Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Jill Wechsler

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

 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, 

 testing, and pharmacokinetics. And it will advance chemistry, manufacturing, and controls and regulatory efforts to support early phase clinical trials.

Articles

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.

Biden Pandemic Plan Highlights Vaccine Access and Therapeutic Development

Although there was much analysis and anticipation over the past year about the difficulties and challenges in distributing millions of doses of new vaccines across the nation, the process so far has been much less effective than anticipated. Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

While the Trump administration’s Operation Warp Speed (OWS) deserves kudos for supporting the accelerated development and production of safe and effective anti-COVID vaccines in record time, its plan for distributing and administering the preventives has been marred by political infighting and conflicting messages. State health officials have complained loudly of the lack of resources to support a massive new vaccination program and on limited information from Washington on the timing and size of anticipated vaccine distributions. The initial roll-out to health care workers and nursing home residents were tricky to schedule and arrange, and federal vaccine prioritization guidelines proved cumbersome. Many states are moving on to include more elderly populations, acknowledging that efforts to target certain groups such as nursing homes, teachers, and other front-line workers have been confusing and wasteful.

A main problem was the administration’s delay in authorizing the Centers for Disease Control and Prevention (CDC) to provide states with clear guidelines for updating existing local procedures for distributing vaccines that critical “last mile” to clinics and health centers, a challenge familiar to supply-chain experts. Uncertainty about vaccine shipments and supplies, at a time when hospitals were dealing with surges in COVID-19 infections and deaths, prompted medical centers to cancel in-house vaccination activities. And there still is confusion about whether clinics should hold back supplies for second doses or administer all on hand.

Although vaccine manufacturing has been ramping up, and supply has not been blamed for current distribution failures, there remains concern about unanticipated production problems. In November 2020, Pfizer rattled OWS by disclosing that it would provide only 50 million doses in 2020, instead of the 100 million doses initially expected. And just last week, Pfizer announced plans to reduce vaccine supplies in Europe as it moved to renovate production processes at its Belgium facility. At one point in December, Moderna had to discard 400,000 vaccine doses due a filtration issue during production, although the company maintained that it would still produce its promised doses. Pfizer agreed recently to increase vaccine deliveries in the United States by another 100 million doses in 2021, but that is linked to access to certain supplies and raw materials needed for production. There is great hope that Johnson & Johnson will gain emergency authorization soon for its one-shot COVID vaccine, which would greatly bolster supplies of a product much easier to deliver, store, and administer.

Meanwhile, research is underway on strategies for extending the current vaccine supply. These include studies on whether smaller or less frequent doses of the Moderna vaccine provide sufficient protection. There’s a search for a certain kind of syringe that is able to extract an additional sixth dose from Pfizer five-dose vials. There also has been talk of delaying or dropping the second doses for current vaccines, but FDA officials oppose such an untested move.

Congress finally approved a $900 billion relief package in late December, which provides an additional $8 billion for state vaccine distribution and administration, and that is now beginning to trickle down to local operations. However, efforts by the Biden transition team to form a new vaccine distribution program were hampered by limited communication and information sharing by the Trump administration and OWS. In fact, current vaccine policy was further confused by the recent announcement by Health and Human Services (HHS) secretary Alex Azar that OWS would ship to states thousands of vaccine doses held in warehouses to provide second shots for patients, only to learn that there was little supply on hold to do this.

Meanwhile, President-elect Joe Biden released a

new initiative for ramping up vaccine distributio

n to meet the goal of administering 100 million doses to Americans in the next 100 days. The plan calls for mobilizing the National Guard and the Federal Emergency Management Agency to establish federal vaccination centers, while also working with pharmacies, community health centers, and mobile vaccination clinics to reach broader populations. There’s a promise of more support and resources for states and plans to ensure that all entities know well in advance and understand vaccine allocations and timing of deliveries, including an assurance of second-dose availability, in keeping with current FDA recommendations.

