immunity and emerging variants, the country will need booster shots at some point. And the protein-based technology used in the Novavax vaccine may do a particularly good job at amplifying protection, even if people have previously been vaccinated with a different formulation.

“They may be really the right ones for boosters,” said Dr. Luciana Borio, who was the acting chief scientist at the FDA from 2015-17.

Last year, the Trump administration’s Operation Warp Speed program awarded Novavax a $1.6 billion contract for 100 million future doses.

In January, Novavax announced that its 15,000-person trial in Britain found that the vaccine had an efficacy of 96% against the original coronavirus. Against Alpha, a virus variant first identified in Britain, the efficacy fell slightly to 86%. In South Africa, where Novavax ran a smaller trial on 2,900 people and the Beta variant was dominant, the company found an efficacy of just 49%.

But the South Africa trial was complicated by the fact that a number of the volunteers had HIV, which is known to hamper vaccines.

-New York Times

 

 

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