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Covid vaccines for children under 5 approved by FDA panel

Food and Drug Administration advisers voted Wednesday to recommend allowing Moderna and Pfizer-BioNTech’s Covid-19 vaccines for young children, removing one of the last barriers to vaccinating the youngest Americans.

The Vaccines and Related Biologicals Advisory Committee took a vote for each vaccine at its meeting on Wednesday. The two recommendations were unanimous: 21-0.

Moderna’s vaccine is for children aged 6 months to 5 years, while 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 injections, but the votes will now trigger a quick process that should be completed by Tuesday – a big relief for parents who have waited over a year and one-half to have their youngest vaccinated.

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

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

“I’m really excited that we reached this kind of milestone,” said Dr. Ofer Levy, director of the precision vaccine program at Boston Children’s Hospital.

Despite the celebratory mood of the committee, panel members acknowledged the heightened emotions surrounding the vaccination of young children. During a particularly heated public comment period, parents and other members of the public argued passionately for and against the vaccine.

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

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

Three-year-old Andel was the first youngster to receive the Pfizer-BioNTech COVID-19 vaccine at Stanford Medicine.  His parents, Otavio and Zina Good, enrolled him in a clinical trial for children aged 6 months to 4 years.
Three-year-old Andel was the first youngster to receive the Pfizer-BioNTech Covid-19 vaccine at Stanford Medicine. His parents, Otavio and Zina Good, enrolled him in a clinical trial 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 terrifying for parents that their child is sick and has to go to the hospital or even go to the emergency room or to their GP because they are sick and struggling to breathe.”

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

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

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

Two vaccines available for children

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

Moderna’s vaccine consists of two injections, given four weeks apart. Tot-size doses are 25 micrograms, which is a quarter of the dose given to adults. The injections were about 40-50% effective in preventing milder omicron infections in young children.

Acknowledging the lesser effectiveness, Moderna said it expects children in this age group to be offered a booster dose of the vaccine “at some point”.

Pfizer ran into similar problems to Moderna earlier this year when clinical trials found its two-dose regimen offered only limited protection against infections.

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

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

Dr. Amanda Cohn, chief medical officer of the CDC’s National Center for Immunization and Respiratory Diseases, cautioned against comparing the effectiveness numbers 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.

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

In an analysis posted online over the weekend, FDA scientists said pediatric trials may be too small to detect a rare inflammatory heart condition called myocarditis.

Moderna and Pfizer vaccines have been associated with rare cases of myocarditis, particularly in adolescents and young men, although no cases were seen in trials for younger children.

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