The plan acknowledges the need for added access to critical vaccine components, such as vials, syringes, stoppers, and needles, and may leverage the Defense Production Act to fill any gaps. And there’s support for boosting vaccine finish/fill and packaging operations, as well as for augmenting required cold chain systems needed for effective vaccine distribution and storage. The new administration furthermore backs efforts to “maximize the manufacture of vaccine,” but is vague on how to do this.

In looking to put a new stamp on its federal vaccine initiative, Biden named former FDA commissioner David Kessler to replace OWS leader Moncef Slaoui in directing continued development and production of vaccines and therapies to combat the pandemic. Kessler is best known for expanding FDA regulation of tobacco, establishing FDA user fees, and revising regulatory policies in the face of the AIDS epidemic. There is concern that he has little experience in vaccine research or distribution and has been away from federal health policy for the past 20 years. But now he will be key to the success of the new administration’s promise to vaccinate 1 million people a day to gain control of the pandemic and restore the nation’s health and economic well-being.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far. 

Vaccine Rollout Even Worse than Expected

As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA. One new requirement could revise oversight and review for prescription drugs and certain medical devices. This follows adoption of a broader new rule to “sunset” many established regulations and programs in the Department of Health and Human Services (HHS) unless they can justify their continuation. And in another area, the administration has tried to push through a new plan blocking FDA oversight of genetically modified animals despite strong objections from agency leaders.

The task of dealing with these issues may fall to Janet Woodcock, who appears poised to serve as Acting FDA Commissioner until the Biden administration selects and gains confirmation of a new leader for the agency. Woodcock was recently named medical advisor to Commissioner Stephen Hahn and has been director of the Center for Drug Evaluation and Research (CDER) for many years but was detailed to head up development of anti-COVID-19 therapeutics under Operation Warp Speed.

A sign of FDA’s difficult position is the recent White House move to block Hahn from selecting a replacement for departing Chief Counsel Stacy Cline Amin. Just as the commissioner named experienced attorney Mark Raza to fill the job during the administration’s final days, HHS announced that political appointee James Lawrence would become FDA’s chief counsel, where he could continue the administration’s deregulatory campaign.

A late surprise from the Trump administration is the plan for FDA to publish new information on drug approval timelines and to explain and justify when reviews exceed 180 days. Touted as a “transparency” measure, the new policy instructs FDA to provide data on each approved application for new drugs and generics stating dates filed and approved and number of days over the statutory 180-day timeframe. CDER currently has user fee review goals of 10-months for most new drugs and generics and six months for priority therapies, but change would require the agency to collect and report data on review time frames using different metrics. The larger fear is that this policy could lead to more onerous requirements; at a minimum it’s seen as a meaningless distraction at a time when all hands are overloaded with initiatives to address the pandemic.

A related HHS policy would waive FDA premarket review for certain medical devices. This extends the current review exemption under the COVID-19 health emergency for items such as gloves, personal protective equipment, ventilators, and infusion pumps. Not a critical change, but it is regarded as another challenge to FDA internal policy making.

In addition, the battle over FDA authority to regulate laboratory developed tests (LDTs) continues to create problems. A contentious issue for several years, HHS revoked FDA’s authority over such tests in August in response to pressure from private labs for reduced regulation. However, in November, HHS reinstated FDA’s authority to issue Emergency Use Authorizations (EUAs) for lab tests in order to provide companies with liability protection for erroneous results during the pandemic. By then, however, FDA staff claimed a lack of resources to handle this activity, prompting a shift to outsourcing the EUA reviews.

The most contentious challenge to FDA’s authority, though, involves a late move by the Trump administration to shift oversight of genetically modified animals to the Department of Agriculture, a move backed by industry working in this area. Commissioner Hahn evidently refused to sign an HHS memorandum of understanding authorizing the change, claiming that it required further analysis of the legal and health repercussions.

