FDA discusses Pfizer’s Covid vaccine approval for children ages 5-11 | Pfizer

An independent expert from the Food and Drug Administration (FDA) Pfizer Covid-19 vaccine for children ages 5-11 on Tuesday. The vaccine is currently approved for children over the age of 12.

Vaccination of infants was widely expected by parents in the United States as the wave of Covid-19 fueled by the Delta variant became established nationwide, just as many students returned to the classroom. NS Biden administration We also consider this to be an important next step in the vaccine deployment program, which has slowed significantly.

The advisory board listens to evidence from Pfizer and regulatory agencies, discusses whether to recommend an emergency permit for child-sized vaccines, and votes for the recommendation. Regulators do not always follow the advice of independent committees, but they usually do.

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Vaccine approval will then be transferred to the US Centers for Disease Control and Prevention (CDC), where a complementary panel of experts will consider recommendations on who should be vaccinated. Finally, the regulatory agencies of both agencies need to approve the vaccine for emergency use in children before distributing the vaccine.

Once approved, a campaign to vaccinate approximately 28 million elementary school children will begin, with vaccines being delivered through pharmacies, community clinics, pediatrician clinics, and several school-based clinics. It will be distributed.

Hospitalization and mortality rates are lower for infants than for adults, but children are increasing the proportion of cases amid the Delta-led summer surge, especially as face-to-face schools are reopened. Children can also act as a reservoir of illness and spread Covid-19 to adults even if they are not seriously ill themselves.

About 6.1 million children According to the CDC, the American Academy of Pediatrics has infected Covid-19 in the United States, killing 143 people since the pandemic began.

According to Pfizer’s application, children with underlying disorders such as asthma, diabetes and obesity accounted for the majority of severe Covid-19 cases, but about one-third had no known health status. ..

Pfizer conducted a study of 2,268 children between the ages of 5 and 11 to study the safety and efficacy of the vaccine in children. A total of 1,518 children were vaccinated and 750 were vaccinated with placebo. Each received two shots every three weeks and was followed for two months thereafter.

The study found that Pfizer’s vaccine was approximately 91% effective in children, based on 16 cases of Covid-19 in the placebo group and 3 cases in the vaccinated group.

Most of the side effects experienced by the child occurred within a few days, including pain at the injection site, malaise, headache, muscle aches, and chills. The study did not find any cases of myocarditis or heart inflammation, but due to the scale of the study, it is unlikely that symptoms will occur.

According to the CDC, there is probably a link between messenger RNA vaccines, such as those developed by Pfizer, and heart inflammation. NS Accurate rate Myocarditis has not been established. It is rare and is believed to be more common in younger men than in other groups.

About one-third of parents said their young children would be vaccinated “immediately” and another one-third said they would “wait and see” whether to vaccinate their children. Kaiser Family Foundation.. The White House last week announced an education campaign for parents.

FDA discusses Pfizer’s Covid vaccine approval for children ages 5-11 | Pfizer

Source link FDA discusses Pfizer’s Covid vaccine approval for children ages 5-11 | Pfizer

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