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Novavax says it plans to apply for US Food and Drug Administration (FDA) emergency use authorization for its COVID-19 vaccine in the second quarter of the year.
Gregory M. Glenn, MD, president of research and development at the Gaithersburg, Maryland-based company, said on a Washington Post live interview that he cannot give a specific date, but that it could come early in the quarter, which would be the beginning of April.
Glenn noted that Novavax has just completed enrolling the targeted 30,000 individuals in its main US trial — which also is being conducted in Mexico. The company must wait for 72 infections to occur after a second dose, which Glenn said he anticipated would take about 6 weeks.
“We’re expecting that result in right at the beginning of quarter two, so pretty soon,” he said.
“Shortly thereafter we would be filing for what we call EUA, emergency use authorization, in the US,” Glenn said. “Then deployment could come fairly quickly,” he added, noting that the FDA has been quickly reviewing COVID-19 vaccine data submitted by manufacturers.
Glenn also said Novavax is proposing to the FDA that it accept data from the company’s trials in the United Kingdom and South Africa as pivotal for US approval. That could shorten the EUA timeframe.
But he said people need to think of the COVID-19 effort not as a sprint, but as a marathon. “This virus is not going to go away,” said Glenn. “We’re going to need to boost. We’re going to need to have a strategy like with flu, where the virus changes.”
Novavax is also working on combining its influenza vaccine with its COVID-19 vaccine, he said.
The company is on track to produce 2 billion doses of its COVID-19 vaccine in 2021, said Glenn.
The Novavax vaccine, NVX-CoV2373, uses recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and also employs an adjuvant of a detergent-like particle. The vaccine stimulates high levels of neutralizing antibodies, according to Novavax.
In UK trials, NVX-CoV2373 demonstrated 89% overall efficacy in the setting of the circulating B.1.1.7 variant, and 96% against the original strain. In South African studies, it has shown 50%-60% efficacy against newly emerging variants in the country.
Alicia Ault is a Lutherville, Maryland-based freelance journalist whose work has appeared in publications including Smithsonian.com, the New York Times, and the Washington Post. You can find her on Twitter @aliciaault.
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