Biden Vaccination Plan Would Grow Domestic Manufacturing Base
Executive Summary
Proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.
President-Elect Joe Biden included an expansion of domestic manufacturing in his proposal to deal with the coronavirus pandemic and ramp up US vaccination efforts.
Dubbed the American Rescue Plan, the $1.9tn proposal would create a national vaccination program, increase testing and provide additional economic relief and stimulus. It includes $10bn to create more US capacity to produce pandemic supplies, which would prevent or avert shortages of glass vials, gloves, masks and other equipment.
Biden also has committed to using the Defense Production Act and ensure more supplies are made in the US. Another $30bn would go toward the Disaster Relief Fund to ensure sufficient protective gear and other supplies are available.
In a 14 January address, Biden called the vaccination effort one of the most challenging operational efforts ever undertaken by the US. He is expected to further outline the plan during a 15 January speech.
The $20bn national vaccination program would include creating community vaccination centers nationwide and deploying mobile vaccination units for hard-to-reach areas. Testing and lab capacity expansion would get another $50bn.
In addition, Congress will be asked to expand the Federal Medicaid Assistance Percentage for administration of the coronavirus vaccine to 100% to ensure everyone can receive it free of charge.
Interestingly, Biden’s plans for more domestic manufacturing reflect ideas of his predecessor in the White House. President Trump throughout his term pushed for increased domestic manufacturing capacity of drugs and other products in his annual budget requests.
Trump called for establishment of an Outsourcing Center of Excellence and wanted money for the US Food and Drug Administration to ensure regulatory pathways were more efficient for advanced manufacturing technologies. (Also see "US FDA Budget Boost Would Increase Domestic Drug Manufacturing By Better Regulating New Technologies" - Pink Sheet, 28 Mar, 2019.)
The FDA also funded a new lab in the Center for Drug Evaluation and Research that will house a pilot plant to simulate and test advanced manufacturing techniques and support research. (Also see "New CDER Lab Will Help Push Advanced Manufacturing Adoption" - Pink Sheet, 3 Mar, 2020.)
The domestic manufacturing effort grew in importance when the pandemic emerged, as supplies of critical drugs and equipment quickly ran short. (Also see "COVID-19 Funds Flow To Startup In Bid To Restore US Pharmaceutical Manufacturing" - Pink Sheet, 20 May, 2020.)
Moncef Slaoui, the outgoing chief scientific advisor at Operation Warp Speed, also has called for the US to establish a permanent dedicated vaccine manufacturing facility to prepare for future pandemics. (See sidebar.)
Third Vaccine Not Needed To Meet 100 Million Shots Goal, Officials Say
Biden has set a goal of administering 100 million vaccine shots in his first 100 days in office. A senior Biden Administration official said that the two vaccines already available, from Pfizer Inc./BioNTech SE and Moderna, Inc., constitute enough supply to meet that goal, although they hope more products become available soon.
The Biden vaccination program includes making more doses available for use and holding less product in reserve if there is a shortage or manufacturing problem. (Also see "Biden Wants To Release More COVID-19 Vaccine, But Also Maintain Strategic Reserve" - Pink Sheet, 11 Jan, 2021.)
US officials announced on 12 January that all reserve vaccine now would be available for allocation, in part because of increased predictability of the manufacturing process. Manufacturing confidence increased because of “the successful use of the Defense Production Act priority ratings, reports from our military logisticians embedded within the companies, and the consistent demonstration that vaccine is moving predictably through all the stages of production and distribution,” HHS said.
HHS officials also recommended that states expand their vaccine eligibility requirements to include everyone age 65 and older as well as those younger than 65 with qualifying co-morbidities. (Also see "Adolescent Recruitment For COVID-19 Vaccine Trials Is Worry For Operation Warp Speed" - Pink Sheet, 12 Jan, 2021.)
Janssen Pharmaceutical Cos.’s vaccine, which requires only one shot, is expected to be the next vaccine made available. The company could request an emergency use authorization from the FDA before the end of January. (Also see "Adolescent Recruitment For COVID-19 Vaccine Trials Is Worry For Operation Warp Speed" - Pink Sheet, 12 Jan, 2021.)
More Funding For COVID-19 Treatments, Trials
Biden’s proposal also calls for additional investment in coronavirus treatments to support development and manufacturing as well as studies of the long-term impacts of the disease and potential therapies to address them. No amount was given.
The proposal also includes funding to increase US genomic sequencing, surveillance and outbreak analytics capacity to expand tracking of coronavirus outbreaks and variants. In addition, Biden wants to create a 100,000-person public health corps for vaccine outreach and contact tracing.
The FDA would seem poised to receive a portion of the funding in the Biden proposal, given the agency's role supporting treatment and vaccine assessment and approval. The agency received $80m in the March 2020 package (Also see "Inside The COVID-19 Bill: Breaking Down The Pharma Policy Provisions" - Pink Sheet, 26 Mar, 2020.), as well as another $55m for pandemic purposes in the fiscal year 2021 appropriations legislation, including dedicated funding for advanced manufacturing. (Also see "FY 2021 Appropriations Provides FDA Healthy Boost – Plus More COVID-19 Funds" - Pink Sheet, 22 Dec, 2020.)
The American Rescue Plan will be followed in February by an economic recovery plan, according to senior Biden Administration officials. Whether Congress will approve either or both plans is unclear, but seems possible with Democrats controlling both houses of Congress. (Also see "With US Senate Wins In Georgia, Democrats Gain Path For Rx Price Reform, But It May Be Lower Priority" - Pink Sheet, 6 Jan, 2021.)