Vaccines, the target of some of the earliest scientific conspiracy theories, are now racing along at warp speed toward Food and Drug Administration approval. But at such a breakneck pace, how can safety be ensured? What defines success? Are all vaccines created equal? Do we want a vaccine revolution? How about a vaccine revelation?
The scientific session on Tuesday, December 15 at 11:00 am Central, “SARS CoV-2 Vaccine Basics -Current State of Affairs” will answer these questions along with other unknowns surrounding the design, development, and deployment of a vaccine for SARS-CoV-2.
Speaker Sharon Frey, MD, explains the pipeline of vaccine development from virus biology, stages of vaccine development, regulatory safety and oversight, and Operation Warp Speed, the federal government’s initiative to develop and deliver to the American public a vaccine for the novel coronavirus. She describes why understanding the basic biology of a virus and cell-mediated immunity impact the design of vaccines. She discusses the various viral elements targeted by vaccine developers to generate or sustain an immune response, including RNA, DNA, and protein subunits. Simply knowing the difference between SARS-CoV-2’s spike and nucleocapsid proteins won’t cut it with the amount of vaccines currently under development.
When it comes to efficacy and safety studies, vaccine trials are not immune to the negative impacts of disparities due to social determinants. Diverse enrollment ensures a vaccine is studied in a cohort that accurately reflects the general population. “It’s important to understand the general issues related to safety, health disparities, and people’s fear of vaccines,” she states. “These items are outside of clinical research but are important to a vaccine’s success.”
During this scientific session she outlines the role that the laboratory medicine community will play in the process. She emphatically states that everyone has a part in developing and deploying vaccines. The laboratory community learned valuable lessons from serology testing for disease management for hepatitis A and B, and rubella.
“Herd immunity is not going to get us out of the COVID-19 pandemic,” she says. “Laboratory medicine is key in differentiating natural infection from a vaccine-mediated immune response.” The design, development, and deployment of a vaccine might fundamentally change what clinical laboratories measure.
Another key topic Frey tackles is the vaccine rollout. Operation Warp Speed has set some ambitious targets for approving and deploying vaccines. Most likely it won’t be a one size fits all situation so prioritizing the order in which different groups receive vaccines will be key. Existing vaccines for influenza are already customized for populations: high doses for the elderly, intranasal for kids. The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices is already developing prioritization strategies for multiple SARS-CoV-2 vaccines.
How these vaccines get distributed will be very important. “Deciding who gets access first will be heavily scrutinized,” she adds. History has its eyes on you.
The success of a SARS-CoV-2 vaccine faces many hurdles. But the lab medicine-immunology union is driving the vaccine revolution so it provides a solution. Attendees of this session will no doubt be satisfied.