On July 31, 2020 Sanofi and partner GSK became the latest pharmaceutical companies to become part of Operation Warp Speed, the US government’s effort to bring 300 million doses of a safe, effective COVID-19 vaccine to market by January 20211. Although unprecedented progress has been made in moving vaccines into clinical testing, at a Congressional subcommittee meeting on July 21, 2020, of the Warp Speed vaccine developers who were present, only AstraZeneca and Pfizer stated that a vaccine might be available on an emergency use basis by the end of 20202. In its Q2 2020 earnings release on August 11, 2020, Pfizer’s COVID-19 vaccine partner BioNTech stated that it may be in a position to file for FDA approval in October 2020 if its trials are successful3. The US government has paid for the entire 100 million doses of the Pfizer/BioNTech vaccine that the companies expect to produce through the end of 20204, covering 50 million people based on the two-dose regimen. As such, at least in the next four-six months, and possibly longer, vaccines alone will likely not be the solution that will allow the United States to fully reopen its economy, schools and businesses, because:
- Not all vaccines are likely to make it to market. Drug development is a risky process and many of the vaccines in development around the world are using technologies that have never been used in large scale clinical trials before. Whereas vaccine development typically takes many years, the industry is, understandably, attempting to expedite development on an extremely aggressive timeline, but it is possible that not all of these vaccines will be successful in the clinic
- Vaccines most likely won’t be available in the quantities that we need. The sheer amount of vaccine needed to inoculate on a global scale, even with the best planning and proactive scale-up, will be vast. There will likely be shortages and tiering of who gets a vaccine and when, and on a local, regional and country level scale. At this time next year, even in the best of circumstances, it is possible that we will still not have full vaccination coverage for the global population.
- Some people may be afraid to get a vaccine that has been approved on an accelerated timeline. A Politico/Morning Consult poll of approximately 2,000 registered voters published on July 29, 2020 found that 60 percent of respondents believe that, even if it means a delay to rollout and allows continued spread of COVID, that any vaccine should be fully tested5. Just 22 percent of respondents thought the US government should bring a vaccine to market as quickly as possible5. Recognizing these fears, FDA commissioner Stephen Hahn sought to allay concerns in an opinion piece in the Washington Post on August 5, 2020, when he said “any vaccine authorized for widespread use will meet the appropriate standards for quality, safety and efficacy”6.
In the meantime, what do we do, as vaccines are unlikely to be fully deployed in the near-term? The only way to return workers to work, children to school and sports teams to play is to determine who is infected with COVID-19. And the only way to know that is through testing.
However, our daily testing targets are still falling dramatically short (see Figure 1). Through the end of July, the nation was running approximately 5.2 million tests per week, equating to around 744,000 tests per day. Although this was more than double the 343,000 tests per day from April through June, we have fallen dramatically short of the 20 million tests per day required by the end of July in order to “fully remobilize the economy,” as outlined in a recent Harvard report7.
To that end, we have highlighted three key areas for improvement in diagnostic testing that can begin to ramp up testing numbers to where they need to be in order to get the economy back up to speed.
Improve the supply chain for COVID-19 tests
Immediate supply chains issues with COVID-19 diagnostic testing remain unresolved. Chemical reagents, RNA extraction kits, swabs, and viral transport media shortages are not uncommon. A survey published in May 2020 indicated that more than 85 percent of U.S. clinical labs had suffered significant delays in COVID-19 testing programs as a result of ongoing supply chain disruptions9. With schools now set to reopen, combined with the upcoming flu season, the demand for testing is expected to increase exponentially. This calls for expanded government investment, a more robust and centralized approach to resolution of supply chain issues, and regulatory support to bolster supply of critical items. While some states have set up supply chain initiatives, this supply challenge must be addressed at a national level.
Actual and targeted COVID-19 diagnostic testing numbers for the US7, 8
Invest in new diagnostic technologies
Diagnostic testing frequently relies on decades old technologies like PCR. Investing in new modalities, including point-of-care (POC) tests, may allow the creation of tests that are faster, cheaper, and more convenient to use than existing technologies. This, in turn, could help address some of the biggest problems associated with COVID-19 testing today, which are capacity, turnaround time and affordability of tests. Based on a Department of Health and Human Services report, it is estimated that the combined capacity of manufacturers, diagnostic platforms, test kits, and reagents is well over 50 million tests per week10
However, the combined capacity of labs, hospitals and POC (e.g., at major drug store chains) is only 7.5 million tests a week10. Pooled, batch testing and POC technologies can potentially bridge this gap and increase testing capacity by more than 10 times current levels10.
Collaborate to meet demand for testing
Despite the reality of test shortages at the national level, surveys have shown that multiple states are testing below their capacity11. To address this mismatch, we should consider collaborations that can route demand for testing to areas that have extra capacity. This starts with a collaborative effort to standardize the testing process. For instance, if samples are collected and tracked in a way that a nasal swab could be sent to any lab in the country and samples were sent to the nearest lab with capacity, issues around capacity and turnaround time would be drastically reduced.
Combatting a novel disease like COVID-19 requires novel commercial models and greater investment in some of the most exciting new technologies of our generation.
- HHS Website, July 31, 2020;
- Regulatory Affairs Professionals Society Website, Michael Mezher, July 21, 2020;
- BioNTech Website, August 11, 2020;
- Pfizer Website, July 22, 2020;
- Politico Website, Zachary Brennan, July 29, 2020;
- Washington Post, Dr. Stephen M. Hahn, August 5, 2020;
- Harvard University, Edmond J. Safra Center for Ethics, Roadmap to Pandemic Resilience, April 20, 2020;
- The Atlantic’s COVID Tracking Project;
- Association for Molecular Pathology SARS-Cov-2 Molecular Testing Survey, April 23 - May 5, 2020;
- Rockefeller Foundation, National Covid-19 Testing & Tracing Action Plan, July 16, 2020;
- MIT Technology Review, Neel V. Patel, June 27, 2020
About the authors:
Alasdair Milton and Jessica Lin are Managing Directors and Osman Yousuf is a Manager in the Life Sciences Strategy practice within Deal Advisory at KPMG. Kristin Pothier is the Global and National Healthcare and Life Sciences Strategy Leader and the Global Deal Advisory Leader, Healthcare and Life Sciences at KPMG. They are actively working with pharma, labs, medical institutions, large employers, and regions combatting COVID-19 on their planning and implementation of COVID-related programs. For more information on how we support these entities, please visit link.