FDA Advisors Vote to Authorize COVID-19 Vaccine for Children Under 5 – CBS Detroit

(CNN) — Vaccine advisors to the U.S. Food and Drug Administration voted unanimously on Wednesday to expand emergency use authorization for the Moderna COVID-19 vaccine to include younger children.

All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” to the question: Based on the totality of available scientific evidence, reap the benefits of the Moderna COVID-19 vaccine when administered if a series of 2 doses (25 micrograms per dose) outweighs the risks for use in infants and children 6 months to 5 years of age?

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The committee is expected to vote later Wednesday on whether to support the approval of Pfizer’s COVID-19 vaccine for children under the age of 5.

Children under the age of 5 are the only age group currently ineligible for vaccination against COVID-19. About 17 million children under the age of 5 are eligible for COVID-19 vaccines once they are authorized for this age group.

The FDA, which typically follows the committee’s decisions, will now decide whether to approve the vaccine for emergency use in this young age group.

However, shots can’t be given until the US Centers for Disease Control and Prevention’s own vaccine advisers vote on whether or not to recommend them and CDC director Dr. Rochelle Walensky has signed the recommendation.

‘Benefits clearly seem to outweigh risks’

“The benefits clearly seem to outweigh the risks, especially for those with young children who are in preschool or collective childcare,” said committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School. Moderna vaccine.

VRBPAC member Dr. Art Reingold added that while the risk of hospitalization and death from COVID-19 is lower for young children than adults, children often receive vaccinations to protect them against diseases for which their risk is low.

“If we have a vaccine whose benefits outweigh the risks, it’s a reasonable choice to make it available to people,” said Reingold of the University of California, Berkeley.

“I would like to point out that as a country, we are still giving a large number of vaccines to children, with the risk of the child dying or being hospitalized is virtually zero,” Reingold said, referring to diseases such as polio and measles.

The number of hospitalizations and deaths from COVID-19 in children is alarming and much higher compared to flu-related deaths and hospitalizations, said FDA official Dr. Peter Marks at Wednesday’s meeting, before the committee voted.

“During the Omicron wave, there was still a relatively high number of hospitalizations during this period,” said Marks, director of the FDA’s Center for Biologics Evaluation and Research. “That number of hospital admissions is actually quite disturbing and if we compare this to what we see in a terrible flu season, it’s worse.”

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Marks said the number of deaths for children aged 4 and under during the first two years of the pandemic “compares quite a bit with what we’ve seen with flu in the past.”

“We’re dealing with an issue where I think we need to be careful not to get stunned by the pediatric death rate because of the overwhelming number of elderly deaths here. Every life matters,” he said, adding that “vaccine-preventable deaths are deaths we want to do something about.”

Marks said the COVID-19 vaccines are an intervention similar to the flu vaccine, which is widely and routinely used and accepted to prevent deaths.

The Moderna vaccine is already approved for adults. At a previous meeting Tuesday, VRBPAC members voted unanimously to extend the emergency use authorization of Moderna’s vaccine to older children and teens ages 6 to 17, saying it would provide benefits rather than risks.

COVID-19 vaccine ‘well tolerated’ in youngest children

Moderna’s COVID-19 vaccine, when administered as a dose of 25 micrograms, is “well tolerated” in children ages 6 months to 5 years, Dr. Rituparna Das, Moderna’s vice president of clinical development of COVID-19 vaccines, told VRBPAC members Wednesday, as she described the vaccine’s safety profile in this age group and side effects.

“Pain was the most common occurrence,” Das said. “Events in young children included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting and chills. For infants and toddlers, the events were fever, irritability, crying, drowsiness and loss of appetite.”

In vaccine recipients, these reactions were more common after the second dose of the vaccine and resolved within two to three days, Das said, adding that fever was an important assessment of vaccine safety for this age group.

Fever after each dose of vaccine occurred in about a quarter of the children — but fever was more common after the second dose — and one incident of febrile seizures was considered vaccination-related, Das told VRBPAC members. The child who developed the febrile seizures remained in the vaccine study and completed a second dose of vaccine with no serious events.

No deaths, myocarditis or pericarditis were reported among vaccine recipients, Das said.

“In summary, mRNA-1273 was well tolerated,” she said, referring to Moderna’s vaccine. Local and systemic reactions were seen less frequently in these youngest groups.”

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