FDA Says Pfizer Vaccine Benefits Outweigh Key Risks in Children Ages 5 to 11

FDA Says Pfizer Vaccine Benefits Outweigh Key Risks in Children Ages 5 to 11


WASHINGTON — Federal regulators on Friday evaluated the safety and efficacy of a coronavirus vaccine for children ages 5 to 11 for the first time, saying the benefits of averting Covid-19 with the Pfizer-BioNTech vaccine generally outweighed the risks. of the most worrisome possible side effects in that age group.

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

The findings could spur the FDA’s approval of the pediatric emergency dose as early as next week, opening a much-anticipated new phase of the country’s vaccination campaign. The agency’s independent committee of vaccine experts will vote Tuesday on whether or not to recommend authorization.

In a briefing paper on the FDA website, the agency said it had weighed the dangers of hospitalization, death or other serious consequences of Covid-19 against the risk of myocarditis. A rare condition involving inflammation of the heart muscle, myocarditis has been associated with the Pfizer-BioNTech and Moderna vaccines, especially in young men.

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

As usual before a vote in the FDA’s advisory committee, regulators took no stance on whether to allow the new use of a vaccine.

If the FDA votes for authorization and the Centers for Disease Control and Prevention and their own panel of vaccine experts agree, the 28 million children in that age group could be eligible for injections by the first week of November.

“There is a lot of data to be encouraged by,” said Dr. Kathryn M. Edwards, a professor of pediatrics in the division of infectious diseases at Vanderbilt University School of Medicine. She said the results surpassed protection of the best flu vaccine and could eventually lead to easing restrictions intended to prevent primary school children from contracting the virus.

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

But they have remained 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. Less than two percent 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 comprehensive clinical data was made public until Friday. Children in the study were given two 10-microgram doses — a third of the adult dose — three weeks apart. Researchers said the dosage was safe and trial participants had seen only mild side effects.

Of the 2,268 children in the study, twice as many children received the vaccine as 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 transmissible Delta variant spread in the United States and worldwide, according to the company. The FDA said it could not determine whether the cases were caused by the Delta variant.

Pfizer said it had safety data for another 2,250 children, but only for a median of two and a half weeks after they received a second dose.

There were no cases of severe Covid among study participants, and there were no cases of two rare heart conditions associated with the vaccine in teens and adults, especially young men. But the trial probably wasn’t large enough to detect whether those specific conditions — myocarditis and pericarditis — might occur with any frequency in younger children.

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

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

Even given a low number of Covid infections, they said, the benefits of vaccination would outweigh the risks, as the virus could lead to 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 then concluded that the protection afforded by the lower dose in children may be equivalent to that afforded by the higher dose in adults. This approach is especially important for small trials.

After the second injection, the children had levels of neutralizing antibodies at least equal to those seen in 16-to-25-year-old volunteers in another Pfizer-BioNTech study. While antibody levels are only one measure of immune system response, experts have said such a finding would indicate that a third of an adult dose was the appropriate dosage for young children.

What you need 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. Recipients of Pfizer and Moderna who are eligible for a booster include people 65 and older and younger adults at high risk of severe Covid-19 due to medical conditions or where they work. Eligible Pfizer and Moderna recipients can receive a booster at least six months after their second dose. All Johnson & Johnson recipients are eligible for a second injection at least two months after the first.

Yes. The FDA has updated its authorizations to allow medical providers to incentivize people with a different vaccine than the one they were initially given, a strategy known as “mix and match.” Whether you’ve been given Moderna, Johnson & Johnson, or Pfizer-BioNTech, you can get a booster from any other vaccine. Regulators have not recommended one vaccine over another as a booster. They have also kept quiet about whether it is preferable to stick with the same vaccine if possible.

The CDC has said the conditions that qualify a person for a booster injection are: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney, or liver disease; dementia and certain disabilities. Pregnant women and (ex-)smokers are also eligible.

The FDA approved boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The CDC says that group includes: medical workers; education workers; food and agricultural workers; factory workers; corrections employees; US Postal Service workers; employees in public transport; grocery store workers.

Yes. The CDC says the Covid vaccine can be administered without regard to the timing of other vaccines, and many pharmacies allow 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 greater than from vaccination. Still, some countries have recommended a single dose of the Pfizer-BioNTech vaccine for children ages 12 and older, which offers less protection but may have a lower risk of side effects.

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

“I really hope we’re in a position to recommend this because people are definitely waiting for it, they’re eager to have it,” he said. “But it is our responsibility to balance both risk and benefit.”

Vaccine experts have said the lower dosage of Pfizer could reduce 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’s generally associated with fewer side effects.”

dr. Brian Feingold, an expert on pediatric heart inflammation at the UPMC Children’s Hospital of Pittsburgh, said, “If you’re just focusing on myocarditis or other potentially rare things, you’ll probably still want more information.”

But “we cannot consider a risk in isolation,” he added. “Risks from Covid need to be considered when making a decision about whether this vaccine has a greater net benefit.”

dr. Edwards said researchers and regulators were in a dilemma. “The more people you enroll, the more time it takes,” she said. “Often, to really look at the data for very rare events, you can’t do that in studies until the vaccine is really more widely used.”

The Centers for Disease Control and Prevention, which determine vaccine policy for the government, have scheduled a meeting of their advisory committee for Nov. 2 and 3 to discuss the issue. Federal officials have said they plan to immediately ship 15 million doses to the states if regulatory and health officials approve the move. The needles that administer the vaccine and the vials that contain it will have to be smaller for children who are still largely in primary school.

About 17 million adolescents ages 12 to 15 were eligible for the Pfizer-BioNTech vaccine in May. Vaccine manufacturers continue to study the possibility of a vaccine for children from six months to five years old.

Only about one in three parents of 5- to 11-year-olds planned to have their children vaccinated “immediately” once a vaccine is approved, according to a Kaiser Family Foundation poll conducted last month. Another third said they wanted to “wait and see” how the vaccine would affect children.

But that same poll found that parental restraints of teens had declined in the months since vaccines became available for that age group.

Aina J. Khan contributed reporting from London, and Carl Zimmer from New Haven, Conn.



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Rachel Meadows

Rachel Meadows

Trending topics news writer who enjoys cooking, walking her dog and travel.

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