Accelerated COVID19 Vaccine Development Status and Efforts to Address Manufacturing Challenges
https://www.gao.gov/assets/gao-21-319.pdfWhat GAO Found
Operation Warp Speed (OWS)—a partnership between the Departments of
Health and Human Services (HHS) and Defense (DOD)—aimed to help
accelerate the development of a COVID-19 vaccine. GAO found that OWS and
vaccine companies adopted several strategies to accelerate vaccine
development and mitigate risk. For example, OWS selected vaccine candidates
that use different mechanisms to stimulate an immune response (i.e., platform
technologies; see figure). Vaccine companies also took steps, such as starting
large-scale manufacturing during clinical trials and combining clinical trial phases
or running them concurrently. Clinical trials gather data on safety and efficacy,
with more participants in each successive phase (e.g., phase 3 has more
participants than phase 2).
...
Manufacturing. As of January 2021, five of the six OWS vaccine companies had
started commercial scale manufacturing. ... Vaccine companies face a
number of challenges in scaling up manufacturing to produce hundreds of
millions of doses under OWS’s accelerated timelines. DOD and HHS are working
with vaccine companies to help mitigate manufacturing challenges, including:
• Limited manufacturing capacity: A shortage of facilities with capacity to
handle the vaccine manufacturing needs can lead to production bottlenecks.
Vaccine companies are working in partnership with OWS to expand
production capacity. ...
• Disruptions to manufacturing supply chains: Vaccine manufacturing supply
chains have been strained by the global demand for certain goods and
workforce disruptions caused by the global pandemic. ... Vaccine companies and DOD and HHS officials
told GAO they have undertaken several efforts to address possible
manufacturing disruptions and mitigate supply chain challenges. These
efforts include federal assistance to (1) expedite procurement and delivery of
critical manufacturing equipment, (2) develop a list of critical supplies that are
common across the six OWS vaccine candidates, and (3) expedite the
delivery of necessary equipment and goods coming into the United States.
Additionally, DOD and HHS officials said that as of December 2020 they had
placed prioritized ratings on 18 supply contracts for vaccine companies under
the Defense Production Act...
• Gaps in the available workforce: Hiring and training personnel with the
specialized skills needed to run vaccine manufacturing processes can be
challenging. OWS officials stated that 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. OWS officials also stated that
they requested that 16 DOD personnel be detailed to serve as quality control
staff at two vaccine manufacturing sites until the organizations can hire the
required personnel.
...
OWS’s strategy for rapid vaccine development was to build a diverse
portfolio of vaccine candidates based on distinct platform technologies. ...
OWS’s strategy included selecting different platform technologies to
mitigate the risk that any one platform or specific vaccine candidate could
fail because of problems with safety, efficacy, industrial manufacturability,
or scheduling factors. ...
1. Based on what I could see from news stories and news releases from companies and a few government agencies, I've been saying for some time that OWS evidenced careful planning - multiple vaccines, multiple technologies, assistance in production capacity, contracting for miscellanies and distribution. This GAO confirms what I inferred.
(Sound of PeteS patting self on back)2. Hil
LIARy or
LIEden could not imagine trying what Trump accomplished.
3. Hil
LIARy or
LIEden would have had such antagonistic relations with pharmaceuticals companies and other necessary businesses that the degree of cooperation and trust that Trump's OWS worked out would have been unachievable. Nor would use of the DPA as a whip been as effective.
