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FDA approves first vaccine as U.S. COVID deaths up by 3400

The Johns Hopkins COVID Dashboard for Saturday, December 12, at 5:27 a.m.:

Worldwide cases: 71,298,626    Worldwide deaths: 1,598,104

U.S. cases: 15,877,326   U.S. deaths: 295,791

According to the Dashboard, the reported worldwide case report increased by 1,510,486  in the last 24 hours.  Deaths worldwide increased by 12,377.

According to the Johns Hopkins Dashboard, the United States has added 244,990 cases in the last 24 hours.

In the last day,  the number of reported deaths in the U.S. from  COVID-19 increased by 3,409.

The COVID Tracking Project reports that 108,044  people were hospitalized nationwide with COVID-19 as of yesterday.  Hospitalization rates on the mainland have been increasing at an alarming rate, with some hospitals getting close to being overwhelmed with COVID-19 patients.   On the Big Island, Hawaii County Civil Defense reported on  Friday  that 1 person is hospitalized with COVID-19.  Kona Community Hospital on Wednesday confirmed there is one COVID-19 patient in the COVID-19 unit, not in the ICU, and not on a ventilator.

Hawaii has had 18,741 total cases of COVID-19.  The Big Island had 12 new cases yesterday, with 1,664 total cases.

In good news:  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.

 

This 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 night, 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 knows exactly how many doses it will get of both the Pfizer/BioNTech and the Moderna vaccines.  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.

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.

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