Monday, September 26, 2022

FDA Team Supports Pfizer’s Low-Dose COVID-19 Vaccine for Children

Date:

WASHINGTON (NWN) – The United States has moved closer to scaling up COVID-19 vaccinations for millions of children as government advisers approved Pfizer child doses for children ages 5-11 on Tuesday.

An FDA advisory panel voted unanimously with one abstention that the benefits of the vaccine in preventing COVID-19 in this age group outweigh any potential risks. This includes questions about a heart-related side effect, which is very rare in adolescents and young adults, despite using a much higher dose of the vaccine.

Although children are much less likely than older people to develop severe COVID-19, many of the panelists ultimately agreed that it was important to empower parents to protect their children, especially those at high risk of illness or who live in areas where they operate. other precautions such as masks. not used in schools.

“This is an age group that deserves and should have the same opportunity to get vaccinated as any other age,” said panelist Dr. Amanda Cohn of the Centers for Disease Control and Prevention.

The FDA is not bound by the panel’s recommendations and is expected to make its own decision within days. If the FDA agrees, there is one more step: next week, the CDC will have to decide whether to recommend the shots and which young people should receive them.

Pfizer and its partner BioNTech are already recommended for everyone 12 and older, but pediatricians and many parents demand protection for young children. The highly contagious delta variant has caused an alarming rise in childhood infections – and families are frustrated with school quarantines and forced to forgo sleepovers and other childhood rites to keep the virus at bay.

In the 5-11 age group, there were more than 8,300 hospitalizations, about a third of which required intensive care and almost 100 deaths.

The states are preparing to release injections – just a third of the amount given to teens and adults – that will come in special vials with orange caps to avoid dosage confusion. To date, more than 25,000 pediatricians and other primary health care providers have signed up for the vaccine, which will also be available in pharmacies and other locations.

But despite all this anticipation, there are also people who are vigorously opposed to vaccination of young children, and the FDA and its advisers have been inundated with an email campaign seeking to block Pfizer’s vaccination.

Dr. Jay Portnoy, of Children’s Mercy Hospital in Kansas City, Missouri, said that despite over 4,000 emails urging him to vote against the vaccine, he was convinced by data showing it worked. Tailor said that he also represented “the parents I see every day at the clinic who are afraid to send their children to school. … They also need a voice. “

The experts stressed that they do not support the requirements for vaccination of young children, and the FDA does not decide on the introduction of such vaccines. FDA vaccine chief Dr. Peter Marks also said that it would be very unusual for other groups to authorize something that is only authorized for emergency use. Several counselors have stated that they would like to be vaccinated for high-risk youth, and this decision will be made by the CDC.

Dr. James Hildreth of Meharri College of Medicine said he ultimately voted for the vaccine “to make sure that the kids who really need this vaccine, especially black and brown children in our country, get it.”

Pfizer studied 2,268 elementary school students who were given two injections three weeks apart of either a placebo or a child’s dose. Vaccinated young people develop levels of antibodies that fight the virus that are as strong as those of adolescents and young adults who receive full vaccinations. More importantly, the vaccine has proven to be nearly 91% effective in preventing symptomatic infection – based on 16 cases of COVID-19 among children who were vaccinated, compared with three vaccinated.

The pediatric dosage has also been found to be safe, with similar or fewer temporary side effects such as pain in the arms, fever, or pain experienced by adolescents. At the request of the FDA, Pfizer recently recruited an additional 2,300 young people in the study, and preliminary safety data showed no warning signs.

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But this study is not large enough to detect any extremely rare side effects, such as inflammation of the heart, which sometimes occurs after a second full dose, mostly in young men and adolescent boys. The group discussed for hours whether young children who received a lower dose might experience this side effect.

Statistical models developed by FDA scientists have shown that in most scenarios of an ongoing pandemic, the vaccine will prevent far more COVID-19 hospitalizations in this age group than could potentially be caused by this rare heart problem.

FDA models suggest the vaccine could prevent 200 to 250 hospitalizations for every 1 million young people vaccinated – provided the spread of the virus remains high, which is difficult to predict. FDA scientists also said that young children probably won’t have the same risk of heart inflammation as adolescents, but if they did, it could cause about 58 hospitalizations per million vaccinations.

“I really think this is a relatively close challenge,” said adviser Dr. Eric Rubin of Harvard University. “It will actually be a question about the prevailing conditions, but we will never know how safe this vaccine is unless we start giving it.”

Moderna is also researching a vaccine for young children, and Pfizer is doing more research for children under 5.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. NWN is solely responsible for all content.

Nation World News Desk
Nation World News Deskhttps://nationworldnews.com
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