FDA's Full Approval of Pfizer Vaccine Expected to Encourage More Vaccinations

Author: Robert S. Teachout, Brightmine Legal Editor

August 24, 2021

More employers may be willing to consider requiring their employees to be vaccinated, following yesterday's Food and Drug Administration (FDA) announcement of full approval for the Pfizer COVID-19 vaccine.

Previously, all COVID-19 vaccines had been administered under an Emergency Use Authorization (EUA) from the FDA. The Pfizer vaccine is the first to be fully approved following the FDA's review of data on its safety and efficacy.

"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.

The change in vaccine status is also expected to be reflected in updated guidance from other federal agencies, include the Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC). The CDC's Advisory Committee on Immunization Practices has announced that it will be meeting on August 30 to discuss updating its recommendation for this vaccine.

Employers have struggled with the decision of whether to adopt a policy mandating vaccination for their employees since the Pfizer, Moderna, and Johnson & Johnson vaccines were first authorized under an EUA. Many were concerned about legal liability.

Over the past year, several federal agencies, including the Equal Employment Opportunity Commission and the Department of Justice, and numerous court rulings have confirmed that requiring employees to be vaccinated is legal. And OSHA guidance suggests employers consider adopting policies that require workers to get vaccinated or to undergo regular COVID-19 testing.

Another challenge employers have faced is employees' resistance to getting a vaccine that was not fully approved. "Employers have been hesitant to mandate vaccination because employees have pushed back against being 'guinea pigs' for an unapproved vaccine," said attorney Phillip Bauknight, a partner in Fisher & Phillips' New Jersey office. Now that the Pfizer vaccine is fully approved, employees may be more willing to be vaccinated, he said.

Steps Employers Can Consider

Bauknight offered several recommendations for employers who are reconsidering their vaccination options now that there is a fully approved vaccine, including:

  • Take time to consider how employees, customers and other stakeholders are likely to respond to the policy, including how to handle pushback.
  • Determine the best way to communicate the policy to employees. This should include determining how much notice to provide before implementing the requirement, how to keep and maintain proof of vaccination and who within the company will have access to that confidential information.
  • Consider related logistical issues, such as compensation issues for travel time spent to receive the vaccine and any related reimbursement costs and supplemental paid sick leave for time taken to receive or recover from the vaccine or its side effects.
  • Develop a clear reasonable accommodation policy to address religious and disability issues and take steps to communicate and administer the accommodation process in a thoughtful way.
  • Avoid posing pre-screening vaccination questions that may trigger Americans with Disability Act requirements.

Employers who choose not to impose a mandatory vaccination requirement should still consider other options for encouraging vaccinations, said Bauknight. These should include launching a communication campaign or offering incentives to improve vaccination rates among their employees. Employers also may require unvaccinated employees to undergo regular COVID-19 testing and to comply with additional safety measures such as wearing a mask and maintaining social distancing.

Finally, it is important to have a designated "vaccine team" to handle coordinating the entire process, said Bauknight