
The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax.1 The vaccine is indicated for use as a two-dose primary series to prevent COVID-19 in adults; it is not authorized for use in children or as a booster dose. Three other COVID-19 vaccines are available in the US for primary immunization of adults; the mRNA vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are FDA-licensed for this indication, and the adenovirus-based vaccine manufactured...
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ISSUE
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations.1 Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg.2,3 NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult …