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Pfizer vaccine’s ‘final stamp’ from the FDA ‘will be a much bigger deal than people expect’

The Food and Drug Administration (FDA) formally approved the Pfizer-BioNTech coronavirus vaccine this morning for those 16 and older, replacing an emergency use authorization that was granted by the agency in December.

The Pfizer vaccine is the first COVID-19 vaccine to go through the rigorous review process that other marketed vaccinations are subjected to by the FDA. Formal approval will allow more institutions such as companies, educational institutions and the military to mandate vaccinations, Northwestern experts say, and some hope that hesitant individuals will be more likely to get the Pfizer vaccine.

The following experts are available for interviews about the potential impacts of today’s announcement. Contact Lila Reynolds at lila.reynolds@northwestern.edu to schedule an interview with:

  • Dr. Sadiya Khan, assistant professor of medicine in cardiology and preventative medicine in epidemiology at Northwestern University Feinberg School of Medicine
  • Dr. Robert Murphy, infectious disease and global health pandemic expert, executive director, Institute for Global Health at Feinberg
  • Dr. Marc Sala, assistant professor of medicine in division of pulmonary and critical care at Feinberg

Quotes from Northwestern experts:

FDA’s full approval ‘going to have a major effect’

“I think this full approval will be a much bigger deal than people think,” Murphy said. "It’s not going to fix the problem but it’s a move in the right direction. Anything that can get at hesitant people and make it easier to make decisions will help. One poll found that 30% of unvaccinated people said they’d be willing to be vaccinated following full approval. Between mandates and people changing their minds, that’s at least another chunk of the unvaccinated population.”

“The FDA approval will probably give employers and other agencies more confidence to order vaccine mandates,” Sala said. “I am not sure the FDA approval will pragmatically change personal opinions about vaccine safety or efficacy – and therefore tip someone to go out and get their shots – but it may make more people get the vaccine if their employers mandate it in order to continue working.”

‘Politicization and polarization’ may influence wary groups

“I’m somewhat skeptical that it will really change much because this vaccine hesitancy has existed in the presence of large amounts of data even in the absence of full FDA approval,” Khan said. “The politicization and polarization of the vaccine that we’ve already observed goes much deeper than a government agency providing their approval.

“The bigger issue continues to be that people who don’t even have a single dose are not only at risk of getting COVID themselves but continuing to perpetuate the spread, and the biggest concern right now is among children and pregnant woman, who are not included in the FDA approval because they weren’t included in research – even though four million people get pregnant each year.”

“We’re seeing political groups like conservative governors trying to backtrack as it becomes clear what’s going to happen,” Murphy said. “Some of them are begging people to get vaccinated — even Trump asked his followers to get vaccinated.”

‘The different policies we’re seeing are a missed opportunity,’ but now it’s up to individual institutions

“I have kids who are both back to school and we’re seeing different policies all over the place with Texas not requiring masks to schools around Chicago with tracking and weekly testing,” Khan said. “It seems like such a missed and simple opportunity, especially where there’s a high burden and now with FDA approving the vaccine for the 16-24 age range. As a parent I want my kids and everyone’s kids to be in school but there are procedures that need to be in place, like when kids are unmasked and eating around food, there needs to be better ventilation. To make sure schools are successful and don’t get shut down for surges, it’s really important that we have consistent standards across the country.”

“The federal government has very little power to do things like impose vaccination mandates,” Murphy said. “There’s nothing about public health in our constitution because there wasn’t such a thing when it was written. So, it’s all up to the states and governors have a lot of the power. Now that leaders like the Veterans Hospital System and Kaiser insurance are starting to introduce vaccination mandates, all the major players will start to follow suit, and everyone will start to catch up.”

‘We need to use everything in our toolbox’

“We need to continue focusing on the most important thing that will reduce the burden of virus in the community which is vaccinating the most people possible,” Khan said. “In that, while we’re waiting, the mantra we talked about a year and a half ago is still very necessary: Masking, handwashing, social distancing. Vaccinating also can’t eliminate testing and contact tracing, which are still necessary as we see more breakthrough infections.”

“We have to use everything in our toolbox during a pandemic, including the mitigations that are already in place,” Murphy said. “It’s indisputable that masks work. Everyone can slap on a mask or get vaccinated once every eight months. But the only thing that’s really going to work is mandates, and since the federal government has a limited impact, it’s going to be individual companies and hospitals making those decisions.”

“The COVID-19 mRNA vaccines are one of the safest, most effective preventative tools in modern medicine,” Sala said. “This was the moonshot for our generation, made possible by decades of scientific research before it. The FDA approval is the final stamp of this.”