Monkeypox Vaccines May Be Real-World Data’s Time to Shine

October 25, 2022

Real-world data (RWD) played a pivotal role in the rapid development and regulatory approval process for the current slate of COVID-19 vaccines. Similarly, the development and timely rollout of monkeypox vaccines depends on RWD. For example, RWD is helping inform the move to intradermal injection of Bavarian Nordic’s Jynneos vaccine to help stretch limited supplies.

According to Girisha Fernando, “With vaccine doses limited and no opportunity at any point in the past to test dosing changes, or even the clinical effectiveness of the vaccine against actual monkeypox exposure in humans, the only way to establish efficacy now, at least in the short term, will be to collect and analyze real-world data. In fact, the effectiveness of the original dose against actual monkeypox infection was tested only on animals while its safety, and the levels of antibodies produced in the bloodstream, are being tested on humans, meaning that scientists have little understanding of how well it works, how long it lasts, if it stops transmission, and other factors.”

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