Former FDA Commissioner Expects More Vaccine Mandates


With the full FDA approval of the Pfizer-BioNTech COVID-19 vaccine, Mark McClellan, MD, PhD, says more employer mandates will likely be coming, but he does not see federal government intervention in this area.

Mark McClellan, MD, PhD

Mark McClellan, MD, PhD

The official US Food and Drug Administration ( FDA) approval of the Pfizer-BioNTech COVID-19 vaccine was announced earlier today, and with it comes the expectation that more people will be vaccinated—either through their own personal choice or through mandates.

“I expect we’ll see more,” Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and founding Director of the Duke-Margolis Center for Health Policy at Duke University said about vaccine mandates at a press briefing today. “It’s important to know that under US law, for emergency use of a vaccine, companies, universities, other institutions already had quite broad authority if there was good reason from the standpoint of the safety of their workplace to require vaccination.”

In his role at Duke, McClellan works on strategies and policy reforms to improve health care. He was the commissioner of the FDA and administrator of the Centers for Medicare & Medicaid Services serving in both positions during the George W. Bush administration. McClellan also serves on the boards of Johnson & Johnson and Cigna (each company is involved in aspects of the COVID-19 response).

It is important to note, McClellan does not see mandates or a passport coming from the current administration but expects pressure to come on a local level in the private sector.

“The Biden administration has been pretty clear all along they do not see a federal role in requiring or administering a vaccine passport system,” McClellan stated. “That said, we have seen a number of state and local governments impose something like vaccine requirements for indoor dining, indoor sports events, indoor entertainment events. I expect to see more of that happening. I also expect to see more of that happening in the private sector.”

The biggest push will come through employer-based mandates. There is an expectation that medical centers, both Fortune 500 companies and smaller employers, airlines, and local and state municipalities will mandate vaccinations.

Today, Bill de Blasio, the mayor of New York City, announced that all staff in schools will be required to have vaccines. Phil Murphy, the governor of New Jersey, made a similar announcement announcing all school staff will have to get vaccinated or face regular testing.

The City of San Francisco is now requiring people to have proof of full vaccination to gain access to indoor spaces including restaurants, bars, gyms, and entertainment venues.

On Friday, United Airlines said it will mandate vaccines for all US employees. For Frontier employees, they will need to be vaccinated or face regular testing for the virus. Alaska Airlines, which has 20,000 employees, is considering a mandate as well.

McClellan believes air travel will continue to have restrictions and testing. “For purposes of air travel safety, quarantining and things like that, you really want to make sure people have negative tests so they’re not in a position where they can transmit the viruses. I expect those testing requirements are going to stick around until we see COVID rates come down. Right now we’re still at very high rates in the United States.” The mask mandate for traveling on airlines, trains, and buses was extended into January.

McClellan says the FDA approval reinforces the importance of the process. “The most important thing is the fact that full approval can reassure everyone that even though we’re in the midst of a pandemic, and it seems like things were happening quickly, the FDA is applying all of its gold standard regulatory approaches … everything it does in normal circumstances when we’re not in a pandemic.”

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