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FDA Panel Supports Pfizer’s Low-Dose COVID-19 Vaccine for Children | News

Washington (AP) — The United States is one step closer to expanding COVID-19 vaccination to millions more children after a government adviser approved Pfizer’s injections for children aged 5 to 11 on Tuesday. I did.

The Food and Drug Administration’s advisory board unanimously voted to abstain from the benefits of vaccines in the prevention of COVID-19 in that age group outweighing the potential risks. This includes questions about heart-related side effects that are very rare in teens and young adults, despite using much higher vaccine doses.

Children are much less likely to be infected with more severe COVID-19 than older people, but in the end many panelists, especially in children at high risk of illness and where there are other precautions such as masks. Not used in schools, which has determined that it is important to give parents the option of protecting their children.

“This is an age group that deserves vaccination like all other ages and should have the same opportunity,” said Dr. Amanda Korn, a panel member at the US Centers for Disease Control and Prevention. ..

The FDA is not bound by the panel’s recommendations and is expected to make its own decisions within a few days. If the FDA agrees, there are yet another steps. Next week, the CDC will need to decide whether to recommend shots and which young people will get the shots.

Full-strength shots by Pfizer and its partner BioNTech are already recommended for everyone over the age of 12, but pediatricians and many parents want to protect their infants. The highly contagious delta variant caused a surprising increase in pediatric infections-and families were dissatisfied with school quarantine and no to oversleep or other childhood rituals to keep the virus away. I have to say.

In the age group of 5-11 years, more than 8,300 hospitalizations have been reported, about one-third require intensive care and nearly 100 people die.

The state is preparing to deploy shots in special orange-clad vials to avoid dose mixups. This is only one-third of the amount given to teens and adults. To date, more than 25,000 pediatricians and other primary care providers have registered to provide vaccinations, which will also be available in pharmacies and elsewhere.

But because of all that expectation, some people strongly oppose vaccination of young children, and both the FDA and its advisers have been flooded with email campaigns trying to thwart Pfizer shots.

Dr. Jay Portnoy of Children’s Mercy Hospital in Kansas City, Missouri, said he was persuaded by data showing that the vaccine works despite more than 4,000 emails urging him to vote against the vaccine. “It represents the parents we see every day in the clinic, who are afraid to send their children to school,” Portnoy said. … they also need a voice. “

Panelists emphasized that they do not support the mandatory vaccine for infants — and the FDA does not make a mandatory decision. Dr. Peter Marks, FDA’s Vaccine Officer, also said that it is very rare for other groups to require what is authorized for emergency use only. Some advisers said they wanted to be able to adjust the shots for the youngest at risk, which is a decision to fall into the CDC.

Dr. James Hildress of Meharry Medical College said, “To ensure that children who really need this vaccine, mainly black and brown children in our country, can get the vaccine.” He said he voted for the vaccine.

Pfizer surveyed 2,268 elementary school students who received either placebo or a child’s dose twice at 3-week intervals. Vaccinated adolescents have developed antibodies that fight the virus at levels as strong as teens and young adults who have taken full-strength shots. More importantly, the vaccine has proven to be nearly 91% effective in preventing symptomatic treatment. It is based on COVID-19 in 16 children given dummy shots compared to only 3 vaccinated children.

Dosages for children have also proven to be safe, with the same or less temporary side effects experienced by teens, such as arm pain, fever, and pain. At the request of the FDA, Pfizer recently enrolled an additional 2,300 adolescents in the study, but preliminary safety data do not indicate a danger signal.

However, the study is not large enough to detect very rare side effects, such as occasional heart inflammation, that occur after the second full dose, primarily in young men and teenage boys. The panel spent hours discussing whether younger children given lower doses might also face the side effects.

A statistical model developed by FDA scientists shows that in most scenarios followed by a pandemic, this vaccine causes far more COVID-19 hospitalizations at this age than could be caused by this rare heart problem. Shown to prevent with layers.

The FDA’s model has suggested that the vaccine can prevent 200 to 250 hospitalizations for every 1 million young people vaccinated — difficult to predict, assuming that the spread of the virus remains high. That is. FDA scientists also said that young children would not be as at risk of carditis as teenagers, but if so, they could cause about 58 hospitalizations per million vaccinations.

Dr. Eric Rubin, an adviser to Harvard University, said: “It will really be a question of what the general condition is, but unless we start giving it, we will never learn how safe this vaccine is.”

Moderna is also researching vaccines in young children, and Pfizer is conducting additional research in children under the age of five.

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

Copyright 2021 AP communication. all rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.

FDA Panel Supports Pfizer’s Low-Dose COVID-19 Vaccine for Children | News

Source link FDA Panel Supports Pfizer’s Low-Dose COVID-19 Vaccine for Children | News

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