Moderna, the well-known biotechnology firm, has just announced that it is pulling its application. This application was looking for approval of a combined COVID-19 plus influenza vaccine candidate. The company is particularly passionate, seemingly, about the long-expected, hotly anticipated efficacy data from a late-stage trial of its one-influenza shot. That vital information should become available later this year. The withdrawal is emblematic of the increasing pressure on Moderna to adapt to an entirely different regulatory environment.
Moderna’s decision could not have come at a better time. That’s all occurred just a day after the U.S. Food and Drug Administration (FDA) declared that new clinical trials would be required to approve annual COVID-19 boosters for healthy people younger than 65. Regulatory scrutiny on tech space has increased sharply in recent months. This change follows the recent appointment of leading vaccine-skeptic Robert F. Kennedy Jr. to be secretary of the U.S. Department of Health and Human Services. In fact, his leadership has already started spooking investors about what vaccine approvals will look like in the U.S. moving forward.
Moderna’s shares have experienced a steep decline of over 30 percent this year, reflecting investor apprehension about its market performance amid regulatory challenges and declining COVID revenue. Shares of Moderna are still up at $24.20 in premarket trading, despite the application withdrawal news. That’s a modest uptick even with the recent market correction.
Also appealing to investors is Moderna’s confidence that the FDA will act quickly on its next-generation COVID-19 vaccine. According to them, the final verdict should come at the end of this month. The company is obviously under the gun to keep moving its R&D pipeline while satisfying the regulatory hurdles we all know exist.
The pause in the joint vaccine application further underscores the political minefield vaccine developers must navigate. This new development is particularly important in light of the heightened focus from health regulators. Moderna’s commitment to waiting for solid efficacy data before proceeding with the approval process reflects a cautious approach in an uncertain climate.
