After FDA approval, Israel to debate COVID vaccines for kids

Pediatric infectious disease expert: ‘It is more important than ever to vaccinate children’ * Kids vaccines to arrive by mid-November * Health Ministry to broadcast vaccine committee meeting live.

 A CHILD takes a coronavirus test as part of a simulation presented by Sheba Medical Center for how pupils can return to study at the beginning of the new school year.  (photo credit: MIRIAM ALSTER / FLASH 90)
A CHILD takes a coronavirus test as part of a simulation presented by Sheba Medical Center for how pupils can return to study at the beginning of the new school year.
(photo credit: MIRIAM ALSTER / FLASH 90)

The Health Ministry will publicly broadcast a meeting of the Advisory Committee for the Corona Vaccines and Epidemic Control, where members will discuss the issue of giving coronavirus vaccines to children ages five to 11, after the US Food and Drug Administration approved the vaccine for this age cohort.

The live event will take place this Thursday at 3 p.m. and is meant to help build trust among the public in whatever decision the Health Ministry makes about vaccinating kids.

A survey released last week by the Meuhedet Health Maintenance Organization found that less than 50% of parents are planning to give their five- to 11-year-olds the coronavirus vaccine. But the majority of Israeli health officials have said they believe the shot is safe and effective, and unless new information surfaces, Israel is also likely to authorize the vaccines.

“I think we will move toward vaccinating this age group,” said Dr. David Dvir, head of the Primary Care Division at Meuhedet and a member of the advisory committee.

“Nowadays, as more than 50% of infected people are children, it is more important than ever to vaccinate children,” added Dr. Galia Barkai, head of the Pediatric Infectious Diseases Unit at Sheba Medical Center, Tel Hashomer.

A healthcare worker hands over doses of the Pfizer-BioNTech COVID-19 vaccine to a doctor at Messe Wien Congress Center, which has been set up as coronavirus disease vaccination centre, in Vienna, Austria February 7, 2021. (credit: REUTERS/LISI NIESNER/FILE PHOTO)A healthcare worker hands over doses of the Pfizer-BioNTech COVID-19 vaccine to a doctor at Messe Wien Congress Center, which has been set up as coronavirus disease vaccination centre, in Vienna, Austria February 7, 2021. (credit: REUTERS/LISI NIESNER/FILE PHOTO)

The FDA authorized a 10-microgram dose of the Pfizer vaccine for children aged five to 11 years on Friday, lower than the 30 micrograms in the original vaccine for those age 12 and older. The vaccine is to be administered in a two-dose regimen, 21 days apart.

For the pediatric shots, the FDA has authorized an updated version of the vaccine, which uses a new buffer and allows them to be stored in refrigerators for up to 10 weeks.

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

THE COMPANY said it would be immediately shipping the shots to pharmacies, pediatricians’ offices and other places where the vaccine may be administered. However, it will only be available in the US after the Centers for Disease Control and Prevention advises on how the shot should be administered, which will happen on Tuesday.

“This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Pfizer’s chairman and CEO Albert Bourla. “Over six million children in the US have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”

There are some 28 million American children eligible for the vaccine.

In Israel, there are 1,237,792 children between the ages of five and 11, including 213,047 who have recovered from the virus, according to Health Ministry data. This would mean that about a million unrecovered children would be eligible to get the jab.

Only a few other countries – including China, Cuba and the United Arab Emirates – have so far cleared COVID-19 vaccines for children in this age group and younger.

Pfizer said it has also applied for authorization for the pediatric shots from the European Medicines Agency, as well as from other regulators around the world.

The Israeli committee will not be making a final decision at the Thursday meeting, which is meant more for the public to discuss their concerns. Rather, subsequent discussions will take place with the goal of making a final decision by mid-November, when the first vaccines are expected to arrive in the country.

 

THE PUBLIC is invited to submit requests to express a position on the issues of vaccination for children ages five to 11 to the committee by this Tuesday at 9 a.m. Applications should include the position that the individual would like to present and any documents that support the applicant’s position.

Since the number of applications is expected to be large, the speakers will be selected according to the following representation criteria: professionals in the health and civil society arenas and from the general public; by topics, including vaccine safety, benefits and other related issues; and by position, including those for and against vaccinating children.

The Health Ministry has committed to selecting 20 speakers by Wednesday at 9 p.m.

The session will be run similarly to the one held by the FDA advisory committee in that each speaker will have three minutes to present. Speakers can use PowerPoint presentations, so long as they are submitted by Wednesday at 9 p.m. and approved by the ministry.

The order of the speakers will be determined by a lottery. They will only be able to address professional issues. Anyone who defames or uses verbal violence against anyone on the committee will be stopped immediately.

Those who do not want to present but do want to ask a question can submit them by Tuesday at 4 p.m. The questions will be reviewed by the ministry and some of them will be asked by the moderator during the live session.

The link to apply to speak is https://survey.gov.il/he/publichearing. The link to ask a question is https://survey.gov.il/he/pandemicexperts.

Dvir said that he thinks airing the discussion live will help calm nervous parents.

“I think people are afraid of not knowing all the data, not knowing all the safety data, so it is very important to show them all the data,” he said. “In the end, we want children to be vaccinated, if the vaccine is approved by Israel. So, everything we can do to promote [vaccination] is OK.”

He said that in addition to reviewing the FDA data, which he believes strongly shows that the benefits of the vaccine outweigh the harm, the committee will also discuss a small set of Israeli data.

 

DVIR SAID that around 200 Israeli youth between the ages of five and 11 were vaccinated with 30-microgram doses in recent months – children with special conditions or diseases that make them high-risk for complications from COVID-19.

The children were approved to receive the shots by a special Health Ministry committee.

Meuhedet followed up with those children who were members of its health fund to find out how they were doing post-inoculation. The health fund found that if they had any adverse effects, they were not more than usual, and certainly there were no serious adverse events.

In contrast, “we have been seeing complications with COVID among children,” Barkai stressed – children who have developed long-COVID and very serious cases of Pediatric Inflammatory Multisystem Syndrome (PIMS) in the last two months.

“The age group among which PIMS is most prevalent is five to 10 or 11,” she said, “so I think it is very important to vaccinate kids.”

Parents are afraid of myocarditis, she said, but heart inflammation tends to impact slightly older children, around the ages of 16 or 17. For younger children, she said: “I believe the vaccine is safe.”

Dvir stressed that there are around 80 members of the committee that represent all kinds of institutions from universities to hospitals to private doctors and so forth, and therefore it is possible that added information or questions will be raised during the upcoming debate. However, he said that if there are no surprises, authorization is likely.

The decision to vaccinate children would come while there are fewer than 10,000 active cases of coronavirus in the country, and less than 1% of people being screened for the virus each day are testing positive.

The last time Israel had fewer than 10,000 active cases was more than three months ago.

There are no more “red cities,” according to the Health Ministry’s data dashboard, and only a handful of “orange cities.” Red cities are those with high infection rates.

On Saturday night, the Health Ministry reported only 618 new cases. There were 220 serious patients, including 131 who were intubated. The death toll stood at 8,085.

Just two months ago, Israel was recording upwards of 5,000 new cases per day.

In September, 678 people died of the virus, compared to less than 300 in October.

But Barkai said that one should not use the low infection rate as a reason to hesitate to vaccinate children. She said it was at the end of the fourth wave that vaccines were approved for older children aged 12 to 15 and the country thought that maybe it should wait to inoculate this population. Within a month, the Delta variant arrived in the country, instigating the fourth wave.

“We don’t know what will happen,” Barkai said. “I think it is important to vaccinate kids.”

Reuters contributed to this report.