COVID-19 updates
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The FDA proposed that each June the Vaccines and Related Biological Products Advisory Committee (VRBPAC) would meet and determine the composition of a COVID-19 vaccine to used as a booster or primary immunization in the fall. The FDA further proposed use of a bivalent vaccine for both primary and booster immunizations. Patients that have been immunized with a COVID-19 vaccine in the past would receive one vaccination. Patients who have not received a COVID-19 vaccination (i.e. young children) or those with a blunted immune response (i.e. elderly patients or immunocompromised patients) would receive two doses. The VRBPAC agreed and voted 21-0 to recommend a harmonized bivalent composition for COVID-19 for primary and booster vaccines.
In the 28-day, 26,411 patient, open-label, PANORAMIC trial, adding molnupiravir to usual care did not decrease hospitalization or mortality compared to placebo in vaccinated UK outpatients with mild-to-moderate COVID-19 at risk to progress to severe disease.
In a 28-day, 771 patient, Phase III trial (NCT05341609), oral remdesivir analogue, VV116 was non-inferior to nirmatrelvir–ritonavir in the percentage of patients that achieved sustained clinical recovery in Chinese adults with mild-to-moderate COVID—19 with at high risk to progress to severe disease. |
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