FDA says it will 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
Late yesterday, the US Food and Drug Administration (FDA) advisory panel recommended approval of Pfizer’s Covid vaccine for emergency use. In a vote of 17 to 4 with one member abstaining, the panel recommended the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use, the last step before the FDA gives the final OK to broadly distribute the first doses throughout the United States.
This morning, the FDA Commissioner Stephen Hahn and the Health and Human Services Secretary Alex Azar, announced the agency will quickly grant Pfizer and its German partner, BioNTech, emergency use authorization for their COVID-19 vaccine.
However, just two days ago, 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. The announcement comes ahead of the FDA’s Thursday meeting on the Pfizer vaccine. The agency said Tuesday that two trial participants had died after receiving it.
The U.S. Food and Drug Administration is “rapidly” working toward clearing Pfizer’s Covid-19 vaccine for emergency use after a key panel overwhelmingly endorsed the shots Thursday evening, Commissioner Stephen Hahn said in a statement on Friday.
“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” Hahn said in a statement.
“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” he said.