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Perspectives

We Have Vaccines, Now What? How to Ensure Continued COVID-19 Vaccine Discovery and Expedite Access

Authored by

Jason Shafrin, PhD1; Marlon Graf, PhD1; Rifat Tuly, MPH1; Christoph Glaetzer, Dipl Kfm2; Stacey Hickson, PhD2; T Joseph Mattingly II, PhD, PharmD, MBA3

Affiliation

1PRECISIONheor
2Janssen Inc Pharmaceutical Companies of Johnson & Johnson
3University of Maryland School of Pharmacy

Disclosures

The work was funded by Janssen Inc, Pharmaceutical Companies of Johnson & Johnson. The funding agreement ensured the authors’ independence in interpreting the data, writing, and publishing the article. Dr Shafrin reports stock ownership in PRECISIONheor. Dr Mattingly reports speaker honoraria received from PRECISIONheor. All other authors report no relevant financial relationships beyond noted employment.

Citation

J Clin Pathways. 2021;7(1):46-48. doi:10.25270/jcp.2021.02.00002
Received December 21, 2020; accepted January 25, 2021.

Acknowledgements

All authors have made a substantial contribution to the information submitted for publication and drafting or revising the article, and have read and approved the final manuscript. The authors would like to thank Ms Caroline Huber, MPH, and Ms Danielle Rollmann, MPA, for their research guidance and contributions. Ms Huber is an employee of PRECISIONheor and Ms Rollmann is an employee of Janssen Inc, Pharmaceutical Companies of Johnson & Johnson.

Correspondence

Marlon Graf, PhD
PRECISIONheor
11100 Santa Monica Blvd, Suite 500
Los Angeles, CA 90025
Phone: (310) 984 7712
Email: marlon.graf@precisionvh.com

Abstract: The coronavirus disease 2019 (COVID-19) pandemic has resulted in a catastrophic burden in both health and economic costs. Despite the December 2020 emergency use authorizations of two COVID-19 vaccines, there is still much work left to do. In this article, we assert that continued successful COVID-19 vaccine policies must have at least two components: (1) recognition of the value that COVID-19 vaccines bring to society; and (2) collaboration across stakeholders to ensure rapid population access and uptake. Implementing these approaches will facilitate the containment of COVID-19 while ensuring that innovators are able to sustain the discovery, development, and delivery of transformational medicines and vaccines, and—most importantly—improve the lives of billions of individuals around the world.

Key Words: COVID-19, value, vaccine, vaccine development, distribution and access


The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has resulted in a catastrophic burden in both health and economic costs. In September 2020, the global death toll hit 1 million1; by the end of 2020, over 300,000 individuals in the United States alone had died from coronavirus disease 2019 (COVID-19)-related causes.2 Cumulative direct health care costs in the United States may be in the high billions to even trillions of dollars.3,4 Further, the impact on the economy is large; more than 10.7 million Americans were out of work in November 2020,5 leading to increased rent burden,6 food insecurity,7 and loss of health insurance.8 While there have been several epidemics over the past century, such as the first SARS-CoV, Middle East respiratory syndrome coronavirus (MERS-CoV), and Ebola, the burden of the recent COVID-19 pandemic is much more significant by comparison, due to the virus’s high transmissibility9 and global dispersion.

Hope is on the horizon. Following promising data releases for vaccine candidates of both Pfizer/BioNTech and Moderna indicating 95% and 94% efficacy in preventing COVID-19 for their respective vaccines,10,11 the Food and Drug Administration (FDA) granted Emergency Use Authorization for both in December 2020.12,13 As of January 2021, there were more than 20 other vaccine candidates currently undergoing phase 2 or 3 testing.14 While these trials still await final results, and scrutiny and evaluation by the FDA, they are clearly heartening.

Yet, there is much work left to do. Successful COVID-19 vaccine policies must have at least two components: (1) recognition of the value that COVID-19 vaccines bring to society; and (2) collaboration across stakeholders to ensure rapid population access and uptake. Implementing these policies will facilitate the containment of COVID-19 while ensuring that innovators are able to sustain the discovery, development, and delivery of transformational medicines and vaccines, and—most importantly—improve the lives of billions of individuals around the world.

Recognizing the Full Value a Covid-19 Vaccine Brings to Society

If vaccines quickly and effectively combat COVID-19 by eliciting immune response that can prevent or clear infections with SARS-CoV-2, the health and economic benefits for societies across the globe would be substantial.15 Not only would it improve population health, but an efficacious and safe vaccine would also allow businesses and schools to reopen sustainably and take pressure off labor markets, housing markets, and overstretched health care systems. The total cost of the pandemic, consisting of mortality, morbidity, mental health conditions, and direct economic losses, have been projected to reach $16.1 trillion (90% of the US Gross Domestic Product).16

When the pandemic began in early 2020, the development of a vaccine was far from a foregone conclusion. Recent history of development shows that only 7.1% of vaccine candidates for emerging or reemerged viral infectious diseases make it from phase 1 clinical trials to regulatory approval within 12 years.17 Development failures are not costless. The average cost to bring a medicine to market is more than $2 billion.18 One study found that “under realistic financing assumptions, expected returns [to vaccine development for emerging infectious diseases] are negative.”19 Despite these risks, drug and vaccine developers are leaning-in heavily to discover and develop a vaccine to meet this public health emergency, managing expedited research processes and clinical studies, often with production occurring in parallel and with substantial financial risk.

