The FDA’s vaccine advisers voted 17-0 on Tuesday with an abstinence to recommend the EUA for the vaccine, which is formulated at a third dose of the vaccine used for people 12 years of age and older. has been done.
Pfizer says a clinical trial has shown that its vaccine provides more than 90% protection against symptomatic disease in children, even at a triple dose, and the company expects less The dosage will reduce the risk of any side effects.
Shots cannot yet be administered – the question now goes to the US Centers for Disease Control and Prevention. The CDC’s vaccine advisors, the Advisory Committee on Immunization Practices, meet on November 2 to discuss whether to recommend vaccine use among US children. Then the CDC director, Dr. Rochelle Valensky, makes the final decision on the use of the vaccine.
The White House says it already has plans to distribute vaccines to children. Vaccines can be administered as soon as the CDC is signed.
Pfizer’s Covid-19 vaccine was previously authorized for children aged 12 to 15. This vaccine is approved for people 16 years of age and older.
The American Academy of Pediatrics welcomed the decision.
“The authorization of a vaccine for young children is an important step in keeping them healthy and providing peace of mind to their families. Vaccines are a great way for children to meet friends and family members, celebrate holiday gatherings, and restore normal childhood.” activities that they have missed during the pandemic,” said Dr. Lee Savio Beer, the organization’s president, in a statement.
“Pediatricians stand by to talk with families about vaccines and get kids vaccinated as soon as possible.”
“As a mother and a physician, I know that parents, caregivers, school staff and children await today’s authorization. Vaccination of young children against COVID-19 gives us a sense of normalcy. will bring us closer to returning to the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
“Our comprehensive and rigorous evaluation of data related to vaccine safety and effectiveness will help reassure parents and guardians that this vaccine meets our high standards.”
The FDA said children between the ages of 5 and 11 accounted for 39% of Covid-19 cases.
“The FDA is committed to making decisions guided by science that the public and healthcare community can rely on,” Dr. Peter Marks, head of the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said in a statement.
“We are confident in the safety, effectiveness, and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our Public Advisory Committee meeting earlier this week, we took our decision today. Documents supporting the decision have been posted and information detailing our assessment of additional data will be posted soon. We hope this information helps build the confidence of parents who are making this decision whether their children should be vaccinated or not.”
Pfizer said it will begin sending out the orange-topped pediatric dose of the vaccine immediately.
FDA officials urge parents to vaccinate their children if the CDC is signed.
“While we have heard from some parents that their children have had Covid-19 and their symptoms were mild or hardly noticeable, it is important to note the CDC data shows that in children between the ages of 5 and 12, About 1.9 million cases of Covid-19 were recorded,” Woodcock told a news conference.
“This includes more than 8,300 Covid-19-related hospitalizations in this age group through September this year,” she said. “Sadly, Covid-19 was one of the top 10 leading causes of death for children aged 5 to 11 in the US,” Woodcock said.
According to the US Centers for Disease Control and Prevention, 5-11 children have died from Kovid-19.
“These are really starting figures,” Woodcock said.
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