On another front, FDA staff has had to accept administration efforts to limit utilization of prescription drugs to induce an abortion. In March 2020, FDA was able to relax in-person dispensing requirements for many drugs, including certain controlled substances to reduce the risk of spreading COVID-19. However, the Trump administration left in place the specific rule requiring women to make in-person visits to a clinic or doctor’s office to obtain mifepristone, one of two drugs required for a medication abortion. Even though a US District Court judge suspended the in-person pick-up rule during the health emergency, the administration continued to fight for its reinstatement and recently gained a ruling to that effect from the Supreme Court.

Many of these recently issued regulations and policies can be rescinded or dropped by the Biden administration under established transition practices. However, these efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency, separate from HHS.

As he prepared to exit the agency amidst all the political infighting, Commissioner Hahn joined with Anand Shah, deputy commissioner for medical and scientific affairs, in issuing a 

report outlining FDA’s important achievements 

in combatting the “devastation and turmoil” wrecked by the COVID-19 pandemic. The report highlights the agency’s accomplishments and offers recommendations for continuing to address the still-evolving public health emergency. To improve FDA’s emergency response and ability to sustain innovation, it calls for strengthening the EUA process, government partnerships, innovation in clinical trial conduct, and supply chain surveillance, among many other strategies. Hahn and Shah emphasize that FDA decisions are based on rigorous science and aim to protect and promote the health and safety of American patients.

As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA. 

FDA Struggles to Fend Off Further Attacks from Trump Administration

The process for vetting and authorizing important new therapies by the Center for Drug Evaluation and Research (CDER) remained strong and productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies. CDER’s final count was 53 new molecular entities approved for market [see 

], plus another five new biologics from the Center for Biologics Evaluation and Research (CBER) [see 

2020 Biological License Application Approvals | FDA

]. And that doesn’t include important vaccines and drugs that received Emergency Use Authorizations (EUAs) from the agency to combat the pandemic.

The final tally for drugs falls short of the record number of 59 new drugs approved in 2018 but surpasses last year’s total of 48 new drugs. Approval numbers vary, as some analysts don’t count certain imaging agents or may add cellular therapies to the drugs list, and some new biologics are not considered therapies. Gilead Sciences, Roche, Eli Lilly, and Bristol Myers Squibb all won notable new drug approvals, while a number of small newcomers entered the market. Cancer therapies led the tally, with 18 new therapies to treat lung cancer, breast cancer, multiple myeloma, and other conditions. There were eight new therapies for rare conditions, and several for infectious diseases such as Ebola, malaria, Chagas disease, HIV and, certainly, COVID-19.

Analysts question whether the new drug approval rate will continue this year, with most inspections of manufacturing facilities and clinical sites still on hold and FDA issuing more complete response letters (CRLs) announcing delays in vetting new drugs for market. The continued rise in infections from COVID-19, moreover, will further strain agency resources as review staff is diverted to analyze submissions for new vaccines and therapies to counter the pandemic.

The agency also will experience important changes in leadership under the Biden administration, which often leads to policy changes and puts certain initiatives on hold. FDA recently announced that Janet Woodcock has become a principal medical adviser to Commissioner Stephen Hahn. Last year, Woodcock stepped away from her long-held role as CDER director to head up the program for vetting therapeutics under the administration’s Operation Warp Speed. Now she also will work with Anand Shah, FDA deputy commissioner for medical and scientific affairs, to expand FDA’s COVID-19 Pandemic Recovery Preparedness Plan (PREPP). CDER Deputy Director Patrizia Cavazzoni continues to serve as the Center’s acting director, while Woodcock remains recused from participating in regulatory decisions related to new therapeutics.

The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

Despite Pandemic, FDA Ramps Up New Drug Approvals

The new year began with a continued surge in illness and deaths due to COVID-19, along with high hopes for combating the virus with effective vaccines and therapies. Strong efficacy data and reassuring safety reports indicate that new vaccines can prevent disease, while also shifting the focus to the monumental difficulties involved in producing, packaging, shipping, and administering millions of doses as quickly and effectively as possible. The ability of biopharmaceutical manufacturers to develop and test a whole new type of vaccine in less than a year reflects the scientific and technological strength of the industry and biomedical research community, plus the critical financial and regulatory support from governments and international organizations.

