FDA authorizes Pfizer vaccine for ages 5-11

The Food and Drug Administration on Friday authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 5 to 11, a major step in making the shots available to school-aged kids by early November.

Acting FDA Commissioner Janet Woodcock said the shots were 91% effective against disease in trials and will help parents breathe a sigh of relief amid the pandemic.

“As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Dr. Woodcock said. “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.”

Efficacy data was based on a trial involving a little more than 2,000 children. 

The decision follows an FDA advisory panel vote to recommend the shots after a robust discussion in which panelists struggled at times over the need to vaccinate an age group that accounts for 0.01% of all COVID-19 deaths in the U.S.

Advisers weighed whether it would be better to recommend the vaccine for limited groups of children, given that many infected kids don’t show symptoms and the probability that a large percentage of children have caught the virus and have some level of immunity.

A separate advisory panel to the Centers for Disease Control and Prevention will debate next week how the vaccine should be used in the real world. The panel may issue guidance that advises specific groups ages 5 to 11 to take the vaccine instead of everyone in the age group, but it cannot expand the scope of what the FDA authorized.

Biden administration officials have said they will be ready to distribute the vaccine once the agencies weigh in. The vaccine for kids uses a smaller dose and will be packed with an orange label to distinguish it from the vials for older people.

Roughly 58% of the U.S. population is fully vaccinated. Federal officials say letting up to 28 million children ages 5 to 11 get the vaccine will improve rates as they try to reach immunity levels sufficient to make the virus a manageable problem in the background of society.

At the moment, the pandemic situation is improving after a September peak driven by the delta variant of the virus. Reported infections are down roughly 60% and hospitalizations are down over 50% since the apex last month.

Montana, Wyoming and West Virginia are the only states with more than 40 people per 100,000 hospitalized with the disease as the U.S. braces to see if vaccination levels are sufficient to stiff-arm the virus in colder months. Each of those states has a vaccination rate lower than the national average.

Unlike adults, children are largely dependent on their parents to decide whether they should be vaccinated.

Emmanuel “Chip” Walter Jr., chief medical officer of the Duke Human Vaccine Institute and a principal investigator in Pfizer’s trial in kids, said he hopes his own grandchildren get the vaccine.

“Children aren’t totally spared from COVID,” Dr. Walter told reporters in an online briefing Wednesday. “My advice to parents is the best way to protect your children from illness and potentially death from COVID is to get them vaccinated. It’s the best tool we have,” he said.

But fewer than one-third of parents plan to vaccinate their children “right away” once the shots become available to ages 5 to 11, according to polling released Thursday.

The Kaiser Family Foundation said 27% plan to act immediately. Another 33% of parents told KFF they would “wait and see” how the vaccine works in other children before making a decision, while 30%  said they definitely will not get the vaccine for their children ages 5 to 11.

More than three-quarters of parents, 76%, told KFF they are very or somewhat concerned that not enough is known about the long-term effects of the vaccine in children ages 5 to 11, while 71% were concerned their kids would feel side effects.

About two-thirds said they had concerns the vaccine may hurt their children’s fertility in the future. That is an often-repeated fear, even though there have been no signs the vaccines cause fertility problems and the CDC has encouraged pregnant people to get vaccinated.

Roughly half of the parents, 53%, said they are concerned their child would be required to get the vaccine even though they don’t want them to be immunized.

Ginny Merrifield, executive director of the Parent Inc. nonprofit that helps parents advocate for their public-school students, said parents were relatively comfortable about vaccinating children ages 12 to 17.

“Parents of younger children may be somewhat less enthusiastic, but I expect about 40-50% of younger kids will get vaccinated in the near term,” she told The Washington Times. “There are also many parents whose children are fully vaccinated as required for polio, MMR, chickenpox and other childhood illnesses, but who are not intending to vaccinate their children against COVID. They have weighed the risks and have legitimate concerns about the lack of long-term safety data for this particular vaccine. These parents strongly oppose the vaccine mandate.”

FDA advisers this week got an earful from parents who said their decision to recommend the vaccine might usher in mandates at schools.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, addressed the situation head-on during Tuesday’s meeting. He said the FDA is not in charge of mandates and the agency’s decision to authorize emergency use probably won’t trigger new rules in schools.

“In general, people have not done mandates with emergency use authorization,” he said. “And there have been certain governors who have already announced that they would not do a mandate until there was an approval as opposed to an emergency use authorization.”