SOUTH HILL – Since December 2020, people have been rolling up their shirtsleeves for the Pfizer COVID-19 vaccine. Authorized by the Food and Drug Administration for emergency use, the vaccine has now received formal FDA approval. What does that mean?
Kelly Goode, Pharm.D., is a professor in the Department of Pharmacotherapy and Outcomes Science at VCU School of Pharmacy and director of the VCU Community Pharmacy Practice Program and VCU Community Pharmacy Practice Residency Program.
An expert on vaccinations, including the COVID-19 vaccines, Goode is a liaison member of the National Vaccine Advisory Committee. Here, she answers questions on the FDA's approval of the Pfizer COVID-19 vaccine for individuals 16 years of age and older.
What does FDA approval mean?
FDA approval grants the company permission to market and distribute the vaccine in the United States. The FDA has evaluated information about safety, effectiveness and whether the manufacturing and facility data ensures product quality and consistency.
How does approval differ from emergency use authorization?
For FDA approval, the manufacturer must submit a biological license application. An independent scientific review is conducted, and there must be substantial evidence of safety, effectiveness and whether the manufacturing and facility data will ensure product quality and safety. For approval, the FDA was requiring 6 months of safety monitoring and follow-up after completion of the clinical trial.
FDA approval is indefinite unless new evidence emerges that presents any cause for concern.
The FDA can make a product available to the public during a public health emergency using the Emergency Use Authorization (EUA). The EUA process is based on the best available evidence when evaluating potential risks versus benefits but without waiting for all the evidence that would be needed for FDA approval. EUA’s are only effective through the emergency declaration or public health emergency.
Are vaccines really safe with just emergency use authorization?
Yes. The vaccine development and clinical trial processes for the EUA required the vaccine to meet rigorous scientific standards for safety, effectiveness and manufacturing quality. However, the primary difference is that some of the data from ongoing clinical trials may be used in the EUA approval, as opposed to data from completed trials.
If you know someone who is hesitant to get vaccinated for fear it might not be safe unless it's FDA approved, how would you talk to that person now that the Pfizer vaccine has full approval?
Full approval is exciting news for the Pfizer-BioNTech COVID-19 vaccine. A comprehensive assessment of post-authorization safety data was conducted, including risks versus benefits, to guide the approval.
Over 2 million people in the U.S. have received the Pfizer-BioNTech COVID-19 vaccine — with few adverse effects. When compared to the risk of severe adverse effects from COVID-19, the evidence greatly supports the benefit of the vaccine.
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner.
Is there anything else you would like to add?
COVID-19 vaccines are our best protection against COVID-19, including hospitalizations, severe illness and death. We need everyone who can get a vaccine to be vaccinated to protect themselves and the people who cannot be vaccinated, and to prevent the spread and mutation of the SARS-CoV-2 virus. Broad vaccination in communities can prevent the spread of disease and illness and prevent needless deaths.
Get your COVID-19 vaccine today! And starting in September, get your influenza vaccine too!
If you have been fully vaccinated with the Moderna or Pfizer-BioNTech vaccine, watch for recommendations for a booster vaccine.
For more information
For a variety of news and information on COVID-19 and how VCU Health is keeping patients safe, please visit our COVID-19 News Center.