FDA approves Pfizer booster for 16- and 17-year-olds
The effectiveness of the COVID-19 vaccine has been shown to wane months after the second dose of the primary series.
Photo: Luis Alvarez/Getty Images
The U.S. Food and Drug Administration has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a booster dose for 16-and-17-year olds at least six months after completion of the primary vaccine.
The EUA for a single booster dose of the Pfizer vaccine for individuals 16 and 17 years of age is based on the FDA's previous analysis of immune response data that supported the use of a booster dose in individuals 18 years of age and older.
The FDA analyzed the immune response data from approximately 200 participants 18 through 55 who received a single booster approximately six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine, when compared to the response one month after the two-dose primary series in the same individuals, demonstrated a booster response.
WHY THIS MATTERS
Effectiveness of the COVID-19 vaccine has been shown to wane months after the second dose of the primary series.
As colder weather brings people together, the Delta variant, and now the Omicron variant, continue to drive COVID-19 hospitalizations.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research said, "Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group."
THE LARGER TREND
On November 19, the FDA authorized the use of a single booster dose of the Pfizer vaccine for all individuals 18 and older.
Pfizer is currently the only vaccine to receive FDA approval as a booster dose for 16- and 17-year-olds. The two-shot primary vaccine series has been available for that age group for about a year.
"The Pfizer-BioNTech COVID-19 Vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks," Marks said by statement.
In August, the FDA granted Pfizer full vaccine approval.
ON THE RECORD
"Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19," said Acting FDA Commissioner Dr. Janet Woodcock.
"As people gather indoors with family and friends for the holidays, we can't let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19."
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
