Pfizer asks FDA to authorize its COVID-19 vaccine for children ages 5 to 11
WASHINGTON — Pfizer and BioNTech said Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that will protect more than 28 million people in the United States. can help.
The companies have said they were submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has scheduled a meeting on October 26 to consider it. A verdict is expected between Halloween and Thanksgiving.
Parents across the United States are anxiously awaiting a decision from regulators, which could affect family life and the operation of schools. Approval depends not only on the strength of clinical trial data, but also on whether they can prove to regulators that they are capable of properly manufacturing a new pediatric formulation.
FDA Acting Commissioner Dr. Janet Woodcock said last week that children “may require a different dosage or formulation than that used in the older pediatric population or adults.”
Pfizer proposes giving children one-third the adult dose. This may require adding more diluent to each injection or using a different vial or syringe. The company was expected to describe the method used in the submission to the Food and Drug Administration.
Regulators will have to check the accuracy and consistency of mass-manufactured doses of the vaccine and determine that it matches the quality and potency of doses given to children in clinical trials. A pediatric dose would also require new labeling with a special code, which would allow the Centers for Disease Control and Prevention to track specific lots in case serious side effects are reported.
Children are rarely seriously ill from COVID-19, but the Delta version transported nearly 30,000 of them to hospitals in August. According to the American Academy of Pediatrics, about 5.9 million Americans under the age of 18 have been infected with the coronavirus. Of the nearly 500 Americans under the age of 18 who died, about 125 were children between the ages of 5 and 11.
“It really bothers me when people say kids don’t die from Covid,” said Dr. Grace Lee, an associate chief medical officer at Stanford Children’s Health who leads a key advisory committee for the CDC. die of covid. It is heartbreaking.”
One out of every six Americans infected since the start of the pandemic was under the age of 18. But according to the American Academy of Pediatrics, children accounted for one in four infections in the past month, with the delta variant on the rise. The Food and Drug Administration authorized the emergency use of Pfizer’s vaccine in May for children ages 12 to 15.
Infection rates in the United States are currently falling, which is expected to reduce the delta variant. But public health experts worry that the onset of cold weather could lead to an increase in transmission.
Although federal regulators are under heavy pressure to promptly review Pfizer’s application, they are also faced with other pressing decisions. Next week, they may rule that people who have received Moderna and Johnson & Johnson coronavirus vaccines should receive booster shots, both potentially controversial decisions.
Public health experts have said the agency’s review of Pfizer pediatric dosages will be closely scrutinized. According to a recent survey by the Kaiser Family Foundation, nearly a third of parents of children ages 5 to 11 said they would wait and see before allowing their children to receive such a shot.
Dr. Walt A. Orenstein, an epidemiologist at Emory University and former director of the US Immunization Program, said public discussion was necessary, given the competitive pressures on the Food and Drug Administration to make vaccine decisions quickly but carefully.
He said many parents were staggered between the fear of Covid-19 and the side effects of pediatric vaccines. If they were less concerned about the consequences of the coronavirus infection, he said, safety would be their top priority. If they were more concerned, the effectiveness of the vaccine would matter more. Like other vaccines, Dr. Orenstein said, pediatricians will play an important role in reducing parental anxiety.
The status of the vaccine mandate in the US
- Vaccine Rules. On August 23, the FDA granted full approval to Pfizer-BioNtech’s coronavirus vaccine for people 16 and older, paving the way for mandates in both the public and private sectors. Such a mandate is legally permitted and upheld in court challenges.
- Colleges and Universities. More than 400 colleges and universities require students to be vaccinated against COVID-19. Nearly all are in states that voted for President Biden.
- School. California became the first state to issue a vaccine mandate for all teachers and announced plans to add the COVID-19 vaccine as a requirement to attend school, which could begin as early as next fall. Los Angeles already has a vaccine mandate for public school students ages 12 and older that begins Nov. 21. New York City’s mandate for teachers and staff, which took effect on October 4 after being delayed due to legal challenges, appears to have taken thousands of last-minute shots.
- Hospitals and Medical Centers. Many hospitals and major health systems require staff to be vaccinated. Mandates for health care workers in California and New York state appear to have forced thousands of holdouts to get shots.
- indoor activities. New York City requires workers and customers to show evidence of at least one dose of COVID-19 for indoor dining, gyms, entertainment and performances. 4, Los Angeles will require most people to provide proof of full vaccination to enter a range of indoor businesses, including restaurants, gyms, museums, movie theaters and salons, in one of the nation’s strictest vaccine regulations .
- at the federal level. on 9 september, President Biden announced a vaccine mandate for the vast majority of federal workers. The order will apply to employees of the Executive Branch, including members of the White House and all federal agencies and the armed services.
- NSThat private sector. Mr Biden has mandated that all companies with more than 100 workers be required to be vaccinated or tested weekly, helping to push for new corporate vaccination policies. Some companies, such as United Airlines and Tyson Foods, already had mandates in place before Mr Biden’s announcement.
Pfizer’s clinical trial for children was not intended to draw meaningful conclusions about the vaccine’s ability to prevent illness or hospitalization. Instead, the researchers looked at antibody levels, comparing them to levels in adults that provided higher protection. Regulators are expected to compare those immune responses to vaccine efficacy data in the adult population.
The trial involved 2,268 children, two-thirds of whom received two doses of the vaccine spaced three weeks apart. The remaining volunteers were injected with two doses of a saltwater placebo. Over the summer regulators asked to expand the size of the trial to 3,000 children.
In a virtual panel on COVID-19 last week, Norman Baylor, former director of the Food and Drug Administration’s Office of Vaccines, said the number of participants in the Pfizerpediatric study was quite small. The adult trial involved about 44,000 people.
“This begs the question of size, which we have for adults: would one expect more for the pediatric population?” he said. “They might be thinking, ‘Well, we know the vaccine is safe, because look at how many people we had in adults. But as we know, things may change in that pediatric population.”
Pfizer-BioEntech and Moderna Vaccines have been associated with an increased risk of myocarditis, or inflammation of the heart muscle; and pericarditis, an inflammation of the lining around the heart, especially in young men. In August, the Food and Drug Administration published results from Pfizer-BioNTech’s analysis of vaccines, which used the US health care claims database and found that 16- and 17-year-old vaccinated boys had a higher risk of the conditions. Maybe 1 in 5,000.
The cases in the database were unconfirmed, but were considered a reasonable estimate of potential risk, the agency wrote.
Low doses of vaccines for children may ease those concerns.
Authorities in many countries have recommended a single dose of the Pfizer-BioEntech vaccine for children 12 years of age and older, which would provide partial protection from the virus, but without the potential effects sometimes seen after two doses. . Sweden and Denmark joined countries that announced on Wednesday that teenagers should get only one dose of Moderna Vaccine.
amy schoenfeld walker Contributed to reporting.
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