On Tuesday, Vaccine advisers to the US Food and Drug Administration voted 17-0 with one abstention to recommend emergency use authorization of Pfizer's Covid-19 vaccine in children ages 5 to 11.

The FDA panel accepted Pfizer's data indicating the vaccine is safe and 90.7% effective in preventing COVID-19 infections in this age group.

Pfizer senior vice president William Gruber said,“The vaccine provides a broad defense against COVID-19 and ‘effectively neutralized the delta variant"in young kids.’”

A dose of Pfizer for young children contains one-third the amount of active ingredient compared to the adult dose.Children would receive a second dose 21 days or more after their first shot.

Gruber said the dose size was chosen to"strike the right balance" between providing strong immunity and limiting side effects.He said that the observed adverse effects seen in the company's studies "did not suggest any safety concerns."An FDA review supported that conclusion.

One big issue was the theoretical risk of myocarditis—an inflammatory heart condition.It's been seen in some people who got Pfizer and Moderna vaccines and is more common among young men, although it's usually mild.Not enough young children were tested to show whether they're also at risk.

"We've identified a lower dose which we expect is going to decrease the frequency of the rare side effect of myocarditos,"said Dr.Arnold Monto, chairman of the committee an a professor of epidemiology at the University of Michgan.

"I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that," said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine. "I think that would be an error at this time."

The FDA will now take the committee's vote under consideration and is likely to extend EUA to the vaccine for younger children in the coming days.Vaccine advisers to the US Centers for Disease Control and Prevention will meet next week to decide whether to recommend that US kids get the vaccine.






Source: CNN, n p r.