U.S. COVID-19 Vaccination Challenges Go Beyond Supply
Authors: Thomas J. Bollyky
Journal: Annals of Internal Medicine (2021)

Editorials5 January 2021U.S. COVID-19 Vaccination Challenges Go Beyond SupplyFREEThomas J. Bollyky, JDThomas J. Bollyky, JDCouncil on Foreign Relations, Washington, DCAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M20-8280 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail A trio of current Annals articles each takes a different route to the same conclusion: Using initial supplies of coronavirus disease 2019 (COVID-19) vaccines to immunize as many persons as possible with a single-dose regimen may achieve more benefit than a more effective 2-dose regimen in a smaller population.The model of Paltiel and colleagues (1) makes the case for a single-dose vaccine, even if it is somewhat less effective than a 2-dose regimen of another vaccine. Barnabas and Wald (2) argue for single-dose immunization campaigns involving the Pfizer/BioNTech and Moderna vaccines, despite the absence of long-term efficacy data from clinical trials. The model from Tuite and colleagues (3) questions the practice of reserving the second dose for every person immunized.In large-scale trials with tens of thousands of participants, the 2-dose regimens of the Pfizer/BioNTech and Moderna vaccines both demonstrated about 95% efficacy in preventing COVID-19. These studies were designed to test a 2-dose regimen, but the data reported to the U.S. Food and Drug Administration (FDA) raised the possibility that even a single dose of these vaccines might offer a clinically significant, albeit lower, level of protection against the disease. The FDA has issued emergency use authorization for a 2-dose regimen of these vaccines, a prime and a booster, 21 days apart for the Pfizer/BioNTech vaccine and 28 days apart for the Moderna vaccine.In a public health emergency, a powerful argument exists for doing something with less-than-perfect results if it can help more persons quickly. However, whether alternative approaches with current vaccines would accomplish this goal is far from clear.Several constraints stand in the way of getting COVID-19 vaccine doses into the arms of the persons who stand to benefit most from them. Supply constraints in the production and procurement of vaccine doses, as well as vials, syringes, and other vaccine-related materials, limit or delay their availability to patients and providers. Administration constraints are obstacles that emerge in the distribution and administration of the vaccines to patients. Demand constraints reflect the hurdles that exist in vaccinating members of high-risk and high-priority populations who may be reluctant to be vaccinated.A single-dose regimen of the current vaccines that offers a lower but still substantial level of protection against COVID-19 may alleviate vaccine supply constraints, but may do so at the expense of aggravating the demand and administration constraints that present the greater hurdle to vaccinating vulnerable groups in the United States. The United States has historically struggled to vaccinate adults. In the past decade, the rate of seasonal influenza vaccination among U.S. adults has never exceeded 50%. Coverage rates for seasonal influenza have been even lower for Black and Latinx Americans and high-risk adults between the ages of 18 and 49 years (4). During the last pandemic for which there was a vaccine—the 2009 H1N1 pandemic—only 22.7% of American adults were vaccinated (5). After months of wariness, recent polls show that interest in receiving COVID-19 vaccines is finally rising among Americans, including Black and Latinx populations, in part because of the news that clinical trials showed the Pfizer/BioNTech and Moderna vaccines to be highly effective (6). Offering reluctant populations a less effective regimen of a vaccine, or failing to offer its second dose on schedule, may cause confusion, create a multitiered system of vaccine access, and exacerbate historical concerns that certain groups are more likely to receive substandard care.In the United States, COVID-19 vaccine administration will depend on the same overworked and underresourced U.S. state, local, and tribal public health systems that have delivered H1N1 and seasonal flu vaccines. Despite months of pleas for at least $6 billion to prepare state and local governments for what will be the largest vaccination campaign in U.S. history, Congress only recently appropriated the necessary funds, and it will be weeks more before those federal resources are distributed and put to good use. In the interim, administration will continue to be a greater challenge than limited doses in the early roll-out of COVID-19 vaccines. As of December 30, the Centers for Disease Control and Prevention reported that only 2.6 million of the 12.4 million vaccine doses distributed had been administered to U.S. patients (7).The United States is unfortunately demonstrating the public health axiom that what saves lives is the practice of vaccination, not just the existence of vaccines. The immediate task facing the public health system is to deliver