CDC Director Dr. Wolenski approved: Pfizer's vaccines against corona to children aged 5 - 11

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by Ifi Reporter Category:Health Nov 2, 2021

The crucial stage in curbing the corona plague is underway: Experts from the US Centers for Disease Control (CDC) have recommended approving Pfizer's childhood vaccines against corona for ages 5-11. Vaccinations for ages 11-5 will begin in the coming days after CDC Director Dr. Rochelle Wolenski confirmed tonight (Tuesday through Wednesday) the experts' decision.
U.S. President Joe Biden referred to the CDC decision following Dr. Wolanski's final signing, saying it was "a turning point in the war against the Corona." According to him, the voting will begin in the coming days and will be in full swing as early as November 8. Thousands of pediatric clinics and pharmacies have already ordered millions of doses to be given at a dose of one-third that of adults. On Thursday, a live discussion will be held prior to the approval of the children's vaccines in Israel as well.

The U.S. Centers for Disease Control and Prevention is the body responsible for approving medical moves and administering medications in the United States, and is entrusted with enforcing the decisions of the U.S. Food and Drug Administration, FDA.
Over the weekend, the FDA issued an emergency clearance for children's vaccines in the United States.
The FDA panel of experts who began the lengthy approval process and gave the professional recommendation is an independent committee, external to the U.S. Food and Drug Administration, that includes experts in many medical fields who reviewed the findings from Pfizer's clinical trials and discussed all medical, scientific, and ethical aspects.
At the end of each panel, a vote is taken and the results are submitted to the FDA, which makes the final decision - which usually complies with the panel's recommendation. Even before the discussion in the committee, many preparations are being made, and for the sake of full transparency, the discussion in the committee was broadcast live to the entire world.
"Vaccination in the pediatric group is extremely important and this age group should not be ignored," said Dr. Ofer Levy, a member of the panel. I emphasize that the vaccine in children is expected to prevent infection with Corona, and we encourage the low dose that is safe and effective. "
At the center of the discussion was a clinical study conducted by Pfizer, in which she followed 2,258 children aged 5 to 11. They received two injections three weeks apart: some children received a placebo injection without an active ingredient, others received the usual adult dose, or the third dose. From 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. At the same time, reports of any possible side effects 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 three 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.
The company said that the side effect profile was found to be very safe: no serious side effects were reported after the vaccine among the vaccinated children, and the mild side effects found were similar to those reported among children aged 12 and over. It is important to note that in recent months, 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 us either, 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. Towards the end of the panel discussion and voting, the virtual meeting included a public hearing attended by U.S. citizens expressing their views on Pfizer's request. Among other things, opponents of the vaccine have voiced their opinion, along with parents who support the vaccine and urge the Food and Drug Administration to approve the vaccine for children - some of whom have had severe coronary heart disease, lost a relative, or are immunocompromised and therefore afraid of being vaccinated.
The American Pediatric Association has presented its support for corona vaccines in children. A union spokeswoman said: "We recommend Pfizer vaccines for children aged five and over. The vaccine has shown high safety and effectiveness in preventing corona and has undergone stringent FDA and CDC testing." The association also recommended adding the corona vaccines to the routine vaccines given to children at child health centers.
The American Family Medicine Association also announced that it supports the approval of Pfizer vaccines for children, as well as the American Association for Infectious Diseases in Children, whose representative said: Social and sporting. "
This coming Thursday, the epidemic treatment team, the body that recommends vaccinations to the Ministry of Health, will open a discussion that will be broadcast live, in which the experts will review the coronary epidemic and childhood morbidity, the complications observed, and the studies performed in the 11-5 age population. The discussion will also be attended by citizens who have sought to raise arguments for or against the vaccine. According to all estimates, members of the IDF staff are expected to approve the vaccine in Israel as well. Pfizer has already made orders for the vaccines for children.
Approval of the vaccine for ages 5 to 11 will be considered a significant milestone in the fight against the plague: only a few countries in the world have already begun vaccinating young children, including China, Cuba and the UAE.

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