FDA says benefits of Pfizer vaccine outweigh major risks in children aged 5 to 11

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FDA says benefits of Pfizer vaccine outweigh major risks in children aged 5 to 11

WASHINGTON – Federal regulators on Friday evaluated the safety and efficacy of a coronavirus vaccine for children 5 to 11 for the first time, saying the benefits of preventing Covid-19 with the Pfizer-BioNTech vaccine generally outweigh the risks of the most worrying. reduced. side effects in that age group.

The analysis came on the same day that the Food and Drug Administration posted data from Pfizer showing that the vaccine had an efficacy rate of 90.7 percent in preventing symptomatic Covid-19 in a clinical trial of 5- to 11-year-olds. .

The findings could add momentum to FDA authorization of pediatric dosing on an emergency basis, perhaps as early as next week, opening up a long-awaited new phase of the nation’s vaccination campaign. The agency’s independent vaccine expert committee is set to vote on Tuesday to recommend authorization.

In a briefing document posted on the FDA website, the agency said it has balanced the risks of hospitalization, death or other serious consequences from Covid-19 against the risk of myocarditis. A rare condition associated with inflammation of the heart muscle, myocarditis has been linked to Pfizer-BioNTech and Moderna Vaccines, especially in young men.

“The overall analysis predicts that the number of clinically significant Covid-19-related outcomes will clearly exceed the number of additional myocarditis cases associated with the vaccine,” the regulators wrote.

As is customary prior to the FDA’s advisory committee vote, regulators did not take a stance on whether new uses of the vaccine should be authorized.

If the rules favor FDA authorization and the Centers for Disease Control and Prevention and its panel of vaccine experts agree, 28 million children in that age group could become eligible for shots in the first week of November.

Professor of Pediatrics in the Division of Infectious Diseases at Vanderbilt University School of Medicine. Catherine M. “There’s a lot of data to be encouraged by this,” Edwards said. She said the results exceeded the protection offered by the best flu vaccines and could eventually lead to an easing of restrictions aimed at preventing primary school children from contracting the virus.

The Biden administration is eagerly promoting the possibility of the pediatric shot, and many parents are eagerly awaiting the development. Covid-19 cases among people below 18 years of age peaked in the first week of September, when nearly one lakh cases were reported.

But they remain high, with more than 130,000 cases reported in the second week of October, the American Academy of Pediatrics said, accounting for a quarter of all cases nationwide. The organization said that less than two percent of these cases resulted in hospitalization, but that figure was based on data from only half the states.

Pfizer and BioNTech announced a month ago that their vaccine worked well for young children, but as of Friday no comprehensive clinical data had been publicly released. Children in the trial received two doses of 10 micrograms — a third of the adult dose — three weeks apart. The researchers said the dosage was safe, and that the trial participants saw only mild side effects.

Of the 2,268 children in the trial, twice as many were given the vaccine as those who had received a placebo. Sixteen children who received the placebo got Covid-19, compared to three who received the vaccine. All cases of covid occurred in July or later, as the highly permeable delta variant was spreading in the United States and globally, according to the company. The FDA said it could not determine whether the cases were caused by the delta variant.

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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 the second dose.

There were no cases of severe Covid in 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 test probably wasn’t enough to find out whether those particular conditions — myocarditis and pericarditis — may 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 pain, fatigue, and headache at the injection site.

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

Even given the low rate of covid infection, he said, the benefits of vaccination may outweigh the risks as the virus can cause more serious health consequences than any side effects.

Researchers looked at immune responses, comparing them to levels in adults who had received the vaccine. Pfizer then concluded that the protection afforded by low doses in children may be as adequate as that afforded by high doses in adults. This approach is especially important in small trials.

After the second shot, levels of neutralizing antibodies in the children were at least equal to those of volunteers aged 16 to 25 in another Pfizer-BioNtech trial. Although antibody levels are just one measure of the immune system’s response, experts said such a finding would indicate that a third of the adult dose was the appropriate dose for young children.

What to know about Covid-19 booster shots

The FDA has authorized booster shots for millions of recipients of the Pfizer-BioNtech, Moderna and Johnson & Johnson vaccines. Pfizer and Moderna recipients who are eligible for a booster include people age 65 and older, and young adults at high risk of severe Covid-19 due to medical conditions or where they work. Eligible recipients of Pfizer and Moderna can receive a booster at least six months after their second dose. All recipients of Johnson & Johnson will be eligible for a second shot at least two months after the first shot.

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

The CDC states that conditions that qualify a person for a booster shot include: high blood pressure and heart disease; diabetes or obesity; cancer or blood disorder; 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 authorized boosters for workers whose jobs put them at high risk of coming into contact with potentially infectious people. The CDC says the group includes: emergency medical workers; education worker; food and agricultural workers; construction workers; improvement worker; US Postal Service employees; public transport workers; Grocery store workers.

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Yes. The CDC says the Covid vaccine can be administered regardless of the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.

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

Cody Meisner, a panel member and chief of the Division of Pediatric Infectious Diseases at Tufts Children’s Hospital in Boston, experts will certainly raise concerns about those side effects at an FDA advisory committee meeting.

“I certainly hope we are in a position to recommend it because people are definitely looking forward to it, they are eager to have it,” he said. “But our responsibility is to balance both the risk and the benefit.”

Vaccine experts have said that a low dose of Pfizer may reduce the risk. “We always like to use the least amount of vaccine that is needed to produce an immune response,” said Vanderbilt specialist Dr. Edwards, “as it is usually associated with fewer adverse events.”

Brian Feingold, a specialist in heart inflammation in children at UPMC Children’s Hospital in Pittsburgh, said that, “If you focus only on myocarditis or other potentially rare things, you probably still want more information.”

But “we cannot consider the risk in isolation,” he said. “Covid risks need to be considered when you make a decision about whether this vaccine has a greater net benefit.”

Dr. Edwards said researchers and regulators are in a dilemma. “The more people you enroll, the longer it takes,” she said. “Very often, very rare events data to really look at, you won’t be able to do that in studies until the vaccine is really used more widely.”

The Centers for Disease Control and Prevention, which sets vaccine policy for the government, has scheduled a meeting of its advisory committee on November 2 and 3 to consider the issue. Federal officials have said they intend to send 15 million doses to states immediately if regulators and health officials authorize the move. The needle that administers the vaccine and the vials that hold it should be small for children who are still in primary school.

About 17 million teens 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 between the ages of six months and five years.

According to a poll conducted last month by the Kaiser Family Foundation, only one in three parents of children ages 5 to 11 plan to have their children vaccinated “immediately.” Another third said they wanted to “wait and see” how the vaccine affected children.

But the same poll showed that reluctance among parents of teens had decreased in the months since vaccines became available for that age group.

Aina Jay Khan contributed reporting from London, and Karl Zimmer From New Haven, Conn.

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