FDA Vaccine Advisors Vote To Recommend Pfizer’s Covid-19 Vaccine For Children 5-11 Years Old – .

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FDA Vaccine Advisors Vote To Recommend Pfizer’s Covid-19 Vaccine For Children 5-11 Years Old – .



Members of the FDA’s Vaccines and Related Biologics Advisory Committee agreed that the benefits of immunizing young children appeared to outweigh the risks, but some members appeared concerned about voting to immunize a large population of young people. children based on studies of a few thousand.

“It’s reassuring to me that we are giving a lower dose,” said Dr. Paul Offit, who directs the Vaccine Education Center at Children’s Hospital of Philadelphia.

Pfizer has reduced its vaccine to one-third of the adult dose for children under 12, and clinical trials have shown this lower dose to protect children well against symptomatic infections. The hope is that it will cause fewer side effects.

“We believe that we have optimized the immune response and minimized the reactions,” Pfizer senior vice president William Gruber said at the meeting.

One big issue was the theoretical risk of myocarditis – an inflammatory heart disease. It has been seen in some people who have received the Pfizer and Moderna vaccines and is more common in young men, although it is generally mild. Not enough young children have been tested to show whether they are also at risk.
“We have identified a lower dose which we believe will decrease the frequency of the rare side effect of myocarditis,” said Dr. Arnold Monto, chair of the committee and professor of epidemiology at the University of Michgan.

“I’m just worried that if we say yes, states will force the administration of this vaccine on children to go to school and I don’t agree with that,” said Professor Dr Cody Meissner. of Pediatrics at Tufts University. Medicine School. “I think it would be a mistake right now. “

But Dr Peter Marks, who heads the vaccines arm of the FDA, the Center for Biologics Evaluation and Research, said it was unlikely.

“Just to reassure the committee, because we’re taking emergency use authorization rather than approval, in general, although it is possible that warrants can be put in place, I guess, in general people don’t. ‘have not done any warrants with emergency use authorizations and there are some governors who have already announced that they will not give warrants until there is approval, as opposed to a emergency use authorization, ”Marks said after the vote.

And Dr Amanda Cohn of the US Centers for Disease Control and Prevention reminded the committee that children have died from Covid-19. According to the CDC, more than 700 children aged 18 and under have died from Covid-19. “We don’t want children to die from Covid,” she said. “And we don’t want children in intensive care. “

The FDA had said that, in most of the scenarios it predicted, the benefits of vaccinating young children would outweigh the risks, and Pfizer said clinical trials have shown the vaccine to be more than 90% effective. % to prevent symptomatic infections in children.

The FDA will now consider the committee’s vote and is likely to extend EUA to vaccine for young children in the coming days.

Then, vaccine advisers from the U.S. Centers for Disease Control and Prevention will meet next week, Nov. 2-3, to discuss the decision and decide whether to recommend that American children get vaccinated. The final say will rest with CDC director Dr Rochelle Walensky, and vaccination could begin next week if she gives the green light.

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The US federal government has a plan in place to deliver the smaller vaccines to pediatrician offices, pharmacies and other locations across the country.

“Safety monitoring of this vaccine will continue. It was actually pretty intense, ”Marks added.

Pfizer’s vaccine is licensed for young people between the ages of 12 and 17, and a CNN analysis of CDC data shows that about half of teens in that age group in the United States are fully vaccinated.

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