Pfizer asks the US Food and Drug Administration to authorize a Covid-19 vaccine for children ages 5 to 11
Pfizer and BioNTech said Thursday morning that they have asked federal regulators to allow emergency use of a coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States.
The companies 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 tentatively set a meeting for October 26 to look into the matter. A verdict is expected between Halloween and Thanksgiving.
Parents across the United States are anxiously awaiting the regulators’ decision, which may affect family life and school operation. The authorization depends not only on the strength of clinical trial data, but on whether they can prove to regulators that they can properly manufacture a new infant formula.
Dr. Janet Woodcock, acting commissioner of the Food and Drug Administration, said last week that children may need “a different dose or formulation than that used in older children or adults.”
Pfizer suggested giving children one-third of 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 it intends to use in submitting it to the Food and Drug Administration.
Regulators will have to examine the purity and stability of mass-manufactured vaccine doses and determine that they are consistent with the quality and effectiveness of doses given to children in clinical trials. The pediatric dose is also likely to require new classification, with special codes that would allow the Centers for Disease Control and Prevention to keep track of more if serious side effects are reported.
Children rarely get severely ill from Covid-19, but the delta variant led Nearly 30,000 of them are hospitalized in August. According to the American Academy of Pediatrics, Nearly 5.9 million Americans are under the age of 18 They were infected with the Corona virus. Of the nearly 500 Americans who died under the age of 18, about 125 were children ages 5 to 11.
“It really bothers me when people say that kids aren’t dying from Covid,” said Dr. Grace Lee, the associate chief medical officer of Children’s Health at Stanford who also leads a key advisory committee for the Centers for Disease Control and Prevention. It’s heartbreaking.”
About one in six Americans who have been infected since the start of the pandemic has been under 18 years old. But with delta variable mutation, Children account for up to one in four cases last month, according to the American Academy of Pediatrics. Food and Drug Administration Authorized emergency use of the Pfizer vaccine for children aged 12 to 15 years in May.
The The infection rate in the United States is currently declining, which gives hope that the delta variable is declining. But public health experts are concerned that the onset of cold weather may lead to increased transmission.
Although federal regulators are under tremendous pressure to quickly review Pfizer’s application, they also face other pressing decisions. Next week, they may judge whether people who have received the coronavirus vaccines Moderna and Johnson & Johnson should receive booster doses, both of which are controversial decisions.
Public health experts said the agency’s review of the pediatric dose of Pfizer will be closely scrutinized. according to recent study Conducted by the Kaiser Family Foundation, nearly a third of parents of 5- to 11-year-olds said they would wait and see before allowing their children to receive such a shot.
Dr. Walt Ornstein, an epidemiologist at Emory University and former director of the US Immunization Program, said that given competing pressures on the Food and Drug Administration to make decisions about a vaccine quickly but cautiously, public discussion was necessary.
He said many parents were hesitating between fear of Covid-19 and fear of the side effects of the children’s vaccine. If they were less concerned about the consequences of contracting the coronavirus, he said, safety would be their top priority. If they were more concerned, the effectiveness of the vaccine would be more important. As with other vaccines, Dr. Orenstein said, pediatricians play an important role in alleviating parental anxiety.
The status of vaccine mandates in the United States
- Vaccine rules. On August 23, the US Food and Drug Administration (FDA) Full approval for coronavirus vaccine granted to Pfizer-BioNTech For people aged 16 and over, paving the way for states in both general And Spread sectors. These states are legally allowed It was upheld in judicial appeals.
- colleges and universities. More than 400 colleges and universities have required students to be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- schools. California becomes the first state to issue a vaccine mandate for all teachers And announcing plans to add a Covid-19 vaccine in the name of Prerequisite for admission to the school, which could start as early as next fall. Angels He already has a vaccine mandate for public school students 12 and up starting on November 21. New York City State For teachers and staff, which came into effect on October 4 after delays due to legal challenges, appears to have paid Thousands of last minute shots.
- Hospitals and medical centers. many Major hospitals and health systems They ask employees to be vaccinated. Mandates for healthcare workers in California And New York State He appears to have forced thousands of naysayers to take the shots.
- indoor activities. New York City requires workers and customers Show evidence of at least one dose Covid-19 for indoor dining, gyms, entertainment and shows. Starting November 4, Los Angeles will be asking most people to save it Evidence of complete vaccination To enter a host of indoor businesses, including restaurants, gyms, museums, cinemas and salons, into one of the nation’s strictest vaccination rules.
- at the federal level. On September 9 President Biden announced the authorization of a vaccine for The vast majority of federal workers. This authorization will be applied to employees Executive Authority, including the White House, all federal agencies, and members of the armed forces.
- in TIt is the private sector. Mr. Biden has authorized it All companies employing more than 100 workers They require weekly vaccinations or testing, which helps drive new vaccination policies for companies. Some companies like United Airlines And Tyson Foods, had mandates in place prior to Mr. Biden’s announcement.
The Pfizer Pediatric Clinical Trial was not intended to draw meaningful conclusions about the ability of the vaccine to prevent disease or hospitalization. Instead, the researchers looked at antibody levels, and compared them to levels in adults who were given high protection. Regulators are expected to compare those immune responses with vaccine efficacy data in the adult population.
The trial included 2,268 children, two-thirds of whom received two doses of the vaccine three weeks apart. The remaining volunteers were injected with two doses of placebo with saline. Organizers during the summer Request to expand the size of the experiment to 3000 children.
In a virtual session about 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 remarkably small. The adult trial involved approximately 44,000 people.
“It begs the question of size, given what we have for adults: does one expect more children?” He said. “They might be thinking, ‘Well, we know the vaccine is safe,’ because look at how many adults we have. “But as we know, things may change in this children’s class.”
The Pfizer-BioNTech and Moderna vaccines have been linked to an increased risk of developing myocarditis, or myocarditis. Pericarditis, the inflammation of the membrane surrounding the heart, especially in younger men. In August, the Food and Drug Administration Published results from a Pfizer-BioNTech vaccine analysis which used the US Healthcare Claims Database and found that the case risk in boys aged 16 to 17 may be as high as 1 in 5,000.
The agency wrote that the cases in the database were unconfirmed, but considered a reasonable estimate of the potential risk.
A lower dose of the vaccine for children can ease these concerns.
Officials in a number of countries have Single dose recommended of the Pfizer-BioNTech vaccine for children 12 years of age or older, which would provide partial protection against the virus, but without the potential effects sometimes seen after two doses. Sweden and Denmark have joined these two countries, announcing Wednesday that teens should get only one dose of the Moderna vaccine.
Amy Schoenefeld Walker Contribute to the preparation of reports.