The U.S. Food and Drug Administration granted Novavax’s COVID-19 vaccine Emergency Use Authorization (EUA) after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
On June 7, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0, with one abstention, to recommend authorization of the vaccine. FDA briefing papers released prior to the advisory committee meeting expressed concern over four cases of myocarditis, or heart inflammation, that were seen in pivotal clinical trials. This is the same issue reported with other vaccines, especially the AstraZeneca-Oxford product, although it has also been observed with the Pfizer-BioNTech and Moderna vaccines. All the incidences are very rare.
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