What’s Important to Know About COVID-19 Vaccines
By Bruce Davis
Since March, the coronavirus has caused great suffering in American society. It has significantly interfered with social life, education, and our economy. Even without the lockdowns that marked the early weeks of the pandemic, people are understandably concerned about going back to places where crowds gather. We’ve been asked to wear masks, distance from others socially, and work from home.
The greatest concern, of course, is that more than 350,000 Americans have died because of COVID-19, as of Jan. 5, 2021. Tennessee has not been spared, and deaths are increasing. In November, Tennessee experienced 1,305 COVID-19 deaths, and December is even higher with 1,798 deaths. Tennesseans with intellectual and developmental disabilities have been especially hard hit with a death rate 3 times higher than that of the typical Tennessean. The coronavirus has indeed created a crisis of epic proportions for every American.
Flattening the Curve
In March, we were asked to take several actions to stem the virus. We were flooded with advice to wash our hands several times per day for 20 seconds, use hand sanitizer frequently (at least 60% alcohol!), stay at least 6 feet from others, and wear masks. Our goal was to flatten the curve to avoid overwhelming hospitals and health care workers. The goal of flattening the curve was clear: To buy time until a vaccine for COVID-19 could be developed. Only then would we be able to relax and return to some semblance of the American life that we hold dear. Now, thanks to an unprecedented effort on the part of the scientific community, effective vaccines have been developed by several companies. The next step is for Americans to take these vaccines and protect themselves from COVID-19.
Not So Fast…
Many people are reluctant to take the vaccines. Their reluctance is understandable. Among the main reasons people are reluctant is that they are concerned that the process for creating and approving the vaccine has been rushed. Its true, the vaccine has been developed and approved in record time. In the past it has taken much longer to find a vaccine that works. Conducting the safety studies, getting approval from the federal Food and Drug Administration, producing the vaccine for widespread distribution, and getting it to people has taken years to accomplish. So why shouldn’t we be concerned about these vaccines that were developed in such a short time?
No Shortcuts Allowed
Despite the tremendous motivation to find a solution to COVID-19 quickly, all of the required steps to develop a new vaccine were required of the vaccine developers. The Food and Drug Administration requires that any new treatment like the vaccine go through three phases of testing. In the third and final test or trial, the vaccine developer must conduct a study with thousands of volunteers to evaluate the safety and effectiveness of the vaccine. So, if there weren’t any shortcuts, how did they reach the goal so fast? Three factors contributed to getting the vaccines out quickly.
Existing Technology
The companies developing vaccines took advantage of technology that was already close to use for other diseases. These vaccines use something called “messenger ribonucleic acid” (mRNA) to send a message to cells throughout the body to create a protein that is the same as one found in the coronavirus. This protein attaches itself to the outside of the cell. The presence of this protein helps your body produce antibodies that are effective in fighting off the severe effects of COVID-19. Different from previous vaccines, the mRNA vaccines do not contain any live virus. Therefore, they cannot cause COVID-19. Because the messenger RNA technology was already in development, only a few adjustments were needed to make it work for the coronavirus. Therefore, the task of creating the new vaccine was much simpler than usual. Researchers only needed to figure out how to make these technologies work for COVID-19.
Simultaneous Vaccine Testing and Production
Each of the companies developing vaccines began producing the vaccine while they were going through the testing process. Yes, this meant they were relatively confident these vaccines would work. Some of the companies received funding from the federal government to reduce their financial risk. Ordinarily, companies wait until the testing process is complete to produce the vaccines. Because their costs of production were covered by the government, the companies were able to produce the vaccine without financial risk.
Emergency Use Authorization
The FDA has had the authority to provide Emergency Use Authorizations of certain drugs since 1938. This authority was initially granted to allow for the rapid approval of antidotes for chemical, biological, or nuclear warfare. The FDA’s authority to provide Emergency Use Authorization for vaccines was granted in 2013. Emergency Use Authorization allows the FDA to quickly approve a vaccine that is shown to be safe and effective in initial trials while research data is still being collected. Full approval comes later after more data is collected. However, the current vaccines have been through all of the trials necessary to allow Emergency Use Authorization. Because the FDA has this authority, it allows important treatments get to Americans more quickly.
Vaccine Effectiveness
Trials were conducted with thousands of volunteers for both the Pfizer and Moderna vaccines. Half of the participants in the trials took the vaccine and the other half received a placebo (an injection of saline solution). Data showed that both the Pfizer and Moderna Vaccines were highly effective in preventing the severe symptoms of COVID-19 and that there were no serious side effects. The Pfizer vaccine was shown to be 95.3% effective in preventing COVID-19 illness, and the Moderna vaccine was 94.1% effective. Side effects have been mostly rare and typical for any type of vaccine (see the Emergency Use Authorization Fact Sheet for the Moderna vaccine and for the Pfizer BioNTech vaccine). People who have experienced severe allergic reactions to anything should consult with their physician and make their condition known to the vaccine provider before getting the vaccine.
