Page 10 – The Parsons Advocate - December 30, 2020 DavisHealthSystem: Committed to the Safety of our Employees, Patients, and Communities. West Virginians are looking for information about COVID-19 vaccines. Clear, consistent, and scientifically sound messaging about the COVID-19 vaccines is imperative to ensure everybody has the knowledge and confidence that they need to make a decision about getting vaccinated. The West Virginia Joint Information Center (WV JIC) for COVID-19 Vaccine recognizes the essential roles that partner agencies hold as trusted information sources and tireless advocates for communities in our Mountain State. Thus, the WV JIC for COVID-19 Vaccine developed the following communication toolkit to help our valued partner agencies respond to questions about the COVID-19 vaccine(s). This is intended as a reference guide for healthcare and public health agencies to use in communication with their audiences. Additional information on EUAs: https://www.fda.gov/vaccines-blood- biologics/vaccines/emergency-use-authorization-vaccines-explained How does the FDA Assess Safety and Effectiveness of a COVID-19 Vaccine Submitted for EUA? COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to gather required safety and efficacy data. FDA evaluates the information submitted by a vaccine manufacturer and uses all available tools and information, including records reviews, site visits, and previous manufacturing compliance history. For an EUA to be issued, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. Link: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use- authorization -vaccines-explained Which vaccines have been granted EUA? The Pfizer COVID-19 vaccine received EUA on December 11, 2020 for individuals ages 16 and older. It is a 2-dose vaccination series, given intramuscularly, 21 days apart. Why is vaccine development happening so fast? The vaccine process is happening faster because vaccine research and development, clinical trials, manufacturing, and plans for distribution are occurring at the same time. This method removes delays that occur when these processes are carried out one after the other. Steps to ensure safety are NOT being eliminated. Which COVID-19 vaccines are expected to be available first? Manufacturer Technology Phase 3 Trial Participants* Doses Status as of 12/14/2020 Pfizer mRNA 44,000 2 doses 21 days apart EUA granted Moderna mRNA 30,000 2 doses 28 days apart Requested EUA Johnson & Johnson Viral Vector 60,000 1 dose Currently in phase 3 clinical trial Oxford/AstraZeneca Viral Vector 30,000 2 doses 28 days apart Currently in phase 3 clinical trial *Phase 3 clinical trials is when the vaccine candidates are tested for safety and efficacy in tens of thousands of participants. WHICH COVID-19 VACCINES ARE EXPECTED TO BE AVAILABLE FIRST? *Phase 3 clinical trials is when the vaccine c ndidates are tested for safety an efficacy in tens of thousands of participants. Davis Medical Center Broaddus Hospital Webster County Memorial Hospital COVID-19 VACCINATION BASICS WHAT ROLE DOES COVID-19 VACCINATION PLAY IN HELPING TO CURB THE PANDEMIC? COVID-19 vaccination will help protect ourselves and others from the disease and save lives. Vaccines both prevent and reduce severity of disease. The benefits of the immunity that vaccines provide outweigh the serious risks associated with getting infected naturally. Wearing masks and social distancing help reduce the chance of being exposed to the virus or spreading it to others, but these measures are not enough. The COVID-19 vaccine is designed to work with immune systems so it will be ready to fight the virus if a person is exposed. If a large portion of a community becomes immune to COVID-19 through vaccination, it can reduce the spread of the disease to others. WILL THE COVID-19 VACCINES BE SAFE? The new COVID-19 vaccines have been evaluated in tens of thousands of individuals who volunteered to be vaccinated and to participate in clinical trials using the same methods for many other U.S. Food and Drug Administration (FDA) approved vaccines currently in widespread use. The information from these clinical trials allowed the FDA to determine the safety and effectiveness of the vaccines. These clinical trials were conducted according to rigorous FDA standards. The FDA has determined that the newly authorized COVID-19 vaccines meet its safety and effectiveness standards; therefore, the FDA has made these vaccines available for use in the United States under what is known as an Emergency Use Authorization (EUA). The Centers for Disease Control and Prevention (CDC) and the FDA will continue monitoring the vaccines for