Pfizer To Ask FDA To Allow 3rd Covid Jab For Healthy 5- to 11 Year Olds
Based on a study of 140 children, Pfizer is set to ask the FDA to allow a 3rd ‘Covid’ jab for healthy 5-to-11-year olds.
Pfizer and BioNTech said they plan to apply for Emergency Use Authorization of a covid booster dose for 5- to 11-year-olds based on results of a small study that has not been published or analyzed by independent experts.
They also plan to request authorization from the European Medicines Agency and other regulatory agencies around the world as soon as possible.
The study was based on data from only 140 children 5 through 11 years old who received a booster dose six months after the second dose of Pfizer-BioNTech’s COVID vaccine as part of the primary series.
A closer look at 30 children showed a 36-fold increase in virus-fighting antibodies — levels high enough to fight the Omicron variant, ABC News reported.
Pfizer claimed the third dose was “well tolerated with no new safety signals observed.”
Although Pfizer said more than 10,000 children under the age of 12 have participated in clinical trials investigating Pfizer’s COVID vaccine, only 140 were selected for the study forming the basis for the company’s EUA request.
Commenting on the news, Dr. Brian Hooker said, “The clinical trial used to support the notion of a COVID-19 booster for 5- to 11-year-olds is entirely inadequate to make any such recommendation.”
Hooker, chief science advisor at Children’s Health Defense (CHD), added: