FDA approves use of Novavax COVID-19 vaccine as a booster dose

United States // 19 October, 2022

19 October: The Food and Drug Administration (FDA) authorised the use of Novavax's COVID-19 vaccine to be used as a first booster dose in adults ages 18 and older. The Centers for Disease Control and Prevention (CDC) followed up with their recommendation as well. The booster dose is available for use in adults who are at least six months past their primary series (with the Novavax, Moderna, or Pfizer/BioNTech vaccines).

20 August: The FDA announced it had "authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age."

19 July: The CDC's independent panel of advisors have recommended the Novavax COVID-19 vaccine for use in adults and this has been endorsed by the CDC Director. As a result, the Novavax shot will be made available for individuals ages 18 and older who have not yet received a COVID-19 vaccine.

13 July: The FDA has granted Emergency Use Authorization for Novavax's COVID-19 vaccine. The vaccine can be used in people aged 18 and older.

11 July: The United States government announced it has secured 3.2 million doses of Novavax's COVID-19 vaccine. If Novavax is granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and a recommendation from the CDC, the vaccine will be made available for administration.

In June, the FDA's expert committee on vaccines recommended granting an EUA for the Novavax shot in adults ages 18 and older. The vaccine company is expected to finish quality testing in the next few weeks, after which the FDA will make a decision about authorisation.

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