Locations of COVID vaccine trials impacted by vaccine efficacy results

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Abhijith Anand, Assistant Professor at Sam M. Walton College of Business

A new study by a U-of-A information systems researcher and his colleague from the University of Waikato in New Zealand shows that COVID vaccine trials conducted in geographic locations with low infection rates increased compared to trials in locations with high infection rates resulted in higher efficacy results.

Abhijith Anand, an assistant professor at the Sam M. Walton College of Business, and Rajeev Sharma, a professor at the University of Waikato in New Zealand, were puzzled by the efficacy rates of approved COVID-19 vaccines, which ranged from 95 to 45 percent, and wondered whether the prevalence of COVID-19 infection rates at the sites where pharmaceutical companies conducted studies could have something to do with the differences in observed efficacy.

The researchers based their guess on the fact that higher infection rates generally imply more mutant strains, which are likely to lead to more breakthrough infections and consequently reduce the effectiveness of the vaccines observed in the study.

“Based on the reported figures on vaccine effectiveness, many important decisions have been made by legislators, politicians and even the general public,” Anand said. “Reported vaccine efficacy figures have varied widely across different vaccines. We were interested in why there was a discrepancy.”

Using data from the World Health Organization, McGill University, the London School of Hygiene & Tropical Medicine Vaccine Centre, scientific publications, clinicaltrails.gov and others, Anand and Sharma tracked the pharmaceutical companies that had reported efficacy results from phase 3 studies of their COVID-19 . 19 vaccines. The researchers then pulled together all the publicly available data on the pharmaceutical companies and focused on the location, conduct, and efficacy results of the phase 3 trials.

The database compiled by Sharma and Anand represents “all the current publicly available worldwide evidence” on the efficacy of approved SARS-CoV-2 vaccines.

Based on the data, the researchers examined whether there was a link between the prevalence of COVID-19 infection rates at the trial sites and the effectiveness of COVID-19 vaccines. Geographic location was found to have a significant association with observed COVID-19 vaccine efficacy. Vaccine studies conducted in locations with low infection rates showed higher effectiveness, while studies conducted in locations with high infection rates showed lower effectiveness.

The results have important implications for shaping public policy, patient care and individual decisions. Public health organizations advise individuals, organizations, medical professionals, and government agencies on the effectiveness of vaccines based on the results of clinical trials conducted by pharmaceutical companies. This advice is often the starting point for legislation and/or policy for the public, businesses, schools, medical clinics, and government regulators.

Most of the advice comes from well-established and respected government agencies like the Centers for Disease Control, the Food and Drug Administration, and the World Health Organization, which also work with pharmaceutical companies that develop and test vaccines.

The researchers argued that vaccine efficacy could only be validly interpreted in conjunction with the level of pandemic prevalence, and that Phase 3 trials should include analysis of participant samples of mutant strains, which could result in breakthrough infection and high levels of virus.

“When efficacy results from phase 3 trials are reported, they should include the level of pandemic prevalence at the study sites,” Anand said. “That would provide policymakers with more meaningful information than the current practice of only reporting efficacy results.”

The researchers’ study was published in PLUS ONEa publication of the Public Library of Science.

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