FDA authorizes Pfizer-BioNTech vaccine for children 5 to 11

The Food and Drug Administration's emergency action cleared the first pediatric coronavirus vaccine in the United States - a two-shot regimen administered three weeks apart. The dose, 10 micrograms, is one-third of that used for adolescents and adults. In a clinical trial of 5- to 11-year-olds, the vaccine was almost 91% effective at preventing covid-19, the disease caused by the virus. The vaccine's safety was studied in about 3,100 children who received the shot and had no serious side effects, the agency said.

"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," FDA acting commissioner Janet Woodcock said in a statement. "Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."

The issue of safety was a main focus of regulators and their advisers partly because the vaccine has been linked to rare cases of cardiac side effects in another group - male adolescents and young men. The symptoms of the side effects - myocarditis and pericarditis, which are inflammation of the heart muscle and lining, respectively - tended to be mild and treatable, doctors say.

The FDA authorization is the latest step by the Biden administration to extend the reach of vaccines in hopes of taming a dangerous and vexing virus. The inoculation of adults, which began last December, recently entered a new phase, with booster shots for all three vaccines used in the United States available for many. About 28 million children are in the newly eligible group of 5- to 11-year-olds.

But the process of getting vaccines cleared for younger school-age children has been fraught, with members of the FDA's outside advisory committee expressing some angst and disagreements during a vociferous public debate this week. In the end, the panel voted 17 to 0, with one abstention, to recommend the vaccine, agreeing with the FDA that the shot's known and potential benefits outweighed the known and potential risks - the criteria for an emergency authorization.

The discussion about the shot is expected to resume Tuesday when the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention, is scheduled to meet to recommend how to use the vaccine. After CDC Director Rochelle Walensky signs off, probably on the same day, providers, including pediatricians and pharmacists, will be able to begin administering the vaccine.

The debate over the shot points up the complexities of making decisions involving vaccines, which are nearly always intended for healthy people. Covid poses special challenges because "while children are at lower risk of bad outcomes, they are not at no risk," said Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania.

About 1.9 million children 5 to 11 years old have been infected, and at least 146 have died, according to federal health officials. Those infected are vulnerable to "long-haul covid," with lingering symptoms including fatigue, brain fog and respiratory problems, and a serious but rare condition called MIS-C, or multisystem inflammatory syndrome, which can cause inflammation of the heart, lungs, kidneys, brain and other organs.

In addition, Lynch said, there are other types of side effects that go beyond the strictly physical: "When children have exposures, they have to stay home from school and parents have to miss work."

Parents' uncertainty about the vaccine was captured in a new survey by the Kaiser Family Foundation that found only 27% of parents are planning to get their children vaccinated right away. A slightly larger group said they don't intend to have their children vaccinated. About one-third said they will "wait and see."

Trishan Arul, chief executive of a digital health company who lives in Cincinnati, said he plans to have his 7-year-old daughter vaccinated as soon as possible. But he is having second thoughts about his 10-year-old son.

"We may want to wait a little bit" until there is more information about the myocarditis risk for younger boys, he said. The complication did not show up in the trial, which was too small to detect such rare side effects. Arul said he might wait for a pediatric version of the Johnson & Johnson vaccine, which has not been linked to the cardiac ailment.

Pediatrician Elizabeth Meade at Swedish Medical Center in Seattle said she is convinced the vaccine is "highly safe and highly effective," and is eager to have her 7-year-old daughter vaccinated so the family can resume normal activities. But she acknowledged the decision is difficult for many parents.

"It's one thing to make a medical decision for ourselves and a different thing to make it for our kids," she said.

Jennifer Su, a pediatric cardiologist at Children's Hospital Los Angeles, said she tells worried parents that the chance of developing myocarditis or other side effects from the vaccine is much lower than harm from covid and that she strongly recommends the shot.

The safety issue was on full display this week when the FDA's outside advisers reviewed the pediatric vaccine. Many members wanted all younger children to get the shot while others suggested it should be reserved for children at high risk of severe covid, and urged the CDC to narrow its use.

James Hildreth Sr., chief executive of Meharry Medical College, said he wanted to make sure that those who really need it, including children of color, could get the vaccine. "But to be honest, the best way to protect the health of some kids would be to do nothing at all because they're going to be just fine," he said.

