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Covid vaccines for children under 5 years of age approved by the FDA panel

Food and Drug Administration advisers voted Wednesday to recommend the approval of both Moderna and Pfizer-BioNTech’s Covid-19 vaccines for young children, removing one of the latest obstacles to getting the youngest Americans vaccinated.

The Vaccine Advisory Committee and related biological products held a vote for each vaccine during Wednesday’s meeting. Both recommendations were unanimous: 21-0.

Modern vaccine is for children aged 6 months to 5 years, while Pfizers are for children aged 6 months to 4 years.

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The committee̵[ads1]7;s recommendations are not the final signoff needed to administer the shots, but the votes will now set in motion a fast-moving process that is expected to be completed by Tuesday – a major relief for parents who have been waiting more than a year – half to vaccinate their youngest.

The decision will now go to the FDA, which is expected to grant an emergency use permit for the vaccines in the coming days. On Friday and Saturday, an advisory panel to the Centers for Disease Control and Prevention is expected to vote on whether to approve the shots. The final step is the signoff from CDC Director Dr. Rochelle Walensky – then shots in the arms (or thighs).

The votes represent in a sense the culmination of more than a year and a half of work by the committee. VRBPAC held its first meeting on Covid vaccines on 10 December 2020. The decision at that time was to recommend the Pfizer vaccine for people aged 16 and over. With Wednesday’s vote, lowering the vaccination age down to 6 months, soon everyone will be eligible.

“I’m very happy that we’ve reached this kind of milestone,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital.

Despite the festive mood of the committee, members of the panel acknowledged the growing sentiment surrounding the vaccination of young children. During a particularly heated public comment period, parents and other members of the public spoke passionately both for and against the vaccine.

Clear communication to parents and guardians about the vaccine will be incredibly important, the panel said. And almost all members of the committee, which includes paediatricians, infectious disease doctors and vaccine experts, mentioned during the discussion that the decision for parents to vaccinate children in this age group should be a choice.

Although younger children are usually spared the worst effects of Covid, serious cases and deaths can still occur. This was especially evident last winter, when the omicron wave sent the hospitalization rate for children under 5 higher than any previous point in the pandemic, according to CDC data.

Covid vaccines for children under 5 years of age approved by the FDA panel
Three-year-old Andel was the first young person to receive the Pfizer-BioNTech Covid-19 vaccine at Stanford Medicine. His parents, Otavio and Zina Good, enrolled him in a clinical study for children aged 6 months to 4 years. Steve Fisch / Stanford Medicine

Committee member Dr. Jay Portnoy, a professor of pediatrics at the Children’s Mercy Hospital in Kansas City, Missouri, described walking past the hospital’s emergency room earlier this year and seeing it filled with Covid patients.

“I know the Covid death rate among young children may not be extremely high,” Portnoy said. “But it is absolutely frightening for parents to have their child sick and have to go to the hospital or even go to the emergency room or the primary care doctor because they are sick and have trouble breathing.”

As of May 28, at least 442 children under the age of 5 have died from Covid, Dr. Peter Marks, the FDA’s top vaccine regulator, told the committee. The number of deaths, in just over two years, is far higher than what is usually seen over the same period of time for other dangerous respiratory viruses, such as the flu, he said.

Children are also prone to a rare complication of Covid called MIS-C, or multisystem inflammatory syndrome in children, which causes severe inflammation throughout the body.

Nevertheless, the panel acknowledged that the risk of these serious outcomes is very small – the vast majority of children with Covid recover.

Two vaccines available for children

Data from clinical trials presented by both Moderna and Pfizer representatives at Wednesday’s meeting showed that the vaccines were safe and effective in the youngest children.

The modern vaccine consists of two syringes, given at four-week intervals. The total dose is 25 micrograms – a quarter of the dose given to adults. The shots were around 40 to 50% effective in preventing milder omicron infections in young children.

Moderna acknowledges the lower effect, saying that they expect children in the age group to be offered a booster dose of the vaccine “at some point.”

Pfizer experienced similar problems to Moderna earlier this year when clinical trials found that the two-dose regimen provided only limited protection against infection.

At Wednesday’s meeting, Pfizer presented data on three doses of the vaccine, which proved to be 80% effective in preventing symptomatic Covid. The first shots are given three weeks apart, followed by the third shot, eight weeks later.

Pfizer’s shot for children under 5 is also a lower dose than the adult version: 3 micrograms versus 30 micrograms.

Dr. Amanda Cohn, chief physician at the CDC’s National Center for Immunization and Respiratory Diseases, warned against comparing the efficacy figures of the two vaccines, given that they were based on only a small number of Covid cases.

“I think the vaccine is effective,” she said.

Both Moderna and Pfizer vaccines were shown to be generally well tolerated in children, with similar side effects, which included injection site pain, irritability, drowsiness and fever.

In an analysis published online this weekend, FDA researchers said that pediatric trials may have been too small to detect a rare heart condition called myocarditis.

The Modern and Pfizer vaccines have been linked to rare cases of myocarditis, especially in teenage boys and young men, although no cases were seen in the trials for the youngest children.

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