The Food and Drug Administration (FDA) gave the Pfizer vaccine full approval Aug. 23 for those 16 and older, a move some USF Health experts hope will move the needle in the push for getting vaccinated.
While the Pfizer vaccine was initially approved May 10 under emergency use authorization for those 12 and older, College of Public Health professor Jill Roberts said the recent full approval will potentially sway skeptics into receiving the vaccine.
“One of the things that people have been a little concerned about getting the vaccine is that it was initially approved under an emergency use authorization,” she said.
“While that’s still a very common use of FDA resources, it didn’t make some people very confident in the product itself. They felt like it was developed too quickly. Because this now has full approval, that actually gives a lot more confidence to people.”
The vaccine was originally approved in less than a year due to the copious amounts of resources directed toward the vaccine, Roberts said. Around 10 times the amount of people worked on its creation than would any other product, leading to results much quicker than a standard trial.
As for students, Roberts said it may be trickier to inform and persuade those who are unconvinced to make the move.
“I can’t say I know a lot of students that would say to me their hesitancy is born out of whether it’s approved or not approved. I think a lot more of that is the pressure to be vaccinated if your peers or parents are vaccinated, or if you or a family member is at high risk,” she said.
“The unfortunate thing I can say with our students is that most of them think they’re invincible. You’re young, you’re healthy and you probably think you’re not going to have negative consequences of diseases … The reality is we have to keep reminding students of the consequences of a COVID infection.”
Though the full approval of the vaccine will help solidify further confidence in the vaccine, as well as hopefully encourage the general public to get vaccinated, Roberts said businesses will also now have an easier time mandating the vaccine.
“Some places that actually decided they were going to mandate the vaccine with only an emergency use authorization is something that can be really hard to do. With full approval, that’s actually very easy to do,” she said.
“I think some people may not be aware, but you can mandate the use of vaccines. We mandate them as a requirement to get accepted to USF and to come here. It is mandated that people have flu shots to work in certain types of health care environments, so it can and probably will happen.”
While millions of vaccines had already been administered before the full approval, the Pfizer vaccine was still proven to be safe and effective for emergency use until it could officially get a stamp of approval from the FDA.
For a vaccine to receive emergency use authorization and continue on the path of full approval, it must pass three phases of clinical trials to ensure there are no long term issues with those who had already received it, according to Michael Teng, associate professor at the Morsani College of Medicine.
The first phase, according to Teng, can be described as a safety test as it takes a small group of healthy young adults to see if the vaccine is safe. Then, once the vaccine is proven to be safe, phase II expands the amount of testing to hundreds of people in order to identify a correlative protection. Finally, in phase III, about 30,000 people receive a placebo or the genuine article. Once it passes phase III, the vaccine can get emergency use authorization.
For a vaccine to be fully approved, Teng said it needs to pass through six more months of safety data following phase III of the trials. After that, a company submits its results to the FDA which assesses whether a vaccine can be fully approved based on safety, effectiveness and other processes and data based on the studies from beginning to end.
As Pfizer’s full approval from the FDA spreads optimism for the future, those who received other vaccines, such as Moderna or Johnson and Johnson (J&J), may have inquiries as to when, or if, they can expect full approvals any time soon. It should be just a matter of time before they receive the green light, according to Teng.
“Moderna started their rolling submission about a month after Pfizer did. However, it all really depends on the company and how quickly they give the FDA all the data that the FDA wants,” he said. “But I would expect that it would take at least a month after the Pfizer, because they did start later.”
As for J&J, Teng said it will be difficult to predict when a full approval can be expected, given it is only a one-dose vaccine.
“Johnson and Johnson knew they were a little bit behind in the race for the vaccine, so what they tried to do was to have a single shot vaccine, which allowed them to get through their phase three data quicker, meaning they could get emergency use authorization quicker,” he said.
“But getting one shot versus two shots is a little bit different, as one shot of Pfizer or Moderna is just not going to cut it, so they have a little bit lower vaccine efficacy. It’s still really effective and what we have seen in real-world situations is that it seems to still maintain that efficacy”
With an official full approval from the FDA, Michael Edwin, professor at the College of Public Health, said in order to continue momentum of the efforts to curb the effects of the pandemic, both the university and students must do their part effectively.
“In terms of what the university can do, it’s one thing to leave this to authority. I think if you’re going to impose something on people’s lives, then it is up to us to actually explain the rationale behind it,” he said.
“Students must also take responsibility and contribute as individuals by acting safely. We are very close to herd immunity, but not if we stop now. We still have to wear face masks and physical distance, and in another four to six weeks, we should see the back of this, unless a mutant arrives.”
Looking beyond the impact of a full approval, Pfizer plans to release a third booster shot in the near future to help those who have previously received the first two doses stay protected against the virus, according to Teng.
“The process is going through right now, as Pfizer has actually submitted data to the FDA to get full approval for a third dose of the vaccine,” he said. “I don’t know when that’s going to happen, but it should happen within the next couple of months.”
Beyond physical progress, Edwin said the nation as a whole should keep intact with its communities, and continuously question its ability to do more for them, in order to come out of the other side of the pandemic with new knowledge that could propel those most affected into a positive future.
“We sometimes only think about ourselves and our own freedoms, and we feel entitled, like we can do what we want,” he said. “But what about the others? What kept society going during the pandemic? It’s all those people who are on the front line. Not just nurses in the hospital, but the transportation workers, the people who clean our streets and the supermarket people who kept the food supply going.
“We often don’t see it, and don’t feel that we are all Americans, but we need to realize that their lives are just as valuable as ours.”