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Saturday, July 2, 2022

FDA advisors vote to authorize Moderna COVID-19 vaccine for ages 6-17

Vaccine advisors from the US Food and Drug Administration on Tuesday unanimously decided in favor of expanding the emergency use authorization of Moderna’s COVID-19 vaccine to include older children and adolescents aged 6 to 17, it said. Having said that it will provide benefits outweighing the risks.

All 22 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to two questions about whether the vaccine benefits — when given two 100-microgram doses and two 50-microgram doses for ages 12 to 17. Given as: 6 to 11 years of age – Its risks based on available scientific evidence outweigh.

“The question is whether the data supports voting for emergency use authorization, and I would say that’s probably true,” said committee member Dr. Archana Chatterjee, dean of the Medical School of Chicago at Rosalind Franklin University.

“I support these two voting questions,” said member Dr. Hank Bernstein, professor of pediatrics at the Zucker School of Medicine in Hofstra/Northwell.

“Evolving variants would indicate the possibility of a third dose that is going to continue as many people with the primary series have been continued without vaccination,” he said. “I think adding this vaccine, making it more available to families, is good. Families like more options. ,

The FDA, which generally follows committee decisions, will now decide whether to authorize the vaccine for emergency use in these age groups. The Moderna vaccine is already authorized for adults.

However, the shots cannot be given until the US Centers for Disease Control and Prevention’s own vaccine advisers have voted to recommend them and CDC Director Dr. Rochelle Valensky has not signed the recommendation.

Questions arise around the third dose

Committee members voted on the benefits of Moderna’s vaccine as a two-dose primary series for children and adolescents, but discussions on whether a booster dose may be needed for younger ages may continue.

Dr Paul Offit, Director of the Center for Vaccine Education at Children’s Hospital, member Dr Paul Offit, “I am comfortable saying that I think the benefits clearly outweigh the risks, but I say comfort is being provided That would be the third dose.” Pennsylvania said at Tuesday’s meeting.

Pfizer/BioNTech’s COVID-19 vaccine is already authorized for use as a booster dose in children under 5 years of age.

Ofit said three doses of the vaccine are needed to help protect against coronavirus variants such as Omicron’s ba.1 and ba.2 subvariants.

“I disagree with the term ‘booster dose.’ The third dose is not a booster dose for the Omicron subvariant,” Offit said. “It is a three-dose primary series.”

Chatterjee said language about the need for additional doses in future could be included in the emergency use authorization for the vaccine.

Yet “the importance of additional doses cannot be overstated as the epidemic progresses,” she said.

“It’s probably something worth noting to our FDA colleagues,” she said. “They certainly can put language into the authorization document to suggest that additional doses may be needed in these children who will only receive two doses to begin with.”

According to an FDA briefing document, Moderna found in clinical trials for children and adolescents 6 to 17 years old that two doses of its vaccine provided the same immune response as two doses in adults.

Moderna’s vaccine has been estimated to be 93.3% effective against symptomatic COVID-19 in adolescents aged 12 to 17 years, when the original coronavirus and alpha versions were dominant.

The vaccine was estimated to be 76.8% effective against symptomatic COVID-19 for children aged 6 to 11 years, when the delta variant was dominant. However, the FDA also noted that for children in that age group, “the efficacy of the vaccine could not be determined reliably because of the small number of COVID-19 cases during the study.”

According to an FDA briefing document, the vaccine was found to be safe in all age groups, with adverse reactions described as “mostly mild to moderate in severity, generally of short duration” and occurring more frequently after the second dose than the first. ,

Injection site pain was the most commonly reported adverse reaction. As far as serious adverse events are concerned, the document described them as rare and did not raise any concerns. No death was reported.

Although there were no known cases of vaccine-associated myocarditis or pericarditis, they have been acknowledged as one of the known risks and have been mostly reported in men aged 18 to 24 years.

Next: Vaccines for Young Children

Vaccine advisors are due to meet again on Wednesday to consider an amendment to Moderna’s vaccine emergency use authorization to also include young children aged 6 months to 5 years.

They will also discuss amendments to the Pfizer/BioNTech vaccine authorization, which covers ages from 6 months to 4 years.

The safety of COVID-19 vaccines for young children will be an important part of those discussions, an FDA official said on Tuesday.

“These vaccines will essentially extend to an age limit of at least 6 months,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, told the committee. “Obviously, safety is paramount in this population, and I think this particular area will be discussed in a fair amount by the committee.”

The White House has said that vaccines for the youngest children could begin next week if the FDA and CDC authorize them.

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