To support sustainable future vaccine innovation, economists and leading institutions have argued that pricing for vaccines should reflect the value it provides to society.20 Value should include not only the direct value to individual health but also the broader notion of societal value.21 In fact, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has identified a number of broad value elements deserving consideration in value assessments, such as fear of contagion, impact on societal inequality, and scientific spillovers.21 Fear of contagion has led many people to stay home and reduced the likelihood that individuals will seek high-value preventive care services22 as well as treatment and diagnosis for health conditions such as cancer.23 Additionally, the health and economic burden of COVID-19 disproportionately falls on disadvantaged and minority communities.24 Investing in the development of vaccines for COVID-19 may also have scientific spillovers to help address future pandemics25; for instance, continued investment into vaccine technology and research for other viruses such as MERS and SARS has facilitated speedy development in the current COVID-19 pandemic.26

Recognizing the tremendous societal value of a vaccine for COVID-19 and the extreme circumstances of this global pandemic, a number of companies have committed to a discounted price or not-for-profit price during the pandemic—a departure from a price to value approach. Other pricing approaches have also been proposed; for example, Bill Gates has proposed a tiered pricing option in which rich countries subsidize vaccines so poorer countries can pay less.27

Regardless of the pricing approach taken in the specific case of the COVID-19 pandemic, driving and sustaining the discovery and development of transformational medicines and vaccines in the long term, including the scientific expertise that has provided the critical backbone for a rapid response to COVID-19, requires an innovation-based approach to discussions about their far-reaching value.

Collaborating to Ensure Rapid Population Access to Covid-19 Vaccine

Although both the Pfizer/BioNTech and Moderna vaccines have already been authorized in the United States for use in the emergency situation, producing and distributing a sufficient number of vaccines for billions of individuals are considerable challenges. Not only does production of billions of vaccines take time, but some countries are not able to use existing vaccines due to logistical challenges with cold storage and distribution.28 To bridge these infrastructure gaps, additional vaccine candidates will be needed. Innovators face a difficult choice: produce tens or even hundreds of millions of doses for a vaccine that could fail (ie, production at risk) or delay production until a vaccine is approved but risk not meeting society’s demand. Due to the enormous societal cost of the COVID-19 pandemic, production at financial risk is a necessity.

To facilitate production on a parallel path to development, governments, insurers, and nongovernmental organizations are already engaging in advance purchase commitments and funding manufacturing and supply channels to ensure rapid and equitable distribution. For example, the United States has committed billions of dollars in vaccine pre-purchases. The Operation Warp Speed Vaccine Initiative aimed to “produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021,” about 1 year from COVID-19’s emergence in the United States,29 and the United States is not the only one doing this. GAVI, a vaccine alliance, has developed the COVID-19 Vaccine Global Access Facility  to facilitate the financing and distribution of COVID-19 vaccines to countries irrespective of income level. These efforts contrast with recent virus outbreaks, such as H1N1 influenza, Ebola, and Zika, where vaccines were developed rapidly but not before the outbreaks were contained.30 In the case of COVID-19, policymakers and manufacturers must continue to fund commercial scale manufacturing before pivotal trials are complete and expand distribution capacity to ensure sufficient supply once a vaccine gains approval.

While vaccinations began at the end of 2020 in some countries, vaccination rates are falling behind targets31 due to the vast logistical hurdles involved. The need to store one of these vaccines at extremely cold temperatures poses particular challenges for rural health care providers and providers in developing countries.32 Furthermore, the need for repeat doses requires tracking and monitoring capabilities.28 Administrative hurdles such as the requirement for onerous documentation,33 for example, may also be contributing to slower vaccination rates.

Although addressing uptake is a multipronged challenge, payers and policymakers should remove one key barrier to COVID-19 vaccination: direct costs to individuals. This means that the out-of-pocket costs to individuals for COVID-19 vaccines should be zero. An individual’s economic resources should not stand in the way of their ability to access any approved COVID-19 vaccines through their health care systems. In many developed countries, patients already have limited or no cost sharing for health care services. In other developed countries—like the United States—and developing countries, drug cost sharing for patients can be substantial. Even if safe and effective vaccines are produced rapidly and at scale, the impact will be nonexistent unless they are used.

Other barriers to COVID-19 vaccine uptake will also need to be addressed, including social dynamics such as vaccine hesitancy34 and the changing perception35 of disease threat and severity. For example, large proportions of the American public have expressed hesitancy to be vaccinated once a vaccine for COVID-19 is available (27%),36 and the same poll conducted in November/December 2020 by the Kaiser Family Foundation suggests that hesitancy might be as high as 29% among health care workers.36 As a result, vaccine refusal among frontline health care workers has not been uncommon, especially in rural communities.37 To mitigate these concerns, it is important to address public perception through education and awareness campaigns.

Conclusion

Although early and interim results across multiple studies have shown the potential for vaccines to successfully protect against COVID-19, the pandemic is far from over and continues to cause health, social, and economic devastation. As COVID-19 fatigue sets in, social distancing and other measures become increasingly challenging to adhere to. A safe and effective vaccine against COVID-19 may be our best option to contain this disease and return a sense of normalcy. To vaccinate as many people as quickly as possible and meet the global demand, we must remove financial and social barriers while collaborating to expedite vaccine distribution, allowing rapid population access. To ensure that the discovery and development of new vaccines for COVID-19 and future pandemics can be sustained well into the future, we must recognize the full and holistic value they bring to patients and society, and support the innovation process. Failing to do so will yield even more significant health, social, and economic burden.

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