How the Corporate World, Government Worked Together to Deliver a Solution to the COVID-19 Pandemic

Author(s):

Sheetal Nariani

The alliance between pharmaceutical partners and government organizations signals the possibilities of shared resources in meeting global crises.

In 2020, the specter of a pandemic became a global reality, bringing governments, economies, and health care systems all over the world to a halt. COVID-19’s impact has been significant and far reaching, from job loss and death of loved ones to the deterioration of social outlets and mental health. To date, COVID-19 has taken upwards of 3 million lives worldwide and devastated job markets and small businesses, and yet the prospect of vaccines and treatments offers a light at the end of the tunnel.

This phenomenon begs the question: how were vaccines able to come to the rescue so quickly when new drug development and approval processes—not to mention distribution—are usually lengthy and fraught with delays? The answer is an unprecedented collaboration of private and public entities.

Government support made fast development of vaccines possible and facilitated distribution once approved. The alliance between pharmaceutical partners and government organizations signals the possibilities of shared resources in meeting global crises.

Public-private collaboration

During the pandemic, the federal government, FDA, and private businesses shrunk the timeline to get vaccines to the public—without skipping any vital steps in development, testing, and safety. Early in the outbreak, the US Department of Defense (DoD) launched Operation Warp Speed (OWS), which set the ambitious goal of having approved vaccines by January 2021, condensing a typical 73-month vaccine approval process to 14 months by public-private partnerships, and $18 billion in funding.

OWS brought together disparate entities and arms of government to share their collective knowledge. Hundreds of experts in vaccine-related fields participated, including those from the DoD, Health and Human Services (HHS), scientists from the National Institutes of Health (NIH) and other agencies, and not to mention, private industry. Under the umbrella of OWS, these groups shared information and resources in order to bring vaccines to market faster than ever before.

OWS also threw some financial weight behind the initiative, with more than $12 billion paid to vaccine efforts alone. Billions of dollars in funding were awarded to drug makers as financial backing for research and development or as guaranteed contracts for a designated number of doses.

AstraZeneca, Johnson & Johnson, Moderna, Novavax, Pfizer/BioNTech, and Sanofi/GSK each received upward of $1 billion. At the same time, tens or hundreds of millions in funding were made available to companies involved in services peripheral to vaccine development such as vial-makers Corning and Si02, manufacturer Cytiva, biopharmaceutical firm Emergent BioSolutions, and biotechnology company Texas A&M/Fujifilm.

The government’s funding of at-risk vaccine development and guaranteed contracts for vaccine manufacturing may have drawn some companies to participate, but additional leverage was needed to speed production and ratchet up output. OWS, headed by former GSK executive Moncef Slaoui and Gustave Perna, an expert in military logistics, added in the effort as well, using its clout to negotiate timelines when needed.

Planning, participation, and vaccine platforms

Several other factors worked in favor of a shortened timeline in the United States: concurrent planning for rollout with ongoing research, large numbers of patients willing to participate in clinical trials, and vaccine methodologies already in existence.

The FDA had a key role in speeding vaccine delivery. The cumbersome and regimented drug approval process was adapted to allow for immediate back-and-forth communication, with vaccine makers regularly providing safety and efficacy data rather than waiting for inclusion in a submission. The FDA also prioritized vaccines and condensed the 12 months typically allowed for emergency use authorization (EUA) approval.

Due to the high number of COVID-19 patients who were without significant treatment options in the early part of the pandemic, adequate clinical trial enrollment was possible. Some 30,000 volunteers in early studies translated to swift data collection and safety and efficacy analysis.

The 2 current vaccine formats—a deactivated virus and mRNA—were built on years of research. Deactivated viruses have long been used for vaccines and mRNA was backed by nearly 3 decades of research before being used in the current vaccines. At the same time, recent outbreaks of SARS had also given researchers a leg up on understanding the COVID-19 virus, and to turn around a vaccine quickly.

Pfizer/BioNTech and Moderna both utilize mRNA (messenger RNA) that carry instructions to create spike proteins that alert the immune system to recognize and attack COVID-19. Johnson & Johnson (J&J) and Oxford-AstraZeneca use a deactivated virus to deliver the same spike protein and activate the immune system.

