Numerous media outlets (NPR, Business Insider, CNN, New York Times) are reporting that the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices has concurred with the Food and Drug Administration that the Pfizer/BioNTech COVID-19 vaccine is safe for use in people 16 and older, and should be distributed.  The next step is the approval by Robert Redfield, Director of the CDC.

The FDA formally issued the Emergency Use Authorization for the Pfizer/BioNTech COVID-19 vaccine late Friday, Dec. 11.  Dr. Stephen Hahn, head of the FDA, said the FDA applied its usual rigorous standards to the EUA request, and that no safety standards were shortcut.  He said although the approval of the EUA was quicker than usual, the FDA scientists worked around the clock to review all the safety data.  He said the FDA team determined the known and potential benefits of the Pfizer/BioNTech vaccine far outweighed its known and potential risks.  Hahn said the FDA is considered the “gold standard” of regulators, worldwide. He noted this approval is a significant milestone in the battle against the novel coronavirus.  He also said scientists are continuing to review data.  The EUA is not full approval, and Pfizer/BioNTech must continue to submit safety and efficacy data as it works to get full approval.

The one contraindication of the vaccine is for those people who have a history of severe allergic reactions to a vaccine or one of its components, and that people with a history of severe allergies should talk with their doctors before getting vaccinated.  There were a few people in Great Britain who did have a history of severe allergic reactions, who carried EpiPens, who had a reaction to the vaccine, but were able to be treated for those reactions immediately.  The vaccine will also not likely be used for pregnant women.

 

Saturday morning, Gen. Gustave Perna, who is responsible for distribution of the vaccine as part of the Federal Government’s Operation Warp Speed, said the first shipments of the vaccine will begin Sunday, to start arriving nationwide early Monday morning.  Gen. Perna said all states know exactly how much of this vaccine they will get.

In an interview recorded Friday with Lt. Gov. Dr. Josh Green with Sherry Bracken of New West Broadcasting for Island Conversations,  Lt. Gov. Green said the State will receive 81,000 doses of the Pfizer/BioNTech and the Moderna vaccines by the end of December, enough to innoculate 81,000 people with the first dose of one of the two-dose vaccines.  The second doses will arrive in January.  Green said the island’s three hospitals are ready to receive the vaccine.  Both Kona Community Hospital and Hilo Medical Center have both said they are ready to handle the vaccine.

The discussion with Lt. Gov. Josh Green, M.D., will be available as a podcast starting Sunday morning at 6 a.m., at https://www.kwxx.com/podcast/island-conversations/

Members of the CDC are meeting now to discuss that agency’s approval for the vaccine.  Dr. Green said there are agreements the state will sign for the CDC before distributing the vaccine.

The FDA is scheduled to review the EUA request from Moderna this Thursday, Dec. 17.

To view today’s FDA virtual press conference about the vaccine and how the EUA process works with Dr. Hahn and Peter Marks, M.D., Ph.D. the director of the Center for Biologics Evaluation and Research , click here.