FDA advisors review Pfizer’s COVID vaccine for children aged 5-11 years

Child-sized doses of Pfizer’s COVID-19 vaccine may come closer as government advisers on Tuesday began considering whether there is enough evidence that the shots are safe and effective for 5- to 11-year-olds.

A study of primary school children showed that Pfizer shots are almost 91% effective in preventing symptomatic infection – even though young people received only a third of the dose given to teenagers and adults.

In a preliminary analysis last week, Food and Drug Administration reviewers said protection “clearly would outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic. Now, FDA advisors are looking through this data to see if they agree.

If the FDA approves child-sized doses, there’s another step: Next week, the Centers for Disease Control and Prevention will decide whether to recommend the shots and which young people should get them.

While children have a lower risk of severe COVID-19 than older people, 5- to 11-year-olds have still been exposed to significant illness – including over 8,300 admissions, about a third requiring intensive care and nearly 100 deaths, says FDA Vaccine Director Dr. Peter Marks told the advisory panel.

Also, “infections have caused many school closures and disrupted education and socialization of children,” he said.

“I would like to acknowledge the fact that there are strong feelings” among the public for and against childhood vaccinations, “Marks added, noting that the discussion would be about scientific data” not about vaccine mandates left to other entities outside the FDA. “

Full-strength shots made by Pfizer and its partner BioNTech are already recommended for all 12 years and older, but pediatricians and many parents are crying out for the protection of younger children. The extra contagious delta variant has caused an alarming increase in pediatric infections – and families are frustrated with school quarantines and having to say no to overnight stays and other childhood rituals to keep the virus at bay.

States are getting ready to roll out shots to small arms – in special orange vials to distinguish them from adult vaccines – as soon as the government gives OK. More than 25,000 pediatricians and other primary care providers have so far signed up to offer vaccination.

Pfizer’s study tracked 2,268 children aged 5 to 11 who received two shots at three-week intervals of either placebo or child dose. Vaccinated adolescents developed levels of antiviral antibodies as strong as teens and young adults who received full-strength shots.

And so far, 16 children who have received dummy shots have developed symptomatic COVID-19 compared to three vaccinated adolescents, meaning the vaccine was almost 91% effective. Most of the survey data were collected in the United States during August and September as the delta variant increased.

The child dose also proved safe, with similar or fewer temporary side effects – such as sore arms, fever or pain – that teenagers experience. At the FDA’s request, Pfizer recently enrolled an additional 2,300 young people in the study, and preliminary safety data have not shown any red flags.

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

The FDA’s panel of independent experts will weigh whether Pfizer’s shots are likely to prevent more COVID-19 hospitalizations in young children than may be caused by the rare side effect.

The FDA analysis calculated that in most scenarios of the ongoing pandemic, the vaccine would prevent about 200 to 250 COVID-19 admissions for every 1 million young people vaccinated, with about 58 admissions for heart inflammation. The risk of side effects is based on levels in teens, and Pfizer expects it to be much lower in adolescents receiving a child-sized dose.

Moderna is also studying its vaccine for young children.

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