The FDA’s expert panel just gave a thumbs-up for Pfizer’s COVID-19 vaccine in younger children, clearing the path for authorization in a matter of days

A group of kids wearing masks and backpacks walk toward their classrooms.
Students, some wearing protective masks, arrive for the first day of school at Sessums Elementary School in Riverview, Florida. AP Photo/Chris O’Meara, File
  • An FDA panel voted Tuesday in support of using Pfizer’s COVID-19 vaccine in younger kids.
  • Five- to 11-year-old children could get the shot in early November, if the FDA and CDC sign off.
  • Pfizer is applying to use a lower-strength dose in this younger age group.

A coronavirus vaccine for elementary school-aged children is closer than ever to reality, as a Food and Drug Administration expert panel voted Tuesday in support of offering Pfizer’s shot to 5- to 11-year-old children.

Out of the 18 voting members, 17 panelists voted yes and one member abstained.

With the committee’s endorsement, the Pfizer-BioNTech vaccine is set to become the first shot to be authorized for younger children. The vaccine was 91% effective at preventing symptomatic illness in this younger age group, a clinical trial found. The FDA has already OK’d Pfizer’s shot for people 12 years and older.

The FDA has not yet authorized Pfizer’s vaccine in this younger age group and isn’t required to follow the panel’s recommendations, although the agency typically does so. But the agency has already made clear it believes the benefits outweigh the risks, as agency staffers wrote in review documents released Friday.

The FDA is likely to reach an authorization decision before the Centers for Disease Control and Prevention’s advisory group meets on November 2 and 3. If the CDC’s review is also positive, that would clear the way for younger children to start receiving Pfizer’s shot as soon as early November.

Despite the positive vote, several members on the FDA’s panel said they are less confident in saying that every child should get the shot, or if it should only be recommended for kids at high-risk of severe disease for now, such as those who are obese, have asthma, or have weakened immune systems.

“I do believe children at high risk do need to be vaccinated,” panelist Dr. James Hildreth, president of Meharry Medical College, said. “But vaccinating all of the children to achieve that does seem a bit much for me.”

The question of how broadly the shot should be used is likely to be addressed by the CDC’s committee. That group is charged with making recommendations on how to roll out vaccines.

Dr. Eric Rubin, a panelist and editor-in-chief of The New England Journal of Medicine, said worries about the potential for a rare side effect, particularly a type of heart inflammation called myocarditis, are worth weighing in that decision. Despite those concerns, Rubin, Hildreth, and other panelists agreed the benefits outweigh the risks.

“We’re never going to learn about how safe the vaccine is unless we start giving it,” Rubin said. “That’s just the way it goes, and that’s how we found out about rare complications of other vaccines.”

Pfizer is seeking to use a smaller dose for this younger population, giving two 10-microgram doses of its vaccine spaced three weeks apart. Each Pfizer dose for older children and adults is 30 micrograms. The New York-headquartered company says the smaller dose still produced a strong immune response and was gentler in terms of side effects for children.

Reaching younger kids with shots could help quell the pandemic

The packaging and vials for the Pfizer-BioNTech coronavirus vaccine for 5- to 11-year-old children.
The -BioNTech COVID-19 vaccine will have special packaging for 5- to 11-year-old kids, using a lower-strength dose. Pfizer

Vaccinating younger kids is another step forward in a nearly two-year fight against the pandemic. Public-health experts hope this will not only stop children from getting sick with COVID-19, but more vaccinations will protect the broader population, by further dampening down the potential spread of the coronavirus.

Even as the number of new infections and deaths from COVID-19 each day has steadily dropped since a September peak, both figures remain high. The US is averaging about 70,000 new cases and more than 1,500 deaths daily, according to data from The New York Times.

Kids have largely been spared the worst outcomes of COVID-19, but there have still been thousands of cases of severe illness. Among children ages 5 to 11 years old in the US, the CDC has tallied 1.9 million cases, resulting in more than 8,600 hospitalizations and 166 deaths. In a presentation to the FDA’s committee, CDC scientists said children as at least as likely as adults to be infected.

Pfizer’s clinical trial enrolled 2,268 volunteers and recorded 19 COVID-19 cases, 16 among kids who got placebo shots and three cases in the vaccinated group. Across both the vaccinated and placebo groups, there were no severe COVID-19 cases or deaths. The most common side effects from the shot were injection-site pain, fatigue, and headache.

Even if OK’d, it’s unclear how many young kids will be vaccinated if a shot is available.

A Kaiser Family Foundation poll conducted in September showed parents of elementary school-aged children are split: 34% of parents said they would get their child vaccinated right away, while 32% said they would wait and see and 24% said definitely not. The other 7% said they would only if required.