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FDA's upcoming full approval for emergency use authorized COVID-19 jabs may change perceptions

By Ishika Dangayach on Aug 11, 2021 | 04:31 AM IST

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Pfizer's Covid-19 vaccine is presently only approved for emergency use in the United States, but full clearance by the US Food and Drug Administration might come as soon as next week.

The consequences might change the path of the pandemic in a variety of ways.

For starters, complete approval of a Covid-19 vaccine may encourage more individuals to be vaccinated as more than 30% of the eligible population in the United States has yet to receive a vaccination.

"People are going to see full approval, and they are going to feel much more confident in taking the vaccine," said Dr. Robert Murphy, executive director for the Institute of Global Health at Northwestern University's Feinberg School of Medicine, NBC reported.

Murphy said that part of the skepticism about vaccination with just emergency use permission stems from a misunderstanding of what that sort of authorization entails.

"It does not mean it's experimental. All the experimental work has been done," he said.

Covid-19 vaccine manufacturers submitted roughly three months of clinical trial data to qualify for emergency use authorization. This included at least two months of safety data on fully vaccinated subjects since most vaccine adverse effects emerge between two- and three months following immunization.

For some Americans, it isn't enough evidence to persuade them to receive the vaccine.

Full approval of a Covid-19 vaccine needs considerably more evidence, including real-world safety and effectiveness data obtained outside of a clinical study. The CDC has been collecting real-world statistics on the vaccinations, and over 165 million people in the United States have already been immunized against the virus, CNN reported.

The additional information may help persuade more individuals that vaccinations are safe.

According to The Associated Press, the Biden administration has stated that the federal government would not require immunizations beyond the federal workforce, but White House officials have urged state and local governments and companies to pursue vaccine mandates.

Several companies, including Disney, Facebook, Google, Microsoft, Tyson Foods, United Airlines, and Walmart, have announced vaccination mandates for employees. Indiana University will require students and workers to be vaccinated against COVID-19, while other universities are awaiting final FDA approval before implementing a mandate.

According to Anthony Fauci, who also serves as President Joe Biden’s chief medical adviser said final FDA approval will result in a "flood" of vaccination requirements across the country.

If more people are vaccinated, the pandemic might be over this year. However, he is concerned that if too many individuals stay unvaccinated, outbreaks of illness would persist in the long run.

“You will get a smoldering level of infection that will just go right into the fall, get confused with influenza in the winter, and then come back again in the spring,” he told USA Today.

Unvaccinated people will continue to become sick, and some will die, according to Fauci. As more people become infected with the infectious Delta variant, the likelihood of an even more complicated and deadly mutation arising grows.

According to a Kaiser Family Foundation poll, three out of every ten unvaccinated individuals indicated they would be more inclined to be vaccinated if one of the vaccines received full clearance.

However, Kaiser noted that several of those polled were confused about the shots. Two-thirds believed the vaccinations already had complete approval or were doubtful. This discovery might simply suggest that complete approval "is a proxy for general safety concerns."

With inputs from CNN

Picture Credits: Al Jazeera

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