Moderna spent years and hundreds of millions of dollars developing a flu vaccine using the same technology that allowed the United States to produce covid-19 vaccines in record time. But now the drug company’s flu shots are not getting a fair shake from the Food and Drug Administration.
This week the FDA’s top vaccine regulator, Vinay Prasad, rejected Moderna’s application without even reviewing it. The longtime critic of mRNA vaccines also overruled objections from agency scientists, according to Stat News. The message to companies that develop lifesaving medicine is clear: Investing in new vaccine technology is a waste of time and money. It’s particularly dangerous at a time when China looks increasingly capable of leapfrogging the U.S. in biosciences.
The FDA criticized the company’s application for not including an “adequate and well-controlled” study. But Moderna did submit a trial that included data comparing the shot to Fluarix, a traditional vaccine made in chicken eggs, which the agency said before the trial commenced would be “acceptable.” Moderna also conducted a smaller study comparing its mRNA vaccine to a high dose shot for older people, as the FDA recommended.
The Massachusetts-based company acknowledges that the FDA indicated last August that there could be a “significant issue” with the data “during review.” Yet that review won’t even happen, which is highly irregular. Health and Human Services spokesman Andrew Nixon said Moderna “refused to follow very clear FDA guidance.” Agency leaders also dispute reporting that scientists were overruled, insisting the decision followed “healthy scientific debate.”
Prasad did not share any concerns about the safety or efficacy of Moderna’s shots. Indeed, Moderna’s trial indicated that they performed better than the control groups.
The administration has made no secret of its bias against mRNA vaccines, and this seems to be an instance of moving the goalposts to undermine the technology. Last year, HHS Secretary Robert F. Kennedy Jr. canceled almost $500 million in contracts for projects to develop shots with the game-changing technology, claiming absurdly that mRNA covid vaccines are ineffective and “encourage” viruses to mutate. In reality, they have saved millions of lives.
Prasad previously overruled agency officials to limit eligibility for covid vaccines. He also hyped up a rare but serious side effect from covid shots known as myocarditis, or inflammation of the heart. In November, he sent a staff memo claiming that FDA scientists identified at least 10 cases in which the vaccines were tied to a child’s death. But the FDA has not produced additional data to back up that claim.
Overzealous government agencies arbitrarily suppressing innovation is lamentable. When that innovation could save countless lives, it becomes a tragedy.
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