FDA advisors weigh COVID-19 infant and young child admissions

U.S. government advisers met Wednesday to decide whether to endorse COVID-19 vaccinations for babies, toddlers and preschoolers in a bid to bring the nation closer to immunizations for all ages.

Children under the age of 5 are the last remaining age group in the US to be vaccinated, and many parents are eagerly awaiting action from the Food and Drug Administration to protect their young children. If all regulatory hurdles are cleared, shots should be available next week.

Independent advice…

CONTINUE READING

U.S. government advisers met Wednesday to decide whether to endorse COVID-19 vaccinations for babies, toddlers and preschoolers in a bid to bring the nation closer to immunizations for all ages.

Children under the age of 5 are the last remaining age group in the US to be vaccinated, and many parents are eagerly awaiting action from the Food and Drug Administration to protect their young children. If all regulatory hurdles are cleared, shots should be available next week.

The independent advisory panel is considering total doses from two coronavirus vaccine makers — Pfizer and Moderna.

dr Peter Marks, FDA vaccine chief, opened the meeting with data showing a “rather disturbing increase” in infant hospitalizations during the Omicron wave, noting that 442 children under the age of 4 have died during the pandemic. That’s far fewer than adult deaths, but shouldn’t be dismissed given the need for the youngest children to be vaccinated, he said.

“Each lost child essentially breaks a family apart,” Marks said.

FDA reviewers said both brands appear to be safe and effective for children as young as 6 months of age in analysis released ahead of 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.

“That’s a really important point,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine director. “You can’t directly compare the vaccines.”

If the FDA approves the recordings, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after their own advisers meet on Saturday. If the CDC signs off, shots could be available at doctors’ offices, hospitals and pharmacies as early as Monday or Tuesday. Around 18 million young people would be eligible to participate.

Pfizer’s vaccine is for children aged 6 months to 4 years; The term of Moderna is 6 months to 5 years.

Moderna’s shots have a quarter the dose of the company’s adult shots. Two doses seemed potent enough to prevent serious infections, but were only about 40% to 50% effective in preventing minor infections. Moderna added a booster to its study.

“I think we can all agree that at some point these kids will need a third dose,” said Dr. Moderna’s Jacqueline Miller to the panel.

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

The data presented by Pfizer revealed no safety concerns and suggested that three vaccinations were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 COVID-19 cases; The calculation could change if more cases emerge in the company’s ongoing studies.

The same FDA panel on Tuesday endorsed Moderna’s half-size shots for children ages 6 to 11 and full-size shots for teens. If approved by the FDA, it would be the second option for those age groups. Currently, the Pfizer vaccine is her 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 that it is also seeking regulatory approval for its recordings of young children outside of the United States. According to the World Health Organization, 12 other countries are already vaccinating children under the age of 5 with other brands.

In the US, it remains uncertain how many parents want their youngest to be vaccinated. While COVID-19 is generally less dangerous for young children than older children and adults, there have been severe cases and some deaths. Many parents trying to protect unvaccinated young children have postponed family trips or child enrollment in daycare or preschool.

Nevertheless, it is estimated that three quarters of all children have already been infected. Only about 29% of children ages 5 to 11 have been vaccinated since Pfizer allowed them to be vaccinated last November, a rate well below the rate health officials consider ideal.

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 others who are just waiting to go,” she said.

___

Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.

___

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

Copyright © 2022 . All rights reserved. This website is not intended for users within the European Economic Area.

Comments are closed.