Public health officials, however, face significant challenges in effectively delivering vaccines that require two doses and ultra-cold shipping and storage. The new preventives will go first to healthcare workers and to nursing homes; many populations will have to wait for more accessible products still in the pipeline. Meanwhile, state and local health departments need additional federal support for identifying priority vaccine recipients, delivering appropriate doses safely, and tracking these operations effectively.

With limited access to COVID-19 vaccines for months ahead, the research community will continue to test hundreds of new and existing therapies for potential in treating infected individuals. FDA has authorized emergency use for a few monoclonal antibodies and antivirals found slightly effective against the virus, and investigators are testing dozens of antimalarials, immunosuppressants, and other compounds. Production is proving to be a roadblock, however, as manufacturers face high hurdles in providing sufficiently large quantities of medicines to treat more than a fraction of widening infections.

FDA’s ability to assess and communicate appropriate use of new COVID-19 vaccines and therapies will be critical for the agency to regain public trust and confidence in the objectivity and expertise of its review process. In 2020, FDA became entangled in Trump administration efforts to speed new treatments to patients based on limited and often subjective information, prompting strong push-back from respected agency officials and furthering public mistrust regarding new vaccines. It is vital for new leadership to navigate carefully between promoting public access to potentially life-saving treatments and limiting expectations for unproven therapies.

In addition to dealing with COVID-19, FDA will continue efforts to move a broad range of promising new therapies to market through guidance development, accelerated approval initiatives, and efficient review and approval programs for innovator drugs, generic drugs, and biologics. FDA has seen a surge in R&D on new cellular and gene therapies, and more new biosimilars promise to facilitate access to important biotech therapies. In addition, FDA is negotiating new agreements with industry on updated user fee programs for drugs, biologics, generic drugs, and biosimilars, which need to be sent to Congress by the end of 2021 in order to be renewed by Oct. 1, 2022 when current programs expire.

The importance of reliable and flexible manufacturing processes for drugs and vaccines has gained more attention as the pandemic has brought to light global supply chain vulnerabilities. After years of prodding by FDA officials, more streamlined and responsive production methods for medical therapies may gain traction, along with strategies for better anticipating and resolving drug supply shortages. There is bipartisan support for boosting drug manufacturing in the United States, but agreement is needed on appropriate requirements and incentives.

FDA support for more streamlined clinical testing methods during the pandemic is expected to bring lasting changes to the clinical research process. Trial sponsors and investigators increasingly utilize digital health technologies to track data from remote testing sites, support virtual patient visits, and expand use of real-world evidence to identify trial participants and compare study responses to broader patient populations. While the randomized, placebo-based clinical trial will remain the gold standard for assuring product efficacy, standard protocols, common comparators, and outcomes assessments will gain wider acceptance. An important issue is how COVID-19 vaccine manufacturers gaining emergency authorization can continue placebo-based trials to gain at least a year of important safety data, and how early results will affect trials for additional vaccines.

FDA enforcement activities also face changes following a halt in most field inspections of drug manufacturing facilities due to the pandemic. Agency officials are under pressure to resume onsite inspections to better assess quality production issues needed to approve promising therapies for market. But there also will be greater reliance on alternative sources of information on the capabilities and regulatory standing of an operation.

The emergence of more COVID-19 therapies will continue to raise questions about pricing and access to vital treatments in the US and around the world. There is bipartisan support for a range of drug price control measures, including versions of the Trump administration’s reference pricing and rebate reform initiatives. Drug industry leaders insist that too-harsh price controls will limit the broad range of innovation and drug development that has been critical for combating the pandemic. There is general support for increased import of less costly drugs from Canada, but policies will remain difficult to implement due to safety concerns.

In addition to facilitating access to new drugs and vaccines, the new administration will need to address broader economic relief and public health measures as the pandemic continues. The Biden team has mapped out a broad health policy agenda that includes extension of Affordable Care Act (ACA) provisions for healthcare coverage, which may be shaped by an upcoming Supreme Court decision. Further expansion of Medicaid to low-income populations, reduction in health disparities, and lowering Medicare eligibility to age 60 as part of a public option coverage program are main goals, as well as rejoining the World Health Organization and other international public health and research programs. Pandemic control will remain the number-one challenge, while also setting the stage for broader review of healthcare coverage and access.

