For immediate release:
Opinion from:

Janet Woodcock, MD
Actor
Commissioner of Food and Drugs – Food and Drug Administration

Peter Marks, MD, PhD.
Director – Center for Biological Evaluation and Research (CBER)

The US Food and Drug Administration has been notified by Pfizer that new data has recently emerged regarding its application for an emergency use permit to use the Pfizer-BioNTech COVID-19 vaccine for children aged 6 months to 4 years. As part of its rolling submission, the company recently notified the Agency of further results from its ongoing clinical trials. Based on the Agency’s preliminary assessment and to allow more time to evaluate additional data, we believe that additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision on possible authorization.

Therefore, the FDA is postponing the meeting of the Advisory Committee on Vaccines and Related Biological Products, which was originally scheduled for February 15th. This will allow the Agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for Vaccines against covid-19. We will provide an update on the timing of the advisory committee meeting when we receive additional data on a third dose in this age group from the company’s ongoing clinical trials and have the opportunity to conduct an updated evaluation.

Since the early days of the pandemic, we have always followed science in this ever-changing situation. Given the recent omicron rise and the notable rise in hospitalizations of the youngest children to their highest level to date during the pandemic, we felt it was our responsibility as a public health agency to act quickly and consider all available options, including requesting that the company provides us with preliminary data on two doses from its ongoing study. The aim was to understand whether two doses would provide adequate protection to proceed with the approval of the use of the vaccine in this age group. Our approach has always been to conduct a legislative review that is responsive to the urgent public health needs created by the pandemic, while complying with our strict standards of safety and efficiency. Being able to start evaluating initial data has been helpful in our review of these vaccines, but at present we believe that further information regarding the ongoing evaluation of a third dose should be considered.

The Agency will ensure the effectiveness and security of data support before approving a COVID-19 vaccine for use in our youngest children. Meanwhile, the best way to protect children, even when in school or day care, is to practice social distancing and masking in accordance with public health recommendations, and to have their family members and caregivers vaccinated or given a booster dose when warranted.

###

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.