Saturday, June 10, 2023

What does “Emergency Use” mean? A break down of how the COVID-19 vaccine came to be

Nearly 30% of adults say they do not plan on getting vaccinated, according to a poll from the Pews Research Center. This hesitation represents a larger portrait of distrust in government officials to produce a safe vaccine. (WYDaily/Courtesy of Unsplash)

NATIONWIDE — It’s pretty miraculous that in less than a year, not one but three effective COVID-19 vaccines were created and implemented. 

Still, many are apprehensive about receiving a COVID-19 vaccine. According to a study done by the Pews Research Center, 30 percent of people say that they would not get a vaccine; a decrease from what earlier polls in September and November 2020 showed. 

But how can officials declare a vaccine is safe when it was created so quickly? Were corners cut in the approval process? How much do scientists really know about the vaccine?

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Let’s discuss this, shall we? 

What is an Emergency Use Authorization (EUA)?

An Emergency Use Authorization (or “EUA”) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. 

Once submitted, the Food and Drug Administration (FDA) will evaluate an EUA request and determine whether the relevant criteria has been met, taking into account all of the scientific evidence. 

EUAs are issued when the FDA agrees that the current health crisis is so dangerous that there is no time for the usually required long-term studies. 

But even in an emergency, short-term studies and trials must show that the vaccine is effective and as safe as possible. 

Updates or amendments to an EUA, like when the Pfizer-BioNTech vaccine was recently approved for 12-15 year-olds, similarly require presentation of the updated data or other information to the FDA.

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In a nutshell, an EUA helps expedite the distribution process of a vaccine. 

More information about how a COVID-19 vaccine’s path from research to an EUA can be found on the FDA’s website here.

How is it that COVID-19 vaccines have been developed so quickly?

Having a head start helps. 

And so does money.

Scientists had two chances to get ahead of the curve because of two previous coronavirus diseases. SARS emerged in China in 2002, and, in 2012, the Middle East had MERS. These viruses taught scientists a lot about developing safe and effective coronavirus vaccines, according to the Virginia Department of Health (VDH)

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Other factors, such as new resources becoming available, new partnerships between government and private-sector organizations forming, and reduced bureaucratic obstacles allowed the COVID-19 to be developed faster than any other U.S. vaccines. 

Check out a list of Frequently Asked Questions about the COVID-19 vaccine on the VDH’s website by clicking here.


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