FDA committee approves Pfizer-BioTech COVID-19 vaccine for children ages 5-11

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The Federal Advisory Committee on Tuesday voted 17-0 to authorize Pfizer-BioTech’s COVID-19 vaccine for children aged 5-11.

Children are less likely to be hospitalized with COVID-19 than adults, or suffer long-term consequences of the disease – putting the burden on the vaccine to prove safe and effective to justify its risk.

A panel of vaccine experts and pediatric doctors, while they are concerned about strangers, thought the data would be sufficient to support the use of the Pfizer-BioTech vaccine in this age group because it would benefit more children than it does harm.

Several members described their support for the move as families who are particularly vulnerable to COVID-19 should have access to the vaccine. And the virus poses a danger to children, he said.

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“It’s very hard for me to believe that the risk of severe outcome will come closer to the known risk that we’ve seen for this virus in this age group,” said Dr. Petersburg’s virus expert. Patrick Moore said. Cancer Institute. “On top of that, there are thousands of hospitalized children, some of whom are disabled by the virus, an upward cost to parents, society, schools, etc. So for me, this seems like a tough decision, but obvious.

According to a study presented to the committee, more than 40% of American children of this age group are already infected with COVID-19. It is not clear whether the vaccine will provide more protection for those children.

Dr. Kerr is a pediatric epidemiologist at Tufts Medical Center in Boston. Cody Meisner said he does not want to make shots mandatory, while supporting the vaccine available for this age group.

Hundreds of children of this age have been hospitalized for COVID-19 and 94 have died this year. Accidents, cancer, malformations, murder, heart disease, chronic lower respiratory illness, and the eighth leading cause of death in that age group last year after flu or pneumonia.

September is the most dangerous month for the pandemic for American children, who are more susceptible to the delta transformation they took this summer than previous adaptations.

Children seem to be more likely to catch COVID-19 and transmit it to adolescents and adults, but are less likely to become seriously ill or notice that they are infected.

Many members note that while every medical treatment can cause harm, and the side effects seen so far with the Pfizer-BioTech vaccine are small, vaccinating millions of children can be more significant.

“We need to find a way to live with (COVID-19),” said Jeanette Lee, a member of the faculty of the Bioethics Department of Medical Sciences at the University of Arkansas at Little Rock. “Vaccines give us a way to do that.”

The vaccine is given in two shots to children 5 to 11 years old, three weeks apart, with one-third of the dose given to adults and teens.

Moderna, the maker of another COVID-19 vaccine, released its own study on Monday showing that half of its original adult dose vaccine is safe and effective for children aged 6 to 11. The company has yet to ask for the authority to provide its vaccine to this age group.

With the approval of the Advisory Committee, there are still three phases to be made available to Pfizer-BioTech vaccine children. First, the Food and Drug Administration has to sign off on power, which is expected in the next few days.

Later, another panel of independent experts advises the Centers for Disease Control and Prevention, reviewing the safety and efficacy data of the Pfizer-BioTech vaccine. If they give a thumbs up, CDC directors will need to add their support before the vaccines become available, perhaps by the middle of next week.

The Biden administration says it has purchased enough vaccine to cover 28 million American children of this age. Shots will soon be available at no cost at commercial pharmacies and some pediatric offices.

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The FDA Vaccines and Related Biological Products Advisory Committee held a full-day meeting Tuesday to hear from Pfizer-BioTech vaccine information from company officials and experts within the government.

Pfizer presented the results of several studies conducted on approximately 5,000 5- to 11-year-olds.

It found the vaccine was safe, with no serious vaccine-related side effects, however, as adults and older children, many of the 5 to 11-year-olds suffered from sore arms, fatigue, headaches, muscle pain, for a day or two. Cold andLow grade fevers.

In a subset of children, the Pfizer-BioTech vaccine was found to be more than 90% protective against compression of symptomatic COVID-19. Of the 19 children in the study who were infected with COVID-19, only 3 received active vaccine compared to 16 children who received placebo.

In one study, more than half of children, more than 11% had obesity and about 8% had asthma. Both groups were vaccinated as children without this problem

Pfizer-BioNTech COVID-19 Vaccine for Children, Labeled and Packed in a European Production Facility.

Pfizer executives told the committee that children who had previously been infected with COVID-19 responded to the shots as they were not exposed to the virus.

Studies are too small to detect myocarditis, with myocardial infarction occurring in a small number of adolescents and young adults, mostly male, after their strokes.

Myocarditis is more common in adolescents and young adults in this younger age group, according to Dr. Kerr, a pediatric cardiologist at Children’s Healthcare in Atlanta. Matthew Oster told the committee.

Cases of myocarditis are expected to occur and are tracked by the government’s multi-layered system to identify adverse reactions from the COVID-19 vaccine, said Peter Marks of the FDA. No one has died of myocarditis after vaccination and most have recovered quickly.

“We are never going to learn how safe it is until we start to give it up,” said committee member Dr. Dale. Said Eric Rubin, editor-in-chief of the New England Journal of Medicine and an immunologist at the Harvard TH Chan School of Public. Health and Brigham and Women’s Hospital in Boston. “We’re worried about the side effect we can’t measure yet, but it’s probably true.”

None of the studies detected any dangerous allergic reactions.

Analysis of different scenarios by the FDA shows that the benefits of vaccination outweigh the risks in this age group, unless COVID-19 cases drop to about 5% of September rates.

COVID-19 is responsible for more than 5,000 immune-over-reaction cases in children, an average of 9 years old. Children are less likely to have chronic symptoms of COVID-19 than adults, but they still suffer from what is known as chronic COVID.

The Pfizer-BioTech vaccine given to children is similar to the formula previously available except for the addition of a chemical called tri-sucrose. Pfizer executives told the committee that tri-sucrose has already been used in several other vaccines and will weaken the vaccine and keep it stable in the refrigerator for up to 10 weeks.

COVID-19 vaccines are now available to everyone over the age of 11 and many are eligible for booster doses. Adults can receive one of three vaccines, whose vaccine is fully approved by Pfizer-Bioentech and Moderna and Johnson & Johnson, whose vaccines are still available under emergency authorization.

According to the company’s study, the Moderna vaccine tested in 4,753 children aged 6 to 11 years is safe and produces the same immune response seen in adolescents and adults.

Pfizer-BioNTech completes its vaccine test in children before modern day. J&J has not released any data on the safety or effectiveness of its vaccine in minors.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage is made possible in part by a competition grant from the Massimo Foundation for Ethics, Innovation and Healthcare. The Massimo Foundation does not provide editorial input.

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