Vice President Pence visits Miami for launch of Phase 3 of COVID vaccine clinical trial

Christel Deskins

With President Donald Trump’s poll numbers flagging in Florida as the state continues to struggle with one of the nation’s highest rates of new COVID-19 cases, Vice President Mike Pence visited the University of Miami’s Miller School of Medicine on Monday afternoon to focus attention on one of the pandemic’s […]

With President Donald Trump’s poll numbers flagging in Florida as the state continues to struggle with one of the nation’s highest rates of new COVID-19 cases, Vice President Mike Pence visited the University of Miami’s Miller School of Medicine on Monday afternoon to focus attention on one of the pandemic’s few potential bright spots: the rapid development of a vaccine against the disease.

Pence touched down at Miami International Airport at about 12:30 p.m. on Monday. He walked off the plane with Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration. Both wore masks, as is required in public in Miami-Dade County under an order from Miami-Dade Mayor Carlos Gimenez, who greeted the vice president at the plane along with Florida Gov. Ron DeSantis. DeSantis and Gimenez wore masks.

Pence greeted DeSantis and Gimenez by bumping forearms. They spoke on the runway for about five minutes, reviewed a document DeSantis was carrying and then the vice president waved at onlookers before climbing into a Chevy Suburban, part of a motorcade that took Pence and Hahn to the UM medical school’s campus in downtown Miami for a round table meeting to discuss progress of the vaccine.

When the vice president’s motorcade arrived at the UHealth Don Soffer Medical Center at about 1 p.m., crowds gathered on the street to take pictures and video of his arrival. Some onlookers wore green medical scrubs.

Following an introduction by Dr. Henri Ford, dean of UM’s medical school, DeSantis began discussing his belief that health indicators show that Florida has moved past the worst of a statewide resurgence in coronavirus cases that began in mid-June.

He thanked Pence and the White House: “Any time we’ve called, y’all have sprung into action,” DeSantis said to Pence.

Pence thanked DeSantis, and said the Trump administration will ensure that Florida has the resources it needs.

“Some day we’ll put this coronavirus in the past,” Pence said.

Pence said there was “no better place” to visit than Miami to discuss Moderna’s Phase 3 vaccine clinical trial.

“It’s a historic day, a day when we begin in earnest to work on a vaccine,” he said.

Pence thanked trial volunteers. “All of us have a role to play.”

‘Warp speed’ vaccine development

A collaboration between the National Institutes of Health and the biotechnology company, Moderna, Inc., the vaccine is the first in the United States to enter Phase 3 of a clinical trial to determine the drug’s safety and effectiveness against COVID-19. UM’s Miller School plans to enroll 1,000 volunteers in South Florida as part of a 30,000-person study nationwide.

The NIH-Moderna vaccine is a new approach to disease protection, using the virus’s genetic material — or so-called messenger RNA — to trigger an immune response, generating antibodies that fight the virus. The vaccine is injectable and participants in the clinical trial will receive two doses, 28 days apart, to measure how the vaccine takes effect.

Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said in a teleconference Monday that the vaccine’s development has moved incredibly fast — reaching Phase 3 of a clinical trial about six months after Chinese scientists first published the genetic sequence of SARS-CoV-2, the virus that causes COVID-19.

“That is very quick,” Fauci said. “It certainly is a world’s record … from sequence availability to the time of a Phase 3 trial. There is no compromise at all with regard to safety nor of scientific integrity.”

The first 45 volunteers injected in March with the experimental vaccine developed “neutralizing antibodies in their bloodstream — molecules key to blocking infection — at levels comparable to those found in people who survived COVID-19,” according to an article published in the New England Journal of Medicine on July 14.

The clinical trial’s rapid pace has been aided by Operation Warp Speed, a partnership among government agencies to accelerate development, manufacturing and distribution of a vaccine. The group’s goal is to deliver 300 million doses by January 2021. The first volunteer was dosed Monday morning in Savannah, Georgia.

Fauci said the clinical trial is still enrolling volunteers as scientists seek to ensure representation in the study by a diverse group of Americans, particularly the elderly and racial and ethnic minority groups disproportionately impacted by the virus in terms of serious illnesses, hospitalizations and deaths.

More than 150,000 people have applied to participate in the trial.

Volunteers will receive either a placebo or a dose of the experimental drug. Those interested in volunteering for Phase 3 of the clinical trial can sign up through the website, coronaviruspreventionnetwork.org.

Fauci said scientists and researchers likely won’t have reliable data on the experimental vaccine’s effectiveness until November or December, at the earliest.

“I would be reluctant to say it would be any earlier than the end of the year even though that is a distinct possibility,” he said.

Once the vaccine’s safety and effectiveness are established, manufacturing and distribution can begin. Moderna CEO Stéphane Bancel said the company is “on track to deliver 500 million doses” by September 2021 if the vaccine is approved.

“I think a billion [doses] is doable,” he said. “500 million doses, I think, is in the bag for next year.”

Fauci noted Monday that the NIH-Moderna vaccine is not the only candidate in development. It’s just the furthest along, with at least three additional vaccine candidates nearing Phase 3 of their trials. Each of those clinical trials will also need 30,000 volunteers, he said.

Moderna’s Bancel said the company has invested about $2 billion into the development and manufacturing of the vaccine, including construction of a new facility in Massachusetts capable of producing large quantities of the drug.

“We are focused on speed because every day matters,” Bancel said. “We are losing people every day around the world.”

Getting vaccine to those who need it most

Once the vaccine is approved, the drug will be distributed based on the recommendations of a panel of doctors and medical ethicists with the National Academy of Medicine.

Dr. Francis Collins, NIH director, noted that “tens of millions” of doses will be available early on, but that won’t be enough for the United States, where more than 4.2 million COVID-19 cases have been confirmed since March, according to Johns Hopkins University’s online disease tracker.

“It won’t be available for everybody,” Collins noted, “so decisions will need to be made.”

The panel headed by the National Academy of Medicine will produce interim recommendations by Labor Day, Collins said, followed by a public discussion by the end of September. The Centers for Disease Control and Prevention will then make more detailed recommendations on who will receive the vaccine first after healthcare workers and first responders.

Collins said the panel will look closely at what groups are at highest risk of severe outcome from COVID-19, including the elderly, those with chronic illnesses, African Americans, Latinos and Native Americans. “All of those who have taken a particularly heavy burden of this disease and for which we owe them the opportunity to get as much protection as we can provide,” he said.

Miami Democratic Rep. Donna Shalala, who served as Health and Human Services Secretary under President Bill Clinton and also is UM’s immediate past president, said distributing vaccines is “an ethical decision that ought to be paneled” by healthcare experts.

“ Hopefully…we’ll have enough doses so it’ll be not a narrow decision but a broader decision and have the distribution system in place so we know how we’re going to distribute the vaccine,” she said.

Shalala was one of at least two Miami Democrats who criticized the vice president ahead of his visit to UM on Monday.

Democratic state Sen. Jose Javier Rodriguez said Pence and Trump are “trying to take credit for developments they don’t deserve credit for, and were actively trying to thwart until now.”

UM is one of 89 locations around the country, and one of six in Florida, recruiting volunteers for the randomized clinical trial.

Miami Herald staff writer Alex Daugherty contributed to this report.

Source Article

Next Post

The Boys season 2 release date, new footage, short film, and more

The problem with following The Boys is that one minute you think you’ve seen all season 2 has to offer and – in an A-Train style blink of an eye – there’s enough to fill the vaults of Vought Seven times over. But we’ve just about caught up from not […]