US begins Phase 3 trial of potential Covid-19 vaccine

Miami, Jul 27 (efe-epa).- Vice President Mike Pence was here Monday to celebrate the start of Phase 3 clinical trials of a potential coronavirus vaccine, suggesting that millions of doses could be distributed in the United States before year’s end.

“America first” will be the principle guiding distribution of any US-produced vaccine, he said during a public event at the University of Miami’s Miller School of Medicine, one of the 89 sites across the country taking part in testing the formula devised by biotech firm Moderna with the National Institutes of Health (NIH).

The US is the global center of the pandemic, with more than 147,000 deaths and upwards of 4.3 million confirmed cases.

On Monday, the White House disclosed that President Donald Trump’s national security adviser, Robert O’Brien, was self-isolating at home after testing positive for Covid-19.

“We look forward to the results. And we thank you for the cooperation that’s brought us, really, to this – this historic day, a day when we begin in earnest, in Phase 3, down the path toward securing a vaccine for the American people,” Pence said in Miami.

Though the process has been expedited as part of Trump’s Operation Warp Speed, the vice president vowed that every care will be taken to ensure that the vaccine is safe.

“There’ll be no shortcuts. There’ll be no cutting corners on safety in the development of this vaccine,” he said, stressing that the Food and Drug Administration, whose head, Dr. Stephen Hahn, accompanied him to Miami, was applying the “highest standards to the development of this medicine.”

Half of the 30,000 volunteers will receive the Moderna-HIV vaccine, while the rest will get a placebo.

Florida Gov. Ron DeSantis and Congressman Mario Diaz-Balart, who had Covid-19, were also present for the roundtable along with Dr. Susanne Doblecki-Lewis, who is leading the University of Miami arm of the Moderna Covid vaccination trial.

Pence said there was “no better place” to visit than Miami to discuss the Phase 3 clinical trial.

The Sunshine State is second only to New York in the number of cases and greater Miami is the epicenter of the outbreak in Florida.

Pence said that the Trump administration insisted that Moderna and pharmaceutical giant Pfizer – also working on a vaccine – begin large-scale production in parallel with the clinical trials to ensure that they can supply tens of millions of doses once a formula is approved.

The vaccine should be available by late 2020 or early next year, the vice president said.

Moderna’s CEO, Stephane Bancel, said earlier Monday in a conference call with reporters that the company was “on track to deliver 500 million doses” by September 2021 if the vaccine proves safe and effective.

Unlike traditional vaccines, the Moderna-NIH drug is designed to function by using the genetic material of the virus, messenger RNA (mRNA), to activate the body’s immune system so it will produce antibodies to the virus.

Dr. Anthony Fauci, the country’s top epidemiologist, acknowledged Monday that mRNA vaccines represent an untested approach, but urged people not to be alarmed by the use of “novel technology.”

“I’m not particularly concerned,” he said. “But I don’t want a lack of severe concern to get in the way that we are keeping an open mind to look for any possible deleterious effects as we get into and through the Phase 3 trial.”

Fauci joined the NIH director, Dr. Francis Collins, for a virtual press conference on the Moderna vaccine, the first outside China to have reached Phase 3.

“We’re beginning a Phase 3 trial that is very quick – it certainly is the world’s record – when one thinks from the time of the sequence (of the virus) to a Phase 3 trial,” Fauci said, adding that the speed of the process has entailed “no compromise at all in safety or scientific integrity.”

He said that he expected the results of the Moderna trial to be published in November of December, but he declined to exclude the possibility of what is known in the US political context as an October surprise: a dramatic development or revelation just weeks before the presidential election.

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