When drugmakers Pfizer, Moderna and Johnson & Johnson received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for their COVID-19 vaccines, the country celebrated, as it was assumed the availability of such effective infection prevention meant we were closer to ending the pandemic. Fast forward several months and, unfortunately, the disease continues to spread due to the development of more contagious variants and the reluctance of some people to receive a vaccine.
However, while just over half of the U.S. population is now fully vaccinated, there is renewed hope that the recent FDA full approval of the Pfizer COVID-19 vaccine for people age 16 and older could result in more vaccinations, spurring a turning point in the pandemic. The pending full approval of the Moderna vaccine, requested by the company in early June, will likely offer an added boost.
What’s the difference between EUA and full approval?
Under EUA, the FDA allows the use of not-yet-fully approved medical products to diagnose, treat or prevent serious or life-threatening diseases or conditions during public health emergencies, such as a pandemic. These products must undergo rigorous efficacy and safety testing according to the agency’s standards.
The three COVID-19 vaccines being administered in the U.S. underwent a thorough development process that included tens of thousands of study participants. The extremely thorough trials produced the clinical, nonclinical, and manufacturing data needed for the FDA’s evaluation, which led the agency to determine that the benefits of the vaccines outweigh their known and potential risks. EUA was granted to all three; and now, full approval has been given to the Pfizer vaccine.
Once granted EUA, the vaccines’ manufacturers must continue to monitor for any serious side effects in those who received the vaccine, as well as continue clinical trials to obtain additional information about vaccine safety and efficacy. The FDA and the U.S. Centers for Disease Control and Prevention (CDC) will also work alongside other agencies to monitor the safety of the Moderna and Johnson & Johnson vaccines and seek further significant evidence of their effectiveness before granting them full approval.
What changes when the vaccine receives full FDA approval?
There are changes that might occur now that the Pfizer COVID-19 vaccine has been granted full FDA approval, affecting both the drugmakers and the public. For one, EUA only permits the use of the vaccines during the public health emergency. Full approval allows the manufacturers to market the COVID-19 vaccines after the pandemic is declared to be over by the U.S. Department of Health and Human Services, and doctors are permitted to use the vaccines for off-label purposes.
Additional changes to expect:
- More people will feel comfortable getting vaccinated. According to a recent study, 3 out of 10 unvaccinated adults — and approximately half of those who say they would like to “wait and see” for more data about the safety and effectiveness of the COVID-19 vaccines before being vaccinated — report they would be more inclined to get vaccinated once the vaccines receive full approval from the FDA.
- Companies and other institutions will develop vaccine mandates for employees. While some local, state and national governments, along with some companies and colleges, have already declared vaccination mandates for select populations — health care workers, U.S. military service members, and college staff and students — more are likely to follow suit now that Pfizer’s vaccine has been granted full approval. Some others will offer the choice of either vaccination or frequent COVID-19 testing to maintain employment, which can be costly as well as time-consuming for both employers and their workers.
- Businesses will require customers to be vaccinated. Along with requiring vaccination for their staff members, some businesses may begin to ask customers for proof of vaccination before being allowed to shop, dine, enjoy a show or travel. Despite the proliferation of social media posts that falsely assert asking someone for their vaccination status is a HIPAA violation, the law only protects a person’s health information from being disclosed by health care entities, such as hospitals, clinics and doctors’ offices. In most U.S. states, businesses can legally ask customers’ vaccination status and limit access or refuse service if they are unvaccinated.
“Because we are confident that the vaccines are incredibly safe and effective, we continue to encourage everyone who is eligible to be vaccinated,” says Dr. Stephen Munday, medical director of epidemiology and provider safety with Sharp Rees-Stealy Medical Group.
“With COVID-related severe illness, hospitalizations and deaths overwhelmingly affecting those who have not yet received a COVID-19 vaccine, vaccination is key to saving lives and ending the pandemic,” he says.
Sharp HealthCare joins the Centers for Disease Control and Prevention (CDC) in encouraging everyone who is eligible to receive a COVID-19 vaccine. Get COVID-19 vaccine information and access to COVID-19 resources from Sharp.