Pfizer, BioNTech COVID-19 vaccine gets emergency use authorization
The first vaccine to prevent COVID-19 has been cleared for use in the United States. The Food and Drug Administration on Saturday granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine for use in individuals 16 years old and older. The first shipments began leaving facilities on Sunday.
The FDA’s decision was based on data from its Phase 3 clinical study, whose results were published last week in the New England Journal of Medicine and which saw a 95% vaccine efficacy rate. The two companies continue to gather additional data and prepare a biologics license application for full approval from the FDA in 2021.
“As a U.S. company, today's news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win,” said Albert Bourla, Pfizer’s chairman and CEO.
“We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. “Today we are another step closer to our vision. We believe that today’s Emergency Use Authorization, and the subsequent distribution of our vaccine that has demonstrated an efficacy rate of 95% and a favorable safety profile, will help to save lives across the United States and could accelerate a return to normality.”
Now it is left to states to decide which groups will get the vaccine first, with the Centers for Disease Control and Prevention recommending front-line health workers and long-term care facility residents be among the first groups to receive the vaccine. Both CVS Health and Walgreens have been tapped by Operation Warp Speed to lead the charge in vaccinating long-term care facility residents, and both recently shared in-depth plans for the vaccine rollout.
CVS Health’s president and CEO Larry Merlo took to CNBC last week to outline the company’s plans for administering the vaccine, and Reuters reported that the company plans to begin vaccinating patients on Dec. 21. Walgreens held a LinkedIn Live event with three of its top healthcare and pharmacy executives, as well as the chief pharmacy officer of long-term care facility operator PharMerica. Walgreens chief medical officer Dr. Kevin Ban also pegged Dec. 21 as the date the company would begin vaccinating long-term care facility residents.
Taking a broad view, pharmacy organizations are viewing the vaccine as an opportunity for the profession to shine, with 18 pharmacy groups sharing a joint statement that noted, “This is a historic moment in the nation’s effort to end the pandemic. The pharmacy profession is ready to do its part as qualified, active participants in administering these vaccines in accordance with guidance issued by the FDA, CDC, HHS and state and local health departments, as well as increasing access for the American public to these important disease prevention tools.”
The organizations noted that 90% of Americans live within 5 miles of a pharmacy, making pharmacists the most accessible healthcare providers in the country. “Across the nation they stand ready, in all patient care settings, to administer the vaccine and counsel patients through this critical moment in our nation’s history,” the statement said. “As trusted health professionals dedicated to serving the health care needs of our communities, we stand ready to serve.”
The joint statement was issued by the Academy of Managed Care Pharmacy, the Accreditation Council for Pharmacy Education, the American Association of Colleges of Pharmacy, the American College of Apothecaries, the American College of Clinical Pharmacy, the American Pharmacists Association, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, the College of Psychiatric and Neurologic Pharmacists, the Hematology/Oncology Pharmacy Association, the National Alliance of State Pharmacy Associations, the National Association of Boards of Pharmacy, the National Association of Chain Drug Stores, the National Association of Specialty Pharmacy, the National Community Pharmacists Association, the National Pharmaceutical Association, the Society of Infectious Diseases Pharmacists and the Pharmacy Quality Alliance.