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Only When Safe, Effective

A number of vaccine developers have issued a statement in which they pledge to not seek regulatory approval of a SARS-CoV-2 vaccine until it has been shown to be safe and effective, the Wall Street Journal reports.

The statement comes as there are increasing concerns that the approval of a vaccine may be rushed for political purposes so one is ready by the November US election. The New York Times, for instance, reported that a Department of Health and Human Services presentation in April laid out a late October deadline for an Operation Warp Speed vaccine, a timeline that was later extended to the end of the year or early 2021. Meanwhile, CNBC reported the US Centers for Disease Control and Prevention has issued a memo to governors to prepare their states for mass distribution of a vaccine or vaccines by the end of October.

Interference worries, the Journal noted in a previous article, have been reinforced by criticism of the Emergency Use Authorizations issued by the Food and Drug Administration for convalescent plasma and, earlier, for hydroxychloroquine. The hydroxychloroquine EUA was later rescinded, it adds.

According to the Journal, the companies, which include Johnson & Johnson, Moderna, and Pfizer, plan to promise not to submit applications for an EUA or a license unless there is "substantial evidence of safety and efficacy" from phase III clinical trials.

"We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved," the statement says, according to the Journal.