Sasha Latypova

Vaccine and therapeutic manufacturers have benefited greatly during this pandemic operating under near complete immunity from any liability under the Public Readiness and Emergency Preparedness (PREP) Act. Pfizer and Moderna generated historic revenues in just a couple years as the federal government mandated use of their novel mRNA-based vaccine products. Yet how can we be certain the consumer is protected from the rapidly developed medical products known as “Countermeasures” during these emergency conditions? The answer to a great extent: Strict adherence to Current Good Clinical Manufacturing Practices (cGMP). Compliance with cGMP is a Requirement of DOD/BARDA/HHS Contracts for the procurement of Covid-19 Vaccines and therapeutics: Compliance with current Good Manufacturing Practices was, and remains a condition of the DOD/BARDA/HHS contracts awarded to the Covid-19 vaccine manufacturers, including Pfizer, Moderna, Emergent BioSolutions, Janssen (J&J), AstraZeneca, Merck, Sanofi, Protein Sciences, Novavax, GlaxoSmithKline, ICON (as a clinical research organization), Inovio, Ology Bioservices, Texas A&M and many others. Numerous references to compliance with cGMP are included throughout the government COVID-19 vaccine procurement contracts establishing the responsibilities. But what if despite heretfore unheard of publically-funded revenues to the vaccine producers—coupled with near universal liability protection– based on 100% adherence to cGMP–the vaccine production value chain continues to exhibit disturbing examples of deviation from cGMPs? Wouldn’t this represent a gross breach of contractual terms. What’s the associated accountability?  What are the implications for the state health agencies that import these products for distribution and administration to their populations?