Some 28 million American children between 5 and 11 years old could soon be able to get their first doses of Pfizer’s. A panel of the Food and Drug Administration’s outside vaccine advisers to back authorization of the shots for children as young as 5, and the final steps are just days away.
The first shots of Pfizer’s smaller doses formulated for children could be administered as soon as Wednesday, November 3.
But first, the shot must clear three more key regulatory hurdles at the FDA and Centers for Disease Control and Prevention before they can be rolled out to younger children:
This week, the FDA is expected to issue emergency use authorization for the shots.Ads
Next, the CDC’s own panel of outside vaccine advisers is scheduled to meet on Tuesday to discuss the COVID-19 vaccine for children.
Finally, the CDC director must formally issue guidance adopting the committee’s recommendations.
Here’s what we know about what will come next:
The CDC could narrow eligibility for the shots
Asked if the benefits “outweigh its risks for use” in children as young as 5, the FDA’s outside vaccine advisers voted in favor of expanding emergency authorization for Pfizer’s pediatric shots, with one abstention. However, some expressed reservations.
Several of the FDA’s advisers said they hoped their counterparts on the CDC’s panel of outside experts, the Advisory Committee on Immunization Practices, would further refine or narrow eligibility for the shots.
“I think we have to very carefully monitor the safety profile of this vaccine going forward, if the ACIP does recommend it, and hopefully it will be for those children who have other risk factors,” said Dr. Cody Messiner, one of the FDA’s advisers.
The panel’s decision came after a day-long meeting weighing the risks of rare side effects like myocarditis and pericarditis, types of heart inflammation that have been seen in mostly younger male recipients of the mRNA-based vaccines made by Pfizer and Moderna. People with the side effect are typically hospitalized, but often feel better within a day.
The FDA’s advisers agreed that the need was clear for many children to be vaccinated, especially for those at high risk of severe COVID-19 because of exposure or underlying conditions. Widespread vaccination could also help curb transmission of the virus in schools, minimizing disruptive closures and the risk of new outbreaks of a disease that has had a disproportionate toll on families of color.
But some on the committee voiced concern over uncertainty over the shot’s benefits for healthy children who had already recovered from a bout of COVID-19. Data presented to the panel by the CDC suggests more than 40% of children in the U.S. could have antibodies to the virus from a prior infection.
“I want to make sure that the children who really need this vaccine, primarily the black and brown children in our country, 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,” said Dr. James Hildreth, one of the FDA’s advisers.
The FDA is expected to “authorize,” not “approve,” the shots
Some of the FDA’s advisers said at Tuesday’s meeting that they were “torn” over the decision, caught between wanting access for high-risk children who urgently need the shots and concern about the possibility of sweeping vaccine requirements following authorization.
Dr. Peter Marks, the FDA’s top vaccines official, sought to “reassure” the panel that he thought it was unlikely schools would impose mandates because the agency was only considering an emergency use authorization — not full approval — for the vaccine.
“In general, people have not done mandates with emergency use authorizations. And there are certain governors who have already announced that they would not do a mandate until there was any approval, opposed to an emergency use authorization,” said Marks.
That includes California Governor Gavin Newsom, who announcedfor school children only after it gains full approval.
So far, the first two doses of Pfizer’s COVID-19 vaccine for Americans 16 and older hasprocess. Adolescents 12 to 15 can receive it under emergency use authorization. Other vaccine brands and regimens, including booster shots of Pfizer’s vaccine, have only been granted emergency use authorization.
Reaching a full license is a rigorous process that can take months, ranging from resolving potential issues flagged at scrupulous inspections of manufacturing sites to triple-checking data gathered during the clinical trials.
The FDA is expected to also analyze data from the shot’s use in the real world to inform their decision on approval, especially over unanswered questions around measuring the shot’s rare side effects and its ability to curb spread of the disease.
Rates of myocarditis and pericarditis in young children were likely too low to be accurately assessed in the clinical trials, Pfizer and the FDA said, but data from adolescents suggests they might be even rarer in 5 to 11 year olds. Pfizer’s decision to cut the size of its children’s dose down to 10 micrograms could also reduce the risk, the company said.
“Safety monitoring of this vaccine will continue. It has actually been quite intense, with a small army of individuals who are very committed to this, and they will continue this,” said Marks, describing it as “one of our greatest responsibilities.”
Millions of doses will ship immediately after the FDA’s authorization
From local health departments to the Biden administration, officials have been preparing for months for the possibility that Pfizer’s vaccine for younger children could soon be authorized and recommended for use.
Unlike the 30 microgram doses that were greenlighted for Americans 12 and older, Pfizer developed a new formulation for younger children at a lower 10 microgram dose.
While the “active ingredient” in the vaccine remains the same, Pfizer says it tweaked the shot’s “buffer” to prolong its shelf life in pediatricians’ refrigerators. The drugmaker will also package the vial in different colors to prevent mix-ups with the full-strength doses, and has a new procedure to prepare the shots that will make it easier to draw up doses.
The first orders for Pfizer’s new pediatric vaccine have already been placed, White House officials say, with millions of doses ready to ship immediately after the FDA authorizes the shots.
Under federal supply agreements, vaccinators will still need to wait for the CDC to formally recommend use of the shots before they can be given. That decision could come after Tuesday’s meeting.
“The bottom line is that we will be ready immediately following FDA and CDC’s decisions so that parents can get their kids vaccinated quickly, easily, and conveniently,” Jeff Zients, the White House’s COVID-19 czar, told reporters.