The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on June 8, 21 and 22 to review use of Moderna and Pfizer/BioNTech COVID-19 vaccines in children under six.
The FDA expanded approval for remdesivir, on 4/25/2022, for children 28 days and older, who weigh at least 3 kg (7 lbs), if they are hospitalized or outpatients at high risk for progression to severe COVID-19.
Pfizer announced that in the 14-day, 2,597 patient, Phase II/III, EPIC-PEP trial (NCT05047601), prophylactic treatment with nirmatrelvir plus ritonavir did not reduce the risk of developing symptomatic COVID-19 compared to placebo in healthy patients exposed to a patient that developed COVID-19.
COVID-19 Monoclonal Antibodies
NIH does not recommend using bamlanivimab plus etesevimab, casirivimab plus imdevimab, nor sotrovimab for the treatment of COVID-19 due to lack of activity for the Omicron variant. NIH only recommends use of bebtelovimab when ritonavir-boosted nirmatrelvir (Paxlovid) or remdesivir are not available.
COVID-19 Convalescent Plasma
NIH recommends against the use of convalescent plasma that was collected prior to the emergence of the Omicron (B.1.1.529) variant. Convalescent plasma should not be used for treatment of COVID-19 in hospitalized, immunocompetent patients. NIH did not find sufficient evidence to recommend either for or against the use of high-titer convalescent plasma, collected after the emergence of Omicron for the treatment of immunocompromised patients and nonhospitalized, immunocompetent patients with COVID-19.
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