Today the Food and Drug Administration (FDA) approved the use of the Pfizer-BioNTech COVID-19 booster vaccine in adolescents ages 16 and 17.
The group will be eligible through an emergency use authorization (EUA) for a third dose of the mRNA vaccine 6 months after their initial vaccination series. Acting FDA Commissioner Janet Woodcock, MD, said the announcement will come in time to protect families during the holidays.
"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," Woodcock said in a press release.
The announcement comes almost exactly 1 year after the Pfizer-BioNTech vaccine became the first COVID-19 vaccine to receive an EUA in the United States.
"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 Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.
Marks said evidence of vaccine efficacy waning after two doses and the growing threat of the Omicron (B.1.1.529) variant warrant the new authorization.
Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, approved the FDA's decision to recommend a booster dose to teens ages 16 to 17.
"Although we don't have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants," she said in a press statement.
Vaccine uptake among children slows
The race to expand the pool of people who can be boosted in the United States takes place as initial vaccinations series for children ages 5 to 11 have slowed in recent weeks, according to the latest Kaiser Family Foundation analysis.
After 5 weeks of availability, only 16.7% of 5- to 11-year-olds have received a first dose of COVID-19 vaccine, and 4.3% of the 28 million eligible children are fully vaccinated. Uptake varies widely across the country: The percentage of children having received at least one COVID-19 vaccine dose was 45.6% in Vermont, compared with just 3.6% in West Virginia.
Eight of the ten states with the lowest vaccine coverage among 5- to 11-year-olds are in the South, while the states with the highest vaccine uptake in children are all in New England.
The CDC COVID Data Tracker shows that 60.4% of Americans are fully vaccinated against COVID-19, 71.4% have received at least one dose, and 24.4% of fully vaccinated Americans have received a booster dose.
Omicron: 43 confirmed US cases so far
As of yesterday, 43 Americans in 19 states have been infected with the Omicron variant so far, more than three-quarters were fully vaccinated, and nearly all of the cases have been mild, Walensky told the Associated Press. Only one of the patients has been hospitalized.
The United States reported 151,739 new COVID-19 cases yesterday, and 1,714 deaths, according to the Johns Hopkins COVID-19 tracker. In total, the country has tracked 49,613,909 cases, including 793,946 deaths.
Maine is now in crisis mode as hospitals announced they may have to ration care in the coming weeks if the pandemic gets worse, the Bangor Daily News reports. If that happens, Maine would join Idaho, Montana, and Alaska as states that would allow hospitals to prioritize patients most likely to live.
Maine is seeing a surge in cases, as is New York and New Hampshire. Governors of all three states have announced plans to deploy the National Guard in response to dangerously low capacity at statewide medical facilities due to the pandemic, CNN reports.
Other US developments
- The FDA yesterday issued an EUA for AstraZeneca's antibody drug Evusheld for prevention of COVID-19 in immunocompromised individuals.
- The Senate voted 52-48 yesterday to repeal the Biden administration's vaccine mandate for large businesses, Politico The vote is mainly symbolic, as the House of Representatives may not even take up the measure, and President Joe Biden can veto it.
- Pfizer CEO Albert Bourla told CNBCyesterday that while a third dose of the Pfizer-BioNTech vaccine should give people good protection against Omicron, people may need a fourth dose of the vaccine within a year.
