Also in the plan are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential.
The “full-scale, wartime” plans have considerable relevance for the pharmaceutical and medical device industries. (More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.)
While the plan stands out from the prior administration’s COVID-19 response in its detail and earnestness, several portions effectively represent a continuation of existing policy. The policy, for instance, says it will end the U.S. government’s practice of stockpiling COVID-19 vaccines to ensure patients received a second dose, but the prior administration had already ended that policy in December. The proposals also aim to include the Department of Defense in COVID-19 vaccine logistics, which was already the case. The plan also calls for mounting “a safe, effective, comprehensive vaccination campaign,” which has been a longstanding FDA goal.
There are also plenty of new proposals in the strategy document.
Here are some of the foundational elements of the plan:
1. Ramp up the pace of COVID-19 vaccination
Biden has promised to deliver 100 million vaccine doses in his first 100 days in office and to improve communication with teams administering vaccines.
The president has vowed to make extensive use of the Defense Production Act to bolster vaccination efforts. The plan will confront bottlenecks in vaccine production and supply chain. The former goal will optimize supplies of raw materials needed to make vaccines, including biological materials such as lipid nanoparticles needed for mRNA vaccines.
The federal government will also continue to stockpile vaccine-related supplies such as syringes, glass vias, alcohol swabs and PPE needed to administer the vaccines. It will optimize supplies after conducting an “immediate end-to-end inventory.”
The administration has promised to offer manufacturers and contract manufacturers “ongoing technical assistance” to optimize vaccine production.
The plan calls for the Department of Defense to offer “logistical expertise” and the Federal Emergency Management Agency and other government agencies to work with state and local governments to administer vaccines in hard-hit regions.
The administration will continue working with vaccine manufacturers to get more doses while supporting the manufacturing and logistical challenges.
In addition, the plan will increase federal government involvement in vaccination programs, including monitoring progress, increasing the number of vaccinators and “working hand-in-hand with states, immunization managers and localities to support their efforts.”
The federal government also proposes prioritizing serving high-risk individuals such as the elderly, underserved communities and patients with chronic conditions. The plan would also prioritize vaccinating at-risk populations such as the military, teachers, school staff and childcare workers in addition to prison staff and inmates. Once more data are available, giving vaccines to children will be another priority.
The Department of Health and Human Services (HHS) will also offer advice on redistributing unused vaccines within states to ensure they don’t go to waste.
2. Increase the number of vaccination sites
Related to the above goal, the plan will increase the number of vaccination sites to encompass storefronts, churches, grocery stores, pharmacies, stadiums and conference centers in addition to medical facilities. To improve vaccination in rural areas, the government will work with manufacturers to develop new vaccine packaging and shipment strategies to minimize lot sizes. The program will also use mobile vaccination clinics and support rural healthcare providers.
3. Educate the public about vaccines
A public education campaign will identify and address core causes of COVID-19 vaccine hesitancy and build public trust in a vaccine “with a focus on people who may be vaccine-hesitant, including rural populations and communities of color.”
One part of the program will be a National COVID-19 Vaccination Ambassadors program, which will highlight positive stories from individuals who have received the vaccine.
The campaign would also explain logistical details of how the public can get vaccinated.
4. Keep an eye on vaccination costs
Biden’s plan would ensure that vaccines are free for the public while also working to defray costs that providers, state and local governments incur in the mass-vaccination program. The initiative would also reimburse the cost associated with the state deployment of the National Guard.
5. Ensure vaccine safety and efficacy
FDA prides itself on promoting safe and effective drugs for more than a century. This point thus represents more of an evolution of existing policy. In particular, the “National Strategy for the COVID-19 Response and Pandemic Preparedness” plan vows to continue FDA’s involvement in monitoring COVID-19 vaccine safety and efficacy and its prioritization of authorizing additional safe and effective COVID-19 vaccines and therapies.
The federal government will continue to explore “dose-sparing strategies” — making use of, for instance, unexpected dose volumes in vials or giving patients reduced dose volumes if that strategy proves to be effective and ultimately supported by FDA. (To date, FDA has resisted the idea, but the NIH is working with Moderna (NSDQ:MRNA) to determine whether the mRNA they jointly developed is effective in half doses.)
The plan also calls for creating vaccines that are “universal or broadly acting,” i.e., effective against emerging COVID-19 variants.
The initiative also seeks to spur the development of modern vaccine manufacturing facilities while accelerating next-generation vaccine development.
6. Improve ability to monitor emerging SARS-CoV-2 variants
NIH, FDA and BARDA will focus on emerging viral strains and gauge their impact on vaccine effectiveness. If needed, they will work with pharmaceutical companies to alter vaccines to stamp out emerging strains, which could threaten to diminish the efficacy of existing vaccines.
To date, countries such as the U.K. have used genomic sequencing more aggressively to monitor SARS-CoV-2 mutations than the U.S.
7. Support the development of COVID-19 therapeutics
The federal government aims to support the development of novel COVID-19 therapeutics. It seeks to “establish a comprehensive, integrated, and coordinated preclinical drug discovery and development program, with diverse clinical trials, to allow therapeutics to be evaluated and developed rapidly in response to COVID-19 and other pandemic threats.”
Examples of such therapies include new antivirals effective against the coronavirus family. Coronaviruses are also responsible for severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). The family also includes viruses such as 229E, NL63, OC43 and HKU1 linked with the common cold.
In particular, the plan calls for developing preclinical tools needed to create new antivirals and COVID-19 therapeutics. For the latter, the federal government will support assay development for drug targets, support high-throughput screening of relevant FDA-approved drugs. The federal government also pledged to help conduct in vitro and in vivo testing, pharmacokinetics, and toxicology testing while offering Investigational New Drug application support to the FDA and support for early-stage clinical trials.
More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.