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.


Vol. 45, No. 1
January 2021
Pages: 14-15

When referring to this article, please cite it as J. Wechsler, "Pandemic Control to Shape Biopharma in 2021," 

The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.

Pandemic Control to Shape Biopharma in 2021

President Trump signed the critical year-end COVID-19 package on Dec. 27, 2020, appropriating $2.3 trillion to finance the federal government through September 2021 and providing critical support for individuals and entities suffering from the economic crisis wrought by the pandemic. The $900 billion 

 extend subsidies and unemployment benefits to millions, while also approving hundreds of less visible tax breaks and pet programs.

Important for pharma, the 5000-page measure furthermore authorizes $20 billion for the additional purchase of COVID-19 vaccines, $9 billion to support state and local vaccine distribution programs, and $22 billion more to help states bolster testing, contact tracing, and virus mitigation efforts. The complex measure also extends the pediatric priority review voucher program at FDA, which was about to expire, and it closes certain loopholes in the Orphan Drug Act. At the same time, the bill omits reforms designed to limit spending on prescription drugs, as well as changes in drug rebates paid to pharmacy benefit managers (PBMs) or revisions in patent “ever-greening” policies.

FDA may be affected also by a measure requiring in-person age verification for the purchase of e-cigarette and vaping products. And the legislation implements a policy to update drug labels for certain generic drugs where the original innovator product is no longer marketed, a change endorsed by the cancer research community anxious to maintain access to older therapies only available in generic form.

On the health care front, providers and insurers were hit by a “surprise” billing provision that aims to protect patients from exorbitant charges for receiving care from hospitals and physicians outside covered networks. Health plans, employers, and insurers opposed the measure strongly, likening it to price controls and government rate-setting. But the legislators agreed on the need for some kind of safety net for patients caught in this coverage loophole, here through a new dispute-setting process for high, unexpected medical bills. At the same time, physicians had an important win in the approval of a provision delaying planned cuts in Medicare fees and other changes.

The omnibus spending bill for 2021 included in the larger legislation was approved just in time to avoid a federal government shutdown this week. The measure provides $42.9 billion for the National Institutes of Health (NIH) and $7.9 billion for the Centers for Disease Control and Prevention (CDC) as part of multiple funding provisions for the Department of Health and Human Services (HHS).

 on its $3.2 billion in appropriated funds plus $2.7 billion in authorized user fees for a funding total of $5.9 billion for 2021. About half of the added $42 million is allotted for medical product safety, specifically $9 million to upgrade systems for overseeing medical devices, $5 million to modernize influenza vaccine production, $3.5 million to expand foreign drug inspections, $2.5 million in support of developing rare cancer therapeutics, and $2 million for drug compounding oversight.

The budget agreement also instructs FDA to support regulatory and policy development, notably research for cannabis-derived substances, treatments for neurodegenerative diseases, nutritional labeling requirements, expedited approval of complex generics, and oversight of orphan drugs. Congress wants FDA to consult the diabetes community on designing clinical studies to assess potential diabetes biomarkers related to islet autoimmunity. And agency experts should work with glass packaging suppliers and pharmaceutical manufacturers on developing innovative glass packaging technologies to reduce product recalls and related drug shortages.

The COVID-19 relief measure further provides $55 million to FDA to support continued development and review of medical countermeasures, devices, therapies, and vaccines to combat the virus. The measure also adds funding for the CDC, the Biomedical Advanced Research and Development Authority, and other HHS offices to support broader coronavirus testing and tracking and vaccine procurement and administration.

It may take some time for analysts to assess the multiple funding provisions, some from appropriated funds and other from the COVID-19 relief/stimulus legislation. And the new administration and new Congress will be looking to put its own stamp on these programs, particularly in the area of health and medical relief.

President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic. 