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The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.
One day after his inauguration, President Joe Biden unveiled a lengthy program for combatting COVID-19 by ramping up distribution and inoculation of millions of Americans over the next three months. This comprehensive pandemic response began with the President signing a packet of executive orders that expand COVID-19 testing and required mask-wearing on federal property and in public transportation and makes wider use of the Defense Production Act (DPA) to reduce shortages of supplies such as protective equipment, lab equipment, and vaccine production and delivery materials.
The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership, as outlined in a summary statement from the White House. A 200-page document provides more details for implementing specific initiatives, many important to biopharmaceutical manufacturers.
More specifically, the Goal 2 strategy for ensuring access to safe and effective vaccines outlines ways to simplify allocation and distribution of preventives to states and localities across the country, acknowledging that rapid vaccination of millions of Americans requires access to a reliable supply of authorized vaccines. States will continue to play key roles in vaccine allocation and distribution, but the Biden plan also increased federal support for both state and national vaccination operations and for improved collection of data on vaccine distribution and inoculation. A stated change is to distribute most vaccine supplies as they are made, and not to withhold quantities for second doses.
The Biden plan also aims to fill gaps in supplies needed for manufacturing and production, such as biological materials and packaging and dispensing equipment. There’s support for expanding lipid nanoparticle formulation capacity to scale mRNA vaccine production and for the Biomedical Advanced Research and Development Authority (BARDA) to provide ongoing technical assistance and monitoring of contracted vaccine manufacturing facilities. The government will explore dose-sparing strategies that can potentially expand vaccine supply and will work with manufacturers to devise new packaging methods that can reduce minimum shipment sizes in order to reach rural and underserved communities more effectively.
An interesting wrinkle on the vaccine supply situation is whether Pfizer can count its vials as containing five or six doses. If the higher number is valid, than the company can meet its commitment of providing 200 million doses much sooner than July. FDA agreed in early January to update the vaccine’s fact sheet to confirm to clinicians that the vials contain a sixth dose. That change, however, puts pressure on pharmacies and clinics to extract that sixth dose, and that requires using special low dead volume syringes, which have been in short supply. Some vaccine clinics now find that Pfizer is shipping fewer vials, based on the expectation of more shots per vial, but are unable to access the extra vaccine.
Recent press reports indicate that Pfizer has agreed to allow the government to track vaccine shipments accompanied by the special syringes to better calculate the number of doses provided and their cost. At the same time, the Biden executive order authorizing greater use of the DPA to ensure sufficient production of supplies needed for vaccine distribution, such as packaging, glass vials, stoppers, and syringes, also sets the stage for utilizing this authority to obtain more dose-saving syringes able to extract six doses from the vials for the Pfizer-BioNTech vaccine.
One of the initial executive orders signed by Biden calls for issuing a high-level plan for developing and testing promising COVID-19 treatments. The President calls for the secretary of Health and Human Services (HHS) and the director of the National Institutes of Health (NIH) to devise a plan supporting large-scale randomized trials and other studies able to identify promising treatments that can be “easily manufactured, distributed, and administered, both domestically and internationally.” In emphasizing the need for randomized trials, the provision highlights the administration’s emphasis on relying on science in medical decisions, as opposed to the promotion of untested products by the Trump administration.
To limit contamination from the coronavirus, Goal 3 of the National Strategy, which seeks to mitigate spread through expanded masking and testing and an increased medical workforce, also supports accelerated research and clinical development of new treatments. Starting with a comprehensive preclinical drug discovery and development program of treatments that can be readily scaled and administered, it also calls for diverse clinical trials to ensure that new therapies address the needs of communities of color, children, pregnant women, and high-risk populations. And it aims to improve access to more affordable, high-quality treatments by preventing shortages through investment in advanced biopharmaceutical manufacturing, advanced purchase agreements, and strengthened surveillance systems.
The comprehensive vaccination campaign also supports ongoing vaccine R&D as a way to bolster vaccine access. Important goals are for the government to fund research and testing of vaccines for adolescents and children and the development of formulations that may be easier to deliver and administer. To assess whether current vaccines remain effective against new viral strains, NIH, FDA and BARDA will evaluate the need to alter current vaccines. FDA is cited as key to authorizing effective vaccines for rapid delivery, for assessing emerging viral mutations, and for establishing recommendations for dosing and expanding vaccine supply.
These initiatives, moreover, look to support drug discovery and development programs to combat future pandemic threats, as well as the current virus. This larger program will develop broad-spectrum antivirals to protect against the coronavirus family, which includes SARS, MERS, as well as COVID-19. There’s an emphasis on developing basic preclinical tools for vaccine testing, including assays, high throughput screening of existing and novel chemicals, in vitro and in vivo testing, and pharmacokinetics. And it will advance chemistry, manufacturing, and controls and regulatory efforts to support early phase clinical trials.