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Wednesday, June 29, 2022

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

by Lindsay Tanner and Mike Stobe

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

Vaccine advisors from the Food and Drug Administration give Moderna and Pfizer’s vaccines a thumbs up for the youngest children.

Outside experts voted unanimously that the benefits of the shots outweigh any risks for children under the age of 5 – that is, about 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 regulatory steps are approved, the shots should be available next week.

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

The FDA’s vaccine chief, Dr. Peter Marks, opened the meeting with data showing a “quite troubling surge” in hospitalizations of young children during the Omicron wave, and the epidemic of 442 children under the age of 4. died during He said this is much lower than adult deaths, but it should not be ruled out considering the need to vaccinate the youngest children.

“Every child that is lost inevitably disintegrates a family,” Marx said.

Supporting vaccines, some members of the panel said they believe the potential for serious illness and death in young children is minimal.

Dr. Cody Meisner of Tufts University said, “The risks from 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 younger than 6 months of age in posted analyzes prior to the full-day meeting. Side effects, including fever and fatigue, were generally minor in both, and were less common than those seen in adults.

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

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

If the FDA agrees with its advisors and authorizes the shots, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation on Saturday after voting on its own advisers. If the CDC signs, the shots may be available Monday or Tuesday at doctor’s offices, hospitals, and pharmacies.

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

Moderna’s shots are one-quarter the dose of the company’s adult shots. The two doses appear strong enough to prevent severe disease but are only 40% to 50% effective in preventing mild infections. Moderna added a booster to its tests and hopes to eventually offer one.

Pfizer’s shots are just one-tenth of its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added during the ohmmicron wave.

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

Many counselors, noting that protection is low after two Pfizer doses, are concerned that some parents may skip the third shot, or mistakenly think that their children are better protected between shots, leaving them vulnerable. Huh.

“Educating parents should be done very carefully so that they are not misled about what vaccines actually provide,” said Dr. Archana Chatterjee from Rosalind Franklin University.

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

The country’s vaccination campaign began in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents being the first in line. Teens and school-age children were added last year.

Moderna said in April that it was also seeking regulatory approval outside the US for shots of its young children. 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 to be vaccinated. By some estimates, three-quarters of all children have already been infected. And only about 29% of children aged 5 to 11 have been vaccinated since Pfizer opened the shots last November, a rate far below the norm for public health officials.

Dr. Nimmi Rajagopal, a family medicine physician at Cook County Health in Chicago, said she has been preparing parents for months.

“We have some who are hesitant, and some who are eager to leave,” she said.

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Follow Associated Press 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. Associated Press is solely responsible for all content.

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