Portland, Oregon 2021-10-23 10:01:10 –
Washington (AP) – Federal health regulators late Friday, child-sized doses of Pfizer’s COVID-19 vaccine are very effective in preventing symptomatic infections in elementary school children, and the United States has vaccinated young people. He said he was considering getting started and would not cause any unexpected safety issues.
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 — lined with the first young people who are fully protected by Christmas.
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. In four pandemic scenarios, the vaccine clearly prevented more hospitalizations than expected due to cardiac side effects. Vaccines cause more hospitalizations than preventive only if there are very few cases of the virus. But overall, regulators have concluded that the protective effect of the vaccine “clearly outweighs” its risk.
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.
FDA says Pfizer COVID vaccine looks effective for young kids Source link FDA says Pfizer COVID vaccine looks effective for young kids