FDA Panel Votes to Approve Pfizer’s Vaccine for Children

 

October 26, 2021 – The benefits of Pfizer’s COVID-19 vaccine outweigh its risks for children aged 5 to 11, according to an independent panel. Vaccine Experts who advise the FDA.On Tuesday, 17 of the 18 members of the VRBPAC Advisory Committee on Vaccines and Related Biological Products voted in favor of recommending 10 microgram shots for children, one-third of the dose given to adults.One member, Michael Karela, MD, director of the Division of Clinical Innovation at the National Institutes of Health, abstained.

If the FDA complies with the recommendation, as it usually does, and issues an emergency use permit. Vaccine, Shots may be available in days.

FDA DECISION:

Following the FDA’s final decision, the CDC’s Advisory Committee on Immunizations will meet to make specific recommendations for the use of the vaccine.


The CDC Committee must adhere to the terms of use in the EUA, so its recommendations will be similar to those made by the FDA. The next meeting of the committee is scheduled for November 2 and 3.

“It’s much more difficult than we expected it to be,” committee member Eric Rubin, MD, editor-in-chief of the New England Journal of Medicine, told a committee meeting on Tuesday.Prior to the vote, the committee listened to presentations outlining the potential benefits of vaccinating children, as well as the potential risks.”The children are very affected. Global pandemicFiona Heuer, MD, a medical officer with the CDC in Atlanta, said she examined COVID-19 epidemics in children.

In the second year of the epidemic, as more seniors have been vaccinated against the virus, cases of covid have largely shifted from older people to younger groups.

To date, there have been more than 1.9 million Covid 19 cases in children aged 5 to 11, with U.S. trips leading to summer travel in July and August, school reopening, and school dominance. The jump was seen. Delta variant.

And these are just cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States shows that six times more children are coded than those shown in official figures.

Last winter, tests of blood samples showed that about 13% of children had antibodies against the virus, indicating that they were infected. By this summer, that number had risen to 42 percent.The figures clearly gave an impression to many committee members who asked FDA vaccine reviewers if they had tried to be accountable. Immunity From past infections in their modeling. They did not have.Some people found that even with a highly effective vaccine – new data presented by Pfizer found that baby food is 90% effective in preventing symptomatic infections in children – caution was needed because the heart Nothing is known yet. Inflammation, A rare side effect of the mRNA vaccine.

This is called inflammation. Myocarditis Or pericarditis, more common in younger age groups. It usually goes away over time but requires hospital care. It is not known if myocarditis can have long-lasting effects on people who have it.

Vaccine pfizer found

The vaccine study in Pfizer’s children found no cases of myocarditis, and no other serious cases.

“We think we’ve improved the immune response and reduced our response,” said William Gruber, MD, senior vice president of vaccine research and clinical development at Pfizer.But the studies did not include enough participants to take rare, but serious adverse events, such as myocarditis.”We’re concerned about a side effect we can’t measure yet, but it’s probably real, and we see an advantage that occurs in older groups,” Rubin said.

Benefits vs. Risks

The FDA has modeled the benefits and risks for children under different scenarios. The benefits of vaccinating children depend on the amount of community transfer.

When the transmission is high, the benefits to children – in terms of infections, hospitalization, and admission to the intensive care unit – are clearly far greater than the risks of the vaccine.

But when COVID-19 rates in the community are as low as they were in June, FDA analysts predict that the vaccine could send more children to the hospital for myocarditis than the virus.

The FDA notes that children who are hospitalized for myocarditis are not as sick as those with myocarditis.”If trends continue the way they’re going, the emergency for children isn’t what we might think. That was my concern,” said James Hildreth, MD, president and CEO of Nashville. Mehri Medical College in TN said.But others warned against flattery.

“To think that this wave is going to end permanently is to be a little too optimistic,” said Arnold Monto, MD, chairman of the committee, professor of public health and epidemiology at the University of Michigan.

Most cases of COVID-19 in children are mild. According to CDC data, only 1% of children are hospitalized for their infection. But children’s hospital admissions are about 3 times higher for people of color – including blacks, Hispanics, and Native Americans, whites, and Asian Americans.

Since the onset of the epidemic, 94 children between the ages of 5 and 11 have died, making it the eighth leading cause of death among children under that age last year.

More than 5,200 children are called Multi-System Inflammatory Syndrome – Children, or MIS-C. MIS-C can be severe and requires hospital care and can lead to myocarditis, or inflammation of the heart muscle. Children 5 to 11 years old are most at risk for this complication.Children can also get post-cod conditions called. Long COVID. There is not much data on how often this happens, although it seems to be less common in children than in adults. But a survey in the UK found that 7% -8% of children have symptoms of an infection that lasts longer than 12 weeks, Hewer said. Symptoms that may be present in children include: Fatigue, CoughMuscle and joint pain, Headache, And insomnia.More than one million children have been affected by school closures so far this year, and quarantine has had a lasting impact on learning, social development and so on. Mental health.

Although children are not usually COVID superseded, they can pass the infection on to others.

“What’s clear is that there is a secondary transition from children to other children and adults,” said Heuer.Because of this, they can continue to spread the virus and give it a chance to change and become more dangerous.Capt. Amanda Cohen, MD, MD, chief medical officer of the National Center for Immunization and Respiratory Diseases, said, “I’m really grateful we had this discussion and voted for it.” “I think the benefits in this age group are really significant, even if they are lower than in other age groups.”

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