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Why the FDA Backs Vaccinating Children and Will Israel Follow Suit

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A COVID vaccination center in Givatayim, in June.
A COVID vaccination center in Givatayim, in June.Credit: Hadas Parush

The U.S. Food and Drug Administration expert panel on Wednesday voted overwhelmingly to authorize the Pfizer-BioNTech coronavirus vaccine for children aged 5-11. Bennett's government is now weighing whether to green light vaccines for this age group in Israel, too.

Why was the vaccine authorized in the U.S.?

Pfizer and BioNTech said their vaccine showed 90.7 percent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

Pfizer's clinical trial included 2,268 children, and the data the drug company presented to the FDA showed the vaccine to be 91 percent effective in preventing symptomatic disease among them.

“According to the information we have received so far, it seems the vaccine for children up to 11 is safe and effective. For now, it seems the risk from the disease is greater than that of the vaccine,” said Prof. Nadav Davidovitch, the outgoing chairman of the Association of Public Health Physicians. Many parents are waiting for approval of the vaccine and are interested in vaccinating their children, he added.

Will they begin vaccinating 5-11-year-olds in the United States?

An advisory panel to the U.S. Centers for Disease Control and Prevention will meet to make a recommendation on the administration of the vaccine. The CDC director will make the final call.

Will they begin vaccinating 5-11-year-olds in Israel?

Israel will wait for final approval in the United States before making a decision. If vaccinations for younger children are approved in Israel, about 1 million more Israelis could potentially be vaccinated – about 11 percent of the population.

Director of Public Health Dr. Sharon Alroy-Preis told the Channel 12 News channel on Tuesday that if the FDA approves the vaccines for this age group, she expects the vaccination campaign in Israel will begin within the next few weeks.

Is the vaccine safe for children?

The vaccine was approved for children aged 12 to 15 in the U.S. at the end of May. Israel was seeing a lull in infections at the time and approved the vaccine for this age group only three weeks later, when the delta variant led to another wave of infections. One of the reasons for the delay in Israel was the appearance of myocarditis, an inflammation of the heart muscle, as a side effect among some people under 30 who had been vaccinated – mostly males – which required examination.

Since then, it has been found that myocarditis is extremely rare: according to the Health Ministry, there were 12 cases of the disease out of 256,000 people aged 12-15 who received two doses of the vaccine. Most of these cases were mild and did not require hospitalization. Despite the data showing the side effect is rare, the fear of myocarditis became a major argument among parents who did not want their children to be vaccinated.

Child sticks out their tongue while getting a COVID vaccine shotCredit: Hadas Parush

The FDA advisers paid close attention to the rate of myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccines, particularly in young men.

How does the vaccine for children differ from the vaccine for teens and adults?

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose of the vaccine in children, versus 30 micrograms for those age 12 and older.

Why is it important to vaccinate children in this age group?

While children rarely become seriously ill or die from COVID-19 compared to adults, some develop complications. Infections in unvaccinated kids have also risen due to the easily transmitted Delta variant.

"To me, the question is pretty clear," said Dr. Amanda Cohn, a pediatric vaccine expert at the CDC and a voting member of the panel. "We don't want children to be dying of COVID-19, even if it is far fewer children than adults, and we don't want them in the ICU."

From the beginning of the pandemic until the middle of this month, 2,660 Israeli children were hospitalized with COVID-19. Out of this number, 398 were in moderate, serious or critical condition. The Knesset Committee on the Rights of the Child was presented with data this month showing that 31 children aged 5 to 11 had contracted the coronavirus and been in serious or critical condition – and that three had died.

Children are tested for the coronavirus at a testing center in Jerusalem, last month.Credit: Ohad Zwigenberg

But while most children infected with the virus had mild symptoms, the effects of “long COVID” are also part of the debate. Children who suffer from long COVID experience ongoing symptoms even after recovering, including nerve and lung damage, and problems with their digestive system.

A Health Ministry survey showed that 11 percent of those who had contracted the virus developed long COVID. Among children aged 3 to 6, the percentage of cases who suffered from the symptoms of long COVID six months after they recovered was 1.8 percent. For children aged 6 to 12, the number stood at 2.4 percent. But doctors also say long COVID is under-diagnosed and seems to be more common than the data shows.

Children are also at risk of contracting PIMS, or Pediatric Inflammatory Multisystem Syndrome, after recovering from the coronavirus – a condition which can be serious or even life-threatening. Roughly 120 such cases have been reported in Israel so far, a 16-year-old has died from the syndrome.

Do Israeli parents support vaccinating children?

An opinion poll conducted at the beginning of the month by Liora Shmueli of Bar-Ilan University, found that among 894 parents of children aged 5 to 11, 57 percent expressed willingness to vaccinate their children against the coronavirus this coming winter if the vaccine is approved and available. Among those parents who do not plan on vaccinating their children, 66 percent said they were worried about the vaccine’s safety, 61 percent feared severe side effects, and 57 percent worried that the clinical trials and approval were conducted too quickly for political reasons.

“I certainly don’t think that we need to do things under duress, but I think that between half and two-thirds of the parents very much want to vaccinate their children,” said Davidovitch. “They are sick and tired of the tests and isolation and the fears the child will be infected and infect grandma and grandpa.”

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