FDA Says Benefits of Pfizer Vaccine Outweigh Major Risks in Children 5-11 Years

WASHINGTON – Federal regulators first assessed the safety and efficacy of a coronavirus on Friday vaccine for children aged 5 to 11 , cl...


WASHINGTON – Federal regulators first assessed the safety and efficacy of a coronavirus on Friday vaccine for children aged 5 to 11, claiming that the benefits of warding off Covid-19 with the Pfizer-BioNTech vaccine generally outweighed the risks of the most disturbing side effects possible in this age group.

The analysis came the same day that the Food and Drug Administration released data from Pfizer showing the vaccine had a 90.7% effectiveness rate in preventing symptoms of Covid-19 in a clinical trial of children from 5 to 11 years old.

The results could provide momentum for FDA clearance of the emergency pediatric dose, possibly as early as next week, ushering in a long-awaited new phase of the country’s vaccination campaign. The agency’s independent expert committee on vaccines is due to vote Tuesday on whether to recommend authorization.

In a information document Posted on the FDA’s website, the agency said it had weighed the dangers of hospitalization, death or other serious consequences from Covid-19 against the risk of myocarditis. A rare disease involving inflammation of the heart muscle, myocarditis has been linked to Pfizer-BioNTech and Moderna vaccines, particularly in young men.

“The overall analysis predicted that the number of clinically significant Covid-19 outcomes averted would clearly exceed the number of vaccine-associated cases of excessive myocarditis,” the regulators wrote.

As is customary before an FDA advisory committee vote, regulators have taken no position on whether to authorize the new use of a vaccine.

If the FDA votes in favor of the authorization and the Centers for Disease Control and Prevention and its own panel of vaccine experts agree, the 28 million children in this age group could become eligible for the vaccines during the first week of November.

“There is a lot of data to be encouraged,” said Dr. Kathryn M. Edwards, professor of pediatrics in the division of infectious diseases in the faculty of medicine at Vanderbilt University. She said the results exceeded the protection offered by the best flu vaccine and could potentially lead to a loosening of restrictions aimed at preventing elementary school children from contracting the virus.

The Biden administration has been eagerly promoting the prospect of a pediatric injection, and many parents are anxiously awaiting development. Covid-19 cases among those under the age of 18 peaked in the first week of September, when nearly a quarter of a million cases were reported.

But they remained high, with more than 130,000 cases reported in the second week of October, said the American Academy of Pediatrics, accounting for a quarter of all cases nationwide. Less than 2% of those cases resulted in hospitalization, but that figure was based on data from only half of the states, the organization said.

Pfizer and BioNTech announced a month ago that their vaccine was working well for young children, but no full clinical data was released until Friday. The children in the trial received two doses of 10 micrograms – one-third of the adult dose – three weeks apart. The researchers said the dosage was safe and the trial participants saw only mild side effects.

Of 2,268 children participating in the trial, twice as many received the vaccine as a placebo. Sixteen children who received the placebo contracted Covid-19, compared to three who received the vaccine. All of the Covid cases occurred in July or later, as the highly transmissible Delta variant spread in the United States and around the world, according to the company. The FDA said it could not determine whether the cases were caused by the Delta variant.

Pfizer said it had follow-up safety data for an additional 2,250 children, but only for a median of two and a half weeks after receiving a second dose.

There were no cases of severe Covid among trial participants, and no cases of two rare heart conditions that have been linked to the vaccine in adolescents and adults, especially young men. But the trial was probably not large enough to detect whether these particular conditions – myocarditis and pericarditis – could appear with any frequency in young children.

Minor side effects in the study group generally occurred more frequently after the second dose, the FDA reported; the most common were injection site pain, fatigue and headache.

The FDA modeled different scenarios with different levels of viral spread to determine the number of symptomatic cases of Covid, including severe cases, that would be prevented by the vaccine. They weighed this against the risks of myocarditis and pericarditis associated with vaccination.

Even with a low rate of Covid infections, they said, the benefits of vaccination could outweigh the risks, as the virus could lead to more serious health consequences than any effect. secondary.

The researchers looked at immune responses, comparing them to levels in adults who had received the vaccine. Pfizer then deduced that the protection offered by the lower dose in children might be as great as that offered by the higher dose in adults. This approach is especially important in small trials.

