FDA advisers to weigh risks and benefits of Novavax's Covid-19 vaccine

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FDA advisers to weigh risks and benefits of Novavax's Covid-19 vaccine
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After more than a year with two types of Covid-19 vaccines in use in the United States, another will be up for consideration by the US Food and Drug Administration next week.

The FDA's vaccine advisers are set to meet Tuesday to consider Novavax's coronavirus vaccine for the nation.Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe Covid-19 for a period of 2½ months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.

The trial will analyze the Omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.Two doses of either the Omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.

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