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Ahead of panel review, FDA says Pfizer vaccine looks effective for young kids – Pittsburgh, Pennsylvania

Pittsburgh, Pennsylvania 2021-10-23 06:22:00 –

Federal health regulators late Friday, child-sized doses of Pfizer’s COVID-19 vaccine are very effective in preventing sexually transmitted infections in elementary school children, and the United States is considering starting vaccination of young people He said it would not cause any unexpected safety problems. Prior to next week’s public meeting, we will analyze Pfizer’s data to discuss whether about 28 million children between the ages of 5 and 11 are ready for injections. Authorities ask a panel of external vaccine experts to vote for the question. In almost all scenarios, FDA scientists have concluded that the benefits of vaccines to prevent hospitalization and death from COVID-19 outweigh the serious potential side effects of children. However, agency reviewers have stopped requiring Pfizer’s shots to be approved. Authorities will ask the question to a panel of independent advisors next Tuesday and weigh their advice before making their own decisions. If the FDA approves the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them in the first week. Of November. Children may start vaccination early next month-first young people are fully protected by Christmas, although full-strength Pfizer shots are already recommended for people over 12 years old Pediatricians and many parents crave protection for young children to prevent infections According to an FDA review, two doses were nearly 91% effective in preventing symptomatic infections in young children. I checked the results of Pfizer posted earlier in the day, showing. The researchers calculated the numbers based on 16 COVID-19 cases in adolescents given dummy shots and 3 cases in vaccinated children. No serious illness was reported in any of the adolescents, but vaccinated adolescents showed far milder symptoms than unvaccinated adolescents. Most of the study data was collected in the United States in August and September when the delta variant became the predominant COVID. 19 shares. FDA reviews did not find any new or unexpected side effects, such as arm pain, fever, or pain experienced by teens, but FDA scientists said the study found that this study was very much like myocarditis. It states that it was not large enough to detect rare side effects. Occasional cardiac inflammation after the second dose. Authorities sought to use statistical modeling to predict the number of COVID-19 hospitalizations and deaths that the vaccine could prevent and the number of potential cardiac side effects it could cause. Overall, regulators have concluded that the vaccine’s protective effect “clearly outweighs” the case of cardiac side effects. According to the CDC, children have a lower risk of serious illness and death than older people, but COVID-19 killed more than 630 Americans under the age of 18. According to the American Academy of Pediatrics, about 6.2 million children have been infected with the coronavirus and more than 1.1 million have been infected in the last six weeks. The Biden administration purchased a sufficient child-sized dose in a vial with a special orange cap. To distinguish them from adult vaccines — for countries aged 5 to 11 years. Once the vaccine is cleared, millions of doses will be shipped nationwide with child-sized needles quickly. Over 25,000 pediatricians and primary care providers have already signed to put shots on their small arms. It is up.

Federal health regulators late Friday consider that child-sized doses of Pfizer’s COVID-19 vaccine are very effective in preventing symptomatic infections in elementary school children and that the United States will begin vaccination of young people He said it would not cause any unexpected safety problems.

The Food and Drug Administration posted an analysis of Pfizer’s data prior to next week’s public meeting to discuss whether about 28 million children between the ages of 5 and 11 are ready for a shot. That question.

In their analysis, FDA scientists concluded that in almost all scenarios, the benefits of vaccines to prevent hospitalization and death from COVID-19 outweigh the serious potential side effects of children. However, agency reviewers have stopped requiring Pfizer’s shots to be approved.

The agency will ask the question to a panel of independent advisors next Tuesday and weigh their advice before making their own decisions.

If the FDA approves the shot, the Centers for Disease Control and Prevention will make additional recommendations as to who should receive the shot in the first week of November. Children can start vaccination early next month-the first young people who are fully protected by Christmas are lined up.

Full-strength Pfizer shots are already recommended for people over the age of 12, but pediatricians and many parents have sent young children to school to stop infections from highly contagious delta variants. I am anxious for protection to help you get rid of it.

An FDA review confirmed Pfizer’s results posted earlier in the day, showing that double-dose shots were nearly 91% effective in preventing symptomatic infections in infants. The researchers calculated the numbers based on 16 COVID-19 cases in adolescents given dummy shots and 3 cases in vaccinated children. No serious illness was reported in any of the adolescents, but vaccinated adolescents showed far milder symptoms than unvaccinated adolescents.

Most of the study data was collected in the United States in August and September when the delta mutant became the major COVID-19 strain.

The FDA’s review found no new or unexpected side effects consisting of arm pain, fever, or pain experienced by teens.

However, FDA scientists point out that the study was not large enough to detect very rare side effects, such as myocarditis, a type of heart inflammation that occasionally occurs after the second dose. Did. Authorities sought to use statistical modeling to predict the number of COVID-19 hospitalizations and deaths that the vaccine could prevent and the number of potential cardiac side effects it could cause. Overall, regulators have concluded that the vaccine’s protective effect “clearly outweighs” the case of cardiac side effects.

According to the CDC, children have a lower risk of serious illness and death than older people, but COVID-19 killed more than 630 Americans under the age of 18. According to the American Academy of Pediatrics, about 6.2 million children have been infected with the coronavirus, and the proliferation of delta variants has infected more than 1.1 million in the last six weeks.

The Biden administration has purchased a special child-sized dose of orange-clad vials for children aged 5 to 11 years in the country to distinguish it from adult vaccines. Once the vaccine is cleared, millions of doses will soon be shipped nationwide, along with child-sized needles.

Over 25,000 pediatricians and primary care providers have already signed up to turn shots into small weapons.

Ahead of panel review, FDA says Pfizer vaccine looks effective for young kids Source link Ahead of panel review, FDA says Pfizer vaccine looks effective for young kids

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