FDA Delays Action on COVID Shots for Young Children

The FDA announced today, February 11, 2022,  that it would wait for data on whether three doses of Pfizer’s coronavirus vaccine are effective in children younger than five before deciding to authorize a vaccine for the age group. The FDA will no longer meet next week to weigh the evidence and make a recommendation on whether to authorize two doses of the vaccines in young children.

At Clinical Research Associates, we will continue to work with you on the clinical trial. Scheduled visits and calls will continue as normal. Should there be a change in the protocol or emergency use authorized, we will contact you as soon as possible regarding next steps.

In addition, we are now accepting new patients into the study. If friends or family would like to enroll, please encourage them to fill out the form on our website here. Pfizer and the FDA agree that more data will be needed, and you can help reach that goal by continuing to stay in the study and encouraging others to enroll.

Please read Pfizer’s official announcement on the subject here.