As Coronavirus (COVID-19) cases continue to plateau and as the nation experiences the benefit of social distancing, the focus has quickly turned to the development of a vaccine.
Despite the substantial cost of developing, distributing and administering vaccines in a highly regulated industry, manufacturers and research institutions have been spending heavily on their development recently. According to the Wall Street Journal, Moderna and Pfizer are collaborating on Messenger RNA (mRNA) vaccines that instruct a patient’s cells to produce proteins to prevent the virus. In fact, Moderna Inc.’s mRNA-1273
is part of a study
at the Kaiser Permanente National Health Institute in Seattle. Pfizer has also issued a statement that it is working with BioNTech to prepare
for human testing. FierceBiotech similarly reports that Johnson & Johnson (J&J) joined with the U.S. Biomedical Advanced Research and Development Authority
to develop a vaccine for which it plans to begin clinical trials in September 2020. And, the University of Pittsburgh Medical Center announced
that it too has a proposed inoculation called PittCoVacc. According to Reuters, GlaxoSmithKline Plc and Sanofi SA
also recently announced that they would begin to develop a vaccine to combat the fast-spreading coronavirus; the companies said they expect to start clinical trials for the vaccine in the second half of 2020 and the vaccine could be available in the second half of 2021.
Why Vaccine Development Takes Time
Although the scientific community is making rapid progress, U.S. regulations require manufacturers to submit to the FDA’s New Drug Application
(NDA) process or Biologics License Application (BLA) process, as appropriate, to determine safety and effectiveness through clinical trials. These approval pathways generally require ongoing communication with the U.S. Food and Drug Administration (FDA) through multiple research phases of discovery while maintaining Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) as well as performing pre-clinical assessments, conducting clinical or human testing and following updated guidance
from the Agency during the pandemic. Also, before giving any medical product to human subjects, a manufacturer must obtain an Investigational New Drug (IND) designation from the FDA and verification from the Institutional Review Board (IRB) of the center where the clinical study is conducted.
Challenges Moving Forward
Ultimately, before moving forward, researchers must understand the pathogen, align safety parameters and tests, maintain compliance with the HIPAA Privacy Rule
, protect human subjects, and accurately design experiments in a short period for the novel virus. It is equally challenging to find suitable human volunteers because testing must become widely available to identify them and scientists must be able to properly measure a subject’s response to therapy, including any side effects.
How Frier Levitt Can Help
Our life sciences attorneys have in-depth industry knowledge and have served as in-house counsel with pharmaceutical companies and health systems. Frier Levitt’s COVID-19 response team is tracking developments in real time for its clients and colleagues. Contact Frier Levitt
if you have questions about drafting and negotiating clinical trial-related agreements, informed consents and collaboration agreements as well as maintaining compliance with GCP and GLP.