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Good news strikes from an unlikely source. On Aug. 6, the Food and Drug Administration approved Replimune's immunotherapy for metastatic melanoma, a day after it green-lighted mFlusiva, Moderna's mRNA flu vaccine. The shame is that both might have been available sooner but for regulatory delays, which hurt both patients and American innovation.
Replimune has been working on its RP1 immunotherapy for a decade but got caught in the FDA cross-hairs at the last stretch. FDA review staff recommended approval after its late-stage trial showed that a third of patients whose disease had worsened on other immunotherapies went into remission. Yet Vinay Prasad, the former biologics and vaccine chief, deep-sixed RP1 last summer.
The White House gave Dr. Prasad the boot by this spring -- in large part because of his hostility to new treatments -- but the bureaucrats who shared his views then tried to block RP1's approval again. Fortunately, an advisory committee of outside scientists and doctors last week backed approval, and the FDA's new leaders have heeded.
Ditto for Moderna's flu vaccine, which was unanimously supported by an advisory panel in June. In a large randomized trial of patients over age 50, Moderna's vaccine was 27% more effective at preventing symptomatic flu and 50% against hospitalization, compared with a standard shot. Flu shots are typically only about 40% effective, and even modest improvement on that could reduce hospitalizations by tens of thousands a year.
One shortcoming of existing flu shots is that the immune response wanes after a couple of months. Moderna's vaccine elicits more durable immunity, so it should confer better protection as the winter drags on. The mRNA platform also accelerates vaccine manufacturing, which could greatly reduce the lead time required for selecting flu strains.
Scientists currently do their best in early March to choose strains to target for the following flu season. This lag sometimes results in a mismatch between manufactured shots and the flu strains that end up circulating, and the hope is that Moderna's speedier process will allow better targeting. The main drawback is patients who received mFlusiva were likelier to report side effects, such as fatigue, muscle aches and headaches. But the FDA is right to let patients and doctors weigh the benefits against the downsides.
Contrast that with the paternalism of Dr. Prasad, who in February tried to block the review of Moderna's application. He quibbled that the company didn't use a high-dose flu shot as its placebo, even though the latter aren't available in many of the European countries where its trial was conducted.
Moderna plans a follow-up study in seniors to compare mFlusiva's efficacy with traditional high-dose vaccines, which is a reasonable compromise. Still, it's regrettable that gaining approval took five years from when Moderna began testing its vaccine in humans, versus less than a year for COVID jabs under the first Trump administration's Operation Warp Speed.
Acting vaccine chief Karim Mikhail recently said early-stage trials "that may take up to two years to complete here in the United States are completed in nine months in China." As a result, China is attracting more biotech investment. Regulatory uncertainty under the prior FDA leadership also cast a chill over the biotech industry.
The Moderna and Replimune approvals are positive signs that the new leadership may be mounting a much-needed turnaround. Dr. Mikhail recently announced several initiatives to streamline the FDA's bureaucratic processes that slow drug development. America needs a permanent Operation Warp Speed.
ONLINE: https://www.wsj.com/opinion/lesson-moderna-mrna-flu-shot-fda-replimune-e42bd1d0?mod=editorials_article_pos10
-- The Wall Street Journal