FDA panel endorses covid vaccine for youngest children

Food and Drug Administration advisers on Wednesday voted to recommend authorizing Moderna and Pfizer-BioNtech’s COVID-19 vaccines for young children, one of the final hurdles to vaccinate the youngest Americans. cleans up.

The Vaccines and Related Biological Products Advisory Committee voted for each vaccine during Wednesday’s meeting. Both recommendations were unanimous: 21-0.

Moderna’s vaccine is for children 6 months to 5 years of age, while Pfizer’s is for children 6 months to 4 years old.

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The committee’s recommendations aren’t the final sign needed to administer the shots, but the vote will now set in motion The fast-moving process is expected to be completed by Tuesday A big relief for parents who have waited more than a year and a half to vaccinate their youngest child.

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

The votes, in a sense, represent the culmination of more than a year and a half of the committee’s work. VRBPAC organized First meeting about Kovid vaccines on December 10, 2020, Its decision at the time was to recommend the Pfizer vaccine for people 16 and older. With Wednesday’s vote lowering the vaccination age to 6 months, everyone will soon be eligible.

“I’m really happy that we’ve reached such a milestone,” said Dr. Ofer Levy, director of the Precision Vaccine Program at Boston Children’s Hospital.

Despite the committee’s celebratory mood, members of the panel acknowledged the sentiments surrounding vaccinating young children. During a particularly heated public comment period, parents and other members of the public passionately advocated both for and against the vaccine.

The panel said that clear communication to parents and guardians about vaccines would be incredibly important. And almost all members of the committee, including pediatricians, infectious disease doctors and vaccine experts, noted during the discussion that the decision for parents to vaccinate children in this age group should be a choice.

Although young children are usually protected from the worst effects of COVID, serious cases and deaths can still occur. This was especially evident last winter, when the Omicron wave sent a higher hospitalization rate of children under 5 than at any previous point in the pandemic, according to CDC data.

Three-year-old Andell was the first young man to receive the Pfizer-BioNTech COVID-19 vaccine at Stanford Medicine. His parents, Ottavio and Zina Good, enrolled him in a clinical trial for children ages 6 months to 4. Steve Fish / Stanford Medicine

Committee member Dr. Jay Portnoy, professor of pediatrics at Children’s Mercy Hospital in Kansas City, Missouri, described walking through 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 can’t be very high,” Portnoy said. “But it is absolutely terrifying for parents that their child is sick and has to go to the hospital or even the emergency room or their primary care doctor because they are sick and have trouble breathing. is happening.”

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

Children are also susceptible to a MIS-C. rare complication of covid calledor multi-system inflammatory syndrome in children, which causes severe inflammation throughout the body.

Nevertheless, the panel acknowledged that the risk of these serious consequences is very low – most children with COVID recover.

Two vaccines available for children

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

The Moderna vaccine consists of two shots, given at intervals of four weeks. The total serving size is 25 micrograms – a quarter of the dose given to adults. The shots were about 40 to 50% effective at preventing mild omicron infections in young children.

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

pfizer veteran similar problems Earlier this year when clinical trials found that its two-dose dose provided only limited protection against infection.

At Wednesday’s meeting, Pfizer presented data on three doses of the vaccine, which showed 80% effective in preventing symptomatic covid, The first shot is given at three-week intervals, followed by the third one eight weeks later.

Pfizer’s shot for children under age 5 also has a lower dosage than its version for adults: 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 efficacy numbers of the two vaccines, given that they were based on only a small number of COVID cases.

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

Both Moderna and Pfizer vaccines were shown to be equally tolerable 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 test may be too small to detect a rare heart inflammatory condition called myocarditis.

Moderna and Pfizer’s vaccines have been associated with rare instances of myocarditis, particularly in adolescent boys and young men, although no cases were observed in trials involving the youngest children.

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