safety issues after they are authorized and in use. HOWEFFECTIVEWILL THE VACCINES BE FOR DISEASE PREVENTION? In Phase 3 trials, the Pfizer vaccine showed a 95% efficacy rate 7 days after the second dose. The vaccine was 94% effective in adults >65 years old. The Moderna vaccine showed a 94% efficacy rate 14 days after the second dose. These results were consistent across gender, age, race, and ethnicity. HOWDO THE PFIZER AND MODERNA MRNA VACCINESWORK? The vaccines contain ynth tic mRNA, which is genetic information used to make the SARS-CoV-2 spike protein. The spike protein is the part of the virus that attaches to human cells. The spike protein alone cannot cause COVID-19. Once the spike protein is created, it causes the immune system to make antibodies against the virus. These antibodies can then provide protection if a person comes into contact with the virus. The mRNA vaccines are non-infectious and do not enter the human cell nucleus, so they cannot be inserted into human DNA. Additio ally, mRNA is rapidly broken down, and this theoretically r duces chances for long-term side effects. The mRNA vaccines do not have the ability to cause cancer. Learn more here: https://www.cdc.gov/vaccines/covid-19/ downloads/healthcareprofessionals-mRNA.pdf CAN I GET COVID-19 FROM A VACCINE? No. None of the COVID-19 vaccines currently authorized for use or in development in the United States use the live virus that causes COVID-19. Although some of the short-lived mild side effects such as fever, body aches, headaches from a COVID-19 vaccine are the same as COVID-19 infection, this does not mean that the vaccine causes infection. This means y ur immune system is working. However, it should be noted that it typically takes a few weeks for the body to build immunity after vaccination. That means it’s possible for an individual to be infected with the virus that causes COVID-19 if exposed just before or just after vaccination. The vaccine itself, however, does not cause infection. WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? During a public health emergency, the FDA can use a process called “Emergency Use Authorization” (EUA) to allow the use of medical products that are not yet approved to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met. COVID-19 vaccines are currently being developed and tested for their safety and effectiveness in clinical trials (efficacy). Once vaccine manufacturers submit for authorization, the FDA evaluates the EUA request and determines whether they are safe and effective, taking into account the scientific evidence. For a vaccine to receive an EUA, the FDA must determine if the vaccine’s benefits outweigh its risks based on data from rigorous clinical trial(s). Additional information on EUAs: https://www.fda.gov/vaccines- bloodbiologics/vaccines/emergency-use-authorization-vaccines- explained HOWDOES THE FDA ASSESS SAFETY AND EFFECTIVENESS OF A COVID-19 VACCINE SUBMITTED FOR EUA? COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to gather required safety and efficacy data. FDA evaluates the information submitted by a vaccine manufacturer and uses all available tools and information, including records reviews, site visits, and previous manufacturing compliance history. For an EUA to be issued, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. Link: https://www.fda.gov/vaccines-blood-biologics/vaccines/ emergency-useauthorization-vaccines-explained WHICH VACCINES HAVE BEEN GRANTED EUA? The Pfizer COVID-19 vaccine received EUA on December 11, 2020 for individuals ages 16 and older. It is a 2-dose vaccination series, given intramuscularly, 21 days apart. WHY IS VACCINE DEVELOPMENT HAPPENING SO FAST? The vaccine process is happening faster because vaccine research and development, clinical trials, manufacturing, and plans for distribution are occurring at the same time. This method removes delays that occur when these processes are carried out one after the other. Steps to ensure safety are NOT being eliminated. WHY DOWE NEED A VACCINE IFWE CAN TAKE OTHER COVID-19 PRECAUTIONS, LIKE MASKING ANDPHYSICAL DISTANCING, TO SLOWOR PREVENT THE SPREAD? It is vital that each person uses all tools available to stop the pandemic. Vaccines work with the immune system and allow a strengthened response to the virus if exposure occurs. Other steps, like covering mouth and nose with a mask, washing hands, and staying at least 6 feet away from others, help reduce ances of xposure o the virus or spreading it to others. Together, COVID-19 vaccination and following recommendations for self-protectio and to protect others will offer the best prevention for further spread of COVID-19.