The CDC genomic surveillance program continues to identify new and emerging SARS CoV2 variants and provides an estimated bi-weekly proportion of the most common variants circulating in the U.S. Currently, the more transmissible Delta (B.1.617.2) variant accounts for 99% of the sequenced COVID-19 cases in the U.S.

The Food and Drug Administration (FDA) gave full FDA approval for the Pfizer/BioNTech COVID Vaccine (Comirnaty) on August 23, 2021, becoming the first fully FDA approved COVID-19 vaccine. Following the FDA approval, the ACIP endorsed Comirnaty for its use in individuals 16 years and older.

When might we expect full FDA approval for other COVID-19 vaccines? Although a specific approval date has not been provided for the Moderna or Johnson & Johnson COVID-19 vaccines, Moderna has completed its FDA submission and requested priority review for full approval in 18 years of age and older. Johnson & Johnson has stated they plan to submit their application for full approval later this year.

In small studies of the fully vaccinated, immunocompromised people accounted for a larger percentage of breakthrough hospitalization. The ACIP now recommends an additional 3rd dose of COVID-19 vaccine for people who are moderate to severely immunocompromised that have received an initial 2-dose series. The FDA amended the Emergency Use Authorization (EUA) for the mRNA Moderna and Pfizer/Biotech COVID-19 vaccines to allow for use as an additional 3rd dose for certain immunocompromised people, and does not apply to the johnson & Johnson COVID-19 vaccine at this time.

ACIP meeting highlights included benefits and risks after Pfizer/BioNTech COVID-19 vaccination and framework for COVID vaccine boosters.

The CDC has released new data on the safety of COVID-19 vaccination in pregnant people and endorses vaccination against COVID in pregnancy in alignment with the American College of Obstetricians and Gynecologists (ACOG).

Although public health experts and the media have discussed mRNA booster doses, an official recommendation is pending FDA and ACIP review.

The upcoming Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for Sept. 17, 2021 will be discussing the Pfizer-BioNTech supplemental Biologics License Application for Cormirnaty for the administration of a third (“booster”) dose of the COVID-19 in people 16 years of age or older. Click here for additional meeting information.

The increase in cases due to the Delta variant with children and adolescents combined with back-to-school in-person learning has parents concerned with their children’s risk. Two articles in MMWR came to similar conclusions indicating children and adolescents are vulnerable to COVID-19 and that vaccinations combined with prevention strategies are the best way to protect them.

An article published in the New England Journal of Medicine (NEJM) looked at the risk ratio of vaccinated individuals of an mRNA vaccine (BNT162b2) versus vaccinated. In general, BNT162b2 was not associated with an elevated risk of most adverse events. The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons), but this risk and many other serious adverse events were higher after a COVID-19 infection.

A recent CDC health advisory addresses the rapid increase in ivermectin prescriptions and reports of severe illness associated with its use to prevent or treat COVID-19. Ivermectin is not authorized or FDA approved for prevention or treatment of COVID-19 and there is insufficient data to recommend its use.

On August 31, 2021 Ventegra hosted the COVID-19 webinar series Part 2 that included an interactive session with Dr. Park, M.D., PhD - Associate Clinical Professor in the Department of Infectious Disease, University of California Irvine. The session addressed pre-submitted questions by clients on a broad range of COVID-19 topics including COVID-19 variants, long-COVID and COVID-19 treatments. Please visit the Ventegra Resource page to access the recently recorded COVID-19 webinar or click here.

We will continue to update the Ventegra COVID-19 Resource Center as new information becomes available and encourage you to check back frequently.

Mark Shinmoto, Pharm.D., V.P. Chief Pharmacy Officer