National Healthcare Associations Praise FDA Emergency-Use Approval of Pfizer Vaccine
On Friday evening, Dec. 11, after the Food and Drug Administration (FDA) approved emergency-use authorization for the Pfizer/BioNTech COVID-19 vaccine, major national healthcare associations praised the action, and noted the potential for the United States to move forward in the battle against the COVID-19 pandemic. Among the associations making statements Friday evening were the Arlington, Va.-based Infectious Diseases Society of America (IDSA), the Chicago- and Washington, D.C.-based American Medical Association (AMA), and the Chicago- and Washington, D.C.-based American Hospital Association (AHA). As the Associated Press’s Lauran Neergard, Matthew Perrone, and Jonathan Lemire reported on Friday evening, “Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its German partner BioNTech. Initial doses are scarce and rationed as the U.S. joins Britain and several other countries in scrambling to vaccinate as many people as possible ahead of a long, grim winter. It will take months of work to tamp down the coronavirus that has surged to catastrophic levels in recent weeks and already claimed 1.5 million lives globally,” the reporters noted.
In a statement posted to the association’s website, IDSA president Barbara Alexander, M.D., said on Friday evening, “The first Emergency Use Authorization of a vaccine against the novel coronavirus in the United States offers a promising opportunity to reverse the trajectory of the COVID-19 pandemic. Dedicated and intensive biomedical research has been critical to making this pivotal moment a reality. This first step represents an amazing, collaborative accomplishment and is to be celebrated. It should not be politicized, and it is important to recognize it as a first step. Comments from the FDA’s independent advisory committee members highlight the importance of continuing to collect data and of ongoing study of this vaccine across populations. Guidance from the CDC’s Advisory Committee on Immunization Practices on allocation and administration of the Pfizer-BioNTech vaccine will be critical to ensuring fairness, efficiency and trust in the process to follow. Plans for the vaccine’s distribution must be open and consistent with the public health needs of communities across the nation awaiting this vaccine. Significant increases in funding to ensure equitable allocation and administration as well as education to build vaccine confidence will be essential to seizing this moment.”
And the Chicago- and Washington, D.C.-based American Medical Association released a statement attributed to president Susan R. Bailey, M.D. Dr. Bailey said, “For much of this year, physicians, nurses and frontline health care personnel have done herculean, unprecedented work to care for patients and prevent the spread of COVID-19 – all while scientists and researchers sprinted to develop a safe and effective vaccine. After a thorough, rigorous, transparent review process, today’s decision by the FDA to grant an Emergency Use Authorization (EUA) for the first COVID-19 vaccine developed by Pfizer and BioNTech is a monumental milestone with the potential to set us on a road to recovery. The comprehensive, science-based, transparent nature of this process is critical to inspiring the public’s confidence in this vaccine. We now look forward to the Advisory Committee on Immunization Practices’ (ACIP) open deliberations and their recommendations to the CDC Director for use of the vaccine in the US population to control COVID-19.”
And the American Hospital Association’s president and CEO Rick Pollack said in a statement, “America’s hospitals and health systems believe the announcement by the Food and Drug Administration (FDA) of an Emergency Use Authorization (EUA) of the Pfizer COVID-19 vaccine is an important step forward in ending this pandemic. This authorization was made on advice after a careful review by scientific and clinical experts through a thoughtful process. We will continue to be guided by science and follow the evidence that the FDA lays out on the safety and efficacy of the various vaccines in development. In addition to playing an important role in vaccination efforts across the country, we also know that along with our physician and nursing partners, we have an important role to play in providing the public with clear and concise information that informs them about the benefits of being vaccinated. This is especially important so that the public has the necessary confidence to allow them to make this important decision for their families and loved ones. Because of the long road ahead of us until COVID-19 vaccines are widely available, the AHA continues to urge the American public to wear masks, maintain physical distancing and wash their hands.”
Meanwhile, Matt Eyles, president and CEO of America’s Health Insurance Plans (AHIP), the nationwide health insurer association, released a statement on Saturday, Dec. 12. He stated that “Vaccines save lives and are essential to overcoming the COVID-19 crisis. We applaud the FDA for its swift award of emergency use authorization for America’s first COVID-19 vaccine to power our nation toward recovery. The agency’s robust, rapid process and commitment to scientific rigor have been essential to the availability of a safe and effective vaccine that Americans deserve.”
The AP’s news report noted that “About 3 million doses of the vaccine are expected in the first shipments around the country, according to officials with Operation Warp Speed, the Trump administration’s vaccine development program. A similar amount is to be held in reserve for those recipients’ second dose. The government still is hammering out final recommendations, but expected to follow health workers and nursing homes are other essential workers, older adults and people at high risk because of other health problems,” the AP reporters added. “U.S. authorities don’t expect enough for the general population before spring, and that’s assuming there are no manufacturing glitches.”
Things are moving quickly. The Wall Street Journal’s Jared S. Hopkins and Dan Frosch reported on Saturday afternoon, Dec. 12, that “Pfizer Inc. is packing boxes with thousands of its Covid-19 vaccines for shipment around the U.S., as hospitals gear up to give shots while also confronting the surging pandemic. Trucks carrying the fragile cargo at minus-94 degrees Fahrenheit will start rolling out of Pfizer plants in Michigan and Wisconsin on Sunday. Doses are scheduled to start arriving at hospitals on Monday. Health-care workers treating Covid-19 patients, nursing-home residents and perhaps others could start getting inoculated soon thereafter, though it might take a day or two for facilities to train staff and begin injections.”
