FDA Should Approve Faster Clinical Trials for Boosters to Block New Covid-19 Variants

(p. A17) . . . , it is essential to design clinical trials that can be completed within several months, to avert potential outbreaks of new variants. It’s fast, but given today’s scientific capabilities that could be enough time to do the required trials.

Take the South African variant known as B1351. The existing trials will be used to establish that the current vaccines provide clinical protection against Covid disease. But to prove the new versions targeting B1351 work as well as the current vaccines, the FDA can measure the antibody levels in the plasma from patients who have recovered from B1351 and establish a benchmark for the number of antibodies needed to neutralize that virus. Then the FDA can use those antibody levels as a proxy to evaluate whether updated vaccines are able to generate sufficient levels of protection.

This could allow vaccine makers to test new boosters in clinical trials that enroll 300 or 400 patients rather than 40,000, an enormous savings in cost and time. Larger and longer studies can be started at the same time, including ones that follow vaccinated patients.

For the full commentary, see:

Scott Gottlieb. “Another Promising Vaccine, This One From Johnson & Johnson.” The Wall Street Journal (Monday, February 1, 2021): A17.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date January 31, 2021, and has the same title as the online version.)

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