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On Friday, Feb. 5 – a day in which the United States logged nearly 125,000 new COVID-19 cases and more than 3,550 deaths – the U.S. Food and Drug Administration announced it would wait more than three weeks to review Johnson & Johnson’s request for emergency use of its coronavirus vaccine.
The company submitted its application only the day before, but the 22 days between Johnson & Johnson’s application submittal and FDA review would be two days longer than it took the FDA to review data for Pfizer’s COVID-19 vaccine. It would be five days longer than the process to review Moderna’s treatment.
Five days – or, potentially, 500,000 (or more) new coronavirus cases and 17,550 deaths.
Defenders of the FDA will argue regulators have thousands of pages of data to examine. That is true. And to ensure public confidence in the treatment, the process should not be truncated. But it is likely the FDA could move faster without sacrificing scientific integrity, or the health and welfare of the American people.
In a December 2020 column at MedPage Today where he analyzed the length of time between application submittal and FDA review for the Pfizer vaccine, Dr. Marty Makary said, “Staring for three weeks at the data from the Pfizer vaccine trial does not add any more information than reviewing it in two days. The FDA should not compromise on the integrity of its review, just move faster.” These arguments are the same ones we outline here.
A physician, public health expert, and professor of surgery and health policy at the Johns Hopkins University School of Medicine who has conducted more than 100 clinical studies, Dr. Makary also noted, “The FDA has approximately 17,000 employees, scores of qualified experts, and no shortage of external scientists willing to help.” As the New York Post reported, Makary recommends that, to speed up the process, the FDA use “rolling reviews” to evaluate data as it becomes available. This method is used by the European Medications Agency to review drug trial data.
Johnson & Johnson’s international trial data showed that, globally, its vaccine is 66 percent effective at preventing moderate to severe cases of COVID-19. In the United States, the drug is even more effective. It could prevent moderate to severe cases in about three-quarters of the population. In contrast, according to the U.S. Centers for Disease Control and Prevention, the annual flu vaccine reduces the risk of flu illness by between 40 percent and 60 percent.
The Johnson & Johnson vaccine is administered in a single dose and can be stored in a standard refrigerator – making it more convenient than the two other treatments on the market, particularly in hard-to-reach or resource-constrained areas of the country. The Wall Street Journal has said, “The addition of J&J’s vaccine could jump-start a U.S. mass-vaccination campaign that has been choppy since it began in December.”
Instead, the nation’s vaccination effort idles as the FDA dawdles.
The fact that the United States has not one, not two, but potentially three vaccines available to treat a disease that was first diagnosed in the country a year ago is nothing short of remarkable. The scientific community, drug makers, and individual volunteers marshalled their brain power and willpower, to get the country to this point.
The nation is building vaccine manufacturing capacity in real time. When the stakes are so high, regulators should be working nights, weekends, and holidays as well.
Policymakers also must enact reforms to the FDA process to ensure anxious Americans never have to endure unnecessary drug delays again. Click here to urge federal lawmakers to prioritize reforms that will get government out of the way and empower the private sector to innovate.