The Food and Drug Administration approved the use of the Pfizer-BioNTech Covid-19 vaccine for 12 to 15 year olds in the United States on Monday. This is a critical step in the country's steady recovery from the pandemic and a blessing to tens of millions of American families eager to return to normal.
The permit includes weeks of anticipation for parents who have grappled with the way they are supposed to live their lives when only the adults in a household are vaccinated. It removes an obstacle to school reopening by reducing the risk of transmission in classrooms, and provides opportunities for millions of youngsters to attend summer camps, overnight stays, and get-togethers with friends.
"This is great news," said Dr. Kristin Oliver, pediatrician and vaccine expert at Mount Sinai Hospital in New York. "It seems we have waited a long time to protect children in this age group." The Pfizer BioNTech vaccine is available to everyone over the age of 16.
The release of the F.D.A. is not the last hurdle. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to review the data and make recommendations on the use of the vaccine in 12-15 year olds.
If the committee approves the vaccine for this age group as expected, the vaccinations could theoretically start immediately. Clinical studies have shown that these children can safely receive the dose already available for adults.
In a clinical study, Pfizer and BioNTech enrolled 2,260 participants, ages 12 and 15, and gave them either two doses of the vaccine or a placebo every three weeks. The researchers registered 18 cases of symptomatic coronavirus infection in the placebo group and none among the children who received the vaccine, suggesting that it was highly effective in preventing symptomatic diseases.
The vaccine appeared safe for these children too, with side effects comparable to those seen in study participants aged 16-25 years. Fever was slightly more common in vaccinated 12 to 15 year olds; About 20 percent of them had a fever, compared with 17 percent in the older age group.
The trend towards more fever in younger years was consistent with what was observed in a previous study, said Dr. Bill Gruber, senior vice president at Pfizer and pediatrician.
The test results were a “trifecta” of good news, added Dr. Gruber adds: “We have security, we have the immune response we wanted – it was actually better than what we saw in the 16 to 25 year old population – and we had direct evidence of its effectiveness. "
The company is still collecting information about possible asymptomatic infections by continuing to test study participants for the coronavirus every two weeks and check them for antibodies produced in response to a natural infection, according to Dr. Gruber.
Attempting to immunize children may reluctantly encounter the same problems that plagued attempts to vaccinate adults. In a recent survey, just over half of parents said their children are likely to receive a vaccine once one is approved.
Dr. Megan Ranney, an emergency doctor at Rhode Island Hospital in Providence, said she had "no safety concerns" about the Pfizer BioNTech vaccine, noting that hundreds of millions of people around the world have received it.
Her 12-year-old daughter is desperate to be vaccinated and her 9-year-old son will be vaccinated as soon as he is eligible, she said.
"The risk of your child catching Covid and getting really sick is small, but it's not zero," she said. "And the risk of getting sick or hospitalized or worse with Covid or with the post-Covid multi-inflammation syndrome is higher than the risk that this vaccine will cause something bad."
Vaccinating children protects others in the community from the virus, including people who are not protected by the vaccine, such as organ transplant recipients, cancer patients, and those with compromised immune responses.
"It also protects us all from the virus, which continues to spread and continue to mutate," said Dr. Ranney. "That's what I'm most afraid of right now."
Pfizer and BioNTech began testing the vaccine in children ages 5-11 in March and expanded the study to even younger children ages 2-5 last month. The companies next plan to test children aged 6 months to 2 years.
Assuming the trial results are encouraging, companies expect to see the F.D.A. in September for emergency authorization to give the vaccine to children aged 2-11.
Results of studies with Moderna's vaccine in 12 to 17 year olds are expected in the next few weeks. Results from another study of the company's vaccine in children aged 6 months to 12 years should be available in the second half of this year.
AstraZeneca is testing its vaccine in children 6 months and older. Johnson & Johnson plans to wait for the results of studies with participants older than 12 years before testing the vaccine in younger children.
Jan Hoffman contributed to the coverage.