S. E. Williams
On Wednesday, October 20, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations.
The agency is amending the emergency use authorizations 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 may be administered at least 6 months after completion of the primary series to individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
Johnson and Johnson
The use of a single booster dose of the 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 agency clarified that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.
Mix and Match
The agency also recommended the use of each of the available COVID-19 vaccines as a “mix and match” booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
“We are also taking action today to include the use of mix and match boosters to address this public health need,” advised Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research on Wednesday.
According to acting FDA Commissioner Janet Woodcock, these decisions demonstrate the agency’s 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,” said Woodcock.
She further noted that available data suggest there is waning immunity in some populations who are fully vaccinated. “The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
Marks advised that the FDA is working to accrue additional data as quickly as possible regarding the “Mix and Match” authorizations to further assess the benefits and risks of the use of booster doses in additional populations.
“[We] plan to update the healthcare community and public with our determination in the coming weeks,” he concluded.
On Thursday, the CDC followed the FDA and recommended Pfizer and Moderna booster shots for the following groups at 6 months or more after their initial series:
- 65 years and older
- Age 18+ who live in long-term care settings
- Age 18+ who have underlying medical conditions
- Age 18+ who work or live in high-risk settings
“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. 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, ” said CDC Director Rochelle P. Walensky.
Walensky further stressed, “[A]ll the vaccines are highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant.”
Header photo: (source: sciencenews.com)