vaccines swiftly and surely to high-priority populations and, in the process, to build momentum and confidence. There are no shortcuts to inspiring trust among those at greatest risk, developing and implementing an effective vaccination program, and monitoring for safety and effectiveness over time. Models of alternative strategies—particularly those that make large assumptions about vaccine efficacy in the absence of reliable data—should not drive policy without a full consideration of the challenges of implementation and potential unintended effects.Ideas for stretching vaccine supplies may yet have utility, but they will have greater application when and where supply constraints are the rate-limiting steps. There is no shortage of those settings, because a few wealthy nations, including the United States, have already purchased most early supplies of the most promising COVID-19 vaccines (8). Yet, a moment may soon arrive when COVID-19 vaccine supplies are a greater limitation on U.S. vaccination than at present; therefore, considering various alternative approaches is worthwhile. For now, the priority should be to grow the evidence base by pursuing clinical testing and observational studies to determine whether a single dose or a delayed second dose of the current vaccines will generate immunity similar to that of the FDA-authorized 2-dose regimen. Supported by strong public health systems, rapid vaccine production, and equitable vaccine distribution within the United States and around the world, vaccination strategies driven by data can bring an end to COVID-19.References1. Paltiel AD, Schwartz JL, Zheng A, et al. Speed versus efficacy: quantifying potential tradeoffs in COVID-19 vaccine deployment. Ann Intern Med. 2021;174:568-70. doi:10.7326/M20-7866 Google Scholar2. Barnabas RV, Wald A. A public health COVID-19 vaccination strategy to maximize the health gains for every single vaccine dose. Ann Intern Med. 2021;174:552-3. doi:10.7326/M20-8060 Google Scholar3. Tuite AR, Fisman DN, Zhu L, et al. Alternative dose allocation strategies to increase benefits from constrained COVID-19 vaccine supply. Ann Intern Med. 2021;174:570-2. doi:10.7326/M20-8137 Google Scholar4. U.S. Centers for Disease Control and Prevention. Influenza (Flu): Influenza Vaccination Coverage. Accessed at www.cdc.gov/flu/fluvaxview/index.htm on 30 December 2020. Google Scholar5. U.S. Centers for Disease Control and Prevention. Influenza (Flu): Final estimates for 2009–10 Seasonal Influenza and Influenza A (H1N1) 2009 Monovalent Vaccination Coverage – United States, August 2009 through May, 2010. Accessed at www.cdc.gov/flu/fluvaxview/coverage_0910estimates.htm on 30 December 2020. Google Scholar6. Funk C, Tyson A. Intent to Get a COVID-19 Vaccine Rises to 60% as Confidence in Research and Development Process Increases. Pew Research Center. Accessed at www.pewresearch.org/science/2020/12/03/intent-to-get-a-covid-19-vaccine-rises-to-60-as-confidence-in-research-and-development-process-increases on 30 December 2020. Google Scholar7. U.S. Centers for Disease Control and Prevention. COVID-19 Vaccinations in the United States. Accessed at https://covid.cdc.gov/covid-data-tracker/#vaccinations on 30 December 2020. Google Scholar8. Bollyky TJ, Bown CP. The tragedy of vaccine nationalism: only cooperation can end the pandemic. Foreign Affairs. 2020;99:96-108. Google Scholar Comments 0 Comments Sign In to Submit A Comment R RapportRetired5 January 2021 Priorities Instead of theorizing how to change the vaccination regimen (without trials), concern regarding supply availability should be looking at shipment logistics: What is the chain of supply? Who is responsible for validation? Where are the checkpoints? What is the delivery and receiving schedule? Are the appropriate administrators available? Etc. Douglas SatcherDouglas Satcher, M.D.9 January 2021 Patient Confidence I agree totally and completely with the authors regarding our Vaccine issues. The error in giving a Vaccine without great efficacy will have the effect of reducing overall confidence in the Vaccine. We see the same issue now in patients who "got the flu vaccine and still got the Flu". Knowingly reducing the chance of 95% protection (Just to make ourselves feel like we did something) will lessen our ability to convince patients of it's benefit.. We need to concentrate on the logistics!! Disclosures: I have no conflicts of interest Guglielmo M.Trovato*, Simon D.Taylor-Robinson**, Marsha Y Morgan **, Rodrigo Amo de la Fuente**, Vincenzo Costigliola*EMA Brussels, Belgium*; London UK**13 May 2021 Leveraging Open Science to Accelerate Research in COVID-19 vaccines: which are the challenges of exclusive patents? We fully agree with the statements of the Annals’ Editorial: The public health axiom that "what saves lives is the practice of vaccination, not just the existence of vaccines". The immediate task facing the public health system is to deliver vaccines swiftly and surely to high-priority populations and, in the process, to build momentum and confidence. Accordingly, the world’s population needs to be reached by affordable, effective and