COVID-19 Update #99 for 9/15/2021

COVID-19 Vaccines
 
A CDC analysis of 1,175 U.S. veterans aged 18 years or > from five Veterans Affairs Medical Centers found overall vaccine effectiveness against COVID-19–associated hospitalization to be 86.8% with similar effectiveness before (February 1–June 30) and after (July 1–August 6) Delta variant predominance. Effectiveness was 79.8% for patients 65 years or greater compared to 95.1% for patients 18 to 64 years.
 
A CDC analysis of data from 32,867 patient visits in nine states from June to August 2021 found overall effectiveness to be 86% at preventing hospitalizations. Effectiveness was 76% for patients 75 years or greater compared to 89% for patients 18 to 74 years. Vaccine effectiveness to prevent hospitalization was highest for the Moderna vaccine at 95% compared to 80% for the Pfizer-BioNTech vaccine and 60% for the J&J vaccine.
 
A CDC analysis of data from 569,142 viral infections in 13 states found a higher risk for COVID-19 infections, illness, and death in unvaccinated compared to vaccinated individuals.
 
Booster Vaccine Doses
 

• In August, HHS announced the government’s plan for a booster (third) dose of the mRNA vaccines (Pfizer-BioNTech and Moderna) to begin in September, if approved by the FDA and recommended by ACIP.
• In a Viewpoint article in Lancet, Marion Gruber and Philip Krause, FDA top vaccine reviewers who recently announced their retirements, along with members of the WHO argued that data does not support administering a booster dose of COVID-19 vaccines. They feel that efficacy has not waned enough to justify a booster dose, we do not know enough about the safety and efficacy of a booster dose and reiterate WHO’s call for all countries to be vaccinated before booster doses are given. 
• On 9/17/2021, the FDA will hold a virtual meeting of the Vaccines and Related Biological Products Advisory Committee to discuss COVID-19 vaccine booster doses. The adcomm will also make a recommendation on whether a booster should be approved for the Pfizer-BioNTech vaccine. 
• NEJM will publish a final edit of an Israeli retrospective study of an HMO database. The unedited & unreviewed results published on an editorial server found a third dose of the Pfizer-BioNTech COVID-19 vaccine to decrease confirmed infection and severe infection in 1,144,690 individuals aged over 60. NEJM plans to publish the study online before vaccine adcomm meeting.

 
COVID-19 Antibodies
 
In a 30-day, 940 patient, Phase III, CONCOR-1 trial (NCT04348656), treatment with convalescent plasma did not decrease intubation or death compared to standard of care (32.4% vs 28%) in patients with COVID-19 receiving oxygen within 12 days of respiratory symptom onset. Patients that received convalescent plasma experienced more adverse events than standard of care (33.4% versus 26.4%).