Pfizer's Child Vaccines Launch: The FDA approved to vaccinate children ages 5 to 11

Pfizer's Child Vaccines Launch: The U.S. Food and Drug Administration confirmed the panel of experts 'decision Friday night and issued an emergency approval for Pfizer's coronary vaccines for children ages 5 to 11. The FDA agreed with the experts' decision that the vaccine given in a third of adults is safe and effective. In the prevention of infection and disease in the corona.
This coming Thursday, the Ministry of Health's epidemic treatment team is expected to hold a similar discussion ahead of the recommendation to approve vaccines in Israel. The discussion will be held for the first time live, in full transparency and in a format similar to that in the United States, so that the public can participate in it, raise arguments and ask questions.
According to all estimates, the Ministry of Health will also approve the vaccine in Israel, and first courses of Pfizer's vaccines for children are expected to arrive in about two weeks.
The dose of the vaccine prescribed to children is one-third that of adults. Pfizer has announced that it will produce new vials that will avoid "confusion" and allow nursing staff to pump the vaccine directly without having to dilute it with sterile water as is currently the case.
The children will be vaccinated by nursing staff in a separate room or in schools. This is to prevent confusion in the dose of the vaccine - a third of the dose of adults, and also so as not to expose high-risk adults to children, who may infect them with a serious illness.
The decision to approve the emergency vaccines for children came after a long-running discussion attended by 18 medical experts who are part of the advisory committee that is independent and external to the FDA. The experts reviewed the Pfizer study in children and the infection and morbidity data in children, and determined that the data indicate that the vaccine is very safe and highly effective in children aged 5 and over, with minimal side effects, most of them very mild and transient.
At the FDA discussion center, which was broadcast live, Pfizer presented the pediatric study that followed 2,258 subjects aged 5 to 11 years, who received two injections three weeks apart.
Some children received a placebo injection without an active ingredient, others received the usual dose of an adult, or the dose of one-third of an adult dose. The researchers examined in each child the levels of antibodies formed in their bodies at different times after the vaccine, and of course monitored the infection rates of all groups. Meanwhile, reports of every possible side effect were examined.
The results of the study showed that 16 children who received a placebo injection (dummy injection without active ingredient) were infected with corona, compared to only 3 in the vaccinated group. Because twice the number of children in the study received the vaccine compared to the number of children who received the placebo, processing the findings revealed that the vaccine efficacy in children reaches 90.7% in preventing symptomatic infection. Pfizer said the level of antibodies found in the vaccinated children was extremely high, and met FDA requirements.
Pfizer said the side effect profile was found to be very safe: no serious post-vaccine side effects were reported in the vaccinated children, and the mild side effects found were similar to those reported in children 12 years of age and older.
 To date, children aged 11-5, who suffer from chronic diseases that put them at risk for chronic coronary heart disease, have also been vaccinated in Israel in recent months. According to the HMOs, no unusual side effects were observed in Israel, and the condition of the hundreds of children who were vaccinated is very good. It is likely that Israel passed on to Pfizer the Israeli data that may also be presented to the FDA.
The Pfizer study also vaccinated children at the usual dose of adults, and no abnormal risk was reported as a result of this dose. Thus, even in the case where a child receives an adult dose, no serious side effects are expected, and the effectiveness of the vaccine will be similar.
The low dose prescribed for children aged 5 to 11, as mentioned, one third of an adult dose, is intended to reduce the possible chance of side effects, after it has been found that this dose is sufficient for maximum protection against corona at these ages.
During the panel of experts' discussion, not only data on vaccine efficacy were presented, but also the dire consequences of corona infection in the pediatric population: Thousands of children in the U.S. infected in Corona, out of hundreds of thousands, hospitalized Lungs, heart dysfunction, and damage to the nervous system and brain.
The Ministry of Health's team of experts will convene next Thursday to discuss the FDA's decision. The discussion will also be open to public representatives. They must register in advance. The decision will be made in a closed meeting of the team of experts. It is estimated that the vaccines for children aged five to eleven will begin to be given in Israel in the middle of next month (November).