According to Harvard Medical School, Pfizer, BioNTech, and Moderna had been working with mRNA vaccines for some time, essentially developing platforms that would allow their use with any vaccine. The particular virus information would be inserted for each relevant vaccine.

The broad platform-based development of mRNA vaccines also allowed for major scaling when calls for large numbers of vaccines came in. mRNA vaccines are also currently being evaluated for flu, Zika, and Ebola viruses.

Finding efficiencies in existing supply chains

All along the development and supply chain, efficiencies and capacity were identified in order to speed up research, development, and production, often utilizing existing relationships. A supplier, for example, that had previously been involved in production of another therapy at a capacity of 200 units per month was asked to temporarily ramp up its portion of vaccine production to 1000 units per month.

Seeking out companies with surge capacity became important as pharmaceutical companies began to develop vaccines. For example, Pfizer was able to shave its production time from 110 days to 60 and increase the number of vaccines being produced, according to the Wall Street Journal.

Just a week after receiving the FDA’s EUA, the pharmaceutical giant was shipping vaccines. This was possible because suppliers and manufacturers were preparing at the same time as development.

The processes all occurred at once, so that manufacturing facilities were ready to act immediately when a vaccine was approved. Some 25 manufacturing facilities were readied to produce vaccines, according to Bloomberg Businessweek.

NIH program brings together federal researchers and pharmaceutical firms

Parallel to the leveraging of existing vaccine technologies, government agencies stepped in to increase the speed of response to COVID-19. The NIH created ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines), a public-private alliance between government-based researchers and 16 pharmaceutical companies—groups that rarely collaborate.

Under the partnership, scientists would openly share learnings, laboratory resources, and would create standardized practices in order to aid in quick vaccine development. ACTIV also provided an important benefit: coordinated clinical trials that would share one control arm and assist vaccine makers in meeting clinical trial capacity.

Despite the significant cash flow from the government, most pharmaceutical companies do not stand to profit much, if any, from the vaccine, according to a report from the BBC. Many of the drug makers kicked in significant private and non-profit funding and all that funding may have been for not for firms whose research and development ultimately did not result in successful clinical trial results.

Also, unlike traditional therapeutics that might be needed daily, vaccines are not used often. As a result, they are not considered significant profit-makers, coming in at an estimated 2% to 3% of the pharmaceutical market under normal circumstances.

Even under these extreme conditions, companies are pricing their vaccines low, in part because of the optics of high prices during a pandemic. At the least expensive end, AstraZeneca/Oxford set its price just high enough to cover costs ($4), according to UNICEF and WHO. Prices then range from $10 to $37, with Moderna at the higher end.

Pre-ordered and guaranteed doses are expected to provide a boon for the near months, but unless boosters or vaccines for additional strains are produced, the revenue may be short-lived. The financial picture is also focused on the wealthy nations of the world, which received access to the vaccine more quickly than developing countries.

Private-public partnership takeaways

COVID-19 has taken much from the world since its outbreak and global spread, but it may have also shown that there are opportunities to reach across divides in research that were previously thought insurmountable. From a scientific perspective, the success of mRNA vaccines has expanded interest in programs studying the technology’s viability in cancer vaccination.

The success of the vaccine programs has highlighted the possibilities of collaboration. Government-funded scientists and industry scientists shared work as part of NIH’s ACTIV program. Cross-company partnerships sprung up through DoD’s OWS.

What lessons can be learned from the pandemic? The pandemic may have highlighted efficiencies within organizations and government and, at the same time, illuminated opportunities for continuing public-private collaboration and private-private collaboration between pharmaceuticals and medical device companies.

Those lessons, if applied to future global crises, will continue to provide benefits for citizens, businesses, and governments around the world. Lessons learned during this collaborative approach to COVID-19 could be applied to manage other global health issues, such as drug resistance or inequities. A pandemic brought many independent agencies and for-profit companies together; perhaps that collaboration is possible without the threat of a pandemic.

About the Author

Sheetal Nariani has over 13 years of experience in global healthcare industry and has successfully led multiple functions including financial management, mergers and acquisitions, business operations and corporate strategy. She specializes in managing integration and change management across diverse teams and cultures with a passion for travel. She is an alumna of Stanford University with dual degrees in Business Management and Public Policy and can be reached at sheetalnariani@alumni.gsb.stanford.edu

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