5:08 p.m. EST: Today, the Advisory Committee on Immunization Practices (ACIP) voted unanimously to approve the booster doses of Moderna (mRNA) and Janssen (Johnson & Johnson).
A Moderna booster has been approved for the same age and risk groups as the FDA did the Pfizer-BioNTech recall, and is available 6 months or more after completing the mRNA series (2 doses). The booster dose of Moderna will be 0.25 ml in volume, half the dose of the 2 original vaccines.
The Janssen booster (second vaccine) has been approved for people 18 years of age and older for 2 months or more after receiving the initial dose.
The meeting began with Dr Fink recapping yesterday’s FDA decision to allow heterologous COVID-19 booster doses of Pfizer-BioNTech, Moderna and Janssen vaccines.
Dr. Robert Atmar of Baylor College of Medicine presented data from the National Institutes of Health on heterologous or mixed booster doses. Atmar noted that the study was not intended to compare booster doses, but only to examine the safety and effectiveness of mixing different original vaccines and COVID-19 booster doses.
The smallest autoimmune boost came from a boost from Janssen after initially receiving Janssen, which Atmar attributed to the fact that Janssen’s immunity was weaker and took longer to reach his maximum.
During the public comment section, one participant expressed disappointment that the CDC did not extend recall recommendations to 50 and over. She noted that black and brown communities are less likely to live to age 65 because of health disparities. Other commentators representing older Americans and rural Americans have also called on the CDC to lower the age limit.
VAERS and v-safe presented data on the safety of Pfizer-BioNTech and Moderna booster doses. The data did not identify any adverse effects; vaccination errors and systematic symptoms were the most reported.
More than 189 million people in the United States are currently vaccinated (approximately 57% of the population). Moderna represents 37% of people who are fully vaccinated. Its effectiveness against COVID-19 infection decreases over time and against the Delta variant. Efficacy against hospitalizations was observed to be minimal or no in young adults and low in older adults.
8% of vaccinated Americans received Janssen, and although it has lower vaccine efficacy than mRNA vaccines, studies suggest that its protection against infection and hospitalization is persistent over time. All vaccines offered significant protection against hospitalization, as hospitalization rates remain 9 to 15 times higher in unvaccinated people.
Much of the discussion centered on myopericarditis and pericarditis after COVID-19 vaccination. The benefits of a Moderna booster are lessened for younger people because high efficacy is maintained from the original doses and the risk of myocarditis is increased. The Janssen boost may also be lower depending on the age group than an mRNA boost; The risk of STT is higher in young women. Adults 65 years of age and older have the highest risk / benefit ratio.
Overall, booster doses of Moderna, Janssen and Pfizer-BioNTech vaccines elicited strong serological responses. Heterologous boosters from all 3 had similar or greater immune responses as homologous boosters. The mRNA vaccines resulted in higher antibody titers during the first month after the booster.
Although ACIP is meeting to discuss booster doses, it was stressed that the top priority is the distribution of vaccines to unvaccinated people.