CoronavirusCovid-19Health

FDA Expands Use of COVID-19 Booster Dose

The FDA released an update to expand booster shot usage in eligible populations. The authorization of the emergency use of the Moderna and Janssen (Johnson and Johnson) vaccines comes as a precaution to help protect people from the COVID-19 virus.

Those who are 65 years and older are eligible for the booster shot. Along with the population, those between the ages of 18 and 64 who are at high risk of COVID-19 or have frequent institutional or occupational exposure to the virus are also eligible.

“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 suggests waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease,” said acting FDA Commissioner Dr. Janet Woodcock.

Mix and match booster shots have been part of the solution when working to find ways to further protect people from the virus. The FDA has approved the use of mix and matching booster shots with FDA-authorized or approved COVID-19 vaccines. Those who have received their primary single COVID-19 vaccine dose of the Janssen shot could receive a booster shot after two months of their primary dose with a Janssen, Moderna (half dose), or Pfizer-BioNTech shot if they meet the current eligibility requirements.

Those who have had their two primary COVID-19 vaccine doses of Modern or Pfizer BioNTech, can receive a booster shot of Moderna (half-dose), Pfizer-BioNTech or Janssen at least six months after primary vaccinations.

“We are also taking action today to include the use of mix and match boosters to address this public health need. We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

In their release, the FDA stated the authorization of the emergency use of the Moderna COVID-19 booster dose came about after analyzing immune response data from original clinical studies of 149 participants receiving booster shots ages 18 and older after at least six months of their second shot and compared it to the immune responses of 1,055 study participants that finished their two doses. The findings indicated a booster response 29 days after the booster dose.

Authorization of the emergency use of the Janssen COVID-19 vaccine booster dose was due to the immune response data that indicated a booster response from study participants receiving a booster dose about two months after their first dose.

The FDA’s release also included how the FDA’s evaluation was based on “immune response data in 39 participants from a clinical trial including 24 participants who were 18 through 55 years of age and 15 participants who were 65 years of age and older,” the release said.

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