FDA releases new standard for vaccine development, makes vaccine’s 2020 launch hopes even less likely

BEIJING, July 2 (Xinhua) — The U.S. Food and Drug Administration (FDA) has issued new standards for the development of a new coronavirus vaccine, potentially thwarting Wall Street’s hopes that vaccines will be available before the November U.S. election. Geoffrey Porges, an analyst at SVB Leerink, said the first authorization seemed more likely to occur in early 2021 because the FDA’s emergency authorization criteria were not much lower than the standards required for full approval.

FDA releases new standard for vaccine development, makes vaccine's 2020 launch hopes even less likely

Guidelines released Tuesday by the FDA say any candidate vaccine must be proven to be at least 50 percent more effective than a placebo, and that data on immune response alone are not enough.

“It’s hard to predict how these studies will recruit thousands of patients, vaccinate them, and then observe their safety for six months or more, and then get approval (before the end of the year),” Porges wrote in a letter to clients. A fully approved vaccine would require “extensive safety data and comprehensive clinical efficacy,” he said.

As a result of reports that President Donald J. Mr. Trump is pressing health officials for re-election, and investors have been expecting the first vaccine to go on sale in the fall. Drug and vaccine developers, including Johnson and Johnson, Merck, Pfizer and Moderna Inc. Is participating in the U.S. government’s curvature program. The government’s plan aims to speed up vaccine development faster than ever before, though few details are available about the plan.

Pfizer rose 5.6 percent on Wednesday after preliminary data from its partner BioNTech SE showed a candidate vaccine showed a welcome effect, compared with small vaccine development company Inovio Pharmaceuticals Inc. Shares plunged 27%. Moderna, one of the leaders in the sector, fell 7.9 percent. All three vaccine programs may require longer-term results to clearly demonstrate safety, Porges said. In particular, DNA vaccines like Inovio’s, “may face stricter standards given widespread concerns about gene integration.” “

Porges doesn’t think there will be a vaccine on the market in 2020, and “this effort is by no means necessarily going to be successful,” he said. Instead, he predicts that it could take another two or three years for the vaccine to be fully approved, and a year before it is widely adopted.