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FDA Says Pfizer COVID-19 Vaccine Looks Effective For Young Children

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Federal health officials said late Friday that doses of Pfizer’s child-sized COVID-19 vaccine appear to be highly effective in preventing symptomatic infections in elementary school children and not causing any unexpected safety issues as the US weighs in on adolescent vaccinations.

The Food and Drug Administration released its analysis of Pfizer’s data ahead of a public meeting next week to discuss whether vaccinations are ready for the roughly 28 million children ages 5-11. The agency will ask a panel of external vaccine experts to vote on this issue.

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In their analysis, FDA scientists concluded that the vaccine’s benefits in preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children in almost any scenario. But the agency’s reviewers stopped asking for Pfizer’s shot to be approved.
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The agency will raise this question to its independent advisory panel next Tuesday and weigh its advice before making its own decision.

If the FDA approves the syringes, the Centers for Disease Control and Prevention will make additional recommendations on who should be given them in the first week of November. Children could start vaccinations early next month – with the first children in line, fully protected until Christmas.

Pfizer full-strength syringes are recommended for ages 12 and up, but pediatricians and many parents are eagerly awaiting protection for younger children in order to contain infections from the extra-contagious Delta variant and keep the children in school.

The FDA review confirmed Pfizer’s results, released earlier in the day, showing that the two-dose vaccination was nearly 91% effective in preventing symptomatic infections in young children. The researchers calculated the number based on 16 cases of COVID-19 in adolescents given sham injections, compared to three cases in vaccinated children. No serious illness was reported in any of the adolescents, but those who were vaccinated had much milder symptoms than their unvaccinated ones.

Most of the study data was collected in the US in August and September, when the Delta variant had become the dominant strain of COVID-19.

The FDA review did not reveal any new or unexpected side effects. Most of those that occurred consisted of sore arms, fever, or pain.

However, FDA scientists found that the study wasn’t large enough to identify extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.

The agency used statistical models to predict how many hospital admissions and deaths from COVID-19 the vaccine would prevent compared to the number of potential cardiac side effects it could cause. In four scenarios of the pandemic, the vaccine prevented significantly more hospitalizations than would be expected due to the cardiac side effect. Only when virus cases were extremely low could the vaccine cause more hospital stays than it would prevent. Overall, however, the regulatory authorities came to the conclusion that the protective benefits of the vaccine “clearly outweighs” its risks.

While children are at lower risk of serious illness or death than the elderly, COVID-19 has killed more than 630 Americans under the age of 18, according to the CDC. Almost 6.2 million children contracted the coronavirus, more than 1.1 million in the last six weeks when the Delta variant increased, says the American Academy of Pediatrics.

Biden’s government has bought enough child-sized doses – in special orange-capped vials to distinguish them from the adult vaccine – for the country’s 5-11 year olds. When the vaccine is approved, millions of doses, along with child-sized needles, will be shipped across the country in an instant.

More than 25,000 paediatricians and general practitioners have already signed up to receive the syringes in little arms.


AP Medical Writer Lindsey Tanner contributed to this story.


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

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