What You Need to Know About the Development of a COVID-19 Vaccine
The Aging Network has been laser focused on helping older adults and caregivers get through the COVID-19 pandemic, but we also need to understand what is happening with vaccine research and trials so that, when the time comes, we can help with public education around administration of a successful vaccine. n4a met with officials working on Operation Warp Speed recently so read on for details, and an upcoming webinar by n4a ally the Alliance for Aging Research offers another way to get up to speed!
Alliance for Aging Research Webinar:
Join the Alliance for Aging Research and Operation Warp Speed (OWS) for a webinar discussion on Tuesday, November 10 at 1:00 pm ET about a new “one-stop shopping” online portal that will lay out in plain language the three medical pathways currently available through OWS to the public in order to accelerate enrollment across all COVID-19 clinical trials and plasma donations. Invited speakers include NIH's Dr. Anthony Fauci and Lance Robertson, ACL Administrator.
More Information from the Coronavirus Prevention Network (CoVPN):
Have questions about the development of a COVID-19 vaccine? Read on for details from CoVPM.
As you are all aware, COVID-19 is affecting older Americans more intensely than any other age group. Estimates are that 70 percent of COVID-19 deaths have occurred in people older than 65 years of age, and hospitalizations are also highest in this age group. Quality of life for older persons has been dramatically affected, with severe limitations on social outings and a huge change in how people live.
The Coronavirus Prevention Network, or CoVPN, is part of OWS, which is a public-private partnership between the U.S. Government (including the Food and Drug Administration and the National Institutes of Health), pharmaceutical companies, and researchers to make COVID-19 vaccines and monoclonal antibodies a reality. Pharmaceutical companies, working with researchers, have developed vaccine and monoclonal antibody candidates. The most promising candidates are reviewed by the OWS team and granted funding to conduct accelerated research. This research goes through Phases 1, 2, and 3; typically, this process takes years, with a lot of time spent seeking funding. The COVID-19 research is going through the same steps, but by focusing resources and attention, the commitment of regulatory groups to meet and review data promptly, and with the government's financial investment, products are moving through the phases more efficiently.
Phase 3 trials, which take place after vaccines are shown to be safe in small numbers of people, are large studies to prove whether the products actually work to prevent infections or control disease. Currently, the CoVPN is helping pharmaceutical companies implement five large Phase 3 vaccine trials. Each trial will enroll about 30,000 people and follow them over time to learn whether the vaccine is effective. Three trials have already started, and three more are planned to start in 2020.
That means the CoVPN is enrolling a minimum of 150,000 volunteers for these vaccine trials! The study analysis plans to take into account the fact that older adults have the highest burden of coronavirus disease. Therefore, a minimum of 25 percent of the vaccine trial participants will be recruited from adults aged 65 or older. People with all levels of health will need a vaccine. Therefore, people who take medications and have other health conditions will be enrolled in the vaccine trials (with a few exceptions). Older adults are wanted and needed to participate in this research.
Regarding safety, all of the federal agencies, the sponsors and the researchers involved in the trials are very focused on participant safety. All the usual safeguards for trial participants are in place for this research, and the data is reviewed by independent Data and Safety Monitoring Boards throughout the studies, and before results are presented to the FDA. While the process is faster due to everyone's focus on the pandemic crisis, the same safety steps are being followed as for any vaccine.
The CoVPN needs you! CoVPN has set up a Volunteer Screening Registry for interested persons to indicate that they may want to volunteer for research. Being in the Registry does not require you to join a study, it just enables a local study clinic near you to be in contact with you if they have a study available and think that you would be a good match for it. They will provide you with more information, and if you are interested, will schedule time with you to go through the Informed Consent process.
If you would like to be part of research to test the effectiveness of a COVID-19 vaccine, or for monoclonal antibodies, please visit www.PreventCOVID.org and click on the “Volunteer Now!” button to complete the survey and join the Registry. If you do not use a computer or smartphone, you can call the toll-free Call Center at 866-288-1919 for assistance. The Registry is used by all of the study sites in the U.S., and not every site will have every study available. The study sites keep changing based on where the epidemic is most active, and so it is not possible to say for sure whether there is a study site in your area. But, if you sign up in the Registry, you could be called for a study that is enrolling now or that may start in the coming months.
Just as the Polio Pioneers helped bring about a vaccine that changed the world, the CoVPN are hopeful that coronavirus vaccines and monoclonal antibodies represent hope for a better future for everyone. Please consider signing up as a potential volunteer at www.PreventCOVID.org. If you are not able to participate in this research or choose not to enroll, we do want you to know that thousands of researchers, doctors and scientists who specialize in vaccines are working hard to provide older adults with safe and effective products to end this pandemic.
For more information about this effort to recruit potential vaccine volunteers including older adults, contact Alison C. Roxby, MD MSc, Associate Professor, University of Washington; Staff Physician, Coronavirus Prevention Network, at email@example.com.