Policy & Value-Based Care

FDA: Update on the Use of a Booster Dose for COVID-19 Vaccines

Oct. 22, 2021

On Oct. 20, the FDA announced that it has taken action to expand the use of a booster dose for COVID-19 vaccines in certain populations, including the use of each of the available COVID-19 vaccines as a heterologous booster dose

Janette Wider

On Oct. 20, the U.S. Food and Drug Administration (FDA) announced it has taken action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. Last month, CDC Director Rochelle P. Walensky, M.D., recommended Pfizer COVID boosters for Americans most at risk for COVID-19, including those exposed due to occupational or institutional settings.

The announcement states that “The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:

The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least six months after completion of the primary series to individuals:

Sixty-five years of age and older
Eighteen through 64 years of age at high risk of severe COVID-19
Eighteen through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older
The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine
To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.”

The release explains the “mix and match” booster dose in eligible individuals, stating that “A single booster dose of any of the available COVID-19 vaccines may be administered as a heterologous booster dose following completion of primary vaccination with a different available COVID-19 vaccine. The eligible population(s) and dosing interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.”

Acting FDA Commissioner Janet Woodcock, M.D., said in a statement that “Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic. As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”