Personal Choice
The Tennessee Department of Health has affirmed that taking the vaccine is a matter of personal choice. Health Department officials are confident that the vaccine is safe, but recognize the freedom each person has to use the information available to make the best decision they can regarding taking the vaccine. For people who have conservators, those decisions should be made jointly. For other persons with IDD, we must ensure that they are educated about the vaccines using plain language so they can make an informed decision. The Tennessee Council on Developmental Disabilities has published a plain language guide to assist people in making a decision. No one should be forced to take the vaccine, but every person should have adequate information to reach a valid conclusion. The Emergency Use Authorization documents and the plain language guide provide the best vaccine information available.
COVID-19 Vaccine Plain Language Guide
I’ve Decided to Take the Vaccine…Now What?
The Tennessee Department of Health has collaborated with Department of Intellectual and Developmental Disabilities to determine the vaccination priority of persons with IDD and their direct care providers. The result of this collaboration is that persons with IDD, aged 18 and older, who do not live independently are eligible to receive the vaccine in phase 1A1. Direct care providers are also prioritized at phase 1A1. That means that many persons with IDD and their care providers are eligible to receive the vaccine in phase 1A1. The Tennessee Department of Health has not included unpaid family caregivers at phase 1A1 of vaccine distribution. For more information about the priority of family members, please consult the COVID Vaccine Eligibility Tool.
How to Get a Vaccine
Most people with IDD will likely receive their vaccine through their local county health department. Others may make special arrangements with their pharmacy or an urgent care provider to receive the vaccine. Each county has different arrangements for providing the vaccine to the IDD population. Some have established Points of Dispensing (POD) stations where people may go to receive the vaccine. Local departments of health are also sending strike teams to provider agencies that have a large number of people needing the vaccine. DIDD is assisting local departments of health by registering people via an online system and connecting agencies with their local health departments. Many local health departments have an additional registration that may be required to get a specific time and date for the vaccination. Health departments are also providing open Points of Dispensing stations (PODs) where anyone may come to receive a vaccine. If you are eligible to receive the vaccine in phase 1A1, contact your local or regional health department for information about how to receive it. See Local and Regional Health Departments (tn.gov). If your local health department is requiring registration with DIDD, and you have not registered, please email DIDD.Covid19@tn.gov with an explanation of how you meet the criteria for phase 1A1 vaccine distribution.
A Unique Opportunity
A recent Wall Street Journal article (McDonald and Ostroff, 2020) cited Tennessee as the only state to prioritize people with IDD in the first phase of vaccine distribution. I want to personally thank the Tennessee Department of Health for recognizing the value of Tennesseans with IDD as important members of society and their vulnerability to COVID-19. The existing information about the vaccines is that they are safe and effective. Vaccines are our best path back to living the lives we once enjoyed. People with IDD and their care providers should carefully consider information about the vaccines and make an informed choice about taking them.
My thanks to Bruce, who wrote this blog post even as the information was rapidly changing. Our desire is to help individuals with disabilities and their families to make an informed choice about getting one of the COVID-19 vaccines, because as Bruce says this virus poses a greater threat to people with intellectual and developmental disabilities. He and the Department of Intellectual and Developmental Disabilities have worked tirelessly over the past 10 months to get information out, get testing done, and to get “our folks” in the early phases of the vaccine plan. As the parent of a young adult with IDD who will be receiving the vaccine very shortly, I want to thank Bruce and the entire department for their efforts.
References:
Polack, F.P., Thomas, S.J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J.L., Marc, G.P., Moreira, E.D., Zerbini, C., Bailey, R., Swanson, K.A, et al. (2020) Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine, New England Journal of Medicine, December 31, 2020, 83:2603-2615 DOI: 10.1056/ NEJMoa2034577
Baden, L.R., El Sahly, H.M., Essink, B., Kotloff, K. Frey, S., Novak, R., Diemert, D., Spector, S.A., Rouphael, N., Creech, C.B., McGettigan, J., Shishir, K., et al. for the COVE Study Group (2020) Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine, New England Journal of Medicine, December 30, 2020, DOI: 10.1056/NEJMoa2035389
McDonald, A. & Ostroff, C. (2020) Covid-19 Is Deadlier for People With Autism, Down Syndrome. Now Families Are Pushing Hard for Vaccines, Wall Street Journal, December 23, 2020.
Bruce Davis, PhD, BCBA-D, Sr. LPE, LPC, is the deputy commissioner of Clinical Services for the Tennessee Department of Intellectual and Developmental Disabilities.
January 6, 2021