An independent federal advisory committee on Wednesday recommended that the Pfizer-BioNTech COVID-19 vaccine be administered to adolescents ages 12 to 15 — a move expected to be quickly approved by the Centers for Disease Control and Prevention.
Wednesday's decision — 14 in favor with one recusal — could open a new front in the fight against COVID-19 after the Food and Drug Administration's extension of its emergency use authorization for the Pfizer vaccine to cover adolescents. The CDC's anticipated endorsement will mean that many states will now allow the vaccine to be given to adolescents in this age group.
Previously, COVID-19 vaccines in the U.S. had been authorized only for people age 16 and older. Pfizer is the first vaccine manufacturer to gain emergency use authorization for younger Americans after it demonstrated in a March clinical trial that its vaccine was 100% effective in preventing COVID-19 in study participants who were ages 12 to 15.
"We're ready," President Biden said in an address Wednesday afternoon. "This new population is going to find the vaccine rollout fast and efficient. As of tomorrow, more than 15,000 pharmacies across this country will be ready to vaccinate this age group."
Although publicly waiting for the CDC and FDA authorization process to play out, the Biden administration has been quietly laying the groundwork to immediately roll out vaccines to adolescents.
That includes aggressively working to sign up pediatricians and family practitioners to begin administering doses to their patients, making sure pharmacies are ready to serve younger patients and reaching out to Medicaid providers, since 40% of the nation's children are insured through the Children's Health Insurance Program.
Notably, a White House official tells NPR, the administration plans to make sure smaller packages of Pfizer vaccines get to doctors' offices as soon as they become available. This has been a significant obstacle, since the Pfizer vaccine is currently delivered just in packages holding nearly 1,200 doses, more than many private practitioners can handle. Pfizer has said it plans to begin shipping smaller packages by the end of this month.
As summer winds down, there will be an additional back-to-school push to reach young people before they return to classrooms. The administration plans to work to have COVID-19 vaccines offered as part of annual physicals and sports physicals that kids and teens are often required to get before school starts.
Panel finds studies support use of the vaccine in adolescents
During a meeting lasting nearly four hours, the committee heard details of studies showing the vaccine prevented COVID-19 in more than 1,000 adolescents in the age range, while 16 cases occurred in those who got a placebo. No serious side effects were reported.
Public health officials, including those from the CDC and the independent advisers on the committee, said the vaccine will further help control the coronavirus pandemic in the U.S. and in other countries that typically follow the U.S. lead. Data presented by the CDC showed that about 20% of COVID-19 cases in the U.S. have been in children and adolescents 17 years of age and younger.
The American Academy of Pediatrics endorsed the move in a statement read during the meeting.
"This is truly an exciting development that allows us to protect a large population of children and help them regain their lives after a really rough year," said AAP President Lee Savio Beers. "As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected. The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated."
Comments from the public during an open session included questions of whether the relatively low risk of serious COVID-19 complications in children justifies the use of the vaccine in this age group before more studies are performed.
The study included more than 2,000 adolescents but was criticized by some public commenters for not being of sufficient size. Commenters also expressed concern that the studies were not sufficient to demonstrate whether there are any long-term effects associated with this or other COVID-19 vaccines.
CDC and Pfizer officials stressed study findings that show the vaccine is extremely safe in this age group, paralleling what has been seen in adults for several months now. More than 150 million people in the U.S. have received at least one dose of one of the COVID-19 vaccines, with a very low rate of serious side effects.
Authorization comes in time for summer
The authorization and endorsement come in time for many adolescents to get vaccinated before participating in summer activities such as camping and group sports. Efforts to get as many adolescents vaccinated as possible before school restarts in August and September are already underway.
In the pediatric studies, the CDC and FDA evaluated the same two-dose regimen separated by three weeks that is used for people age 16 and up.
While children and adolescents generally have milder symptoms if they contract COVID-19 compared with adults, they can nonetheless pass the coronavirus on to others. That has parents worried about the prospect of schools fully reopening in the fall.
"I think we should be in full school, full in-person school, in the fall," the CDC's director, Dr. Rochelle Walensky, said at a CNBC health summit on Tuesday.
Despite the Biden administration's push to get enough Americans inoculated against COVID-19 to establish herd immunity, the pace of vaccinations in the U.S. has slowed in recent weeks, with many adults opting not to get the shots.
CDC data shows that just over a third of Americans are fully vaccinated, with 46% having received at least one dose. While surveys have shown that only about 46% to 60% of parents said they plan to have their adolescent children immunized, opening up vaccinations for millions of adolescents would likely get the U.S. closer to the goal of herd immunity.
To aid in persuasion, the White House official says the Biden administration has already held webinars and listening sessions with the American Academy of Pediatrics and numerous education associations.
There will be more sessions later this week and into next week, including with the American Camp Association and Indian Health Service providers.
Over the coming days and weeks, there will be TV ads, social media campaigns and events with "celebrities and influencers who have the ability to reach out to teens and their parents." The White House declined to preview who these celebrities might be.
He's not a celebrity by any traditional definition, but U.S. Surgeon General Vivek Murthy is set to host a roundtable discussion with parents next week, aimed at answering questions about the vaccine.
In March, both Pfizer and Moderna launched pediatric trials of their vaccines in children as young as 6 months. Results are expected in the early fall. Neither company has applied to the FDA for emergency use authorization in children younger than 12.
Johnson & Johnson resumed shipments of its one-dose vaccine last month after U.S. federal regulators ended a 10-day pause in administering the vaccine while a potential link to a rare form of blood clot was examined.
The Moderna and Johnson & Johnson vaccines are currently authorized only for adults age 18 and older.
Meanwhile, states had already begun sending the Pfizer vaccine to pediatricians in anticipation of Wednesday's recommendation, according to The Associated Press.