What's Going on with COVID Vaccines?

What's Going on with the COVID Vaccine

We’re finally wrapping up 2020, but with a new year comes new research, especially COVID-19 research. There seems to be a lot of confusion around the COVID vaccine candidates and why we would need to continue researching if certain candidates are already approved. Well, we’re here to set the record straight!

Isn’t there a vaccine already approved?

The short answer to this is yes…, but also no. Two vaccine candidates currently have Emergency Use Authorization. The first candidate that gained this status was the Pfizer-BioNTech COVID-19 Vaccine on December 11, 2020. This vaccine contains a small piece of COVID-19 mRNA, which triggers the body’s immune system to learn how to defend itself. The clinical trial data indicated that the vaccine was 95% effective at preventing COVID-19 among participants. [1]

USA COVID Vaccine

The second vaccine to gain EAU status was the Moderna COVID-19 Vaccine on December 18, 2020. This vaccine also contains a small piece of COVID-19 mRNA, which will not cause the disease but will trigger the body’s immune response. The clinical trial data indicated that the vaccine was 94.1% effective at preventing COVID-19 among participants.[2]

What does Emergency Use Authorization Mean?

Emergency use authorization is a relatively new tool for the FDA that was first used in 2009 during the H1N1 pandemic. There has to be a declared state of emergency to use this tool. In a state of emergency, like a pandemic, it may not be possible to have all of the data usually required by the FDA before they approve a drug, device, or test. During this time, the FDA can make a judgment on whether it’s worth releasing something even without all the safety and effectiveness data. The FDA can approve something for emergency use when there is evidence that strongly suggests a patient benefit.[3]

FDA Not Approved

In reality, there is no FDA approved test, treatment, or vaccine for COVID-19. An EAU is only in effect during a state of emergency. Once we are no longer in a state of emergency, things with an EAU status will have to continue in the usual FDA approval process. So, in short, Emergency Use Authorization is NOT the same as full FDA approval.

Why are we still doing research?

As mentioned above, once the state of emergency is over, the vaccine candidates will not work under their EAU status. Continuing to do research is the only way to continue in the FDA process and receive full approval. We are also striving to find the safest and most effective vaccine. Pfizer and Moderna may be first, but that doesn’t mean they will be the best. It’s possible that if we continue to do research, we can find something more effective at preventing the disease with fewer side effects.

Volunteer at Centex Studies!  

COVID Vaccine Race

If you’re interested in volunteering for COVID-19 vaccine research, we have multiple studies enrolling in South Houston, North Houston, Lake Charles, and McAllen. Those who volunteer will receive access to a COVID-19 vaccine candidate, or placebo, at no cost, no insurance required. After each completed research visit, volunteers are compensated with the possibility of earning up to $1,200 or more when the study is complete. Get involved today to play your part in the battle against COVID-19!

References:

[1] https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

[2] https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

[3] https://www.jhsph.edu/covid-19/articles/what-is-emergency-use-authorization.html

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