Business

FDA Review of Pfizer Covid-19 Vaccine for Expected Children

US health regulators will soon consider evidence of the Covid-19 vaccine.

Pfizer Ltd

PFE 0.14%

When

BioNTech SE

BNTX 6.29%

For children 5-11 years old.

The US Food and Drug Administration will post a written assessment of research data submitted by the company online as early as Friday morning. In early october Pfizer and BioNTech asked the FDA Vaccine for children aged 5-11 years.

The FDA is also expected to post documents from companies outlining the rationale and evidence for extending vaccine use to young children. These documents are published prior to the upcoming meeting of the Vaccine Experts Committee on Tuesday to advise the FDA.

The panel, Vaccine and Related Biopharmaceutical Advisory Board, will meet to review evidence of vaccine safety and efficacy in children and vote to recommend whether the FDA should approve its use.

As the FDA approaches the decision to authorize Pfizer’s Covid-19 vaccine for children ages 5-11, public health officials and pediatricians are conducting research with families to ensure parents hesitate about shot safety. I’m sharing.Photo: John Rocher / Associated Press

If the vote is in favor, FDA approval may continue within a few days.And if the Centers for Disease Control and Prevention subsequently approves, millions of infants Covid-19 vaccine was available first time.

According to the American Academy of Pediatrics, the United States has more than 28 million children between the ages of 5 and 11.

Pfizer and BioNTech said in September that their vaccines are generally well tolerated, Induces a strong immune response In a study of approximately 2,270 children between the ages of 5 and 11, each child received two doses at 3-week intervals, with each shot being one-third of the dose used for adolescents and adults. 1 was included.

The vaccine induced in infants levels of neutralizing antibodies similar to those found in people aged 16 to 25 years who worked as controls in the study, the two companies said.

The Pfizer-BioNTech Covid-19 compound was mixed in August for a study in children under 12 years of age.


Photo:

The Wall Street Journal Daniel Rosada

Pfizer also tested the vaccine at lower doses in 6-month-old young children.

Pfizer vaccine was approved for people in December 2020 16 years and over, Approval was expanded in May Adolescents over 12 years old..

Earlier this week, the Biden administration outlined plans to distribute the Pfizer vaccine to children. Clinics, pharmacies, schools If the regulator clears the shot.

Modana Ltd

When

Johnson & Johnson

We have been studying the Covid-19 vaccine for children, but currently their injections are only allowed for people over the age of 18.

Write in Peter Loftus peter.loftus@wsj.com And Jared S. Hopkins jared.hopkins@wsj.com

Copyright © 2021 DowJones & Company, Inc. all rights reserved. 87990cbe856818d5eddac44c7b1cdeb8

FDA Review of Pfizer Covid-19 Vaccine for Expected Children

Source link FDA Review of Pfizer Covid-19 Vaccine for Expected Children

Back to top button