FDA panel meets Pfizer vaccine for young children

A key federal advisory committee was discussing on Tuesday whether to recommend that a pediatric dose of the Pfizer-BioNTech coronavirus...


A key federal advisory committee was discussing on Tuesday whether to recommend that a pediatric dose of the Pfizer-BioNTech coronavirus vaccine be offered to children aged 5 to 11, triggering a series of decisions that could lead children to be vaccinated as soon as possible. like the end of next week.

Federal officials hope the pediatric dose can help fill a major gap in the U.S. vaccination campaign that worries parents, educators and public health officials. If the Food and Drug Administration grants the clearance, approximately 28 million children will become eligible. Only the youngest, those under 5, would remain uncovered. (You can watch the meeting here.)

Dr Peter Marks, who heads the division of the FDA that oversees vaccines, told the meeting that 1.9 million children aged 5 to 11 have been infected with the virus and more than 8,300 have been infected with the virus. between them were hospitalized, a third of whom needed intensive care. Nearly 100 have died, making Covid one of the top 10 causes of death during the pandemic in this age group.

Children in this age group are “far from being spared from the harms of Covid-19,” he said.

Dr Fiona Havers, a viral disease specialist at the Centers for Disease Control and Prevention, said children in this age group made up 10.6% of all cases, but only 8.7% of the population. Children have higher levels than adults of neutralizing antibodies which are essential for preventing infection, she said, but are at least as likely as adults to be infected, she said. .

The children’s antibody tests also suggested there were many more cases of the virus than those on public record, Dr Havers said.

Hospitalization rates in the 5 to 11-year-old age group are three times higher for black, Hispanic or Native American children than for white children, she said. And more than 2,000 schools with a total of over one million students were forced to close between early August and October due to epidemics, she said.

The committee’s recommendations on whether to authorize vaccines are not binding, but the FDA typically follows them within days of the vote.

It is not known how many parents would quickly vaccinate their elementary school students if given the opportunity. Polls have shown that about a third of these parents are eager to do so right away, while a third prefer to wait. Since federal regulators cleared Pfizer vaccines for children ages 12 to 15 in May, 46% of that age group have been fully immunized, compared to about 69% of those 18 and older.

An organized email campaign against administering the vaccine to young children began over the weekend, with panelists inundated with messages urging to vote against the authorization recommendation, according to Dr Paul Offit, a panelist who directs the Vaccine Education Center at the Children’s Hospital of Philadelphia.

As of Tuesday morning, nearly 140,000 public comments had been formally submitted to the agency on the issue. In contrast, only 66 comments were submitted before the panel recommended the recall for adult recipients of Moderna. and the Johnson & Johnson vaccines.

At the start of the meeting, Dr Marks said: “I want to acknowledge the fact that there are strong feelings which have been clearly expressed by members of the public both for and against” the authorization. He stressed that the only question before the experts was whether the shooting should be allowed, not whether it should be imposed.

The dose for young children would be one-third of the dose given to people 12 years of age and older, with two injections three weeks apart. Pfizer and BioNTech are asking the FDA to authorize emergency distribution.

The process may go more smoothly than when vaccine manufacturers requested authorization for adult booster injections – a problem which worried and divided the agency’s regulators and its external experts for much of the past two months.

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.

Pfizer provided the FDA with safety data on two cohorts of studies of children aged 5 to 11, both of approximately equal size. The first group was followed for about two months, the second for about two and a half weeks. Pfizer cited efficacy data only for the first group of about 2,200 children, saying its vaccine had a 91% efficacy rate against symptomatic Covid-19.

FDA regulators said in Friday analysis pediatric trial data from Pfizer that the benefits of warding off Covid-19 with the vaccine generally outweighed the risks of the most worrying side effects for young children. Hong Yang, an FDA scientist, said in a presentation Tuesday that even in a scenario where nationwide cases are lower, the benefits of vaccination may outweigh the risks of possible side effects, because people hospitalized with Covid-19 tend to be sicker, and for longer, than those with certain vaccine-related heart diseases.

Regulators modeled scenarios involving different levels of virus spread and assumed the rate of two rare heart diseases associated with vaccination would be the same in young children vaccinated with a one-third dose as in adolescents aged 12 to 15 years who received a full dose.

Federal health officials have said that cases of these heart conditions – myocarditis, or inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart – after the second dose of a vaccine tend to be mild and get resolved quickly.

Pfizer, in its presentation to the committee on Tuesday, said it had worked to make pediatric vaccines easily recognizable for health providers who would administer the vaccine. He changed the color of the bottle caps from purple to orange, and also made the kid’s shot packaging orange, so administrators could easily distinguish between these and the adult versions.

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Newsrust - US Top News: FDA panel meets Pfizer vaccine for young children
FDA panel meets Pfizer vaccine for young children
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