It’s Time To Cure The FDA’s Regulatory Sclerosis

It’s Time To Cure The FDA’s Regulatory Sclerosis

Late last month, the Food and Drug Administration advised COVID-19 vaccine manufacturers to develop booster shots aimed at the omicron variant of the virus. Regulators hope the shots will be ready by the fall.

That will probably be too late to stop BA.5, the highly transmissible subvariant that has quickly become the dominant strain in the United States.

It’s been roughly six months since omicron caused COVID cases to spike. Yet the FDA waited until a new, more transmissible version of the virus was threatening a wave of cases and reinfections to recommend updating the vaccines, which are based on a two-year-old version of the virus that bears less and less resemblance to today’s offshoots.

This is all par for the regulatory course. The FDA has not displayed sufficient urgency throughout the COVID-19 crisis—and is threatening to repeat its mistakes with the ongoing outbreak of monkeypox. It’s long past time for lawmakers to reform the sclerotic agency.

BA.5 is already sending case rates skyward. More than 120,000 Americans are contracting COVID each day, on average, according to the Centers for Disease Control and Prevention. Sadly, Los Angeles County is seriously considering reintroducing a mask mandate later this month.

That CDC case count may be an underestimate, since many public testing sites have closed and most individuals are testing at home, if they’re testing at all.

The original COVID shots are still effective at preventing severe disease caused by BA.5. But they’re less adept at preventing infection, since the subvariant is able to evade some antibodies produced by vaccines and previous infections.

That’s why the FDA told vaccine-makers to update the shots to target BA.5, along with a similar omicron subvariant, BA.4.

But the subvariants are moving targets. In South Africa, where BA.4 and BA.5 caused a spike in cases this spring, the surge lasted just two months. Dr. John Beigel, a clinical research director at the National Institutes of Health, estimates cases will similarly peak within the next month or two in the United States.

So new shots could be outdated by the time they’re rolled out. While Pfizer has said it may have its updated doses ready by October, Moderna officials have said they won’t be able to deliver the vaccines “at large scale” until November.

The science is not the problem. The regulatory state is.

As soon as scientists identified omicron last fall, Moderna and Pfizer started working on reformulating their shots to target its BA.1 variant. More than 200 days later, the FDA hadn’t met to discuss the new vaccines.

By the time the agency’s vaccine advisors finally convened last month, BA.4 and BA.5 were the dominant strains. That forced vaccine-makers to pivot and create new formulas for their shots.

The advisors had a wealth of evidence on the original vaccine’s waning efficacy against, and the higher transmissibility of, the new subvariants. But they still had reservations about updating the shots.

One voiced concern about the ethics of creating better vaccines in the United States that wouldn’t be immediately accessible to the rest of the world. Others worried people who received an omicron-specific vaccine would feel too “bulletproof” against COVID-19 and could take unnecessary risks. Another warned that we shouldn’t move too quickly to update the vaccines because we’re not yet sure how much the update will help.

This type of thinking has biased the FDA toward inaction throughout the pandemic. Rather than focusing on getting effective vaccines to the public as quickly as possible, the agency has been bogged down by concerns about equity, armchair psychology, and an insatiable request for more data.

The FDA’s response to monkeypox offers no indication it’s changed its ways. The first cases appeared in the United States in May. As of July 15, the Centers for Disease Control and Prevention had logged more than 1,800 cases.

People at risk of contracting the disease are clamoring for vaccines. Yet about a million doses have languished in a Danish facility for roughly two months. The FDA hasn’t certified the facility yet—and doesn’t expect to give it the formal green light until the end of July. Never mind that European regulators declared last year that the facility complies with the FDA’s own standards.

Instead of enacting reforms to streamline the bureaucracy, some Democratic lawmakers want to ensnare it in even more red tape. One bill, for instance, would hamstring the FDA’s accelerated approval pathway, which has allowed for more than 250 drugs for rare and deadly conditions to reach patients years ahead of schedule.

That bill may prove costly to Democrats’ political fortunes. A recent Morning Consult poll shows that two-thirds of voters in five key swing states—Arizona, Georgia, Nevada, New Hampshire, and Pennsylvania—support accelerated approval.

As midterm elections approach, FDA reform should be on the ballot. Lawmakers would do well to advance policies that would cure the agency’s sclerosis.

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