The US Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for individuals 16 years of age or older. This decision stands to significantly improve the public’s confidence in the safety of the vaccine and offer organizations stronger legal protections should they decide to implement a vaccine mandate.
Full Approval Vs. Emergency Use Authorization
Prior to its “fully approved” status, Pfizer’s COVID-19 vaccine was authorized for “emergency use.” For both emergency use authorization and full approval, the FDA requires large studies (often involving tens of thousands of participants) where half the subjects are given the vaccine and the other half are given a placebo. The main difference resides in the amount of time that participants must be tracked after receiving the vaccine. For emergency use authorization, at least half of the experimental subjects must be followed for at least two months post-vaccination. For full FDA approval, participants must be followed for at least six months. In addition to longer post-vaccine follow ups, full approval also requires a more stringent examination of the facilities that produce the vaccines.
Impact On Employers
The move from emergency use authorization to full FDA approval is important for organizations in for at least two reasons.
1. Stronger legal protection: Though lawyers from the US Department of Justice have already stated that employers can legally mandate vaccines “as a condition of employment,” even when they are only authorized for emergency use, full FDA approval provides an additional layer of legal protection that will likely help companies feel more comfortable mandating vaccinations.
Employers should bear in mind that vaccine mandates must continue to comply with civil rights laws, such as Title VII and the Americans with Disabilities Act (ADA). This means that they must allow certain individuals to refuse the vaccine even though it has been mandated. Specifically, employers should accommodate requests for exemption from the COVID-19 vaccine for disability-related issues under the ADA or sincerely held religious beliefs under Title VII, unless such accommodation would cause the employer “undue hardship.”
2. Greater willingness to voluntarily receive the vaccine: Mandating the vaccine is a last resort for most companies. All things considered, it is better for organizations and the individuals who work for them if everyone gets vaccinated of their own accord. This is far more likely to happen now that Pfizer’s vaccine has been given full FDA approval. According to a recent poll, 31% of unvaccinated adults said they would be more likely to get a vaccine if one of the vaccines currently authorized for emergency use received full approval by the FDA.
What Comes Next?
While full approval of Pfizer’s COVID-19 vaccine marks an important step towards achieving high vaccination rates, several upcoming developments are likely to inspire greater confidence in vaccine safety and, ultimately, to encourage more individuals to get vaccinated.
To start with, Pfizer’s vaccines has yet to receive full FDA approval for booster shots or for individuals younger than 16 years of age. The timeline for full approval of booster shots or other age groups is unclear.
Additionally, Pfizer is one of many companies producing a COVID-19 vaccine. Other makers (e.g., Moderna, Johnson & Johnson, Astra Zeneca, etc.) have yet to receive full approval from the FDA. Moderna is next in line, having recently completed its submission to the FDA for full approval. Its approval may come in just a few weeks. Johnson & Johnson stated they are expected to apply for full approval later this year.