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Home Special Coverage Coronavirus Outbreak

Health Ministry eyes vaccinating children under 12 against COVID within weeks

FDA endorses kid-size doses of Pfizer's vaccine shots for 5-11-year-olds. Delta variant continues to subside across Israel, except for one city that experienced a worrisome outbreak.

by  Maytal Yasur Beit-Or , Erez Linn and AP
Published on  10-27-2021 12:48
Last modified: 10-27-2021 14:03
Desperate parents storm HMOs looking to vaccinate kids ages 5-11Yehoshua Yosef

Healthcare worker administering a coronavirus test | File photo: Yehoshua Yosef

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The highly contagious Delta variant continued to subside in Israel on Tuesday, according to a report by the Health Ministry. Of the 91,496 Israelis it screened for the virus on the day, 727 (0.85%) tested positive. The reproduction rate is 0.73. 

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There are currently 10,914 active cases in the country with 342 Israelis hospitalized. The number of seriously ill patients decreased and now stands at 237. Of those, 79% are unvaccinated. 

Israel has reported 1,325,267 cases, including 8,063 deaths since the outbreak of the pandemic. Thus far, 3,924,163 Israelis have been vaccinated three times, 5,720,398 have received two jabs and 6,224,851 have gotten one dose. 

Nevertheless, the ministry said that despite the general decrease in morbidity in the country, one city experienced a worrisome outbreak. According to data, there was a spike in morbidity in 40 educational institutions in Rehovot, central Israel, where students and educational staff were found to be infected.  

The city is designated as "red" under the government's "stoplight" ranking. The ministry has increased vaccination efforts in Rehovot in order to curb the infection. If successful, it will use it as a "model for tackling future outbreaks between waves," the ministry said. 

Also on Tuesday, the US Food and Drug Administration endorsed kid-size doses of Pfizer's vaccine shots for 5-11-year-olds.

An FDA panel voted unanimously, with one abstention, that the vaccine's benefits in preventing COVID in that age group outweigh any potential risks. That includes questions about a heart-related side effect that's been very rare in teens and young adults despite their use of a much higher vaccine dose.

While children are far less likely than older people to get severe COVID, ultimately many panelists decided it's important to give parents the choice to protect their youngsters – especially those at high risk of illness or who live in places where other precautions, like masks in schools, aren't being used.

"This is an age group that deserves and should have the same opportunity to be vaccinated as every other age," said panel member Dr. Amanda Cohn of the Centers for Disease Control and Prevention.

The FDA isn't bound by the panel's recommendation and is expected to make its own decision within days. If the FDA concurs, there's still another step: Next week, the CDC will have to decide whether to recommend the shots and which youngsters should get them.

Full-strength shots made by Pfizer and its partner BioNTech are already recommended for everyone 12 and older but pediatricians and many parents are clamoring for protection for younger children.

Pfizer studied 2,268 elementary schoolchildren given two shots three weeks apart of either a placebo or the kid dose. Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots. More importantly, the vaccine proved nearly 91% effective at preventing symptomatic infection – based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated.

The kid dosage also proved safe, with similar or fewer temporary side effects – such as sore arms, fever, or achiness – that teens experience. At FDA's request, Pfizer more recently enrolled another 2,300 youngsters into the study, and preliminary safety data has shown no red flags.

But that study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. The panel spent hours discussing if younger children, given a smaller dose, might face that side effect, too.

Statistical models developed by FDA scientists showed that in most scenarios of the continuing pandemic, the vaccine would prevent far more COVID-19 hospitalizations in this age group than would potentially be caused by that rare heart problem.

FDA's models suggested the vaccine could prevent 200-250 hospitalizations for every one million youngsters vaccinated – assuming that virus spread remained high, something that is hard to predict. FDA scientists also said younger kids likely won't have as much risk of heart inflammation as teens but if they did, it might cause about 58 hospitalizations per million vaccinations.

Moderna vaccine manufacturer also is studying its vaccine in young children, and Pfizer has additional studies underway in those younger than 5.

In Israel, Health Ministry Director-General Nachman Ash told Army Radio after the FDA ruling, he estimated the country will begin vaccinating children "in a few weeks." 

He said Israel does not have the doses required for the campaign yet but assured that the ministry would do its utmost "to make the vaccines accessible to all children so that there will be no delay in the immunization. We need to be prepared for another wave – the more people get vaccinated, the less severe the morbidity will be. Getting infected with the coronavirus can lead to more severe side effects than getting vaccinated."

Prime Minister Naftali Bennett is scheduled to meet with senior health officials on Wednesday afternoon to discuss the FDA ruling. The final decision, however, will be made on Nov. 4 during a meeting with the ministry's Advisory Committee on Infectious Diseases and Immunizations. 

In any case, pediatricians in Israel have already welcomed the announcement. 

"I am happy about the decision of the FDA advisory committee, this is a step that will open the door to vaccinating children, and we will discuss this in Israel as well," President of the Israeli Pediatric Association Professor Zachi Grossman said.

"We listened to what was said in the FDA yesterday [Tuesday] and we will have the data and all this will be discussed this coming Thursday. I will recommend proceeding with the [children's] vaccinations and I am sure that most of the members will do the same."

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Tags: CDCchildrenCoronavirusCOVIDFDAvaccine

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