The Pfizer/BioNTech coronavirus vaccine has won approval from the U.S. Food and Drug Administration, but don’t expect to see a national vaccination mandate coming from the Biden administration. Local governments, however, and the private sector to be sure, will be a different story.  

According to Mark McClellan, a former FDA commissioner, physician, economist and now director of the Margolis Center for Health Policy at Duke University, the full approval of the vaccine could motivate those who have been vaccine-hesitant.

“I do think it will make a difference,” McClellan told reporters this week following Monday’s announcement of the FDA’s approval of the vaccine that will now be marketed under the name Comirnaty. “Maybe not a large number of people running out and getting a vaccine today.”

According to a Duke University press release, McClellan’s work at the Duke-Margolis Center focuses on strategies and policy reforms to improve health care. In addition to serving as FDA commissioner, McClellan was an administrator with the Centers for Medicare & Medicaid Services. He currently serves on the boards of Johnson & Johnson and Cigna––each company is involved in aspects of the COVID-19 pandemic response.

McClellan said that the fully-approved vaccine offers important reassurances “that even though we’re in the midst of a pandemic…the FDA is applying all of its gold standard regulatory approaches … everything it does in normal circumstances when we’re not in a pandemic. You’ll see there were no corners cut. They were very diligent in all of this.”

The former FDA commissioner said the agency “needed to be really careful not to do anything that after the fact could be viewed as cutting corners and undermining the confidence that was intended by the full approval process.”

McClellan noted that just over 70 percent of Americans who are eligible for the vaccine are partially vaccinated, while 87 million Americans who are eligible remain unvaccinated. 

“Out of those, according to some recent surveys, about 30 percent say the full approval of the Pfizer vaccine would make a difference in their decisions,” he said.

McClellan says the federally-approved vaccine should help the vaccine-hesitant to overcome their doubts.

“We know it’s very effective,” he said. “We know there are rare, temporary side effects but that the benefits do seem to clearly outweigh the risks.”

McClellan also pushed back on some of the misinformation regarding the vaccines causing infertility or altering one’s DNA that has contributed to a rise of new cases and deaths as a consequence of the Delta variant.

He noted that misinformation is not supported by the data.

“On the other hand, the effectiveness is,” he added.

McClellan said the vaccine’s approval will have a significant impact on businesses, schools, college campuses, and entertainment venues, along with state and local governments, that may require vaccines in settings where people have to be together and there’s a high risk of transmission.

“Those things are going to bump up our vaccination numbers,” he said.

The health policy director was hesitant to suggest that the FDA’s full approval and vaccine mandates would lead to government-prompted vaccine passports, though he noted that the private sector and local governments have already begun to impose vaccine requirements.

“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 explained. “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.”

McClellan said so far, one of most important findings about the vaccine at this point has been its effectiveness and safety, particularly for the Pfizer vaccine, in preventing infection and hospitalization. He noted that although the effectiveness rates are slightly lower than numbers used in December, that we can attribute to a longer follow-up and more challenging variants now. 

“It’s really good news that the effectiveness data is holding up,” he said. “On the safety side, the trials of tens of thousands of people found no evidence of serious long-term side effects.”

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