Federal regulators have requested that Novavax conduct an additional randomized clinical trial of its COVID-19 vaccine, a costly demand that could threaten the company’s ability to comply, The Wall Street Journal reported April 25.
The FDA asked the company to show its vaccine is effective with another randomized trial after officials appointed by HHS Secretary Robert F. Kennedy Jr. intervened in the approval process, people familiar with the matter told the Journal.
The shot showed 90% efficacy in a placebo-controlled trial of 30,000 participants and is available in the U.S. under emergency use authorization.
Vaccine experts told the Journal that a new randomized trial with the same number of participants could cost tens of millions of dollars. However, the FDA’s request for new data gives Novavax room to negotiate for a smaller, less expensive study.
FDA Commissioner Marty Makary, MD, and Principal Deputy Commissioner Sara Brenner, MD, were involved in the decision to hold back on the approval of the vaccine, according to the Journal.
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