The Perfect Enemy | FDA panel recommends Moderna COVID vaccine as second option for kids 6 and older
July 5, 2022

FDA panel recommends Moderna COVID vaccine as second option for kids 6 and older

FDA panel recommends Moderna COVID vaccine as second option for kids 6 and older  USA TODAYView Full Coverage on Google News

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Parents could soon have two vaccines to choose from when vaccinating their children against COVID-19.

After hearing hours of testimony Tuesday, a federal advisory panel voted unanimously to recommend Moderna’s vaccine be made available to children 6 and up. So far, only Pfizer-BioNTech’s vaccine has been allowed for children.

Assuming the Food and Drug Administration commissioner signs off on the panel’s recommendation, as expected, the Centers for Disease Control and Prevention will review Moderna’s vaccine data later this week and the shots could become available as soon as next week.

Children are not required to be vaccinated against COVID-19 to attend public school.

The Moderna vaccine will be delivered in two shots, eight weeks apart, at the same dose as adults for adolescents and at a half-dose for children ages 6 to 11. Both the company and the FDA assume a third booster dose will be encouraged later, as it is with the Pfizer-BioNTech vaccine.

On Wednesday, the same FDA advisory committee will discuss COVID-19 vaccines from both companies for younger children, who have not yet had access to shots.

Although the risk for serious infection and death from COVID-19 declines with age, children and adolescents have become sick during the pandemic, with more than 800 deaths among children attributed to the virus, according to FDA data.

About 70% of American children have been infected with COVID-19 since the start of the pandemic, according to evidence from blood drawn during routine medical care. 

Data shows the Pfizer-BioNTech vaccine prevented childhood hospitalizations during the omicron surge, with vaccinated teens and children less likely to be hospitalized than their unvaccinated peers.

Teens were more likely to be hospitalized with COVID-19 than younger children, and the vaccine will have a bigger effect during major outbreaks than during times when the virus is not spreading widely, data shows.  

In terms of dosage, children 6-11 would be given two 50-microgram shots of the Moderna vaccine, while older children would receive the same 100-microgram shots as adults. 

Although only two doses of the Moderna vaccine were included in Tuesday’s review, the FDA envisions a third dose will be required. Once Moderna presents more data on the safety and effectiveness of its booster vaccine, “we will move expediently toward making the booster dose available,” FDA staff member Dr. Doran Fink told the committee.

Moderna is studying a childhood booster, at half the dose of the original shot, directed specifically at the original strain of the virus that causes COVID-19 and at an omicron-specific version of the virus. The company plans to shortly launch a study of omicron-specific boosters in children under 6.

After hearing hours of testimony Tuesday, a federal advisory panel voted to recommend Moderna's vaccine be made available to children 6 and up. So far, only Pfizer-BioNTech's vaccine has been allowed for children.

Committee member Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he thinks it will be essential for children to get a third vaccine dose, regardless of the manufacturer, to receive adequate protection against currently circulating variants.

Two shots were extremely protective against previous COVID-19 variants, Offit said, but protection against severe disease from omicron requires a third dose.

In terms of vaccine safety, data suggests but is not conclusive that Moderna’s vaccine causes more cases of myocarditis, an inflammation of the heart muscle, than Pfizer-BioNTech’s vaccine. The FDA delayed authorizing Moderna’s vaccine in teenagers for a year awaiting more data on the potentially serious side effect.

While rates of myocarditis after Moderna’s shots in young adults seems to be higher than after Pfizer-BioNTech’s, the side effect is so uncommon that chance could have caused this apparently increased rate, FDA staff told the panel.

Out of nearly 55 million COVID-19 vaccine doses administered to minors, about 430 cases of myocarditis were reported to the CDC. By age group,153 cases of myocarditis were seen for every million second-doses of vaccine given to males ages 12-15 and 139 cases per million in males 16-17, FDA’s data analysis shows.

The risk for myocarditis is highest among males from adolescence through age 40, particularly after a second COVID-19 shot. Nearly 60% ended up in the hospital, the majority for 1 to 3 days. 

Most of the cases following vaccination were milder than seen after infections such as COVID-19, with 80% reported resolved at three months.  

Other than myocarditis, severe allergic reactions are the only potentially serious side effect consistently, though rarely seen with COVID-19 vaccines. None of the children in Moderna’s trials suffered an allergic reaction to the vaccine, the company said. 

There’s no question that any vaccine or medical treatment can cause harm, the FDA’s Dr. Peter Marks said in closing the eight-hour meeting.

“Vaccines are associated with some adverse effects short-term and we monitor them closely for long-term,” said Marks, who directs the FDA’s Center for Biologics Evaluation & Research. “We are very concerned to make sure that we detect adverse events and when we detect them, we’re transparent with them. The hope is that by making available vaccines, we will protect the population.”

COVID-19 vaccines for children are comparable in terms of safety and importance to other childhood vaccines, said Fink, the deputy director of the FDA’s Clinical Division of Vaccines and Related Product Applications in the Office of Vaccines Research and Review.

Committee member Dr. Arthur Reingold, a public health epidemiologist at the University of California, Berkeley, said he’s old enough to remember the arrival of the polio vaccine. Polio, he said, caused about as much asymptomatic disease as COVID-19 does and severe outcomes were just as rare, but still justified vaccination. 

The committee is composed of experts in pediatrics, infectious disease and immunology, all of whom have been screened to avoid financial conflicts of interest.

In discussion, committee members expressed their support for the Moderna vaccine, saying its benefits outweigh its risks in children ages 6 and up and that parents should have a choice of which vaccine to give.

“I believe this will provide families an important option,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital. “We don’t know what this fall will bring, but even under current conditions this can be a valuable tool.”

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.