Pfizer's requests FDA approval to vaccinate children ages 5 to 11 - Israeli experts support

The US Food and Drug Administration (FDA) is expected to discuss in the coming weeks Pfizer's request to approve the corona vaccine it also developed for children ages 5 to 11. According to the U.S. company, Pfizer's vaccines have been found effective - and the trial in children in this age group has been successful.
"I feel a great sense of urgency in allowing the vaccine to be given to children under 12," Dr. Bill Gruber, senior vice president at Pfizer, told the Associated Press. "There is a huge demand from parents to get their children's lives back to normal."
Following the publication of the results of Pfizer's trial, which showed that 5 to 11-year-olds' vaccines against corona were safe and effective for them, Israeli experts called for children under the age of 12 to be vaccinated in Israel - after approved by the US Food and Drug Administration (FDA). Senior medical officials in the United States have said that regulators are expected to make a decision on the effectiveness of the vaccine about three weeks from the time the application is submitted, which has not yet been done.
"Once the FDA approves we need to adopt it. We need to vaccinate as much as possible to eradicate the epidemic," said Prof. Galia Rahav. "Even though we are storing in a booster, our situation is still not good. 50% of those infected are children and therefore need to go in that direction."
"Mortality and morbidity among us are inconceivable, especially among the unvaccinated. Just as there is no reason for people to die of malaria nowadays, there is no reason for there to be so many dead from corona. There is a way to avoid death and people just refuse to listen," she added.
Dr. Tal Brosh, deputy head of the epidemiology team, who advises the Ministry of Health, welcomed the results of the experiment, but warned that a significant vaccination rate among children would be required to return the education system to routine. Although children have a mild illness, and only 1 in 2,000 comes to hospital, it is better that no one gets sick but gets vaccinated. "From what we see, as we age, there are fewer side effects," Brosh said.
"There has to be a very good reason for us to decide not to vaccinate the children," he added, but expressed pessimism about the success of the operation. "I am skeptical that there will be a great response here, but if only 40-30% of the children are vaccinated, we will not be able to return to a normal education routine. It takes 70% or more to return to a routine in this system."
Prof. Yossi Karko, director of clinical research at Hadassah Ein Kerem, said things in a similar vein. "We are seeing more and more children suffering from this wave, but their disease is still mild. If we want to eradicate the epidemic to a minimum, we will have to vaccinate the children as well even though their risk is less severe," he said.
At the same time, he noted that "our other problem is that we are closely linked to other countries when there are transitions between countries, as long as other countries are less vaccinated we will not be able to eradicate the disease.
10-year-old Maya Haber from New Jersey was one of the children who participated in the Pfizer experiment. Her parents, themselves doctors, said they agreed to volunteer for the experiment after their little daughter asked why she could not get vaccinated like them and her older brothers. "I was excited to participate in the experiment and it didn't hurt at all," she said. "After we'll all be vaccinated I want to have a huge pajama party with all my friends."
As part of an experiment the company conducted among children in elementary schools, Pfizer tested giving a dose of one-third of the injection now given to the general public aged 12 and over. According to Dr. Gruber, after giving the second dose, the 5- to 11-year-old experimenters developed levels of antibodies no less potent than those developed by teens and young adults.
The senior at Pfizer also noted that the experiment conducted at a young age proved to be safe and revealed mild side effects similar to those found among teens and young people aged 16 to 25 - arm pain or a slight rise in fever. "I think we hit the 'sweet spot,'" said Dr. Gruber, himself a pediatrician.
Meanwhile, the trial of the Israeli vaccine ended the second phase today, with almost no side effects observed in its wake. Next month, the third phase will begin, with the aim of submitting an application for emergency approval from the FDA in about six months.