FDA approves Pfizer’s COVID-19vaccine for emergency use authorization; asks Pfizer to provide ‘reports that result in hospitalization or death’
This morning, we wrote about The U.S. Food and Drug Administration (FDA) after the agency said it would quickly approve Pfizer’s COVID-19 vaccine for emergency use even after the agency admitted 2 people had died from the phase 3 vaccine trial.
About ten hours later, the FDA on Friday formally granted emergency approval for Pfizer and BioNTech’s coronavirus vaccine candidate, officially paving the way for widespread distribution of the long-awaited vaccine that is recommended to go to health care workers and residents and staff of long-term care facilities first.
In a letter, addressed to Pfizer, FDA said:
“This letter is in response to a request from Pfizer Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 16 years of age and older, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3).”
The announcement comes just two days ago after the FDA admitted that 2 people had died from the phase 3 vaccine trial. The revelation about the deaths was buried on page 50 of a 90-page briefing document.
As part of today’s announcement, the FDA also asked Pfizer to report reports on the following to Vaccine Adverse Event Reporting System (VAERS):
• Vaccine administration errors whether or not associated with an adverse event;
• Serious adverse events (irrespective of attribution to vaccination);
• Cases of Multisystem Inflammatory Syndrome in children and adults; and
• Cases of COVID-19 that result in hospitalization or death, that are reported to Pfizer Inc.
According to the FDA, the reports must be submitted to VAERS as soon as possible but no later than 15 calendar days from initial receipt of the information by Pfizer Inc.