Another member of the committee, Eric Rubin, editor in chief of the New England Journal of Medicine and an adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, said in an interview this week he believes the vaccine will benefit children - but not as much as it has helped adults.

"So in that situation, we worry more about side effects" because the benefits are not as large, he said. "They are kids. The stakes are high."

Ultimately, however, the panel endorsed the shot without a single "no" vote.

Federal officials and some experts said it was highly unlikely the CDC would recommend any limits involving which children could get the vaccine. Any parents who want a shot for their child should be able to get one, they said.

In a call with reporters Friday, Peter Marks, who oversees vaccines at the FDA, underscored the point, noting that at least one-third of children who are hospitalized with covid do not have identifiable risk factors, making it important to make the vaccine broadly available.

"Everyone 5 to 11 is still at risk of serious disease," agreed Paul Offit, a vaccine expert at Children's Hospital of Philadelphia and a member of the FDA advisory committee. "I don't think [the CDC] will layer it."

Offit said there is always some uncertainty in trying to predict side effects that are so rare they show up only when vaccines are used in vast numbers of people.

"You go with the best data you have and hope you made the right decision," he said. "A decision not to release the vaccine is also a decision, one to let children potentially get infected and potentially die."

Peter Hotez, a vaccine expert at Baylor College of Medicine, said he was concerned that the FDA advisers, in debating the vaccine so vociferously, were "damning [the vaccine] with faint praise."

"It's great that people are seeing the sausage being made," he said, but some of the skeptical comments "could chill the acceptance of some parents of the vaccine."

But Paul Spearman, director of infectious diseases at Cincinnati Children's Hospital Medical Center and a member of the FDA advisory committee, said the debate was "just part of the process . . . that is what we are supposed to do, dig in deeper." Spearman did not take part in the meeting because he has worked on coronavirus vaccines, including Pfizer-BioNTech's.

He said he was confident doctors would be able to persuade the wavering "wait-and-see" parents to get their children vaccinated. "This group needs to see that their trusted health-care providers are in favor of it and that kids are doing great after they get it," he said.

The effectiveness data for the authorization came from an ongoing trial with about 4,700 children 5 to 11 years old who received the lower dose of the vaccine, the agency said. The FDA compared their immune responses to those of participants 16 to 25 years old who had received the adult dose in a previous study, and found the responses were comparable.

The trial was considered too small to detect rare complications, so the FDA produced an extensive analysis to try to determine the risk of cardiac side effects in children 5 to 11 years old. It compared the estimated number of covid-related illnesses, hospitalizations and deaths that would be prevented by the vaccine with the number of predicted myocarditis cases, hospitalizations and deaths caused by the vaccine.

Under most scenarios, the vaccine's benefits outweigh its risks. The only exception was when the virus was circulating at very low levels. Even then, the agency said, the benefits might very well outweigh the risks because covid is so much more dangerous than vaccine-induced myocarditis.

The FDA officials, in the call with reporters, tried to assuage parental fears about the potential of long-term side effects, including on their children's fertility.

"There is no evidence that there is an adverse effect on fertility" from the vaccine, Marks said. "And there is no reason why one would suspect" that mRNA vaccines such as those made by Pfizer-BioNTech and Moderna would harm fertility. He emphasized that the FDA and the CDC have several systems for monitoring vaccine safety for all age groups.

The FDA officials also said that although covid cases are declining, there could be a resurgence in cold weather and parents should not delay getting their children vaccinated.

As the release date for the pediatric vaccine approaches, anti-vaccine activity has exploded. FDA officials and members of the advisory committee report being deluged with emails and phone calls from people urging them to reject the vaccine and threatening lawsuits if they didn't. "I'm getting ugly, virulent emails," Rubin said.

On the other end of the spectrum, Piper Ryan, 46, is eager to get the vaccine for her 9-year-old son, Teague. He has been playing tennis and having outdoor play dates, but still is taking virtual classes at home. With the winter holidays approaching, they are both anxious for Teague to get his first dose.

Ryan, who lives in Great Falls, Va., said she wants to host Thanksgiving dinner with her extended family this year - it would be their first holiday gathering since the pandemic began. But Ryan said she would feel comfortable inviting out-of-state relatives only if her son had some protection against the virus.

"As soon as it is authorized, we're absolutely going to get him vaccinated," Ryan said.