Israel Could Approve Vaccines for Ages 5-11 by November

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Vaccination center in Daliat al-Carmel, in August.
Vaccination center in Daliat al-Carmel, in August.Credit: Adi Ofer

If the Pfizer vaccine against COVID-19 is approved for children aged five to 11, as expected, Israel could find itself launching a new vaccination campaign for elementary school children as early as November.

That would also mean the education system would have to manage for only a relatively short period under the “green classroom” plan whose pilot is supposed to start right after the holidays.

According to this optimistic scenario, one of the most difficult consequences of the pandemic – the closure of schools and disruption of studies – would be neutralized within three to four months, bringing untold relief to children, parents and the economy. Currently some 150,000 students are in quarantine, among them 41,000 active cases, even though there have been very few days of school.

Getting to this stage requires Pfizer to submit a request to the U.S. Food and Drug Administration to approve the vaccine for children age five to 11, and waiting for the FDA to issue its approval. Only then would Israeli officials begin discussing whether to recommend that the vaccine be administered to children here, although it is assumed this will be approved if there are no questions regarding the safety or effectiveness of the vaccine for this age group. It is the Health Ministry that will make the final decision on whether and under what conditions to vaccinate.

There are already a few children in this age group who have been vaccinated against COVID-19, because the Health Ministry approved the vaccine for children with underlying conditions that put them at high risk for serious illness or even death if they got infected. The ministry issued such permits to 124 children of whom 88 have actually been vaccinated; 47 received one dose, while 41 got two doses.

According to the ministry, there have been no reports of reactions or side effects that differ markedly from those suffered by the general population; this, even though the ministry had warned the HMOs to keep a close watch on these children after their shots.

Reuters reported that a senior health official in the United States believes that children five to 11 will be able to get the Pfizer vaccine by the end of October. It quoted two sources familiar with the issue who said Pfizer is expected to submit to the FDA the results from the clinical trials it has conducted on this age group and request emergency approval before the end of September, with approval to come approximately three weeks after the request is made.

In July, the FDA asked Pfizer and Moderna to broaden trials of their vaccines on children under 12, out of concern that the studies weren’t large enough to detect rare side effects like myocarditis. The Pfizer trial on children aged six months to 11 years includes 4,500 participants, of whom 2,000 are aged five to 11. The trials are taking place in 90 medical centers around the world.

In theory, if the FDA approves the shot for younger children, Israel could issue its approval within a few days. But it’s doubtful it will do that. While Israel did not wait for FDA approval before vaccinating pregnant women and giving the booster shot, but officials prefer to proceed cautiously with children, says Israel Pediatric Association chairman Prof. Zachi Grossman.

“In addition to examining the findings regarding safety and effectiveness, such a vaccine requires readiness, understanding and trust on the part of the parents,” he said. “Caution is the key to obtaining parents’ trust.”

Expanding the vaccination campaign in Israel to include children aged 12 to 15 was approved in Israel three weeks after it was approved in the United States, primarily to have time to examine the possible link between the vaccine and myocarditis, which presented itself more frequently among vaccinated people under 30. The vaccine for this age group was approved in June, and since then 637,000 Israelis aged 12 to 15 have been vaccinated.

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