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COVID-19 vaccine rollout shows real-world evidence was ready for the spotlight

Carolyn Magill
CEO, Aetion


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Just 10 months since administration of the first COVID-19 vaccine dose, hundreds of millions of people worldwide have been inoculated. As of mid-August, more than 4 billion vaccine doses have been administered worldwide, and over 50 percent of eligible Americans are fully vaccinated.

While there is much work to be done to ensure access across the globe, the pace of progress over the last several months is breathtaking.

The incredibly fast development and rollout of the vaccines would not have been possible without the critical contributions of real-world evidence (RWE)—insights reflecting daily interactions with the healthcare system for millions of people, including those often excluded from randomized controlled trials (RCTs). These are people with different combinations of chronic illnesses, people over the age of 65, people representing various racial and ethnic backgrounds. People with limited incomes. People each of us know and care about.

With three vaccines available in the U.S., Americans generate a lot of data. But the data are only as valuable as the decisions they inform. Reports from around the world demonstrate how RWE is being used to track the effectiveness of vaccines as they are deployed; in May, for example, an RWE study from the Centers for Disease Control and Prevention (CDC) showed that mRNA vaccines are 94 percent effective in the studied population. In July, Pfizer and BioNTech used an Israeli RWE study to determine immunity following the first two doses of its COVID-19 vaccine, and cited its findings in discussions around whether a third “booster” dose is needed to ensure efficacy. 

RWE is also enabling regulators to quickly assess potential safety issues, ensuring a real-time alert system and rapid response—as we saw with the pause and subsequent resumption in use of the Johnson & Johnson vaccine. This evidence provides proof to the public that safety protocols are real and effective.

In addition, RWE on vaccine safety and effectiveness has had a direct impact on policy and has influenced public demand. The CDC cited positive real-world data findings in its decision to lift mask mandates for vaccinated individuals. Meanwhile, the number of people hesitant or unwilling to receive the vaccine has continued to drop in the U.S., falling from 63 percent in December to 30 percent in June. 

What we’ve seen over the last several months is a large-scale test run of the future of medicine. Before the start of this pandemic, regulators were already increasing their use of RWE in decision-making. COVID-19 has accelerated this trend, and just as mRNA vaccines demonstrated that we can produce effective immunizations in a matter of months rather than years, RWE has shown that we can monitor medical technologies in real time so that regulators and the public can continue to learn about their performance. In doing so, RWE can build confidence in these interventions, especially in cases where expedited rollouts are vital to public health.

Importantly, there will be a great opportunity to apply the lessons we’ve learned throughout the COVID-19 pandemic about how RWE can continue to inform critical decisions in health care long past its end. For example, COVID-19 has required us to think beyond our standard methods of choosing data that are fit for the purpose of answering a specific research question.

While data relevance and quality are always important, COVID has pushed, and will continue to push, the RWE community to think about using multiple sources of data in parallel to reach conclusions. This has spurred unprecedented collaboration among diverse stakeholders—regulators, biopharma, payers, academic researchers, technology companies, data providers and others—with one example being the Reagan-Udall Foundation for the FDA and Friends of Cancer Research’s COVID-19 Evidence Accelerator. Early in the pandemic, this group of regulators, data providers, academics, health systems and others convened to answer COVID-19 questions in different real-world datasets, then reported findings to extend lessons beyond singular organizations. This collaboration continues today, and similar groups will be key in addressing future healthcare challenges.

Although COVID-19 has not changed the core tenets of database research, it has presented a new challenge for industry to conduct rigorous science and produce decision-grade RWE at a faster rate and higher volume than ever before.

As an industry, many rose to meet that challenge while staying committed to the validity of studies and methods, transparency in reporting and reproducibility of analyses. In some cases this year, however, this didn’t happen—the widely publicized Surgisphere study, for instance—and revealed how even one poorly conducted RWE study poses a credibility risk to the field at large. Scientific accuracy has been, and will continue to be, the force that drives the generation of rapid, reliable RWE. 

The pandemic has served as a critical proving ground for evidence derived from our everyday experiences in healthcare, demonstrating the potential of RWE to build that trust. As public health leaders, researchers, manufacturers and regulatory bodies continue to fight COVID-19 and its variants, they need to work together to carry these lessons forward for future treatments and technologies.

We will have so much to celebrate—with our friends and family from around the country and across the globe, face-to-face with old and young alike—when we do.

First published in Fierce Healthcare.

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