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Operation Warp Speed: FDA to review Pfizer vaccine for approval

Leaders with Operation Warp Speed say FDA will review the analysis for the Pfizer Vaccine on Thursday. If approved, an Emergency Use Authorization will be issued.

WASHINGTON D.C., DC — Preparations are underway to receive the Pfizer vaccine nationwide, and on Thursday the FDA are expected to review the vaccine for approval.

WZDX News has the latest from leaders of Operation Warp Speed who are spearheading the effort.

"I gave permission to already distribute syringes, and needles, alcohol wipes, and dilutants which is required in support of the Pfizer vaccine," said Operation Warp Speed Chief Operating Officer General Gustave Perna.

Perna says those supplies will be distributed by the end of this week. He also says 6.4 million Pfizer vaccine doses total will be distributed. "The exact number is 6.4, I pulled 500,000. 2.9 first dose, 2.9 second dose," he said.

Leaders say the 500,000 doses that are in reserve is to ensure supply for the second dose, which will be sent out 21 days later.

"As we get more experience on quality control of the production, we'll get greater confidence of course in the level of supply reserve we hold back for that second dose administration," said U.S. Secretary of Health & Human Services Alex Azar, II.

The U.K. has already administered the vaccine. So far, two healthcare workers there experienced an allergic reaction. Leaders say during the clinical trial no one with severe allergic reaction wasn't included, and the FDA may consider if people with allergic reactions should take the vaccine."

"Of course the FDA will make the decisions that tomorrow this will be part of the consideration. As in the U.K., subjects with known severe allergic reactions should not take the vaccine until we understand exactly what happened here," said Operation Warp Speed Chief Scientific Advisor Dr. Moncef Slaoui.

Perna says jurisdictions are also moving forward with preparation for the Moderna vaccine. "They will lock in locations and quantities and will hence be prepared for follow on eventual approval of the EUA for Moderna," said Perna.

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