Pfizer Asks FDA to Authorize Covid-19 Vaccine in Young Children

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Children ages 5 to 11 may be able to start vaccinations by November, if health regulators authorize shots.

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The FDA could approve the shot for use in youth before November, which would mean pediatric offices, schools and other places could get doses to give as early as Halloween.

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The FDA has already scheduled for a panel of outside experts to review the data on October 26. The agency is not required to follow the panel’s recommendation, but normally does.

If authorized, young children would receive two injections of Pfizer-BioEntech spaced three weeks apart, just as teens and adults do, but at a lower dose.

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School districts and public health officials have begun preparing for vaccinations, although the work is in the early stages. Health and vaccine experts expect vaccines to be administered in some schools, pediatrician’s offices, and some pharmacies.

According to experts, schools and public-health departments don’t need childhood vaccines related to COVID-19 as they routinely administer them, although the cold-storage requirements of the Pfizer-BioNTech vaccine can pose some challenges.

According to the companies, the filing comes after the vaccine has been shown to safely generate a strong immune response in young subjects in late-stage trials.

The companies said the antibody levels in child volunteers who received the vaccine were similar to those seen in young adults.

The FDA is already reviewing the Pfizer-BioNtech study data, after the companies made it available to the agency in September. However, companies are still required to submit other information, and the adjusted timeline could extend authorization into November, Businesshala has reported.

Young children are among the last groups in the US waiting for vaccines against the coronavirus to be authorized by the FDA.

According to health experts, they have a lower risk of serious illness and hospitalization than adults, but more children are going to the hospital than ever before in the pandemic because the highly contagious delta variant has spread mainly to unvaccinated people .

Many parents are eager to get their young children vaccinated, hoping they will be protected as the school year passes.

Some parents with young children are so eager to get their young children vaccinated that they enrolled them in clinical trials, in the hope that young people will get real shots instead of a placebo.

Doctors and health officials have said that it will be important to vaccinate children not only to protect them from the virus, but also to protect children and family members around them.

Pediatricians and public health experts say a lot of work will need to be done to address the concerns of parents about vaccinating young children, including those of parents who have received the COVID-19 vaccine themselves. Has happened.

About one-third of parents of 5 to 11-year-olds “wait and see” how the shot performs before vaccinating their children, while about one-quarter of parents said they had their children vaccinated. There are no plans to vaccinate. A survey published in September by Kaiser Family Foundation.

According to the survey, around 34% of parents of children aged 5 to 11 will vaccinate their children immediately.

After authorization in 5- to 11-year-olds, the only group waiting for vaccines will be children up to six months old.

Pfizer has said that the results of a study conducted on young children aged 6 months to 5 years could come by the fourth quarter of this year.

For children ages 5 to 11, the companies provide what is known as an emergency use authorization, which the FDA grants during public-health emergencies based on the best evidence available at the time.

To accelerate the availability of COVID-19 vaccines due to the urgency of the pandemic, the FDA is authorizing shots, including Pfizer-BioNTech, for emergency use.

Children under the age of 12 are allowed to get the Pfizer-BioNTech shot under an emergency use authorization. The vaccine is now fully approved for people 16 years of age and older.

In their flagship study, Pfizer and BioNTech enrolled about 2,268 subjects over 5 to 11 years. Two-thirds of the subjects received two doses of the vaccine, three weeks apart, with the rest receiving a placebo. Children received a smaller, 10 microgram dose, compared to a 30 microgram dose for adults.

Pfizer hasn’t provided detailed results yet, but has said that its analysis of data from children taking the vaccine showed neutralizing antibody levels a month after the second dose, as did people aged 16 to 25. in those who had received a separate 30-microgram dose. Pfizer study.

Neutralizing antibodies, which prevent the virus from entering cells and replicating, play an important role in the body’s immune response against COVID-19.

The companies are yet to say how well the shot protects against COVID-19 because too few young subjects in the study became sick enough to compare rates between children who got the vaccine and those who got a placebo.

Yet the FDA generally approves vaccines based on data showing that a vaccine already shown to be protective in older people produces similar antibody levels in young children as in adults.

Pfizer states that younger children showed fewer side effects, such as fever and chills, than children aged 16 to 25.

Pfizer said there were also no cases of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect mainly in young men.

Jared S. Hopkins at [email protected]

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