A GLOBAL PANDEMIC
HELP SAVE LIVES FROM COVID-19
As the COVID-19 pandemic continues to plague our nation and world, here is some useful information regarding two current Emergency Use Authorization (EUA) Vaccines. With constant information being fed to us daily, it is hard to focus on yet another piece of information. Yet, please take time to review this important information to become more familiar with scientific options in fighting this pandemic.
In fact, the Center for Disease Control and Prevention (CDC) at www.cdc.gov strongly recommends the cancellation of events throughout the world and most recently, there have been talks of a national shutdown to stop the rapid spread of the Virus in certain Countries.
What is an Emergency Use Authorization?
• In a pandemic, it might not be possible to have all the evidence the Food and Drug Administration (FDA) would normally have before approving a vaccine. In such an emergency, the FDA can issue an EUA if there is scientific evidence strongly suggesting that patients have benefited from a treatment.
• One of the minimum requirements for the FDA to consider issuing an EUA is that the known and potential benefits outweigh the known potential risks.
• In addition to all the minimum requirements, you also need a good reason to do the authorization—such as the product meets reasonable thresholds for safety and effectiveness and people are in urgent need of care.
• Please review this short, yet important message from Dr. Kizzmekia Corbett of NIH.
Pfizer-BioNTech Vaccine | Moderna Vaccine |
Approved for EUA 12/12/2020 | Approved for EUA 12/18/2020 |
mRNA vaccine | mRNA vaccine |
Given by a shot injected into the muscle of the upper am | Given by a shot injected into the muscle of the upper am |
2-part vaccination given 21 days apart | 2-part vaccination given 28 days apart |
Approved for children 16 years and older | Approved for children 18 years and older |
Was 95% effective at preventing laboratory confirmed COVID-19 illness in those who received two doses who had no evidence of being previously infected. | Was 94.1% effective at preventing laboratory confirmed COVID-19 illness in those who received two doses who had no evidence of being previously infected. |
What is an mRNA vaccine?
• Researchers have been studying and working with mRNA for decades.
• mRNA vaccines do not contain a live virus and do not affect or interact with a person’s DNA.
• Please see this video for more information on how mRNA vaccines work.
What should one expect after getting the COVID-19 vaccine?
• Common side effects experienced in people who participated in these trials after receiving the Pfizer-BioNTech vaccine (and similar in those that received Moderna to a lesser extent):
o Injection site soreness (83%)
o Fever (6%) and chills (14%)
o Fatigue (47%)
o Headache (42%)
o Muscle Pain (21%)
• Remember, most side effects are signs that your body is building protection and should go away in 24 to 48 hours. Side effects are more likely to occur after the 2nd dose of the vaccine.
References:
- https://www.jhsph.edu/covid-19/articles/what-is-emergency-use-authorization.html
- https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html
- https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Moderna.html
- www.cdc.gov
- https://www.youtube.com/watch?v=uY8cqu_yj7o
Respectfully,
Dr. Pastor William Revely
Chairman Health & Wellness Council