COVID-19 Booster Vaccines
In September, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow a booster dose, given at least six months after completion of the second dose to patients 65 years and older or who are at high risk for severe COVID-19, which includes healthcare professionals, frontline workers and people that live in group settings. The CDC agreed and also recommended a booster dose for these groups.
FDA reviews of booster doses of Moderna’s and Johnson & Johnson’s COVID-19 vaccines, suggested that while some evidence suggest a decrease in efficacy over time for symptomatic and Delta variant infections, the vaccines still provide protection against severe COVID-19 disease and death. The J&J review did note that higher efficacy with the mRNA vaccines. The FDA did not find any safety issues or increased reactogenicity with booster doses for either vaccine.
The FDA is delaying a decision on use of the Moderna COVID-19 vaccine in adolescents to allow more time to examine data on the occurrence of myocarditis. Some European countries have not approved use of the Moderna vaccine in adolescents due to myocarditis, which lead the FDA to more closely examine the data.
The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) will review molnupiravir for the treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, including hospitalization or death on 11/30/2021.
In the 28-day, 969 patient, Phase III, ACTT-3 trial (NCT04492475), adding subcutaneous interferon beta-1a to intravenous remdesivir did not decrease time to recovery or mortality compared to remdesivir alone in hospitalized patients with COVID-19.
Stay informed, subscribe to the Prescribe Right Pharmaceutical Pipeline Tracker