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U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children -Breaking

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© Reuters. FILEPHOTO: This illustration photo, taken on March 19, 2021 shows a vial labeled with Pfizer BioNTech’s coronavirus disease vaccine (COVID-19). REUTERS/Dado Ruvic

(Reuters.) – A panel of experts will assess authorization Pfizer Inc (NYSE 🙂 and BioNTech will vote Tuesday on a recommendation regarding the U.S. Food and Drug Administration.

This panel’s vote represents an important regulatory step to get the vaccine into millions of kids in America, where there is a lot of in-person learning.

Although the FDA does not have to follow advice from outside experts, it usually follows them.

COVID-19 vaccines are only approved by a small number of other countries such as China, Cuba, and the United Arab Emirates for children under five years old.

Advisors will be paying close attention to rare instances of myocarditis (heart inflammation) that are linked to BioNTech/Pfizer. Moderna (NASDAQ:) The vaccine is particularly effective in young men.

Pfizer and BioNTech seek approval for the lower dose, 10 microgram, vaccine for children. The 30-microgram version is for adults over 12. Since May, the shot is authorized for children aged 12-15 years old and for those over 16 years of age since December.

In a clinical study of 5 to 11-year-olds, the vaccine proved 90.7% effective against the coronavirus.

Following the FDA meeting, a committee from the U.S. Centers for Disease Control and Prevention (CDC) will recommend the administration and monitoring of the vaccine. Final decision will be made by the director of the agency.

Anthony Fauci, a top U.S. expert in infectious diseases, stated that if all goes according to plan and CDC recommends it, then vaccines for children aged 5-11 years old will likely be made available within the week.

In documents published before the meeting by FDA staff, they stated that the possible vaccine benefits for this age group outweigh any potential risks, even the risk of developing heart disease.

FDA reviewers stated that if the rate of myocarditis among the young age group is similar to the 12- and 15-year olds, then the COVID-19-related hospitalizations would be greater than those for myocarditis.

Children rarely get seriously ill from COVID-19. However, complications can occur and COVID-19 rates in children who are not vaccinated have increased.

Immunizations for pediatrics can be a valuable public health tool in order to protect children from infectious diseases.

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