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US FDA – It’s a “Go” for Pfizer vaccine
Late on Friday, Dec. 11th, the FDA issued their approval:
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts
Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
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Alex Azar, US Secretary of Health and Human Services announced on Thursday, December 10th, that the US would give emergency authorization of the Pfizer/BionTech vaccine. This would clear the vaccine to begin almost immediate shipment and vaccinations to across the US.
Each state receives doses calibrating to their population over the age of 18.
The vaccine, packed in cooling devices and ready for shipment in boxes with tracking devices and dry ice will leave Pfizer’s warehouses located in Wisconsin and Michigan, and be flown and shipped by UPS and FedEx from coast to coast. UPS created a vast “freezer farm” for -80°C storage at its logistics hub in Louisville, where it will also produce more than 24,000 pounds of dry ice per day. Each day, UPS will deliver a 40-pound box of dry ice to all Pfizer dosing sites that lack their own freezer capacity.
Capitol Carbonic in Baltimore, a family-owned business will produce the custom dry-ice packing for the shipping material. Once a package is received, a re-supply of the dry ice will be sent as well.
Going strong in Canada & UK:
“Canada has started to receive up to 249,000 doses this month and Canadian officials expect to administer them within days. Britain on Tuesday began vaccinations with the shot made by Pfizer and BioNTech. U.S. regulators on Tuesday also released their first scientific evaluation of Pfizer’s COVID-19 vaccine and confirmed it offers strong protection. Vaccines are emerging from an all-out worldwide race and are reaching the market less than a year after the virus was even identified — a remarkable scientific achievement that shaved years off the usual process.” (AP)
CVS Health increases access to flu vaccines in communities of need
CVS Health today announced it is supporting a nearly $3 million commitment to increasing access to flu vaccines for underserved communities throughout the country. Through its Project Health initiative, CVS Health is contributing $2 million to the National Association of Free and Charitable Clinics (NAFC) to help distribute flu vaccines to those who may otherwise not have access. Additionally, the company is working with Bank of America and General Motors to support increased access to flu vaccines in even more communities nationwide.
“Underserved communities have been hit particularly hard by COVID-19, so supporting flu prevention in these communities is even more important,” said Eileen Howard Boone, SVP of Corporate Social Responsibility and Philanthropy, CVS Health. “Through our work with Free Clinics, and in teaming up with Bank of America and General Motors, we aim to expand our reach to individuals who may not otherwise have access to flu vaccines.”
CVS Health’s Project Health flu initiative will support free and charitable clinics in areas across the country, helping clinics increase capacity to provide flu vaccinations. Clinics in California, Florida, Georgia, Illinois, Kentucky, Maryland, New York, North Carolina, Pennsylvania, South Carolina, Texas will receive support. These grants extend the mission of Project Health which aims to break down the barriers for people to access quality and affordable health care.
CVS and Walgreens will be charged with vaccinated some of the very first in congregate care and then utilizing their stores for public COVID-19 vaccinations.
Pushing the slow turtle of the FDA
On Friday afternoon, White House Chief of Staff Mark Meadows told Stephen Hahn, the commissioner of the Food and Drug Administration, to submit his resignation if the agency does not clear the nation’s first coronavirus vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened. President Donald Trump tweeted that the FDA is “a big, old, slow turtle” in its handling of vaccines, while exhorting Commissioner Stephen Hahn to “get the damn vaccines out NOW.” He added: “Stop playing games and start saving lives!!!” Within hours of that news, the FDA released their emergency approval.
