FDA panel endorses Covid vaccine for youngest children

Advisors to the Food and Drug Administration voted Wednesday to recommend approving Moderna’s and Pfizer-BioNTech’s Covid-19 vaccines for young children, removing one of the final hurdles in getting the youngest Americans vaccinated.

The Vaccines and Related Biologicals Advisory Committee voted on each vaccine during its meeting on Wednesday. Both recommendations were unanimous: 21-0.

Moderna’s vaccine is for children aged 6 months to 5 years and Pfizer’s is for children aged 6 months to 4 years.

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The committee’s recommendations are not the final approval needed to administer the recordings, but the votes will now set in motion a fast-moving process that is expected to be completed by Tuesday – a great relief for parents who are over a year and a half have waited -half to vaccinate their youngest.

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

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

“I am very pleased that we have reached such a milestone,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital.

Despite the committee’s celebratory mood, panel members acknowledged the heightened emotions surrounding vaccination of young children. During a particularly heated period of public comment, parents and other members of the public were passionate about both pro and anti-vaccine.

Clear communication with parents and guardians about the vaccine will be incredibly important, the panel said. And almost all committee members, including 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 decision.

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

Three-year-old Andel became the first teenager 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.
Three-year-old Andel became the first teenager to receive Pfizer-BioNTech’s 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 Children’s Mercy Hospital in Kansas City, Missouri, described walking past his hospital’s emergency room earlier this year and seeing it filled with Covid patients.

“I know the death rate from Covid in young children may not be extremely high,” Portnoy said. “But it’s absolutely scary for parents when their child is sick and has to go to the hospital or even to the emergency room or to their GP because they’re sick and they’re having trouble breathing.”

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

Children are also susceptible to a rare complication of Covid called MIS-C, or Child Multi-System Inflammatory Syndrome, which causes severe inflammation throughout the body.

Despite this, the panel acknowledged that the risk of these serious consequences is very low – the vast majority of children with Covid recover.

Two vaccines available for children

Clinical trial data presented by representatives from both Moderna and Pfizer at Wednesday’s meeting showed the vaccines were safe and effective in the youngest children.

The Moderna vaccine consists of two vaccinations four weeks apart. Total doses are 25 micrograms – a quarter of the dose given to adults. The shots were about 40 to 50% effective in preventing minor omicron infections in young children.

In recognition of the lower potency, Moderna expects that children in the “eventually” age group will be offered a booster dose of the vaccine.

Pfizer faced similar problems to Moderna earlier this year when clinical trials found its two-dose regimen offered limited protection against infection.

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

Pfizer’s under-5 shot also has a lower dosage than its adult version: 3 micrograms versus 30 micrograms.

dr Amanda Cohn, chief medical officer at the CDC’s National Center for Immunization and Respiratory Diseases, cautioned against comparing the efficacy numbers of the two vaccines because they were based on only a small number of Covid cases.

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

Both the Moderna and Pfizer vaccines were generally well tolerated in children with similar side effects, including injection site pain, irritability, drowsiness and fever.

In an analysis published online over the weekend, FDA scientists said the pediatric studies may have been too small to detect a rare heart inflammation called myocarditis.

The Moderna and Pfizer vaccines have been associated with rare cases of myocarditis, particularly in teenagers and young men, although no cases were seen in the studies in the youngest children.

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