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COVID vaccine for kids under 5: FDA authorizes first coronavirus shots for babies as young as 6 months; CDC review is next

U.S. regulators approved the first COVID-19 vaccines for infants and preschoolers on Friday, paving the way for vaccinations to begin next week.

The action of the Food and Drug Administration follows the unanimous recommendation of the advisory committee for the plans by Moderna and Pfizer. This means that children under 5 in the US – about 18 million young people – are eligible for vaccines, about 1 1/2 years after the first adult vaccines were released in the US, which have been most affected by the pandemic. .

One step left: Centers for Disease Control and Prevention recommend how to use vaccines. Her independent advisers started discussing the Moderna two-dose vaccine and the three-dose Pfizer vaccine on Friday and will make their recommendation on Saturday. The last signature would come from the Director of the CDC, Dr. Rochelle Walensky.

At a Senate hearing Thursday, Walensky said staff were working during the June 19 federal weekend “because we understand the urgency of it for American parents.”

He said pediatric deaths from COVID-19 were higher than the general flu seen each year.

“Therefore, I believe we need to protect young children, as well as protect everyone with the vaccine, especially the elderly,” he said.

MORE: FDA commission paves way for 6-17 year olds to get another COVID vaccine option at Moderna

The FDA has also approved the Moderna vaccine for school-age children and adolescents. Pfizer shots were the only option for these ages.

For weeks, the Biden government has been preparing to release vaccines for young children, with states, races, community health centers and pharmacies ordering millions of doses. The FDA emergency license allows manufacturers to start shipping the vaccine nationwide. Vaccinations could begin as early as next week.

While young children generally do not get as much COVID-19 as older children and adults, their hospitalizations increased during the Omicron surge, and FDA advisers found that the benefits of the vaccine outweighed the minimal risks. Studies by Moderna and Pfizer have shown that side effects, including fever and fatigue, are mostly minor.

“As we have seen with older age groups, we expect vaccines for younger children to provide protection against the most serious outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert Calif.

In the trials, younger children developed high levels of antibodies to fight the virus, comparable to those seen in young adults, the FDA said. The Moderna vaccine was about 40% to 50% effective in preventing infections, but there were very few cases during the Pfizer study to determine the efficacy reliably, the agency said.

“Both of these vaccines have been approved by science and safety at the forefront of our minds,” said Dr Peter Marks, head of vaccination at the FDA.

The two brands use the same technology but there are differences.

The Pfizer vaccine for children under 5 years of age is one tenth of the adult dose. It takes three shots: the first two with a difference of three weeks and the last at least two months later.

Moderna’s is two vaccines, a quarter of its adult dose, about four weeks apart for children under 6 years of age. The FDA has also approved a third dose, at least one month after the second shot, for children with immune conditions that make them more vulnerable to serious illness.

Both vaccines are for children up to 6 months old. Moderna then plans to study its shots for babies up to 3 months. Pfizer has not finalized plans for shooting smaller babies. Twelve countries, including China, are already vaccinating children under 5 with other brands.

In the US, it remains uncertain how many parents want their youngest to be vaccinated. According to some estimates, three-quarters of all children are already infected. And only about 30% of children between the ages of 5 and 11 have been vaccinated since the Pfizer vaccine was introduced last November.

Dr. Beth Ebel, a professor of pediatrics at the University of Washington in Seattle, said the small-scale vaccines would be especially welcome by U.S. parents with children in kindergarten, where cases can sideline parents from work, adding financial stress. .

“A lot of people will be happy and a lot of grandparents will be happy too, because we missed those babies who grew up when you could not see them,” Ebel said.

Copyright © 2022 by the Associated Press. All rights reserved.

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COVID vaccine for kids under 5: FDA authorizes first coronavirus shots for babies as young as 6 months; CDC review is next Source link COVID vaccine for kids under 5: FDA authorizes first coronavirus shots for babies as young as 6 months; CDC review is next

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