On October 1, 2020, Husch Blackwell conducted the first of an eight-part Health Law & Innovation Series. The first session, focused on vaccines, and was very well received. The discussion was moderated by Thomas N. Shorter, JD, FACHE, partner with Husch Blackwell and accompanied by panelists:
- Dr. Edward Belongia, Director of the Center of Epidemiology and Population Health, Marshfield Institute of Health,
- Seth Mailhot, JD, partner with Husch Blackwell; and
- Julianne Story, JD, partner with Husch Blackwell.
The conversation focused on aspects of vaccine development and efficacy, and the timeline to availability and distribution. In addition, there was discussion regarding the implication of employer vaccine mandates. If you were unable to attend the webinar, it is now available On Demand at Health Law & Innovation Virtual Series – Vaccine: Hope and Controversy.
Progress to a vaccine continues, on October 6th, the U.S. Food and Drug Administration (FDA) released a document titled “Summary of Advice Provided to Individual Sponsors in Response to Questions Regarding Emergency Use Authorization of Vaccines to Prevent COVID-19” which explains additional safety and efficacy standards for developers to follow. Two keys points of the summary document include:
- all clinical trial participants should be monitored for an average of two months after being administered their final vaccine doses, to monitor adverse events; and
- detailed description of companies clinical safety and effectiveness data and manufacturing process and controls should be provided not less than one month prior to an Emergency Use Authorization request submission.
While a vaccine may be available by the end of the year, supplies will be limited to quantities that can immunize subjects with the highest health risks, such as those individuals roughly 70 years old and older, and/or those individuals with significant co-morbidities, and frontline healthcare workers.
As vaccine availability continues to change, look to the Husch Blackwell Healthcare Team to develop an additional webinar to provide up-to-date knowledge from those at the forefront of delivering the vaccine.