The US is getting another COVID-19 vaccine choice as the US Food and Drug Administration (FDA) on Wednesday cleared Novavax shots for adults.
Novavax makes a more traditional type of shot than the three other COVID-19 vaccines available for use in the US — and one that is already available in Europe and multiple other countries.
Nearly one-quarter of US adults still have not received their primary vaccinations and experts expect at least some of them to roll up their sleeves for a more conventional option — a protein-based vaccine.
Photo: Reuters
The Maryland company also hopes its shots can become a top booster choice in the US and beyond. Tens of millions of Americans still need boosters that experts call critical for the best possible protection as SARS-CoV-2 continues to mutate.
For now, the FDA authorized Novavax’s initial two-dose series for people 18 or older.
“I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Commissioner Robert Califf said in a statement.
Before shots begin, the US Centers for Disease Control and Prevention must recommend how they should be used, a decision expected next week.
Novavax CEO Stanley Erck said he expected the US to expand use of the vaccine beyond unvaccinated adults fairly quickly.
Already the FDA is evaluating it for those as young as 12, Erck said.
Novavax also has submitted data on booster doses, including “mix-and-match” use in people who had earlier received Pfizer or Moderna shots.
In related news, the European Medicines Agency (EMA) yesterday identified severe allergic reactions as potential side effects of the Novavax vaccine.
Novavax’s product label in the US warns against administering the shot to people with a history of allergic reactions to any components of the shot.
The EMA said it would also update the product information for the vaccine to add unusual or decreased feeling in the skin as a new side effect.
Only 250,000 doses of Novavax’s COVID-19 vaccine have been administered in Europe since its launch in December last year.
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