A 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine.
Jack Guez | AFP | Getty Images
The FDA’s emergency authorization comes a day after Pfizer and BioNTech released initial lab data indicating that booster shots provide high levels of protection against the highly mutated omicron variant of the virus that causes Covid-19.
The preliminary data found that omicron significantly reduces the protection provided by the initial two-dose series. Boosters, on the other hand, fight the variant at levels comparable to the 95% protection provided by the two-dose series against the original strain of the virus, the lab results showed.
“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,” acting FDA Commissioner Janet Woodcock said in a press release. “With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
Regulators in the U.S. have been more hesitant approve vaccines for younger people due to concerns about myocarditis, a rare inflammatory heart condition that’s been found most prevalent in young men and thought to be related to testosterone levels.
The FDA on Thursday said it determined the benefits of the shots outweighed the risks of myocarditis after evaluating more real-world data.
The most common symptoms reported by people who have received boosters are pain, redness and swelling at the injection site as well as fatigue, muscle and joint point and chills, according to the FDA.
The Centers for Disease Control and Prevention still needs to authorize boosters for 16- and 17-year-olds before the shots are administered. The CDC cleared booster shots for all adults 18 and over last month.
Public health authorities in the U.S. are calling for everyone who is eligible to get a booster shot, amid fears of a winter Covid surge driven by the delta variant and uncertainty about the future course of the pandemic due to omicron.
The efficacy of the initial two-dose vaccination series was declining before the arrival of omicron. The journal Science published a study last month that found the effectiveness of Pfizer’s two-dose vaccine declined to 43% from 86% from February to October of this year.
The vice president of Pfizer’s vaccine clinical research program, Dr. John Perez, told a CDC advisory committee last month that the booster was 95% effective at preventing symptomatic infection in a clinical trial of 10,000 participants 16 years and older.