FDA Approves Pfizer Vaccine. Here’s What it Means.

Margolis Center director Dr. Mark McClellan briefs the media on ramifications

FDA Approves Pfizer Vaccine. Here’s What it Means.

DURHAM, N.C. -- The federal Food and Drug Administration’s full approval Monday of the Pfizer/BioNTech coronavirus vaccine has raised hopes for a marked, swift increase in vaccinated citizens.

Former FDA commissioner Dr. Mark McClellan, who now directs the Duke-Margolis Center for Health Policy, spoke to reporters about the approval and its ramifications in a virtual briefing Monday afternoon.

Watch the briefing on YouTube.

Here are excerpts:

On whether full approval will motivate those still hesitant to get the vaccine

“I do think it will make a difference. Maybe not a large number of people running out and getting a vaccine today. At this point we’ve got a little bit over 70 percent of Americans who are eligible for the vaccine have gotten at least one dose. That’s about 87 million Americans who are eligible who haven’t. 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.”

“For anybody who does have doubts, this should help overcome it. We really aren’t seeing anything fundamentally new in the announcement today about the safety and effectiveness of the vaccine. We know it’s very effective. We know there are rare, temporary side effects but that the benefits do seem to clearly outweigh the risks.”

“I do think we now have very clear evidence that some of the misinformation out there – like the vaccine can cause fertility issues or can cause COVID or things like that – are just not there in the data. On the other hand, the effectiveness is.”

“The other place it will make a difference is in the actions of a number of businesses, schools, universities, maybe entertainment venues, state and local governments, that may take this event and probably move forward with requiring 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.”

On benefits of full approval

“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.”

“You’ll see there were no corners cut. They were very diligent in all of this.”

On whether full approval could have come earlier

“On the one hand, we are in the midst of a pandemic so we want to go as quickly as possible. On the other hand, because people are viewing this as a gold standard, using the review approaches and requirements that apply under normal circumstances … FDA 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.”

On what has been learned about the vaccines so far

“We’ve learned, very importantly, that the basic findings from the beginning, about the effectiveness of the vaccines and the safety of the vaccines, has held up. Particularly for the Pfizer vaccine, with the full approval the estimated effectiveness was 91 percent in preventing infection and very high effectiveness in preventing hospitalization. That’s slightly lower than numbers that went into the emergency use authorization back in December. I think you can attribute that to a bit longer follow up and the fact that we’re dealing with some more challenging variants now. It’s really good news that the effectiveness data is holding up.”

“On the safety side, the trials of tens of thousands of people found no evidence of serious long-term side effects.”

On vaccine mandates stemming from the full FDA approval of the Pfizer vaccine

“I expect we’ll see more. It’s important to know that under U.S. 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. Now, in that, there has to be an out for people who have medical reasons not to be vaccinated and religious reasons not to be vaccinated. That’s going to carry over now to the full approval situation. Companies who could do it before, I think they’re going to be more confident now and I think they’ll get more acceptance from their workers.”

On the impact of FDA approval on air travel regulations and restrictions

“The challenge we have now is that our COVID rates across the country are so high, and COVID rates in many other countries are also high and in some places rising. We know that people can have breakthrough cases with vaccines.”

“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.”

On whether full approval and vaccine mandates could lead to government-prompted vaccine passports

“The Biden administration has been pretty clear all along they do not see a federal role in requiring or administering a vaccine passport system. 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.”

Faculty Participant

Dr. Mark McClellan
Dr. Mark McClellan is a physician and economist who directs the Duke-Margolis Center for Health Policy, where he works on strategies and policy reforms to improve health care. He was commissioner of the U.S. Food and Drug Administration and administrator of the Centers for Medicare & Medicaid Services. McClellan serves on the boards of Johnson & Johnson and Cigna (each company is involved in aspects of the COVID-19 response).

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