The U.S. Food and Drug Administration on Monday amended an emergency use authorization to allow Pfizer’s COVID-19 booster shots for children ages 12 to 15, as well as lowered the timeline for getting a booster shot from six months after full vaccination status to five months.
The Centers for Disease Control and Prevention must give final approval before those younger children can receive booster shots. The CDC’s Advisory Panel on Immunization Practices meets on Wednesday to discuss whether to give final approval.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said acting FDA commissioner Dr. Janet Woodcock in a statement. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing to in order to effectively fight COVID-19.”
The FDA on Monday also approved booster shots for children aged 5 to 11 who have compromised immune systems. Boosters for those who received the Moderna vaccine remain available six months after initial vaccination. For those who received the Johnson & Johnson vaccine, boosters are available after two months.
In approving booster shots for children aged 12 to 17 the FDA reviewed data from Israel that included a study of more than 6,300 children aged 12 through 15 who received a booster dose at least 5 months following a two-dose vaccination series.
“The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals,” the FDA said Monday.
The FDA noted that Pfizer’s booster shot “greatly improves an individual’s antibody response to be able to counter the omicron variant” and that no new safety concerns came from the administration of booster doses among the more than 4.1 million people 16 and older in Israel, given at least five months after being fully vaccinated.
Vaccinations, and booster shots for those eligible, remain critical at preventing serious illness, hospitalizations and death from COVID, health providers continue to tell the public. Those protective measures are all the more important as Alabama’s COVID numbers worsen.
Alabama’s seven-day average positivity rate hit yet another record on Monday, at 36.4 percent. Public health experts say it should be at or below 5 percent or cases are going undetected.
COVID hospitalizations in Alabama broke 1,000 on Monday for the first time since Oct. 7, with 1,102 people hospitalized with the virus, a 179 percent increase over two weeks.
UAB was caring for 105 COVID patients on Monday, 74 of whom were unvaccinated. Twenty-two of the 28 patients in the ICU were unvaccinated and 10 of the 11 on ventilators were unvaccinated. The hospital’s 105 patients was a 62 percent increase from six days prior.