GAO: Vaccine Developers Face Challenges in Scaling Up Manufacturing

A Government Accountability Office (GAO) review of COVID-19 vaccine development efforts found that vaccine producers are facing significant manufacturing hurdles as they scale up operations.

As of Jan. 31, Pfizer/BioNTech and Moderna had released 63.7 million doses to the federal government, about a third of the 200 million shots they are contracted to provide by March 31, the watchdog’s analysis found.

The companies have said that they are on track to meet their end-of-March goals, and Pfizer recently said that it has ramped up its production speed to deliver its entire 200 million-dose order by the end of May (DID, Feb. 9).

But the report details hurdles vaccine makers are encountering. For instance, there is a shortage of facilities capable of handling the grueling manufacturing demands for COVID-19 vaccines. The federal government has worked with companies to address this issue and expand production capacity.

In one example, HHS’ Biomedical Advanced Research and Development Authority assisted a company in finding an additional manufacturing partner to increase production, and the U.S. Army Corps of Engineers is currently supervising construction products to expand capacity at vaccine manufacturing sites, GAO found.

Supply-chain disruptions were also identified as challenges that companies and the U.S. government are working to mitigate. One facility making COVID-19 vaccines found it hard to obtain materials, including reagents and certain chemicals, and waited four to 12 weeks for items that were normally available for shipment within a single week prior to the pandemic.

Several steps have been taken to address the supply-chain issue, GAO said, including federal assistance to accelerate procurement and delivery of essential manufacturing equipment, and the development of a list of important supplies needed for the vaccines in the government’s Operation Warp Speed initiative. As of December 2020, the Department of Defense (DOD) and HHS had prioritized 18 supply contracts for vaccine companies under the Defense Production Act, according to the report.

In addition, vaccine makers have been impeded by the need to hire and train personnel with the specialized skills needed to conduct vaccine manufacturing operations. GAO found that Operation Warp Speed officials have worked with the Department of State to expedite visa approvals for critical technical personnel, including technicians and engineers who help install, test and certify critical equipment made abroad. The government also detailed 16 DOD personnel to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire their own staff.

Read the full GAO report here: www.fdanews.com/02-11-21-GAOReportCOVIDVaccines.pdf. — James Miessler