A recent Government Accountability Office report examines Operation Warp Speed’s (OWS) performance in vaccine development and manufacturing. The Departments of Health and Human Services (HHS) and Defense (DOD) had awarded $13 billion in contracts and flexible, project specific agreements to six vaccine companies by the end of 2020. The report analyses how they were selected, how regulatory easing supported them, and the challenges they face in scaling up manufacturing.
OWS considered candidates’ potential safety and efficacy, testing timetable, and manufacturing capacity. Manufacturing capacity analysis relied on the vaccine platform, the demonstrated technologies producing biomolecules to elicit immune response. As different platforms contain distinct risk factors, three were included in the six chosen candidates. Pfizer and Moderna’s vaccines, the two given emergency use authorization by the FDA in December, both use the mRNA platform. The remarkable story of its development demonstrates the unique nature of pharmaceutical R&D. All three platforms selected, “unlike other vaccine platforms, do not require researchers to grow the SARS-CoV-2 virus, which has sped the time of development and avoided safety concerns associated with using a disease-causing virus.”
A June FDA guidance document advised companies to utilize knowledge from platforms’ use with similar vaccines, a move all companies agreed sped development. The FDA also permitted multiple stages of testing to occur simultaneously saving months of data review and FDA consulting.
Even as the firms ramped up manufacturing capacity before FDA approval with federal financial support, nearly all existing capacity was in use pre-pandemic, so expansion required facility creation or conversion. Supply chain disruptions, including export controls implemented by some countries due to suddenly increased demand, have made access to key materials difficult. An interview with facility representatives revealed that hiring management level employees has also been a challenge for scaling up manufacturing.
The Department of Defense has worked to alleviate all three of these issues. BARDA helped identify manufacturing partners and the Army Corps of Engineers is expanding the capacity of existing facilities. After determining supply chain risks, contracts with producers of those products were prioritized under the Defense Production Act. DOD personnel also temporarily staffed vacant positions.
The vaccine development process was historically swift, but manufacturing expansion remains a key impediment to pandemic recovery in the U.S. and abroad. The efficacy of Operation Warp Speed’s public-private partnership will continue to affect a host of pandemic related challenges.