May 19, 2020

Moderna vaccine progress a positive development according to former FDA commissioner, but theres a lot of work ahead
Early data on a Coronavirus vaccine candidate is encouraging, but there's still "a lot of work" to be done, the former commissioner of the FDA says. Moderna on Monday announced some "positive" interim data on its potential COVID-19 vaccine, saying that eight patients in a phase one trial developed antibodies at levels similar to those who recovered from the coronavirus. The stock market surged in reaction to the hope that a vaccine could be on the horizon. Scott Gottlieb, former Food and Drug Administration commissioner, in an interview on CNBC Tuesday agreed this was a "positive development," since it suggests the vaccine "can produce an immune response." He noted, though, that since Moderna only tested the first eight patients of 45 for neutralizing antibodies, "we need to know the data on the other patients, and whether in fact those are neutralizing antibodies, the kinds of antibodies that target the virus and destroy the virus." "They need to figure out what the right dose is for this vaccine, so they're going to need to do a lot of phase two work before they can get into a phase three trial to determine the optimal dose," Gottlieb said. "We also have to make sure that these vaccines are producing neutralizing antibodies." Based on early data, it now seems "reasonable" to assume we'll get a vaccine against COVID-19 "at some point," Gottlieb concluded. But when? Though President Trump has touted a potential end-of-year timeline, Gottlieb, who previously said a widely-available vaccine is likely a "2021 event," isn't sure about this incredibly tight schedule. "The timing is questionable," he said, "whether or not we can have it before the end of the year, or whether or not we'll have to wait until 2021 to have a product we can use more generally."

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