After FDA approval, Israel to discuss COVID vaccines for children

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

The live event will take place on Thursday, November 4 at 3 pm and is intended to help build trust among the public in any decision made by the Ministry of Health about vaccinating children.

A poll released last week by the Meuhedet Health Maintenance Organization found that 50% of parents are against giving the coronavirus vaccine to their children ages five to 11. But most Israeli health officials have said they believe the injection is safe and effective, and unless new information emerges, the vaccines are likely to gain clearance in Israel as well.

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

“Today, with more than 50% of infected people being children, it is more important than ever to vaccinate children,” added Dr. Galia Barkai, chief of the Pediatric Infectious Diseases Unit at Sheba Medical Center.

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

The FDA on Friday authorized a 10-microgram dose of the Pfizer vaccine for children ages 5 to 11, less than the original 30-microgram vaccine for those 12 and older. The vaccine should be administered in a two-dose regimen, 21 days apart.

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

Pfizer said the vaccine was 90.7% effective against coronavirus in a clinical trial in children ages 5 to 11.

Pfizer said it would immediately send the vaccines to pharmacies, pediatric offices and other places where the vaccine can be administered. However, it will only be available in the US after the Centers for Disease Control and Prevention indicates how the injection should be given, which will happen on Tuesday.

“This is a day that many parents, eager to protect their young children from this virus, have been waiting for,” said Pfizer President and CEO Albert Bourla. “More than 6 million children in the US have been diagnosed with COVID-19 since the start of this pandemic, and large numbers of young people continue to be infected each week. With this FDA clearance, we have achieved another key marker in our ongoing effort to help protect families and communities, and to control this disease. “

There are about 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 data from the Health Ministry. This would mean that around one million children ages five to 11 would be eligible to receive the jab.

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

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

The Israeli committee will not make a final decision at Thursday’s meeting, which is intended more for the public to discuss its concerns. Rather, subsequent discussions will take place with the goal of making a final decision in 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 vaccination issues for children ages five to 11 to the committee by Tuesday, November 2 at 9 a.m. Requests must include the position the person would like to present and any documents that supports the person’s position.

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

The session will be conducted in a manner similar to that of the FDA advisory committee in that each speaker will have three minutes to present. Speakers may use PowerPoint presentations, as long as they are submitted by November 3 at 9 pm and approved by the ministry.

The order of the speakers will be determined by lottery. They can only address professional issues. Anyone who defames or uses verbal violence against any member of the committee will be immediately detained.

Those who do not want to present but do want to ask a question can Send questions before November 2 at 4 pm Questions will be reviewed by the ministry and some of them will be posed by the moderator during the live session.

Dvir said she believes streaming the discussion live will help calm nervous parents.

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

He said that in addition to reviewing data from the FDA, which it 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 youths between the ages of five and 11 have been vaccinated with doses of 30 micrograms in recent months, children with special conditions or diseases that make them at high risk for complications from COVID-19.

The children were approved for vaccinations by a special committee of the Ministry of Health.

Meuhedet followed up with the children who were members of her health fund to find out how they were doing after inoculation. The fund found that if they had adverse effects, they were no more than usual and there were certainly no serious adverse events.

In contrast, “we have been seeing complications with COVID among children,” Barkai emphasized, children who have developed long-standing COVID cases and very severe cases of pediatric multi-system inflammatory syndrome (PIMS) in the past two months.

“The age group where PIMS is most common is five to 10 or 11,” he said, “so I think it’s very important to vaccinate children.”

He added that parents fear myocarditis, but that inflammation of the heart tends to affect slightly older children, around 16 or 17 years old. For children, he said, “I think the vaccine is safe.”

Dvir emphasized that there are around 80 committee members representing all kinds of institutions, from universities to hospitals, private doctors, etc., and therefore additional information or questions may be raised during the upcoming debate. However, he said that if there are no surprises, it will likely be authorized.

The decision to vaccinate children would come as there are fewer than 10,000 active cases of coronavirus in the country, and less than 1% of people who are tested for the virus each day test 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 data panel, 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 critically ill patients, including 131 who were intubated.

Just two months ago, Israel was registering more than 5,000 new cases a day.

The death toll stood at 8,085.

Some 678 people died from the virus in September, compared with fewer than 300 in October.

But Barkai said the low infection rate should not be used as a reason to hesitate to vaccinate children. He said it was at the end of the fourth wave that vaccines for children over the age of 12 to 15 were approved and the country thought 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 children.”

Reuters contributed to this report.



Reference-www.jpost.com

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