nference and Mayo Clinic Studies Confirm Safety and Effectiveness of FDA-authorized mRNA Vaccines for COVID-19
Largest real-world evidence-based studies thus far demonstrate COVID-19 vaccine effectiveness in reducing the rates of SARS-CoV-2 infection and community transmission and confirm the rarity of serious or significant vaccine-associated adverse effects.
CAMBRIDGE, Mass., June 29, 2021 /PRNewswire/ -- nference, the AI-driven health technology company, today announced publication of two peer-reviewed studies in Med that analyzed the largest, context-rich electronic health record (EHR) and clinical notes platform with nference real-time artificial intelligence (AI) software, confirming the safety and efficacy of the two messenger RNA (mRNA) COVID-19 vaccines, mRNA-1273 (Moderna) and BNT162b2 (Pfizer/BioNTech), that are FDA-authorized for emergency use. Med is a monthly journal from Cell Press that publishes rigorously vetted original research across the translational and clinical continuum.
In the first study, "Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines," the authors analyzed over 1.2 million EHR notes in the Mayo Clinic health system and compared rates of post-vaccination clinical follow-up and adverse effects between 68,266 vaccinated individuals (51,795 who received BNT162b2 and 16,471 who received mRNA-1273) and 68,266 matched unvaccinated individuals. Their results show that vaccinated individuals are likely to experience muscle and joint soreness, but they are not more likely to seek out emergent clinical care or to experience any severe medical events than unvaccinated individuals.
In the second study, "FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system," the authors analyzed the same cohorts to assess the real-world effectiveness of BNT162b2 and mRNA-1273 vaccines. By comparing rates of positive PCR testing, hospitalization, and ICU admission between the vaccinated and matched unvaccinated individuals, they found that both vaccines protect against SARS-CoV-2 infection and severe COVID-19. Specifically, the estimated effectiveness in preventing infections was 86% for BNT162b2 and 93% for mRNA-1273, and no individuals receiving either vaccine were admitted to the ICU for COVID-19.
Since multiple CDC-recognized variants of concern, including the UK variant, were circulating significantly during the time period of this study, this research validates the real-world effectiveness of the two messenger mRNA vaccines against this variant of concern. Furthermore, beyond symptomatic COVID-19 diagnosis studied in clinical trials, this study is the first to demonstrate that the COVID-19 mRNA vaccines significantly mitigate even asymptomatic human-to-human transmission of the SARS-CoV-2 pathogen.
"These studies provide critical, independent real-world insights that should assuage those who are vaccine-hesitant because the evidence is undeniable. These vaccines are extremely safe and effective, including to mitigate asymptomatic viral transmission and against some of the prominent variants of concern," said Venky Soundararajan, PhD, co-founder and chief scientific officer of nference.
In the process of conducting these studies, nference employed its leading-edge augmented intelligence software platform, nferX®, which uses proprietary natural language processing, molecular analytics, and clinical institutional wisdom synthesis technologies to rapidly process and triangulate vast amounts of biomedical insights from disparate sources in previously incompatible formats.
"The application of augmented curation technology over the Mayo Clinic institution-wide clinical data analytics platform provides compelling, timely evidence that vaccinations are indeed the key to conquering the COVID-19 pandemic," said Andrew Badley, MD, co-author of the study enterprise chair of the department of molecular medicine and enterprise chair of COVID-19 task force at the Mayo Clinic.
The innovative and powerful augmented intelligence technology implemented by nference during the COVID-19 pandemic has enabled scientific discoveries with a wide range of implications that contribute to a greater understanding of the virus, which are ultimately advancing patient care and informing important policy decisions at the vanguard of protecting global public health.