After the second injection, children had neutralizing antibody levels at least equal to those of volunteers aged 16 to 25 in another Pfizer-BioNTech trial. Although antibody levels are only one measure of the immune system’s response, experts said such a finding would indicate that a third of an adult dose is the appropriate dose for young children.

What to know about Covid-19 booster injections

The FDA has cleared booster shots for millions of drug recipients Pfizer-BioNTech, Moderna and Johnson & johnson vaccines. Pfizer and Moderna beneficiaries who are eligible for a recall include people 65 years of age and older and young adults at high risk of severe Covid-19 due to medical conditions or their workplace. Eligible Pfizer and Moderna beneficiaries may receive a booster at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second injection at least two months after the first.

Yes. The FDA has updated its clearances to allow medical providers to boost people with a different vaccine than the one they originally received, a strategy known as “mix and match.” Whether you have received Moderna, Johnson & Johnson, or Pfizer-BioNTech, you may receive a booster of any other vaccine. Regulators have not recommended any vaccine over another as a booster. They have also remained silent on whether it is best to stick to the same vaccine when possible.

The CDC said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney or liver disease; dementia and some disabilities. Pregnant women and current and former smokers are also eligible.

The FDA has cleared the boosters for workers whose work puts them at high risk of exposure to potentially infectious people. The CDC says this group includes: emergency medical workers; education workers; food and agricultural workers; manufacturing workers; correctional workers; workers in the US postal service; public transport workers; employees of grocery stores.

Yes. The CDC says the Covid vaccine can be given regardless of the timing of other vaccines, and many pharmacy websites allow people to schedule a flu shot along with a booster dose.

Studies have shown that the risk of developing myocarditis or pericarditis from Covid-19 is higher than from vaccination. However, some countries recommended a single dose of Pfizer-BioNTech vaccine for children 12 years of age and older, offering less protection but possibly with a lower risk of side effects.

Experts will almost certainly raise concerns about these side effects at the FDA advisory committee meeting, according to Dr. H. Cody Meissner, group member and head of the pediatric infectious disease division at Tufts Children’s Hospital in Boston.

“I certainly hope we will be able to recommend this because people are definitely expecting it, they are looking forward to it,” he said. “But our responsibility is to balance the risks and the benefits.”

Vaccine experts said Pfizer’s lower dosage could mitigate the risks. “We always like to use the least amount of vaccine needed to generate an immune response,” said Dr. Edwards, the Vanderbilt expert, “because it is generally associated with fewer adverse events.”

Dr Brian Feingold, pediatric heart inflammation expert at UPMC Children’s Hospital in Pittsburgh, said that “if you’re just focusing on myocarditis or other potentially rare things you’re probably always going to want more. information. “

But “we cannot consider a risk in isolation,” he added. “The risks of Covid must be taken into account when deciding whether this vaccine has a greater net benefit. “

Dr Edwards said researchers and regulators were in a dilemma. “The more people you sign up, the longer it takes,” she said. “Often, in order to really look at the data for very rare events, you won’t be able to do it in studies until the vaccine is really used more widely.”

The Centers for Disease Control and Prevention, which sets the government’s vaccine policy, has scheduled a meeting of its advisory committee on November 2-3 to look into the matter. Federal officials said they intended Immediately ship 15 million doses to states if regulatory and health authorities authorize relocation. The needles that administer the vaccine and the vials that contain it will need to be smaller for children who are still largely in primary school.

About 17 million adolescents aged 12 to 15 became eligible for the Pfizer-BioNTech vaccine in May. Vaccine manufacturers continue to study the possibility of a vaccine for people aged six months to 5 years.

Only about one in three parents of children aged 5 to 11 planned to have their children immunized “immediately” once a vaccine is cleared, according to a survey by the Kaiser Family Foundation conducted last month. Another third said they wanted to “wait and see” how the vaccine affected children.

But that same poll showed reluctance from parents of teenagers had waned in the months since vaccines became available for that age group.

Aina J. Khan contributed to reporting from London, and Carl Zimmer of New Haven, Connecticut.

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Newsrust - US Top News: FDA Says Benefits of Pfizer Vaccine Outweigh Major Risks in Children 5-11 Years
FDA Says Benefits of Pfizer Vaccine Outweigh Major Risks in Children 5-11 Years
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