FDA Approves First COVID-19 Vaccine

The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, the first COVID-19 vaccine to move enjoy a status beyond emergency use status in the United States.

The Pfizer vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

William A. Dombi, President of the National Association for Home Care & Hospice (NAHC) hailed the approval, calling the coronavirus vaccines “safe and vitally important for us to move beyond the COVID pandemic.”

From the beginning of the public health emergency, NAHC has been at the forefront of COVID-19 education and advocacy. You can learn more about coronavirus and care in the home at the following pages:

About 85 million eligible Americans remain unvaccinated and the federal government hopes FDA approval will encourage many of them to now get vaccinated. Those who continue to reject vaccination may face considerable problems keeping or getting jobs, as well as gaining access to some public facilities and private businesses.

A June 2021 Kaiser Family Foundation poll found about 30 percent of unvaccinated Americans would be more likely to get vaccinated if a vaccine receives regulatory approval.

The Equal Employment Opportunity Commission approved some COVID vaccine requirements and incentives, as we reported in this space back in early June.

FDA approval of the Pfizer vaccine is likely to trigger a wave of vaccine requirements by cities, businesses, universities, health care systems and organizations, and more. The Veterans Administration became the first federal agency to require the COVID vaccine for employees, followed quickly by the Department of Defense, and the Department of Health & Human Services health care workers. The Pentagon vaccine requirement covers 1.3 million active duty troops and comes into effect after approval of the first vaccine, which has just occurred.

California has come close to a vaccine mandate for health care workers, while Oregon has created a vaccine mandate for schoolteachers and staff in public schools from kindergarten through 12th grade.

United Airlines recently announced it will require all employees to show proof of vaccination within five weeks of FDA approval of a vaccine.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

According to Pfizer, it showed the FDA data from 44,000 clinical trial participants in the United States, South America, European Union, Turkey, and South Africa, demonstrating the vaccine is 91 percent effective in preventing infection.

As NAHC Report reported on Wednesday, August 18, the Biden Administration has developed a plan to begin offering COVID-19 booster shots this fall, subject to an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines, and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence.

The National Association for Home Care & Hospice has strongly communicated to HHS how important it is that shipments of booster vaccines be sent directly to home care providers, so that safe and efficient booster vaccinations of the elderly and disabled – the most at-risk population – can take place in the home. NAHC will continue to make this case and we will keep our members up to date on this critically important topic.

“We look forward to working with the Administration to get vaccines to a very vulnerable group of individuals who, in many cases, are homebound and cannot otherwise secure the life-saving Covid vaccines and booster shots,” said NAHC President Bill Dombi, in response to the news.