FDA advisory endorses first COVID-19 shots for children under 5

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The first COVID-19 vaccinations for US infants, toddlers and preschoolers moved a step closer on Wednesday.

Food and Drug Administration immunization advisors praise Moderna and Pfizer vaccines for youngest children.

External experts unanimously agreed that the benefits of the vaccine outweigh the risks for children under the age of 5 – around 18 million young people. They are the last age group without access to COVID-19 vaccines in the US, and many parents are concerned about the safety of their young children.

If all official steps are approved, the recordings should be available next week.

“This is a long-awaited vaccine,” said one panel member, Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are a lot of parents who are really keen to get this vaccine and I think it’s up to us to give them the opportunity to get vaccinated if they want to.”

FDA vaccine chief Dr. Peter Marks, began the meeting with data showing a “significantly worrying increase” in hospitalizations of young children during the Omicron wave and 442 children under the age of 4 during the pandemic. died. He said this is much fewer than adult deaths, but it shouldn’t be ruled out considering the youngest children need to be vaccinated.

“Every lost child inevitably destroys a family,” Marx said.

Some members of the panel were in favor of vaccines and said they believe the potential for serious illness and death in young children is minimal.

dr Tufts University’s Cody Meisner said: “The risks of vaccination are very small, but so are the risks of COVID-19 for the youngest children.”

FDA reviewers noted that both brands appear to be safe and effective for children under 6 months of age in published analysis prior to the all-day meeting. Side effects, including fever and fatigue, were generally minor in both and less common than in adults.

The two vaccines use the same technology, but there are differences. In a call with reporters earlier this week, vaccine experts noted the shots weren’t tested against each other, so there’s no way to tell parents if one is superior.

“You can’t directly compare vaccines,” said Dr. Jesse Goodman of Georgetown University, former FDA vaccine chief.

If the FDA agrees with their advisers and approves the recordings, there is one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation on Saturday after voting through their own advisers. If the CDC signs off, the shots could be available Monday or Tuesday at doctors’ offices, hospitals and pharmacies.

The Pfizer vaccine is for children aged 6 months to 4 years; Moderna vaccines range from 6 months to 5 years.

Moderna’s shots have a quarter the dose of the company’s adult shots. The two doses appear to be strong enough to prevent serious illness, but are only 40% to 50% effective in preventing minor infections. Moderna has added a booster to its tests and hopes to offer one at some point.

Pfizer’s shots account for only a tenth of the adult dose. Pfizer and its partner BioNTech found that two shots didn’t provide adequate protection in testing, so a third was added during the Omicron wave.

The data presented by Pfizer revealed no safety concerns and indicated that the three vaccines were 80% effective in preventing symptomatic coronavirus infection. But that was based on just 10 COVID-19 cases; The number may change as more cases emerge in the company’s ongoing studies.

Many counselors who find that protection is low after two Pfizer doses are concerned that some parents may skip the third injection or mistakenly believe their children are more protected between injections, leaving them vulnerable. Hm.

“Parent education should be done very carefully so that they are not misled about what vaccines actually do,” said Dr. Archana Chatterjee of Rosalind Franklin University.

The same FDA panel on Tuesday endorsed Moderna’s half-size shots for children ages 6 to 11 and full-size cans for teens. If approved by the FDA, it would be a second option for those age groups. Currently, the Pfizer vaccine is his only choice.

The country’s immunization campaign began in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with healthcare workers and nursing home residents at the forefront. Young people and children of school age were added last year.

Moderna said in April it was seeking regulatory approval to film its young children outside of the United States. According to the World Health Organization, 12 countries are already vaccinating children under the age of 5 along with other brands.

In the US, it remains uncertain how many parents want their youngest child vaccinated. According to some estimates, three quarters of all children have already been infected. And only about 29% of children ages 5 to 11 have been vaccinated since Pfizer opened up on immunizations last November, a rate well below the norm for public health officials.

dr Nimmi Rajagopal, a primary care physician at Cook County Health in Chicago, said she’s been preparing parents for months.

“We have some who are hesitant and some who are dying to go,” she said.

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Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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