FDA committee moves Pfizer-BioNTech COVID-19 vaccine closer to use for children ages 5-11
- The FDA's Vaccines and Related Biological Products Advisory Committee voted Tuesday to authorize use of Pfizer-BioNTech's COVID-19 vaccine in children ages 5-11.
- The Pfizer-BioNTech vaccine would be given in two shots, administered three weeks apart, at one-third of the dose given to adults and older children.
- The Biden administration has said that it has pre-purchased enough COVID-19 vaccine to cover the 28 million American children in this age group.
A federal advisory committee Tuesday voted 17-0 to authorize use of Pfizer-BioNTech's COVID-19 vaccine in children ages 5 to 11.
Children are far less likely than adults to be hospitalized with COVID-19 or suffer long-term consequences from the disease – putting a higher burden on the vaccine to prove safe and effective to justify its risk.
The committee of vaccine experts and pediatricians said that although they are concerned about the unknowns, they felt the data is sufficient to support using Pfizer-BioNTech's vaccine in that age group because it is likely to benefit far more children than it will harm.
Families that are particularly vulnerable to COVID-19 need to have access to the vaccine, several members said in describing their support for the measure. And the virus continues to pose a risk to children, they said.
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“It's very hard for me to believe that the risk for a severe outcome is going to come close to the known risk that we've seen for this virus in this age group," said Dr. Patrick Moore, a virus expert at the Pittsburgh Cancer Institute. "On top of that, thousands of kids that have been hospitalized, some of them are disabled from the virus, on top of the external cost to parents, to society, to schools, so forth. So to me, it seems like it's a hard decision, but a clear one.”
More than 40% of American children in the 5-to-11 age group have already been infected with COVID-19, according to one study presented to the committee. It is not clear whether adding a vaccine will provide more protection for those children.
Dr. Cody Meissner, a pediatric infectious disease specialist at Tufts Medical Center in Boston, said that while he supports making the vaccine available for that age group, he does not want the shots to be made mandatory.
Hundreds of children ages 5 to 11 have been hospitalized for COVID-19, and 94 have died this year. It was the eighth-leading cause of death in that age group over the past year, after accidents, cancer, malformations, murder, heart disease, chronic lower respiratory disease and flu or pneumonia.
September was the most dangerous month of the pandemic for American children, who appear to be more susceptible to the delta coronavirus variant that took off this summer than they were to earlier variants.
Children appear to be just as likely to catch COVID-19 and pass it on as adolescents and adults but less likely to become seriously ill or even notice that they are infected.
Every medical treatment can cause harm, and though the side effects seen so far with the Pfizer-BioNTech vaccine have been minor, it's possible more significant ones will appear as millions of children are vaccinated, a number of members noted.
"We're going to have to find a way to live with (COVID-19)," said committee member Jeannette Lee, a professor in the department of biostatistics at the University of Arkansas for Medical Sciences in Little Rock. "The vaccines give us a way to do that."
The vaccine would be given to children ages 5 to 11 in two shots, administered three weeks apart, at one-third of the dose given to adults and adolescents.
Moderna, which makes another COVID-19 vaccine, released its own study Monday finding that its vaccine at half the original adult dose is safe and effective in children 6 to 11. The company has not yet asked for authorization to provide its vaccine to this age group.
With the advisory committee's approval, three more steps remain before the Pfizer-BioNTech vaccine will become available to children. First, the Food and Drug Administration will have to sign off on the emergency use authorization, which is expected within the next few days.
Then another independent panel of experts, this time advising the Centers for Disease Control and Prevention, will review data on the safety and effectiveness of the Pfizer-BioNTech vaccine. If they give it a thumbs-up, CDC Director Rochelle Walensky will need to add her support before vaccines become available, which is likely as soon as the middle of next week.
The Biden administration has said it has purchased enough vaccine to cover the 28 million American children in that age group. Shots will be available soon at no cost in commercial pharmacies and some pediatricians' offices.
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The FDA's Vaccines and Related Biological Products Advisory Committee met all day Tuesday to hear information on the Pfizer-BioNTech vaccine from company officials as well as experts within the government who had reviewed the data.
Pfizer presented the results of several studies it has conducted among about 5,000 5- to 11-year-olds.
It found the vaccine to be safe, with no severe vaccine-related side effects, though as in adults and older children, many of those ages 5 to 11 did for a day or two have sore arms, fatigue, headaches, muscle pain, chills andlow-grade fevers.
In a subset of the children, the Pfizer-BioNTech vaccine was found to be more than 90% protective against contracting symptomatic COVID-19. Of the 19 children in the study found to be infected with COVID-19, only three received the active vaccine, compared with 16 who received a placebo.
In one of the studies, of about half the children, more than 11% had obesity and nearly 8% had asthma. Both groups appeared just as well protected from the vaccine as children without those conditions.
Children who had been infected with COVID-19 before responded the same way to the shots as those who had not been exposed to the virus, a Pfizer executive told the committee.
The studies were too small to detect myocarditis, a swelling of the heart muscle seen in a small number of teens and young adults, most of them male, after their shots.
Generally, myocarditis occurs more often in adolescents and young adults than in the younger age group, Dr. Matthew Oster, a pediatric cardiologist at Children's Healthcare of Atlanta, told the committee.
Cases of myocarditis are expected to occur and will be tracked by the government's multilayered system for identifying adverse reactions from COVID-19 vaccines, the FDA's Peter Marks said. No one has died from myocarditis after vaccination, and most have recovered quickly.
"We're never going to learn how safe it is until we start giving it," said committee member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and an immunologist at the Harvard TH Chan School of Public Health and Brigham and Women’s Hospital in Boston. "We're worried about a side effect that we can't measure yet, but it's probably real."
The studies did not detect any dangerous allergic reactions.
The FDA's analysis of different scenarios shows that unless COVID-19 cases fall to about 5% of September's rates, the benefits of vaccination outweigh risks in the 5-to-11 age group.
COVID-19 has also led to more than 5,000 cases of an immune overreaction in children, with an average age of 9. Children are less likely to have long-term symptoms of COVID-19 than adults, but they still can suffer from so-called long-haul COVID.
The Pfizer-BioNTech vaccine offered to children is the same formula as the one previously available except for the addition of one chemical called tri-sucrose. Tri-sucrose already is used in several other vaccines and makes the vaccine easier to dilute and stable in a refrigerator for up to 10 weeks, a Pfizer executive told the committee.
COVID-19 vaccines are now available to everyone over age 11, and many people are eligible for booster doses. Adults can receive one of three vaccines, from Pfizer-BioNTech, whose vaccine has been fully approved, and from Moderna and Johnson & Johnson, whose vaccines are still available under emergency use authorization.
The Moderna vaccine, tested in 4,753 children ages 6 to 11, was shown to be safe and to produce the same immune response seen in adolescents and adults, according to the company's study.
Pfizer-BioNTech completed its vaccine testing in children ahead of Moderna. J&J has not yet released any data on the safety or effectiveness of its vaccine in minors.
Contact Karen Weintraub at email@example.com.
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