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.
Hahn added, “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.”
The first shipments will leave Pfizer’s manufacturing plant in Kalamazoo, Michigan, by truck and then be flown to regional hubs around the country. Medical distributor McKesson and pharmacy chains, including CVS and Rite-Aid, also are involved in the initial rollout and vaccinations at nursing homes and assisted living centers.
The vaccine must be stored and shipped at ultra-low temperatures – about 94 degrees below zero which will make the distribution a challenge. Pfizer has developed shipping containers that use dry ice, and GPS-enabled sensors will allow the company to track each shipment and ensure it stays cold.
Distribution sites are mainly large hospitals and other facilities able to meet those ultra-cold storage requirements. Within three weeks, vaccines should be delivered to all vaccination sites identified by states, such as local pharmacies, Perna said.
Delaware is expecting to receive 8,775 doses of the highly effective vaccine. Healthcare systems like ChristianaCare will immediately begin vaccinating their frontline workers. They will need two shots spaced three weeks a part. Earlier this week, Delaware officials received a shipment of an ultra-cold storage unit that arrived at the Department of Public Health (DPH) warehouse on Tuesday, Dec. 8, 2020. The State could begin receiving initial doses of vaccine as early as next week.
The State’s Ethics Advisory Group met to consider the Division of Public Health’s most recent recommendations regarding which specific groups should receive the vaccine as part of the first phase of distribution in Delaware.
According to Jen Brestel, a spokeswoman at the Department of Public Health, DPH makes its recommendations based on the goals of reducing death and hospitalization from COVID-19, protecting critical health services provided by hospitals and other medical staff, while also reducing the burden of disease on those who face disparities.
According to the Phase 1A of the state’s distribution plan, as approved by the Ethics Advisory Group and finalized by DPH, include residents of long-term care facilities and high-risk workers with routine exposure to infected individuals or materials in health or patient care settings. This includes Hospital staff, Emergency Medical Service providers who have direct patient contact, Public Health staff who have direct patient contact, Health care providers in outpatient settings, Pharmacy staff, and Staff of long-term care facilities.
Brestel said that “DPH and the Ethics Advisory Group will continue to monitor recommendations from the federal Advisory Committee on Immunization Practices (ACIP) for further recommendations regarding subsequent phases. Additional details will be shared as decisions are finalized.”
DPH have posted the most updated version of its framework (or Playbook) for vaccine distribution on the de.gov/covidvaccine website, and added a section on Vaccine Safety.