Sources suggested that a number of drugmakers, including GlaxoSmithKline, Johnson & Johnson and Pfizer, are planning to release a statement outlining their commitment to only seek FDA approval of a vaccine against COVID-19 if it is supported by extensive safety and efficacy data. The move is seen as a response to political pressure faced by the regulator to authorize a vaccine as soon as possible.
At a recent news conference, President Donald Trump said a vaccine could be ready “maybe even before November first” or “some time in the month of October.” However, these expectations have been tamped down by others, with Moncef Slaoui, who heads the US government’s Operation Warp Speed coronavirus vaccine initiative, saying that it is “extremely unlikely” a vaccine would be ready by election day on November 3.
The statement, which could be released over the next few days, promises to prioritize the safety of vaccinated people, with the drugmakers committing to only seek an emergency-use authorization or government licensure based on “substantial evidence of safety and efficacy” from Phase III studies. According to a draft copy, the companies, including Moderna and Sanofi, “believe this pledge will help ensure public confidence in the COVID-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated.”
Commenting on the news, Jim Greenwood, the former head of the trade group BIO, remarked “I can say with complete authority that no company wants to have anything approved but under the strictest standards, the gold standard at the FDA.” Greenwood added “it’s in no biopharmaceutical company’s interest to have a product provided to patients that isn’t proven to be completely safe and effective.”