The U.S. Food and Drug Administration (FDA) announced an expansion of the use of COVID-19 booster shots for eligible populations.
On Wednesday, the FDA approved the use of a single booster dose of the Moderna COVID-19 vaccine to be administered at least six months after completion of the initial series. The Moderna booster shot can be given to people 65 years or older, high-risk individuals, or frontline workers who have increased exposure to the virus.
The FDA also approved the use of a single booster dose of the Johnson and Johnson COVID-19 vaccine to be administered at least two months after completion of the single-dose shot to individuals 18 years of age and older.
Additionally, the FDA approved the use of each of the available COVID-19 vaccines as a “mix and match” booster dose in eligible individuals. So, people can receive a different booster shot from their original vaccine. For example, people who initially received the J&J vaccine can receive the Moderna or Pfizer booster shots.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “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,” said Woodcock.
“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“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,” concluded Marks.
On Thursday, the Centers for Disease Control (CDC) advisory committee is scheduled to meet to review the data and make recommendations. The CDC director will then issue a formal recommendation.
—Information provided by the U.S. Food and Drug Administration.