FDA advisory committee recommends vaccination for ages 5-11

Senior advisers from the US Food and Drug Administration voted in favor of vaccinating children ages 5-11.

The decision was taken after a meeting that lasted for several hours on Tuesday afternoon. Seventeen members of the advisory committee voted in favor of the move, with only one member not participating.

Briefing documents circulated for the meeting showed that US experts believed the benefits of the vaccines outweighed the potential risks.

Now that the FDA has voted favorably, the Centers for Disease Control will meet on November 2-3 and give its recommendations about how the shots should be administered. Hopefully Israel will follow suit a few weeks later and approve the shots.

The health ministry has said it will independently review the data and hold its own series of discussions before giving the green light.

The vaccines will also have to be ordered from Pfizer and distributed to Israel, as they are specifically designed for children.

In Israel, there are 1,237,792 children between the ages of five and 11, including 213,047 children who have recovered from the virus, according to health ministry data. This would mean that around one million children in the age group of five to 11 years would be eligible for the jab.

Some 10 children have died from COVID-19 in Israel.

In the US, 94 children in this age group have died, N12 reported.

The FDA’s discussion reopened the debate over childhood vaccinations in Israel among both parents and experts.

Nearly 50% of Israeli parents said they would vaccinate their five- to 11-year-olds if the FDA approved the vaccine, according to a survey published Monday by Mehedet Health Services. The survey included 680 parents of children in that age group.

Specifically, the survey showed that 48% of parents were certain or thought they would jab their children, 23% were certain not to vaccinate their children, and 29% were undecided.

“Right now, when morbidity is not high, it is important to get children vaccinated as soon as possible to prevent or reduce the next wave,” Mehedet Chief Nursing Officer Mali Kush said.

During the summer, when the health ministry approved vaccines for children aged 12 to 15, there was a delay in recommending the shot because infections were low in the country. About a month later, the school outbreak started a fourth wave.

Of those who said they would not vaccinate their children, 37% said this was due to concerns that the vaccine could have negative health consequences in the long run.

Some 18% said there was insufficient evidence regarding the effectiveness and safety of the vaccine.

Another 11% said they simply Did not want Their child was vaccinated, while 7% said they thought their child would catch the virus and then have natural protection.

Kusha said more than a third of parents said they would consult with their pediatrician about vaccinations, and another 23% said they were looking forward to reading articles on the topic.

“We have no doubt that there is a need for comprehensive information here, both in the media and through pediatricians who have direct and ongoing contact with families,” she said.

In an interview with The Jerusalem Post earlier this week, the head of the Israel Pediatric Society, Prof. Zachi Grossman said she hopes her society will support vaccination because although children are less likely to develop serious illness, there are some who can. In this recent wave, many children were hospitalized, including some who were attached to life-saving, heart-lung ECMO machines.

    A woman receives her third anti-Covid vaccination at the Clalit Health Fund Center in Jerusalem.  (Credit: Mark Israel Salem/Jerusalem Post) A woman receives her third anti-Covid vaccination at the Clalit Health Fund Center in Jerusalem. (Credit: Mark Israel Salem/Jerusalem Post)

In addition, there are increasing reports of children – even those who have had asymptomatic cases of the virus – developing chronic COVID or even pediatric inflammatory multisystem syndrome.

Other health experts have said Israel should be more cautious in vaccinating children because the long-term side effects of the vaccine are still unknown. The Pfizer trial involved fewer than 2,000 children, which means any short-term side effects that may not have been found to occur in the large pool of vaccine recipients.

The biggest concern is myocarditis, or inflammation of the heart, which has been found to be more common in younger vaccinated individuals. However, studies have also shown that the chances of developing heart inflammation are more likely from the coronavirus than from the vaccine.

Following complaints from the media and the public that previous discussions by the Advisory Committee for Coronavirus Vaccines and Epidemic Control have been called off, the ministry said it would broadcast at least some of the discussions about children’s vaccines live.

“The Special Committee for the Rights of the Child, led by me, held its first transparent public debate on child vaccines two weeks ago,” MK Michal Shir (New Hope) said in a Facebook video. “The Ministry of Health reports that only one in 3,000 children will develop severe coronavirus. In view of this data… open and transparent discussion should be allowed.”

The decision to vaccinate children comes as the number of new cases continues to decline. The Health Ministry said on Tuesday that 866 new cases of the virus were diagnosed on Monday. It said there were 249 patients in critical condition on Tuesday evening, of whom 156 were intubated.

Israel approved giving booster shots to the entire population over the age of 12 years before any recommendations were made by the FDA. However, the process will take longer, said the head of the public health service, Dr. Sharon Alroy-Preis told N12 on Tuesday night.

In addition, the ministry will not begin by approving those who choose not to vaccinate their children, she said.

“Every parent needs to choose what’s right for them,” Alroy-Preiss said, adding that vaccinating children can bring Israel into herd immunity and help end the pandemic.