GAO: COVID-19 vaccine production falls short of January 2021 goal

Regulatory NewsRegulatory News | 15 February 2021 |  By 

The Operation Warp Speed (OWS) goal to produce 300 million COVID-19 vaccine doses by January 2021 was not met, according to a status report released by the US Government Accountability Office (GAO).
Companies with current emergency use authorizations (EUAs) for vaccines are contracted under the program to release a combined 200 million doses of their vaccines by the end of March 2021 but had released just 63.7 million doses (31.8%) as of 31 January 2021, the report notes.
To date, vaccines produced by Pfizer/BioNTech and Moderna have been issued EUAs by the US Food and Drug Administration (FDA). Vaccines produced by AstraZeneca (AZD1222), Janssen (Ad.26.CoV2.S), and Novavax (NVX-CoV2373) are currently in Phase 3 trials. A vaccine being jointly developed by Sanofi and GSK is currently in Phase 1/2 trials.
Of the six vaccine candidates selected by OWS, all but one – the Sanofi-GSK vaccine – had begun large-scale manufacturing as of January 2021.
The OWS program was created in May 2020 as a partnership between the Department of Defense (DOD) and Departments of Health and Human Services (HHS) to accelerate development of COVID-19 vaccines and therapeutics.
To accomplish the 300-million goal, the program supported development of vaccines with different mechanisms of action to minimize risk, while vaccine companies accelerated development by manufacturing vaccines while clinical trials were still underway and concurrently launching clinical trials.
The GAO report points to a range of issues contributing to the failure to meet the goal, including bottlenecks in manufacturing capacity, supply chain problems, and lack of an available workforce to manage the manufacturing process. It notes, however, that companies have been working with the OWS to increase production capacity, despite a shortage of facilities for manufacturing the vaccines. “For example, one vaccine company told GAO that HHS’s Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the US Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities,” the report says.
Manufacturing supply chains have also been disrupted as a result of the pandemic, with facilities experiencing a range of challenges, including difficulty acquiring reagents and chemicals, as well as shipping delays of weeks or months for materials that usually would be delivered in a much shorter period of time. To address those issues, GAO says DOD and HHS are helping shorten the acquisition and delivery times of “critical manufacturing equipment” to vaccine companies. DOD and HHS also note when critical supplies are needed for OWS vaccine candidates and have used the Defense Production Act to prioritize certain supply contracts for vaccine companies, according to the report.
The report also identifies challenges in hiring and training specialized personnel to manage vaccine manufacturing processes. “OWS officials stated they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas,” according to the report.  Officials at OWS said they have asked for 16 DOD personnel to serve as quality control staff at two of the vaccine manufacturing sites until the companies are able to hire the staff they need.
GAO provided technology readiness levels for each vaccine candidate, suggesting “COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations.” The vaccine companies told GAO that having shorter timelines was the main difference between operating in a pandemic versus non-pandemic environment.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy