Pfizer and BioNTech requested federal authorities to approve the emergency use of their COVID-19 vaccine for children aged 5 to 11, a step that could safeguard more than 28 million individuals in the U.S.
The businesses claim to be presenting data to the Food and Drug Administration in support of the modification. The agency has pledged to respond promptly to the request, and a meeting to discuss it has been tentatively set for Oct. 26. The Food and Drug Administration will to decide by Halloween.
According to individuals familiar with the plans, a conference of expert advisors to the Centers for Disease Control and Prevention has been planned for Nov. 2 and 3. In most cases, the C.D.C.’s recommendations represent the federal government’s last word on vaccination policy.
Pfizer Asks FDA to Authorize Its Vaccine for Children 5 to 11
Parents throughout the country are waiting for the regulators’ verdict, which may have ramifications for many areas of family life and school operations. Clearance is contingent not only on the quality of the clinical trial results, but also on the firms’ ability to demonstrate to authorities that they can produce a new pediatric formulation correctly.
Pfizer’s announcement came on the same day that President Joe Biden traveled to Illinois to urge businesses to mandate vaccines as part of the White House’s larger campaign to reach the tens of millions of Americans who are still unvaccinated. Mr. Biden said last month that he would require workers at businesses with more than 100 employees to be vaccinated or tested every week.
Children’s vaccinations are an important part of the administration’s vaccine effort, since they may help schools, workplaces, and other venues function more smoothly as the epidemic continues.
Pfizer proposes giving youngsters a dose that is one-third that of an adult. Depending on the pediatric dosage formulation used by Pfizer, this may need adding a different quantity of diluent to each injection or using a different vial or syringe. In its F.D.A. application, the firm was supposed to explain the technique it planned to employ.
COVID-19 in Kids
Although COVID-19 seldom causes serious illness in children, the Delta version placed almost 30,000 of them in hospitals in August. According to the American Academy of Pediatrics, the coronavirus has infected approximately 5.9 million Americans under the age of 18. About 125 of the approximately 500 Americans under the age of 18 who died were between the ages of 5 and 11.
Since the beginning of the epidemic, one out of every six Americans infected has been under 18. American Academy of Pediatrics said children accounted for one out of every four infections last month due to the Delta variant’s rise.
In May, the Food and Drug Administration approved the Pfizer-BioNTech vaccination for 12- to 15-year-olds as an emergency treatment. More than 8.2 million children in that age range have gotten at least one shot since then, with more than 6.7 million completely immunized.
The infection rate in the United States is now declining, indicating that the Delta variant’s wave of infection is subsiding. However, public health officials are concerned that the advent of colder weather may result in an upsurge in transmission.
Although federal authorities are under a lot of pressure to evaluate Pfizer’s application as soon as possible, they also have to make other important judgments. They may make a judgment next week on whether or not individuals who got the Moderna and Johnson & Johnson vaccinations should get booster injections, two potentially controversial choices.