quick vaccination campaigns, thus preventing return waves of the pandemic. To effect this, there needs to be patent rights limitation in most countries. Vaccine patents are currently guaranteed by international agreements, but high costs and safeguarding the interests of a few multinational companies are serious threats that obstruct vaccine roll out. From a global problem perspective, patent rights limitation is a step forward and may be a mechanism for inspiring trust among skeptical populations at greatest risk, and for implementing effective vaccination programs. The chain of knowledge, ideas, research, innovation, development, production, distribution, delivery and actual administration should not be the sole prerogative of a few multinationals that purchase and monopolize know-how and supplies with their own rules, as if they were themselves sovereign states. Even after the call by President Biden for patent liberalization, no medical and scientific society has expressed a position, amidst the ongoing debate. This silence further contributes to the distrust of large groups of the world’s population towards science and medicine. We believe that patent rights limitation in the COVID-19 era is a sustainable proposal. In the current climate of this international public health emergency, patent liberalisation should be fully implemented, following governmental agreements in all countries of the world. The point is not to question the right to fair gain for intellectual property of something subject to a patent, but to allow, as in this case, the effective utility of the patent itself. The wider scenario of public funding and research contributions made these achievements possible, and allows further advancement. In our view, removing patent barriers, even temporarily, is a needed first step, along with transferring advanced manufacturing know-how. Without patent suspension, inevitable prevarication will occur, not justified by any economic, scientific or ethical consideration. Author, Article, and Disclosure InformationAuthors: Thomas J. Bollyky, JDAffiliations: Council on Foreign Relations, Washington, DCAcknowledgment: The author thanks Josh Sharfstein for his review and helpful comments on this manuscript.Disclosures: The author has disclosed no conflicts of interest. The form can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-8280.Corresponding Author: Thomas J. Bollyky, JD, Council on Foreign Relations, 1777 F Street Northwest, Washington, DC 20006; e-mail, TBollyky@cfr.org.This article was published at Annals.org on 5 January 2021. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoAlternative Dose Allocation Strategies to Increase Benefits From Constrained COVID-19 Vaccine Supply Ashleigh R. Tuite , Lin Zhu , David N. Fisman , Joshua A. Salomon A Public Health COVID-19 Vaccination Strategy to Maximize the Health Gains for Every Single Vaccine Dose Ruanne V. Barnabas and Anna Wald Speed Versus Efficacy: Quantifying Potential Tradeoffs in COVID-19 Vaccine Deployment A. David Paltiel , Amy Zheng , and Jason L. Schwartz Metrics Cited byAn Analysis of COVID-19 Vaccine Hesitancy in the U.S.Assessing COVID-19 pandemic policies and behaviours and their economic and educational trade-offs across US states from Jan 1, 2020, to July 31, 2022: an observational analysismRNA Vaccine Mitigates SARS-CoV-2 Infections and COVID-19A qualitative analysis of the COVID-19 vaccination rollout in Lagos, Nigeria: Client and provider perspectives on the plan, the process and the progressPsychological determinants of COVID-19 vaccine acceptance among urban slum dwellers of BangladeshTo Boost or Not to Boost: Acceptability of a COVID-19 Booster Dose among Osteopathic Medical Students: A Cross-Sectional Study from a Medical School in New YorkEvaluating the effects of second-dose vaccine-delay policies in European countries: A simulation study based on data from GreeceInformation trust and COVID-19 vaccine hesitancy amongst middle-aged and older adults in Singapore: A latent class analysis ApproachModeling and optimal control of mutated COVID-19 (Delta strain) with imperfect vaccinationAnalysis of Vaccination Rates and New COVID-19 Infections by US County, July-August 2021Mathematical modeling of mutated COVID-19 transmission with quarantine, isolation and vaccinationAge-dependent effects on infectivity and susceptibility to SARS-CoV-2 infection: results from nationwide contact tracing data in GreeceIn Silico Molecular Docking and Molecular Dynamic Simulation Analysis of Phytochemicals From Indian Foods as Potential Inhibitors of SARS-CoV-2 RdRp and 3CLproCOVID-19 Vaccination in Lower-Middle Income Countries: National Stakeholder Views on Challenges, Barriers, and Potential Solutions April 2021Volume 174, Issue 4 Page: 558-559 Keywords Clinical trials COVID-19 Food and Drug Administration H1N1 Immunity Observational studies Prevention, policy, and public health Research design Safety Vaccines ePublished: 5 January 2021 Issue Published: April 2021 Copyright & PermissionsCopyright © 2021 by American College of Physicians. 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