Adolescents aged 12 to 15 may be eligible for the Covid-19 vaccine as early as Thursday. The US Food and Drug Administration said on Monday that the vaccine developed by Pfizer and its German partner BioNTech is safe and effective enough to be administered to younger teens under emergency use authorization.
The Centers for Disease Control and Prevention’s advisory committee is scheduled to meet on Wednesday to review the recommendation for authorization. “We know that this is a significant step for our country because vaccinating a younger population can bring us closer to a sense of normalcy and the end of this pandemic,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a Capitol Hill hearing Tuesday.
A study of 2,260 adolescents aged 12 to 15 years old discovered that vaccination resulted in a higher protective antibody response than in adults and was completely effective against symptomatic disease. None of the 16 COVID-19-infected trial participants had received the vaccine; all had received a placebo.
“Parents and guardians can be confident that the agency conducted a rigorous and thorough review of all available scientific data, as we have done with all of our COVID-19 vaccine authorizations,” Marks said on Tuesday.
The side effects observed in adolescents in the study were consistent with those observed in participants aged 16 to 25. According to the FDA, the most commonly reported side effects in adolescent clinical trial participants lasted 1 to 3 days and included pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain.
“With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose,” the FDA wrote. “It is important for vaccination providers and recipients to expect some side effects after either dose, but especially after the second dose.”
According to the FDA, the vaccine should not be given to anyone who has a known history of a severe allergic reaction to any component of the vaccine, including anaphylaxis. President Joe Biden stated last week that 20,000 pharmacies are ready to begin vaccinating adolescents once the necessary approvals are obtained.
Shots will also be available soon through pediatricians’ offices, according to the president. “And, if teens are on the move this summer, they can get their first shot in one location and a second shot in another.”
However, FDA officials stated late Monday that, while their authorization covers the entire country, each state may have its own rules about who can administer vaccines, so not all pharmacies or vaccination sites open to adults will be open to adolescents.
In addition to adolescent studies, Pfizer is conducting vaccine trials in 5- to 11-year-olds, 2- to 4-year-olds, and 6-month-olds to 2-year-olds, but those will take longer to complete, and shots for younger children are unlikely to be available before the start of the next school year. Since the Pfizer-BioNTech vaccine was approved in December, older teens between the ages of 16 and 17 have been able to obtain it.
Because studies are still ongoing, the other two vaccines approved for use in the United States, from Moderna and Johnson & Johnson, have not been made available to minors. “I urge all parents to have their children vaccinated. Some parents will not want to be the first. “But I’m also encouraging children to request the vaccine,” CDC Director Dr. Rochelle Walensky said at a hearing Tuesday, adding, “These kids want to go back to school.” They want to get back to doing what they enjoy.”