COVID-19 Update #135 6/21/2022

COVID-19 Vaccines
 
FDA reviews of the Moderna and Pfizer- BioNTech mRNA COVID-19 vaccines found them to be as effective for children 6 months to 5 years as in older children and young adults. No cases of myocarditis were experienced in this age group during trials.

• The Pfizer- BioNTech review estimated a three-dose regimen of the Pfizer-BioNTech to be 75.6% effective in infants 6 to 23 months and 82.4% for toddlers 2 to 4 years during an Omicron variant dominant period.
• The Moderna review estimated the vaccine effectiveness for a two-dose regimen of the Moderna vaccine to be:

                   • 93.3% for adolescents 12 to 17 years
                   • 76.8% for children 6 to 11 years
                   • 36.8% for toddlers 2 to 5 years
                   • 50.6% for infants 6 to 23 months

​Note: Only the results for children 6 months to 5 years were during an Omicron dominant period. The results are based on preliminary results and may not represent the actual effectiveness.
 
The FDA expanded use of both mRNA vaccines to all patients 6 months and older. The CDC expanded their COVID-19 vaccination recommendations to include the same age groups.

• The FDA’s Vaccine and Related Biologics Advisory Committee voted 21 to 0 to recommend an EUA for the Pfizer-BioNTech COVID-19 vaccine for infants and toddlers 6 months to 4 years. The FDA granted an EUA for the Pfizer-BioNTech COVID-19 vaccine on 6/17/2022 for infants and toddlers 6 months to 4 years.
• The Advisory Committee also voted 21 to 0 to recommend an EUA the Moderna COVID-19 vaccine for children 6 months to 17 years. The FDA granted an EUA for the Moderna COVID-19 vaccine on 6/17/2022 for children and adolescents 6 months to 17 years.
• The CDC’s Advisory Committee on Immunization Practices’ (ACIP) added a recommendation to their COVID-19 immunization guidance for all children 6 months through 5 years of age. The CDC endorsed the recommendation on 6/18/2022.

An analysis of data from an Israeli managed care health system of patients 60 and older found the relative effectiveness of the Pfizer-BioNTech COVID-19 vaccine for patients who received a fourth dose was 65.1% compared to three doses two weeks after the fourth vaccination. But relative effectiveness began to decline during the fourth week and the two groups were at similar levels by week five. Vaccine effectiveness was 22.0% by week nine.
 
An analysis of data from a Qatar healthcare database found effectiveness against the Omicron BA.2 variant to be:

• 46.1% after a previous COVID-19 infection
• Negligible six months after two doses of the Pfizer-BioNTech COVID-19 vaccine
• 52.2% after three doses of the Pfizer-BioNTech COVID-19 vaccine 
• 55.1% after a previous COVID-19 infection plus two doses of the Pfizer-BioNTech COVID-19 vaccine
• 77.3% after a previous COVID-19 infection plus three doses of the Pfizer-BioNTech COVID-19 vaccine
• Similar results were observed for the Omicron BA.1 variant and vaccination with the Moderna COVID-19 vaccine.

Sanofi and GSK announced that in the 1,500 patient, Phase III, VAT02 trial (NCT04762680), vaccination with their COVID-19 booster vaccine after an mRNA vaccine doubled antibody titers for Omicron BA.1 and BA.2 compared to the their original booster vaccine. 
 
Sanofi and GSK announced that in the 247 patient, Phase III, COVIBOOST trial (NCT05124171), a booster dose after two doses of the Pfizer-BioNTech COVID-19 vaccine resulted in a 10-fold increase in antibody titers in:

• 76.1% who received the Sanofi-GSK next-generation booster.
• 63.2% who received a booster with a third dose of the Pfizer-BioNTech vaccine.
• 55.3% who received the original Sanofi-GSK booster candidate.​

COVID-19 Antivirals
 
Pfizer announced that in the 28-day, 1,153 patient, Phase II/III, EPIC-SR trial (NCT05011513), treatment with nirmatrelvir plus ritonavir did not increase resolution of symptoms compared to placebo in patients with COVID-19, who were at standard risk for developing severe COVID-19.