FDA authorizes Pfizer vaccine

source https://arktimes.com/arkansas-blog/2020/12/11/fda-authorizes-pfizer-vaccine

The Food and Drug Administration tonight approved an emergency use authorization for the release of Pfizer’s COVID-19 vaccine, which means it should be on the way, albeit in a relatively small number of doses.

The FDA has said shipments could begin 24 to 48 hours after approval; UAMS Vice Chancellor said vaccinations could begin as soon as Monday. The Department of Health has been told Arkansas will receive 25,000 doses, but that is not firm.

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University of Arkansas for Medical Sciences Chancellor Dr. Cam Patterson sent this message to all employees and students:

Dear Team UAMS,

For months, we have all watched as pharmaceutical companies worked on a virus for the novel coronavirus that has killed more than 1.5 million people around the world. We waited and hoped for the day that the Food and Drug Administration would approve the release of a vaccine – a day that has finally come.

Tonight the FDA approved Emergency Use Authorization for the release of Pfizer’s vaccine. UAMS is ready to start inoculating our team members after we receive the vaccine. We will start with employees working in units with COVID-19 positive patients, the intensive care unit, the Emergency Department, and COVID testing sites. This includes physicians, nurses, therapists and other health care workers along with transport, registration, environment services and nutrition services employees.

Employees who are eligible to receive the vaccine at this time soon will receive an email and a consent form. Please follow the instructions in that email.

Other health care workers and students who work directly with patients will be offered the vaccine as additional quantities become available. Our goal is to eventually offer the vaccination to all our employees and students as well as our patients. I am ready to receive the vaccine when it is my turn, and I hope that you are too. The stakes are too high for us to stand back.

It is critical to understand that there are two reasons to receive the vaccine. The first is to protect yourself. More people are dying of COVID-19 in the United States every day than died during the battle of Antietam. The second reason is that the virus will not go away unless at least 70% of us are protected. Otherwise, it will continue to linger and hamper our health, our education and our economy.

Today is a turning point. Regardless of what happens with vaccines, there will be several more difficult months that we must prepare for. Our health care system is really strained, as you know all too well. It is not the time to let down our guard. Even with the vaccines, we still need to wear our masks, wash our hands and socially distance from others to reduce the virus’ spread.

Together, we can get through this pandemic – there is a light at the end of the tunnel. I thank you for your months of hard work and sacrifice.

Sincerely,

Cam Patterson, M.D., MBA

UAMS Chancellor

CEO, UAMS Health

The first shipment will include 2.9 million doses, according to the New York Times. Now comes the tricky shipping part, with UPS, FedEx and private shipping companies all working to deliver directly to hospitals and pharmacies in special, ultracool shipping containers that will keep the vaccine at -94 degrees F. Containers are fitted with trackers so the government can keep up with them. Syringes, alcohol pads, face shields and other supplies will be shipped by McKesson Corp.

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The following Arkansas hospitals and pharmacies will receive the first shipment in amounts determined by the Arkansas Department of Health: The health department; Arkansas Heart Hospital; Baptist Health in Fort Smith, Little Rock and North Little Rock; Baxter Regional Medical Center in Mountain Home; CHI St. Vincent in Hot Springs and Little Rock; Conway Regional Medical Center; Hyde Pharmacy in Paragould; Jefferson Regional Medical Center in Pine Bluff; Kavanaugh Pharmacy in Little Rock; Mercy Hospital in Fort Smith, NEA Baptist Memorial Hospital in Jonesboro; Northwest Medical Center in Springdale; St. Bernards Medical Center in Jonesboro; UAMS, Unity Health in Searcy; Village Healthmart Pharmacy in Hot Springs Village; Washington Regional Medical Center;Westside Pharmacy in Benton; White River Medical Center in Batesville and Woodsprings Pharmacy in Jonesboro.

The hospitals will vaccinate staff; the pharmacies will provide vaccine to staff of smaller hospitals that aren’t getting vaccine directly. It’s still unknown the exact number of doses Arkansas will get.

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The Pfizer-BioNTech vaccine uses messenger RNA to transmit a small portion of genetic material encased in lipid to the body to start body’s own immunization process. It was found to be 95 percent effective in its Phase 3 trial of 44,000 people. It requires two shots 21 days apart; a second shipment will include those supplies. It will come in a powder form and be mixed with saline solution once thawed. Persons who are to be vaccinated will receive an information form to be signed, a vaccination card indicating which vaccine was administered (they’re not interchangeable) and a reminder for a 21-day return. That information is provided to the health department’s immunization registry, which will de-identify the information before providing it to a federal registry, state Epidemiologist Dr. Jennifer Dillaha said. (There have been concerns about private information going to the federal registry both for privacy concerns and because it would deter some people from getting the vaccine.)

Vaccinated persons may, if they wish, provide to the CDC data on side effects from the innoculations through a messaging platform. Side effects include soreness at the site of injection, and some in trials have reported headaches and nausea. For that reason, UAMS is not inoculating the complete staff in any one ICU unit but spreading it out to ensure redundancy of caregivers, UAMS’ Dr. Robert Hopkins said earlier today.

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