VP Mike Pence announces first-ever Phase 3 vaccine trial during visit to Florida

by | Jul 28, 2020

Vice President Mike Pence and Governor Ron DeSantis announced the first Phase 3 COVID-19 vaccine clinical trial in the country during a Covid-19 roundtable at the University of Miami School of Medicine. The Vice President started the roundtable by declaring a “day of hope” and that “today is a day of promise.”

Pence emphasized that the development of the vaccine is a tribute to American ingenuity and President Donald Trump‘s “relentless drive”.

“The FDA cleared the way today for what will be the first ever phase 3 clinical trial in the United States. With 89 sites across America with up to 30,000 participants. We will begin the first phase 3 clinical trial for a vaccine for the Coronavirus,” said Pence, who also credited FDA Commissioner Stephen Hahn for his work to move the vaccine trial forward. “And let me just say how the President and I are truly grateful for Dr. Hahn’s leadership at the FDA.”

Hahn, who was also present at the event, emphasized the importance of the reduction in time for the development of the vaccine. He pointed out that in normal vaccine trials, there is typically some significant lag time between phase one and phases two and three. Hahn emphasized that the current situation calls for a much more aggressive and accelerated approach, which included compressing phase one and phase two together.

The Trump administration  is aggressively by safely developing a vaccine in record time under Operation Warp Speed, Hahn said.

“FDA is doing what is called a real-time review, we’re not just waiting for the end of the trial,” Hahn said. “We’re reviewing it in real time so that we can look at the data in real time and then come to a quicker decision at the end of the trial.

Hahn explained that FDA has done that with a lot of medical products during the pandemic and its given the United States “a leg up in terms of speed.” Operation Warp Speed has given vaccine developers the confidence to develop large quantities of the vaccine so that if it does prove effective, it can be deployed rapidly. Normally, without financial protections in place, vaccine makers would have to wait until the drug is approved by FDA before investing millions or billions of dollars to manufacture a drug that may ultimately not be approved. The federal guarantees to vaccine makers have ensured that if a drug is approved, it will be ready for deployment almost immediately.

 

1 Comment

Leave a Reply to Tony T Rodriguez Cancel reply

%d bloggers like this: