FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot
A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say
Key Points
- The FDA is requesting that Novavax conduct another clinical trial for its Covid-19 vaccine.
- Appointees under Health Secretary Robert F. Kennedy Jr. intervened in Novavax’s Covid-19 shot approval.
- A new trial could cost millions, but the FDA may allow smaller study.
Federal regulators are asking Novavax NVAX -6.15%decrease; red down pointing triangle to complete an additional randomized clinical trial on its Covid-19 vaccine after previously delaying approval, people familiar with the matter said, a request that could be so prohibitively expensive the company might not be able to fulfill it.
The Maryland-based company was asked by the Food and Drug Administration to show its vaccine is effective with another randomized study after appointees under Health Secretary Robert F. Kennedy Jr. intervened in the approval process, the people said. The additional step goes beyond what other Covid-19 vaccine makers had to do to win approval, and could be an early sign of new challenges for drugmakers hoping to get approvals.
The company’s shot already showed 90% efficacy in a 30,000-person, placebo-controlled trial, and it is already available in the U.S. under an emergency use authorization and has won full approval in Australia, Europe and Japan.
A new randomized trial with enough participants to judge the vaccine’s ability to prevent disease could cost tens of millions of dollars, vaccine experts said.
The FDA’s request for new data gives Novavax room to negotiate for a smaller, less expensive study, perhaps costing only a few million dollars, a person familiar with the matter said. The company responded to the agency earlier this week, the person said. Negotiations will need to move quickly for the company to have time to adjust its vaccine to the strain of the virus most likely to dominate in the fall and request approval for an updated shot tweaked to match.
A health department official said that the department is committed to safe products and gold-standard science.
The agency asked the company to promise further study of its shot after it wins approval—a sign to some that the FDA will likely give the company a green light. Shares of Novavax got a boost Wednesday after it reported that the FDA had requested a postapproval commitment to generate additional data. The company didn’t specify that it had been asked to do a randomized trial.
New FDA Commissioner Dr. Marty Makary and his principal deputy commissioner, Dr. Sara Brenner, were involved in the decision to hold off on the approval for the vaccine. The agency had set a goal date of April 1 for the decision and missed that deadline.
The FDA has long tried to avoid even the appearance of political interference in drug and other product approvals, allowing career staff in almost all cases to make those judgments.
Since Kennedy was confirmed, vaccines and the processes around their approvals have come into the limelight. Kennedy, known for his vaccine-skeptical views, promised during his Senate confirmation that he would work within current vaccine-approval systems. He also said he doesn’t aim to take vaccines away.
In a recent CBS interview, he said the government is “looking at” Novavax’s vaccine approval because shots similar to it—those targeting a single antigen—“have never worked” for respiratory illnesses. The comment baffled scientists who pointed to other shots for Covid-19 and RSV as examples of similar vaccines that work.