The Food and Drug Administration’s (FDA) approval of Pfizer’s COVID-19 vaccine offers an opportunity to educate the public about the difference between an emergency use authorization (EUA) and full approval, and why Ohioans should feel confident about the safety of the vaccines following this approval process.
Suggestions for messaging to patients and the general public include:
- EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
- The FDA has granted EUAs for three COVID-19 vaccines (Pfizer, Moderna, Johnson & Johnson). The Pfizer vaccine was the first of the COVID-19 vaccines to receive an EUA on December 11, 2020, the first to apply for full approval, and now the first to receive full approval.
- A manufacturer must submit an application for full licensure. The application builds on the data and information that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process and inspections at the sites where vaccine is made. Vaccine applications have the equivalent of hundreds of thousands of pages of data and other information – more than what is submitted as part of an EUA.
- For the EUA, the FDA requires at least half of the participants of the original studies to be followed for at least two months post-vaccination. This is because most vaccine-related side effects occur right after vaccination. Full FDA approval requires participants in the original studies to be followed for at least six months. Reviewers look at data from the same study participants collected over a longer time period. All adverse events are examined.
- The Pfizer COVID-19 vaccine is now the first FDA-approved COVID-19 vaccine. This means the Pfizer vaccine has successfully completed the agency’s standard process for reviewing all medical products.
- This approval is for ages 16 and older because that age group has been studied the longest. The EUA for 16 and older was issued in December 2020, but the EUA for ages 12-15 was granted five months later in May.
- Moderna, which received its EUA one week following Pfizer, also has applied for full FDA approval of its COVID-19 vaccine. Regulators are still reviewing Moderna’s application.
- All COVID-19 vaccines currently authorized in the United States are effective in preventing severe disease, hospitalization, and death from COVID-19.
- Available data suggest COVID-19 vaccines offer protection against known circulating variants, including the Delta variant. Vaccination continues to be critical during this period of rapidly increasing cases and spread of variants of concern.