Opinion: Monkeypox vaccine: a case study for real-world data
With health emergencies becoming more common, the world needs more efficient ways to test the safety and effectiveness of drugs, even if they haven’t yet completed the lengthy series of clinical trials the Food and Drug Administration usually requires. Data from the real-world use of new drugs offers an increasingly valuable and efficient way to do this.
That’s how authorities were able to determine that the initial vaccines for Covid-19 were safe and effective on a large scale in 2020. Because the virus was spreading so quickly, it took only a few months to begin to see the difference in outcomes between trial participants who received an actual vaccine versus those who received a placebo. Later, in 2021, when data showed that significant numbers of vaccinated people were becoming infected, health experts quickly instituted guidance for additional booster shots.
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