Covid-19 vaccine: Pfizer approves for children aged 5 to 11

The emergency authorization, announced Friday in a statement from the Food and Drug Administration, brings the US closer to being administered in schools, pediatricians’ offices and pharmacies across the country. The formulation for young children is one-third the dose of the adult shot.

Before youth can begin receiving the vaccine, the Centers for Disease Control and Prevention’s vaccination advisory committee will also meet to make more specific recommendations about who should receive it and how to administer it. The panel is currently scheduled to convene on November 2 and 3. CDC director Rochelle Valensky will be required to sign off on the advisors’ guidance.

FDA action Friday allows shipments of supplements to begin — the first time the US has delivered anything other than regular pfizer dosage For teenagers and adults. The shipment will position the shots at pediatricians’ offices, pharmacies and other locations nationwide so vaccinations can begin immediately after any CDC approval.

“Vaccination of young children against COVID-19 will bring us closer to returning to normalcy,” Acting FDA Commissioner Janet Woodcock said in the statement. “Our comprehensive and rigorous evaluation of data relating to the safety and effectiveness of the vaccine should help assure parents and guardians that this vaccine meets our high standards.”

Shares of Pfizer rose 1.3% in New York. BioNTech’s US depository receipts declined 1.9%.

Officials at hospitals and clinics are discussing the rollout for children. For example, in Washington, health officials are planning to make new authorized supplements available for children, as are CVS Health Corp. and Walmart Inc. To distribute shots to children at its eight primary care locations and through a mobile unit publicizing the community.

New York’s Westchester Medical Center has served as a coordinator for the distribution of Vaccines across the Hudson Valley. Michael Gewitz, physician-in-chief of the center’s Maria Ferreri Children’s Hospital, said the process of immunizing children aged 5 to 11 would be different from earlier campaigns. This means they will focus vaccination efforts on the offices of pediatricians in their network as well as a small vaccine site on the medical center’s premises.

“For children ages 5 to 11, we want to administer it in a more conducive, personalized environment,” Gewitz said. “We think it will be a better environment for children, especially younger ones.”

CDC Expert

Buddy Creech, director of the Vanderbilt Vaccine Research Program, said many doctors are looking forward to hearing what experts on the CDC’s advisory committee on vaccination practices recommend for vaccine use.

Creech, who helped test Modern Inc., said, “I think pediatricians want them to start a conversation with families, answer parental questions, and then follow through with ACIP to provide guidance next week.” wait for it.” Kovid vaccine in children.

Megan Rainey’s son Clark is eagerly waiting for his shot. She’s jealous of her 10-year-old older sister, who has already been vaccinated and may socialize more, said Rainey, an emergency physician and researcher at Brown University in Rhode Island.

sleepover key

“Our family rule is that you can have sleepovers in the summer going to third grade, and he missed because of Covid,” she said. “He’s never had a sleepover and he really wants to.”

It did not take the decision on vaccination lightly, she said, given the risk of a rare form of heart inflammation called myocarditis, which is associated with the vaccine in some adults, especially men. The data shows the shot is safe, she said.

“The risk of myocarditis from the vaccine, even for boys, is less than the risk of myocarditis from covid,” he said. “Covid is one of the top 10 leading causes of death in children this year. I do a lot. Things to protect my kids from injury and illness that are less common than Covid. It seems like a no-brainer.”

President Joe Biden’s administration has said it has enough vaccine for all 28 million children aged 5 to 11, and is ready to send the shots.

“Upon FDA authorization of the vaccine, millions of doses will be immediately shipped to thousands of pediatricians, family doctors, children’s hospitals, community health centers, rural health clinics and pharmacies–providers parents and children know and trust. ,” Jeff Biden’s Covid-19 response coordinator Ziants said in a press briefing on Wednesday.

“We will be ready to follow the FDA and CDC’s decisions immediately so that parents can get their children vaccinated quickly, easily, and easily.”

The recent increase in infections due to the delta variant and the return of in-person learning has fueled the demand for vaccination of young children. While FDA advisors unanimously recommended approving the shot, some expressed concerns about a lack of data on side effects, the prevalence of Covid in children, and other issues.

During the media briefing following the announcement, Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said the advisors supported the vaccine because so many children with Covid do not show risk factors before catching the disease.

“Trying to narrow it down to just one high-risk group can lead to problems, including issues with ensuring that the general population is protected,” he said. Marx said it could be a few months until officials consider shots for children under the age of 5.

“As we get down to younger children, the benefit-risk becomes even greater for a careful consideration as the youngest children are the least directly affected in terms of severe Covid-19,” he said. .

The US is focusing on ways to strengthen its defenses and stop the growth of another virus. Just last week, the FDA approved Moderna Inc. and paved the way for millions of recipients of Johnson & Johnson’s vaccines to receive their Covid boosters.

This story has been published without modification in text from a wire agency feed. Only the title has been changed.