The Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky's, MD, endorsement Thursday evening came after 2 days of deliberation from the CDC’s Advisory Committee on Immunization Practices (ACIP) where the group recommended the Moderna and Janssen COVID-19 vaccine “booster” doses.
8:30 p.m. EST: The Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has announced her endorsement of the Moderna and Janssen (Johnson & Johnson) vaccines for all Americans eligible for the booster dose who are at-risk for severe disease.
The Pfizer-BioNTech vaccine was already authorized and recommended by federal government agencies, so this latest development will pave the way for eligible Americans to have access to any of the 3 vaccines for booster doses.
“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe—as demonstrated by the over 400 million vaccine doses already given,” Walensky said in a statement Thursday night.
Essentially, this means those Americans who are eligible for the booster dose can choose to receive the Moderna, Pfizer-BioNTech, or Janssen (Johnson & Johnson) shot no matter which vaccine they had in their initial vaccination.
"And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating delta variant,” Walensky said.
5:08 p.m. EST: Today, the Advisory Committee on Immunization Practices (ACIP) voted unanimously to approve Moderna (mRNA) and Janssen (Johnson & Johnson) booster doses.
A Moderna booster was approved for the same age and risk groups as the FDA did the Pfizer-BioNTech booster, and is available 6 or more months after completing the mRNA series (2 doses). Moderna’s booster dose will be .25 mL volume, half the dosage of the original 2 vaccines.
The Janssen booster (second vaccine) was approved for persons 18 years and older for 2 or more months after receiving the initial dose.
The meeting began with Dr. Fink recapping the FDA’s decision yesterday to authorize heterologous COVID-19 booster doses of the Pfizer-BioNTech, Moderna, and Janssen vaccines.
Dr. Robert Atmar of the Baylor College of Medicine presented the National Institutes of Health data on heterologous, or mix-and-match, booster doses. Atmar noted that the study was not intended to compare between booster doses, but only to examine the safety and efficacy of mixing different COVID-19 original vaccines and booster doses.
The smallest autoimmune boost came from a boost of Janssen after initially receiving Janssen, which Atmar attributed to the Janssen immunity staring lower and taking longer to peak.
During the Public Comment section, one participant expressed disappointment that the CDC was not expanding booster recommendations to age 50 and older. She noted that Black and Brown communities are less likely to live to 65 due to health disparities. Other commentors representing older Americans and rural Americans also asked 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 most reported.
Over 189 million people in the US are currently vaccinated (~57% of the population). Moderna accounts for 37% of fully vaccinated people. Its efficacy against COVID-19 infection declines over time and against the Delta variant. Efficacy against hospitalizations was observed to be minimal or none in young adults and slight in older adults.
8% of vaccinated Americans received Janssen, and while it has a lower vaccine efficacy than the mRNA vaccines, studies suggest its protection against infection and hospitalization is persistent over time. All vaccines offered significant protection from hospitalization, as hospitalization rates remain 9-15 times higher in unvaccinated persons.
Much of the discussion centered around myopericarditis and pericarditis following COVID-19 vaccination. The benefits of a Moderna booster are lessened for younger persons, as high efficacy is maintained from the original doses and myocarditis risk is greater. Janssen boosting may also be smaller across age groups than an mRNA booster; TTS risk is higher in young women. Adults 65 years of age and older have the greatest benefit-to-risk ratio.
Overall, the booster doses of Moderna, Janssen, and Pfizer-BioNTech vaccines elicited strong serological responses. Heterologous boosts of all 3 had similar or higher immune responses as homologous boosts. The mRNA vaccines resulted in higher antibody titers in the first month after boosting.
Though ACIP was meeting to discuss booster doses, it was emphasized that the top priority is distributing vaccines to unvaccinated persons.