Novavax's COVID-19 vaccine could be the next to win FDA approval: 7 fast facts

Novavax may jump ahead of AstraZeneca as the drugmaker most likely to get its COVID-19 vaccine approved next by the FDA, Politico reported April 27.

Below are seven key details about Novavax and its COVID-19 vaccine:

  1. Novavax, founded in 1987 and based in Gaithersburg, Md., has never brought a product to market.

  2. The drugmaker's COVID-19 vaccine candidate is a subunit vaccine made of proteins resembling those on the surface of the novel coronavirus, which are meant to generate an immune response to the virus. It does not require ultracold storage, as do the COVID-19 vaccines produced by Pfizer and Moderna.

  3. Novavax began the first human study of the vaccine May 25. On Dec. 28, the drugmaker started a phase 3 clinical trial for its COVID-19 vaccine, making it the fifth drugmaker to enter phase 3 trials for a COVID-19 vaccine in the U.S.

  4. In July, the U.S. granted $1.6 billion to Novavax to develop and manufacture its COVID-19 vaccine candidate. The drugmaker has promised to deliver 100 million doses of the vaccine to the county.

  5. Novavax signed a contract Feb. 18 to sell 1.1 billion doses of its COVID-19 vaccine candidate to Covax, the initiative co-led by the World Health Organization to ensure equitable COVID-19 vaccine distribution across the globe.

  6. Novavax CEO Stanley Erck said March 1 the vaccine could be granted emergency use authorization by the FDA as early as May.

  7. Novavax said March 11 its COVID-19 vaccine was 96.4 percent effective in preventing COVID-19 during its phase 3 U.K. trial. The trial enrolled 15,000 participants between ages 18 and 84, with 27 percent being older than 65. Mr. Erck said Novavax hopes the FDA will allow it to use data from its U.K. trial during the approval process, as the drugmaker's 30,000-participant phase 3 clinical trial is still ongoing in the U.S. 

More articles on pharmacy:
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Cardinal launches pharmacy platform to improve medication adherence
Only 22% of unvaccinated Americans are willing to get J&J shot, survey says

 

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