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Pfizer COVID-19 Vaccine

What Does the FDA’s Approval of the Pfizer COVID-19 Vaccine Mean?

The agency’s full endorsement of the vaccine could ease fears for those hesitant to get vaccinated, says CU School of Medicine professor Michelle Barron, MD.

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Written by Greg Glasgow on August 25, 2021

On Monday, the U.S. Food and Drug Administration (FDA) gave full approval to the Pfizer COVID-19 vaccine for individuals 16 and older. The approval provides the FDA’s strongest endorsement to the Pfizer vaccine, which previously had been approved under an emergency use authorization.

The full FDA approval is expected to lead to an increase in vaccinations as those hesitant about the emergency use authorization may now be more willing to get the shot, and as employers and universities may now feel more comfortable mandating the vaccine for employees and students.

The Pfizer vaccine continues to be available to individuals ages 12 to 16 under the emergency use authorization. The Moderna and Johnson & Johnson vaccines are still under emergency use authorization as well, however, both have applied to be considered for full FDA approval.

We spoke with Michelle Barron, MD, infectious disease specialist and professor of medicine at the University of Colorado School of Medicine, about the FDA approval and what it means.

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What is the difference between the emergency use authorization and the full approval the FDA has given to the Pfizer vaccine?

The emergency use authorization basically states that the initial safety data is there to suggest that the medication is OK and will most likely work, but they don’t have all the components to that. In the setting of a pandemic, it felt like it was emergent that we have access to this vaccine and that we shouldn’t wait until all the data points that normally would be collected could be reviewed. With full FDA approval, the Pfizer vaccine went through the whole process of looking at sustained use of the medication, side effects, safety, all that. The study started over a year ago, and there have been millions of doses given now, so there were a lot of data points for them to be able to go through that normal process to say, “OK, is it safe? Is it effective? Does it meet all the standards we would have used for any other medication?”

Will this put some people’s minds at ease who were previously hesitant to get vaccinated?

The concerns a lot of people had about safety should be put to rest. It’s now been through that full process, and it can now be used for anyone over the age of 16. This is just an extra layer of assurance that the process was done correctly. I think a lot of people had fear about the initial process being too fast or perhaps not being as thorough, and now it’s done. This is better than any other approval just because of the sheer numbers and the real-time ability to evaluate the efficacy. All medications go through clinical trials, but there have never been 3 million or 4 million people in a clinical trial being evaluated or being monitored.

Was the timeline for full FDA approval of the Pfizer vaccine still relatively quick, compared to the approval process for most drugs?

No. Any medication, once they’ve done the initial clinical trial to show safety and efficacy, always has the ability to apply for fast-track status. A lot of antibiotics we use commonly have gone through the fast-track process because the data is that good, and/or they think there is an urgent need to have it reviewed. It doesn’t mean they shortchanged the data in any way.

Does the full approval give physicians any more latitude in terms of ordering a third vaccine shot for those who need it?

It does give more leeway, but people should follow recommendations from the Centers for Disease Control. There is anxiety among many about the Delta variant surging and wanting to have that extra layer of protection, but you may not actually be gaining a layer of protection if the timing isn’t right. There are recommendations forthcoming regarding getting a booster shot eight months after your initial series was completed. If you’re just three months out from your second vaccine dose, you do not need another shot yet. The frequency of boosters is something that’s being established and looked at.

Does the FDA’s full approval make it easier for companies and universities to mandate the vaccine for employees and students?

For some of them, it definitely makes it a little bit easier. There are some businesses that feel pretty strongly about this and have already gone that direction in terms of the mandate, and I think others are still trying to figure out, “Is it something we should do? Does it make sense to us?” Now we have the cover of the FDA saying it’s not experimental anymore, which may make it less controversial for some than it was previously.

The FDA’s full approval was only for the Pfizer vaccine. When will they give similar approval to the Moderna and Johnson & Johnson vaccines?

Moderna is already in play. They submitted their information for fast-track FDA approval several weeks after Pfizer. The Johnson & Johnson is later just because that vaccine got emergency use authorization later, so I imagine it’s two to three months behind Moderna and Pfizer, just based on when it got its emergency use authorization.

Will we see full FDA approval of a vaccine for people younger than 16?

It’s been sitting with the FDA for a while now. They anticipated emergency use authorization for kids under 12 in early September 2021, but that has been postponed temporarily. Part of their postponement for review is gathering more long-term data on the heart inflammation issues that were recognized as occurring in young people. They wanted to make sure they had enough data points on safety and long-term effects to be able to speak to it. I think it’s still on the horizon; I think what put that on pause was them saying, “We have this information, we think it’s extraordinarily rare, but we’ve only been looking for it for this amount of time. Let’s make sure we’ve done due diligence to say it’s safe.”

Anything else you want people to know about the FDA full approval of the Pfizer vaccine?

Vaccines are readily available. If you’ve not gotten your vaccine, now is the time. No more hesitation. COVID is not going away.

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Michelle Barron, MD