COVID-19 Update #136 6/30/2022

COVID-19 Vaccines
 
An FDA review of data available for the Omicron variant vaccines from Moderna and Pfizer-BioNtech found that both vaccines improved the neutralizing antibody response to Omicron BA.1. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2, on 6/28/2022, to recommend incorporating a component of the omicron variant into future COVID booster vaccines. The Omicron BA.4 and BA.5 subvariants now comprise more than 50% of COVID-19 cases. If the FDA requests a new booster vaccine to include these variants, Moderna and Pfizer-BioNTech would be able to create the vaccines by October. VRBPAC recommended a new booster be bivalent and contain BA.4 or BA.5 subvariants of Omicron.

• The FDA found that an investigational 50 mcg bivalent vaccine from Moderna, used as a fourth dose, elicited 75% higher antibodies for the Omicron BA.1 subvariant. 
• An investigational 30 mcg Omicron specific vaccine from Pfizer-BioNTech elicited 56% more antibodies. Pfizer-BioNTech presented data that demonstrated activity against the BA.4 and BA.5 subvariants in mice.
• An investigational COVID-19 vaccine from Novavax, that uses a protein-based vaccine, demonstrated antibodies that remained active against Omicron and its subvariants. Novavax will not have data on an Omicron specific vaccine until September.
• Moderna announced additional interim data from an 800 patient, Phase II/III trial, where an investigational bivalent COVID-19 vaccine, containing a combination of the original vaccine and an Omicron variant specific vaccine, used as a booster dose, increased neutralizing antibodies against BA.4 and BA.5 by 5.4-fold in all participants regardless of prior infection.
• Pfizer and BioNTech announced that in a 1,234 patient, Phase II/III trial, an investigational Omicron specific vaccine, given as a fourth booster dose, increased neutralizing antibody titers by 13.5 with a 30 mcg dose and 19.6 fold with a 60 mcg dose against Omicron BA.1. A vaccine that combined the Omicron vaccine with the original vaccine increased neutralizing antibody titers by 9.1 and 10.9-fold increase against Omicron with 30 mcg and 60 mcg doses.​
  

Sanofi and GSK announced that in the 13,000 patient, Phase III, VAT08 trial (NCT04904549), primary vaccination with two doses of their bivalent COVID-19 vaccine resulted in vaccine efficacy of 64.7% against any symptomatic COVID-19 disease, 72% effectiveness in preventing Omicron variant symptomatic cases.
 
A case–control test-negative study by the CDC found vaccine effectiveness to prevent COVID-19 hospitalization in infants born to mothers immunized with an mRNA vaccines to be 80% during the Delta variant dominant period and 38% during the Omicron dominant period. Administration, of the second COVID-19 vaccine dose after 20 weeks of pregnancy was more effective than when given before the first 20 weeks (69% vs. 38%).
 
An in-vitro analysis of neutralizing antibody titers in serum from 27 patients that had received two doses of the Pfizer-BioNTech COVID-19 vaccine and 27 patients who had been infected with the BA.1 or BA.2 subvariant found that titers were lower for BA.2.12.1, BA.4, and BA.5 subvariants than BA.1 and BA.2.