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The Development of COVID-19 Vaccines: Safeguards Needed.

A safe and effective vaccine against coronavirus disease 2019 (COVID-19) is the best way to control and ultimately end the pandemic. Vaccine development is moving at unprecedented speed, with more than 200 candidates, billions of dollars committed, and manufacturing often proceeding before even knowing whether a given vaccine candidate will succeed. To date, the US federal government has rapidly advanced 5 vaccine candidates through Operation Warp Speed.1 At the same time, a growing movement of skeptics has raised doubt about future COVID-19 vaccines.2 A poll of 1056 individuals in the US found that only 49% reported that they currently are planning to receive a COVID-19 vaccine, 31% are uncertain, and 20% are not, with safety a major concern.3 The best response to such concerns is a transparent and rigorous approach to vaccine development and regulation, including for licensure or any prelicensure use permitted by the US Food and Drug Administration (FDA). For this effort to be successful, it is critical that the independence of the agency be respected, standards maintained, and politicians kept from pronouncements that create the appearance of interference such as that engendered by the emergency use