A federal advisory panel appears poised this week to recommend two COVID-19 vaccines for the youngest children, as well as a second option for older kids who so far have only had access to the Pfizer-BioNTech shots.
In detailed information made public Friday and Sunday, staff for the Food and Drug Administration reviewed safety and effectiveness data for the Moderna vaccine for ages 6 months to 17 years and for the Pfizer-BioNTech vaccine for children ages 6 months through 4 years.
The review was positive, raising no new safety issues or concerns about trial data, most of which had been previously released by the companies.
An FDA expert advisory panel will hold all-day meetings on Tuesday and Wednesday to discuss the data, but the staff review suggests there will be no major surprises and that the panel will recommend authorization of both vaccines.
If that happens and the FDA commissioner signs off on the shots, the Centers for Disease Control and Prevention will follow the same process, with two days of review by a different expert advisory panel on Friday and Saturday. The CDC director would have to endorse the vaccines before the companies would be allowed to provide them.
The Biden Administration has said if the vaccines are authorized this week, they would become available as soon as June 21 (a day after the federal Juneteenth holiday) at local pharmacies, pediatricians’ offices, libraries, children’s museums, health centers, and other outlets .
The federal government pre-purchased vaccine doses, which will be provided at no cost to families.
Advocates are eager for vaccines to finally be extended to young children, the only major group of Americans left unprotected by vaccines.
“This moment is bittersweet,” said Fatima Khan, co-founder of Protect Their Future, a grassroots group of physicians, parents and activists. “We’re grateful to access a safe vaccine, but also troubled by how long it took.… We must learn from this experience and fix root bureaucratic issues that caused the delays so that our children are never left behind again.”
The only vaccine available for children has been Pfizer-BioNTech’s, authorized for those 5 and up. Traditionally, drugs and vaccines are studied first in adults and then in adolescents and progressively younger children, moving down in age as safety and effectiveness are proven in older groups.
Babies younger than 6 months are not expected to receive a COVID-19 vaccine. Instead, vaccination during pregnancy, which has been shown to be safe, passes on protection that lasts for about the first six months of life.
With the COVID-19 vaccines, companies took time to determine the most effective doses for each eligible age group, while minimizing side effects.
Pfizer-BioNTech offers adults and adolescents a two-dose initial vaccine series, with 30 micrograms of active ingredients in each shot. Children ages 5-11 receive 10 micrograms of the vaccine and the youngest children would get a 3 microgram dose.
Pfizer and its German partner BioNTech found that the two doses were not adequately protective against the omicron variant, so they are asking the FDA and CDC to authorize a three-dose series for children ages 6 months through 4 years old. Older children are already authorized to receive a booster dose to protect against the latest variants.
With the Moderna vaccine, which is based on the same mRNA technology as Pfizer-BioNTech’s, adults get two 100-microgram doses for their initial series. The company proposed the same dosage for teens, two 50-microgram shots for younger children and two 25-microgram doses for the youngest children.
Moderna only tested its vaccine in two doses and it appears less effective in the youngest children.
On Tuesday, the FDA advisory panel, called the Vaccines and Related Biological Products Advisory Committee, will review data on Moderna’s vaccine for children 6 to 17.
On Wednesday, the panel will decide whether to recommend Moderna and Pfizer-BioNTech’s vaccines for children as young as 6 months.
Vaccine side effects in the youngest age groups were similar to those of older children, including short-term fever and redness at the injection site, studies showed.
Neither vaccine trial in young children found any cases of allergic reactions to the shots or myocarditis, the swelling of the heart muscle occasionally seen among adolescent boys and young men after vaccination.
In the Pfizer-BioNTech trial, three shots, with the third given at least eight weeks after the second, protected more than 75% of children ages 6 months to 2 years and 82% of those ages 2 to 5, with no significant increase in side effects. The trial included about 4,500 children in five countries, with twice as many getting the active vaccine as a placebo.
The Pfizer-BioNTech trial had been designed to wait for results until 21 children in either the placebo or active vaccine group contracted COVID-19. Although cases have been rising in recent weeks, only 10 had tested positive as of earlier this month, so technically, the effectiveness results are considered preliminary.
In Moderna’s trial of 6,700 children ages 6 months to under 6, company researchers found that two 25-microgram doses led the children to develop levels of virus-fighting antibodies comparable to young adults who received two full-strength shots.
In the study, which took place during the omicron wave, researchers found the vaccine was 51% effective among children 6 months to under 2, and 37% effective among children 2 to under 6.
Among older children, a 50-microgram dose also appeared to be safe and effective, according to company data and the FDA analysis.
Moderna filed a year ago for authorization of its vaccine in adolescents, but the FDA held the application, awaiting more information on the risks of myocarditis following vaccination. The committee will review more recent data and decide whether the benefits of the vaccine outweigh the risks of myocarditis in that age group.
Teens and young adults, particularly males, appear to be at the highest risk for this side effect, although it is generally milder than the myocarditis caused by infection with COVID-19.
The FDA advisory panel is expected to make a recommendation at the end of each day’s meeting: Tuesday on Moderna’s vaccine for children ages 6-17 and Wednesday on both vaccines for young children.
Administration officials said last week they have started accepting state and local orders for the shots and expect to have 5 million doses each of Pfizer-BioNTech and Moderna vaccines for young children available on June 21 and millions more soon thereafter.
“If the FDA and the CDC recommend these vaccines, this would mark an important moment in the pandemic,” Dr. Ashish Jha, the White House COVID-19 response coordinator, said at a news conference last week. “It would mean that for the first time, essentially every American – from our oldest to our youngest – would be eligible for the protection that vaccines provide.”
Contributing: Adrianna Rodriguez
Contact Karen Weintraub at email@example.com.
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