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FDA advisers support Pfizer’s COVID-19 vaccine for young children 5-11 years old

WASHINGTON (AP) – A panel of U.S. health advisers on Tuesday approved a child-sized dose of Pfizer’s COVID-19 vaccine, bringing the United States closer to starting vaccinations in children aged 5 to 11.

A Food and Drug Administration advisory panel unanimously voted that the benefits of the vaccine against COVID-19 in this age group outweigh any potential risks – including a heart-related side effect that is very rare in adolescents and young adults. High dose

The FDA is not bound by the panel’s recommendations and is expected to make its own decision in a few days.

If the FDA approves child-sized doses, there is one more step: Next week, the Centers for Disease Control and Prevention will have to decide which shots to recommend and which teens should take them.

Although children are at lower risk of severe COVID-19 than adults, 5- to 11-year-olds still suffer from significant illnesses – of which more than 8,300 have been hospitalized, about one-third require intensive care and about 100 have died.

The dose for young children is only one-third of the Pfizer shots that have already been recommended for everyone 12 or older. Moderna is studying her vaccine for young children.

This is a breaking news update. The AP’s previous story follows below.

WASHINGTON (AP) – A kid-size dose of Pfizer’s COVID-19 vaccine could come close as government advisers began discussing Tuesday whether there is enough evidence that shots are safe and effective for 5- to 11-year-olds.

A study of primary school children found that Pfizer shots were about 91% effective in preventing significant infections – although young people received only one-third of the doses given to adolescents and adults.

In a preliminary analysis last week, Food and Drug Administration reviewers said the safety epidemic would “clearly outweigh” the risk of very rare side effects in almost all situations. Now FDA advisers are scratching through the data to see if they agree.

If the FDA approves child-sized doses, there is one more step: Next week, the Centers for Disease Control and Prevention will have to decide which shots to recommend and which teens should take them.

Although children are at lower risk of severe COVID-19 than adults, 5- to 11-year-olds still suffer from significant illnesses – more than 8,300 hospitalized, about one-third in need of intensive care and about 100 dead, the FDA vaccine chief said. . Peter Marks told the advisory panel.

Also, “many schools have closed due to the infection and children’s education and socialization have been disrupted,” he said.

“I want to acknowledge the fact that there is a strong public feeling for and against vaccinating children,” Marx added, adding that the discussion would be on scientific information “not about the vaccine mandate, which is left to organizations other than the FDA.”

Full-strength shots made by Pfizer and its partner BioNTech are already recommended for everyone 12 or older, but pediatricians and many parents are calling for the safety of young children. Excessively contagious delta variance has led to an alarming increase in child infections – and families are frustrated with school quarantine and have to say no to other childhood rituals to survive the virus.

States are preparing to roll out shots for small arms – in special orange-cloth vials to differentiate adults from vaccines – as soon as the government is OK. More than 25,000 pediatricians and other primary care providers have so far signed up for vaccinations.

Pfizer’s study tracked 2,268 children aged 5 to 11 who received two shots at three-week intervals without a placebo or baby dose. Vaccinated adolescents have developed as strong virus-resistant antibodies as adolescents and young adults taking full-strength shots.

And so far, 16 children who have been given dummy shots have developed remarkable COVID-19 compared to three vaccinated teens, which means the vaccine was about 91% effective. Most of the research data was collected in the United States in August and September, along with the growth of the Delta variant.

The dose has also been shown to be safe in children, with similar or less temporary side effects – such as arm pain, fever or soreness – that adolescents experience. At the request of the FDA, Pfizer recently enrolled 2,300 more young people in the study, and no red flag was seen in the initial safety data.

The study is not large enough to detect extremely rare side effects, such as heart inflammation that occasionally occurs after the second dose, mostly in young men and adolescent boys.

The FDA’s panel of independent experts will examine whether Pfizer’s shot can prevent more young children from being hospitalized with COVID-19 due to those rare side effects.

The FDA analysis calculated that in most cases of ongoing epidemics, the vaccine would prevent about 200 to 250 COVID-19 hospitalizations per 1 million young people, including about 58 hospital admissions for heartburn. The risk of side effects is based on the level of teenagers, and Pfizer expects it to be much lower in young people taking doses the size of a child.

Moderna is also studying its vaccine in young children.

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





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