1. How is a vaccine developed and tested?

▪ Approval of a vaccine for use in people involves multiple phases with different goals for assessing effectiveness and safety in different populations. There are a total of 4 phases and the vaccine must meet very intense safety criteria before completing each phase. Once a vaccine is approved for use after phase 3, it has been tested in tens of thousands of people and if no significant harmful side effects are noted, it is considered safe for use. Phase 4 involves continued monitoring and gathering of safety data. This type of clinical trial has been used for decades to approve medications and vaccines.

 

2. What are the Food and Drug Administration (FDA) requirements for the safety and efficacy of a COVID-19 vaccine?

▪ FDA requires 50% efficacy of a COVID-19 vaccine (the COVID-19 vaccines from Pfizer and Moderna are showing 94-95% efficacy in preventing COVID-19 disease during this trial phase). Many other companies are working on a vaccine and we expect that others will be approved by the FDA. ▪ FDA requires 8 weeks of safety data on the COVID-19 vaccine.

 

3. How will we know it is safe? ▪ Safety is the most important requirement for the vaccine and is assessed in trials by independent experts. ▪ Most adverse side effects occur within 6 weeks of vaccine administration, and the FDA has required 8 weeks of safety monitoring so it can track any side effects. ▪ FDA advises a minimum of 3,000 participants to assess safety. The current phase 3 trials have 30,000 to 50,000 participants. This really demonstrates how safety is a top priority for the FDA and the medical community.

 

4. Who else will be evaluating this vaccine to ensure it is safe and effective? ▪ There are 2 advisory committees: (1) The Vaccine and Related Biological Products Advisory Committee (VRBPAC) that advises the FDA; (2) The Advisory Committee on Immunization Practices (ACIP) that advises the CDC. ▪ These advisory boards are independent. Their job is to monitor vaccines to ensure safety regardless of money, politics, etc. ▪ The people on these committees are experts from academic institutions and they are vetted to avoid a conflict of interest. Experts who may have a conflict of interest are not put on these committees. ▪ The committees will evaluate the vaccine data for safety and efficacy, and also help to determine how it will be distributed.

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5. What are the types of potential vaccines that may be approved?

▪ Messenger RNA (mRNA) vaccines are a new type of vaccine undergoing clinical trials (see question #6 below for more information on this). There are also other types vaccines being studied that are similar to vaccines we have used for other diseases. None of these can give you COVID19! The goal is to give your body the tools it needs to fight COVID-19 effectively and/or prevent you from getting it at all. ▪ Also, none of the proposed vaccines contain live or killed viral particles, even though some other effective vaccines for other diseases have (see question #6 below for more information on how these new vaccines work). ▪ Most of the vaccines that are currently being tested will require 2 doses to be effective, given about 3-4 weeks apart. ▪ This is to make sure your body has enough antibodies to fight COVID-19. Getting 2 doses within 3-4 weeks has been shown to be safe and there are other vaccines we have been using for years that require multiple doses without causing harm. 6. How does an mRNA vaccine work? ▪ According to the Centers for Disease Control (CDC) website, mRNA vaccines contain material from the SARS-CoV-2 virus that causes COVID-19. This material gives our cells instructions for how to make a harmless protein that is unique to the virus. This protein cannot build a virus or cause infection. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and build antibodies that will remember how to fight the virus that causes COVID-19 if we are infected in the future. ▪ While mRNA technology is new in vaccine development, this technology is being successfully used in cancer treatments. ▪ For more information, visit the CDC website: https://www.cdc.gov/coronavirus/2019- ncov/vaccines/about-vaccines/how-they-work.html 7. What is an Emergency Use Authorization (EUA) and if the vaccine is approved for an EUA, what does that mean? ▪ An EUA is based on the need to use a vaccine quickly to save lives during an urgent health crisis. ▪ You may be anxious about the speed with which a vaccine has been approved. While the EUA is a shorter process, no steps are skipped in the safety evaluation process. ▪ This approval can still take weeks and the FDA will re-evaluate the numbers and data to ensure that the calculations are correct. ▪ The FDA will assess if the vaccine's known and potential benefits outweigh the known and potential risks. ▪ Both advisory boards (VRBPAC and ACIP) will also review all the data and information. 8. How long will the vaccine protect us? ▪ It is likely that we will not know the answer to that question when a vaccine is released. That will take more research.