A federal advisory committee will meet Wednesday to decide whether to recommend Pfizer-BioNTech’s COVID-19 vaccine for adolescents ages 12-15.
The Food and Drug Administration signed off Monday on the shots, saying that the vaccine developed by Pfizer and its German collaborator BioNTech was safe in adolescents and protected them from getting COVID-19.
“This is a big step for our country. Vaccinating a younger population brings us closer to returning to a sense of normalcy and to ending the pandemic,” acting FDA Commissioner Janet Woodcock said.
The Centers for Disease Control and Prevention’s advisory committee will meet from 11 a.m.-5 p.m. EDT to discuss the safety, immune response and effectiveness of the vaccine in 12-15 year-olds, vote on whether to recommend the shots for younger adolescents, and review updated safety data on adults who received a vaccine made by Johnson & Johnson.
“The vote is very important because that vote issues the recommendation for use that clinicians go to in order to start giving the vaccine. At that point, it becomes a recommended standard of care,” said L.J. Tan, chief strategy officer with the Immunization Action Coalition.
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Assuming the committee recommends the Pfizer-BioNTech shots, they could be available as soon as Thursday, FDA officials said.
One consideration is that currently a two-week window of separation is recommended between a COVID-19 vaccine and any other vaccine, said Tan.
Between the ages of 10 and 12, children typically get the meningococcal and HPV vaccines, often at their back-to-school doctor’s visit. That would also be an easy time to get the COVID-19 vaccine.
“If you’re going to give a 12-year-old the COVID vaccine, and that 2 week window applies, how do you then give them the HPV vaccine? Will they come back two weeks later?”
Tan said the two-week window was mostly so that it would be clear whether the COVID-19 vaccine was causing side effects and that in general getting more than one vaccine at a time isn’t a problem.
“My speculation is the ACIP will come up with some fuzzy language that will say ‘Whenever possible try to avoid giving the COVID vaccine with another, but please don’t waste an opportunity to vaccinate a child,’” he said.
Because the dose is the same as for older teens and adults, they can be administered at all of the places now delivering shots, unless state law places limits on where minors can receive vaccinations, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a Monday news conference. In most states, shots are now available at pharmacies, mass vaccination clinics and healthcare centers.
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The CDC’s Advisory Committee on Immunization Practices will review data from a trial run by the companies. They tested the vaccine in more than 1,000 adolescents, giving an equal number a placebo. Among the 2,260 participants, only 16 developed COVID-19, all of whom received the placebo.
None of the adolescents suffered a severe reaction to the vaccine and side effects were in line with those seen in younger adults, largely short-lived pain at the injection site, fatigue, muscle aches and headache.
The same committee last December signed off on the Pfizer-BioNTech vaccine for adults and teens ages 16-17.
Other vaccine makers are also testing their shots in teenagers, but have not yet completed their studies or requested authorization to deliver their shots to minors.
Pfizer-BioNTech and the others are also testing their vaccines in three groups of younger children, stepping down in age: 5- to 11-year-olds, 2- to 4-year-olds and 6-month-olds to 2-year-olds. The first of those studies in older children is expected to be completed in late summer or early fall, but vaccines are unlikely to be available to these age groups before the start of the school year.
It may take until the end of the calendar year or early next year before there is enough data on the youngest children, Pfizer-BioNTech has said, because they may require lower doses of the vaccine, which need to be tested.
It’s unclear whether school districts and summer programs will require adolescents to be vaccinated, now that shots are available to them. Many colleges have said they expect students to be vaccinated before arriving on campus in the fall.
Contributing: Karen Weintraub, USA TODAY