A stump speech at a trial initiation
The start of a Phase 3 clinical trial is certainly a milestone worth marking — particularly when it's for a potential Covid-19 vaccine — but the Trump administration used the occasion of the start of Moderna's pivotal trial to claim success in driving the development of drugs and vaccines for the coronavirus.
Vice President Mike Pence announced that "today is a day of hope" during a visit to the University of Miami, one of the sites that will test Moderna’s vaccine in Phase 3. President Trump, touring a manufacturing facility in North Carolina, touted the investments from the administration's Operation Warp Speed in developing candidates and manufacturing them at risk. "We will achieve a victory over the virus by unleashing America's scientific genius, which is what it is," Trump said, adding that the manufacturing efforts amounted to "a colossal industrial mobilization." (We'll note that both Florida and North Carolina are swing states.)
What went unsaid was that it's the Phase 3 trial that will show whether the vaccine candidate is protective, so any hype right now could be seen as premature. Both Trump and Pence also sought to counter concerns that the administration might pressure the FDA to authorize a vaccine that hasn't demonstrated a full safety and efficacy profile: "We've done it while maintaining the FDA gold standard for safety," Trump said about the progress on vaccines.
Vice President Mike Pence announced that "today is a day of hope" during a visit to the University of Miami, one of the sites that will test Moderna’s vaccine in Phase 3. President Trump, touring a manufacturing facility in North Carolina, touted the investments from the administration's Operation Warp Speed in developing candidates and manufacturing them at risk. "We will achieve a victory over the virus by unleashing America's scientific genius, which is what it is," Trump said, adding that the manufacturing efforts amounted to "a colossal industrial mobilization." (We'll note that both Florida and North Carolina are swing states.)
What went unsaid was that it's the Phase 3 trial that will show whether the vaccine candidate is protective, so any hype right now could be seen as premature. Both Trump and Pence also sought to counter concerns that the administration might pressure the FDA to authorize a vaccine that hasn't demonstrated a full safety and efficacy profile: "We've done it while maintaining the FDA gold standard for safety," Trump said about the progress on vaccines.
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