FDA Says Pfizer Vaccine Benefits Outweigh Key Risks in Children 5


WASHINGTON — Federal regulators evaluated the safety and efficacy of a coronavirus for the first time on Friday Vaccination for children 5-11 years oldSaying that the benefits of fending off Covid-19 with the Pfizer-BioNTech vaccine often outweigh the risks of the most worrisome potential side effects in that age group.

The analysis came on the day the Food and Drug Administration released data from Pfizer showing the vaccine had a 90.7 percent effectiveness rate in preventing symptomatic Covid-19 in a clinical trial conducted on 5 to 11-year-olds.

The findings could give impetus to FDA authorization of the pediatric emergency dose, perhaps as early as next week, and usher in a long-awaited new phase of the nation’s vaccination campaign. The agency’s independent vaccine expert committee is set to vote Tuesday on whether to recommend authorization.

Inside briefing document Published on the FDA website, the agency said it balances the dangers of hospitalization, death, or other serious consequences from Covid-19 against the risk of myocarditis. Myocarditis, a rare condition involving inflammation of the heart muscle, has been associated with the Pfizer-BioNTech and Moderna vaccines, particularly among younger men.

“Overall analysis predicted that the number of clinically significant Covid-19-related outcomes avoided would clearly outweigh the number of vaccine-associated extreme cases of myocarditis,” the regulators wrote.

As was customary before the FDA’s advisory committee voted, regulators did not take any stand on whether new use of a vaccine should be allowed.

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

Professor of pediatrics in the department of infectious diseases at Vanderbilt University School of Medicine. “There is a lot of data to be encouraged,” said Kathryn M. Edwards. He said the results exceeded the protection offered by the best flu vaccine and could eventually lead to easing restrictions on preventing the transmission of the virus to elementary school children.

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

But the American Academy of Pediatrics said it accounts for a quarter of all cases nationwide, with more than 130,000 cases reported in the second week of October. Less than two percent of these cases resulted in hospitalizations, but that figure is based on data from only half of the states, the organization said.

Pfizer and BioNTech announced a month ago that their vaccines work well for young children, but extensive clinical data were not made public until Friday. Children in the trial were given two doses of 10 micrograms—one-third the adult dose—three weeks apart. The researchers said the dose was safe and trial participants saw only mild side effects.

Of the 2,268 children in the trial, twice as many vaccinated as those given placebo. Sixteen children who received a placebo got Covid-19 compared to three children who received the vaccine. According to the company, all Covid cases occurred in July or later, as the highly contagious Delta variant has spread in the United States and globally. The FDA said it could not determine whether the cases were due to the Delta variant.

Pfizer said it has safety data for an additional 2,250 children, but only for a median of two and a half weeks after taking a second dose.

There were no serious cases of Covid among trial participants, and there were no two rare cases of vaccine-related heart conditions in teenagers and adults, particularly young men. But the trial was not large enough to detect whether these particular conditions – myocarditis and pericarditis – would occur with any frequency in young children.

The FDA reported that minor adverse events in the study group generally occurred more frequently after the second dose; the most common were pain at the injection site, fatigue, and headache.

The FDA modeled different scenarios with varying levels of viral spread to determine the number of symptomatic Covid cases, including severe ones, that would be prevented by the vaccine. They balanced this against the risks from vaccine-related cases of myocarditis and pericarditis.

They said that even given a low rate of Covid infection, the benefits of the vaccine may outweigh the risks, as the virus could have more serious health consequences than any side effects.

Researchers looked at immune responses and compared them to levels in adults who had received the vaccine. Pfizer later concluded that the protection afforded by the lower dose in children may be just as important as the protection afforded by the higher dose in adults. This approach is especially important in small trials.

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

What You Need to Know About Covid-19 Booster Shots

The FDA has allowed booster shots for millions of buyers. Pfizer-BioNTech, modern and Johnson and Johnson vaccines. Pfizer and Moderna recipients who qualify for support include people aged 65 and over, and young adults at high risk of serious Covid-19 because of medical conditions or where they work. Eligible Pfizer and Moderna recipients can receive a boost for at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second shoot at least two months after the first.

Yeah. The FDA has updated its mandate to allow medical providers to empower people with a different vaccine than the one they originally received. “Mix and Match.” You can get a booster for any other vaccine, whether you’ve received Moderna, Johnson & Johnson, or Pfizer-BioNTech. The regulators did not recommend any vaccine over the other as a booster. They also remained silent on whether it would be preferable to stick to the same vaccine whenever possible.

The CDC said conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood diseases; 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 allowed boosters for workers whose jobs put them at risk of exposure to potentially infectious humans. The CDC says the group includes: emergency health workers; education workers; food and agricultural workers; manufacturing workers; correction workers; US Postal Service employees; public transport workers; grocery workers.

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

Studies have shown that Risk of developing myocarditis or pericarditis from Covid-19 is higher than from vaccine. However, some countries He recommended A single dose of Pfizer-BioNTech vaccine for children 12 years of age and older provides less protection, but likely carries a lower risk of side effects.

A member of the panel and head of the Division of Pediatric Infectious Diseases at Tufts Children’s Hospital in Boston, Dr. According to H. Cody Meissner, experts will almost certainly voice their concerns about these side effects at an FDA advisory committee meeting.

“I hope we’re in a position to recommend it because people definitely expect it, they can’t wait to have it,” he said. “But our responsibility is to balance both risk and benefit.”

Vaccine experts said the lower dose of Pfizer could reduce the risks. Vanderbilt expert Dr. “We always like to use the least amount of vaccine needed to generate an immune response because it’s usually associated with fewer side effects,” said Edwards.

A specialist in pediatric heart inflammation at UPMC Children’s Hospital in Pittsburgh, Dr. “If you just focus on myocarditis or other rarer things, you’re probably going to keep asking for more information anyway,” said Brian Feingold.

But “we can’t think of a risk in isolation,” he added. “The risks from Covid should be considered when deciding whether there are more net benefits to this vaccine.”

Dr. Edwards said researchers and regulators are in a dilemma. “The more people you save, the more time it takes,” he said. “Often, you won’t be able to do this in studies until the vaccine is really more widely used, to really look at data from very rare events.”

The Centers for Disease Control and Prevention, which sets vaccine policy for the government, has scheduled an advisory committee meeting on November 2 and 3 to discuss the issue. Federal officials have said they intend. Sending 15 million doses to states immediately if regulatory and health officials allow action. The needles that administer the vaccine and the vials that hold 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 explore the possibility of vaccines for those aged six months to five years.

Only one in three parents of 5 to 11-year-olds plans to vaccinate their child “immediately” after a vaccine is approved. According to a survey by the Kaiser Family Foundation carried out last month. Another third said they wanted to “wait and see” how the vaccine affected children.

But the same survey showed that reluctance among teens’ parents has dropped in the months since vaccines were introduced to that age group.

Aina J. Khan Contributing reports from London and Carl Zimmer From New Haven, Conn.



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