On Thursday, the U.S. Food and Drug Administration (FDA) approved the use of Pfizer-BioNTech’s COVID-19 booster shot in people who are 16- and 17-years-old.
The move updates the emergency use authorization for the vaccine, allowing adolescents to get a third dose of the vaccine at least six months after their initial vaccination.
The FDA stated:
The FDA had analyzed the immune response data from approximately 200 participants, 18 through 55 years of age, who received a single booster dose 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. The FDA’s assessment of the effectiveness of a booster dose for individuals 16 and 17 years of age is based on these data. Based on the available data for individuals 18 and older regarding effectiveness, the FDA has concluded that these data support extending the eligible booster age population to 16- and 17-year-olds.
“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.”
“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,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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. A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.”
The question of boosters has been raised recently as pharmaceutical companies begin to push for even more doses.
As reported by The Daily Wire, “Pfizer CEO Albert Bourla revealed during an interview on Wednesday that he believes Americans will eventually need a fourth dose of the COVID-19 vaccine as concerns grow regarding the Omicron variant.”
CNBC’s “Squawk Box” Becky Quick asked Bourla, “Albert, Israel’s already working on fourth vaccination shots. What, what has it gotten them to that point where they think that that’s necessary and what are the results, the real world results, you’ve seen as, as a result of that?”
“I think we will need the fourth dose. I’ve said that multiple times. With the previous, I was projecting that that will be on 12 months after the third dose,” Bourla answered.
“With Omicron, we need to wait and see because we have very little information. We may need it faster,” he added.