COVID-19 Update #105 for 10/19/2021

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.

• On 10/14/2021, the VRBAC voted 19 to 0 to recommend amending the EUA for the Moderna COVID-19 vaccine to include a booster dose of 50 mcg (100 mcg is used for the primary series) given at least 6-months after the primary series is completed in patients 65 or older or those 18 and older at high risk of severe COVID-19.
• On 10/15/2021, the VRBAC voted 19 to 0 to recommend an amendment to the Johnson & Johnson COVID-19 vaccine EUA allowing a second immunization with the vaccine for all patients 18 and older at least two months after the initial injection.
• After discussing the J&J booster, the VRBAC discussed use of a different COVID-19 vaccine than a patient initially received, as a booster dose. A pre-print draft of a 29-day, 458 patient, Phase I/II, NIH-sponsored study found that a booster dose increased antibody titers for all combinations of vaccines received. The largest increase was in patients who had originally received the J&J vaccine and then received a booster dose with either mRNA vaccine. In the study the primary series dose of the Moderna vaccine (100 mcg) was used, while Moderna is requesting use of a 50 mcg dose for a booster. VRBAC was supportive of using an mRNA vaccine after an initial J&J vaccination but did not make a formal recommendation.
• The CDC’s Advisory Committee on Immunization Practices will meet on Oct. 20 and 21 to discuss the boosters and make recommendations.

COVID-19 Vaccines
 
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.  
 
COVID-19 Antivirals
 
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.