Trump Says FDA Has Approved More Than 100 Covid-19 Drugs for Trials

Date: 2020-05-15 17:15:16

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President Donald Trump on Friday officially introduced a former pharmaceutical executive and a four star-general who will lead his crash coronavirus vaccine effort, amid a whistle-blower’s criticism that the administration lacked a plan to combat the outbreak.

Trump named General Gustave Perna, who directs the U.S. Army Materiel Command, as chief operating officer of “Operation Warp Speed,” likening it to the Manhattan Project effort to develop the atomic bomb.

“That means big and that means fast,” Trump said in remarks from the White House Rose Garden.

Former GlaxoSmithKline Plc executive Moncef Slaoui will be the project’s “chief scientist,” Trump said, calling him “one of the most respected men in the world in the production and really the formulation of vaccines.”

“I’d love to see if we could do it before the end of the year,” he said. “It’s risky, it’s expensive, but we’ll be saving massive amounts of time, we’ll be saving years.”

But the president added: “Vaccine or no vaccine we’re back and we’re starting the process.”

The announcement of Perna and Slaoui to lead the project, which was first reported by Bloomberg News, comes a day after the former head of the Biomedical Advance Research and Development Agency, Rick Bright, testified to Congress that the U.S. does not have plan to produce and fairly distribute a coronavirus vaccine once it becomes available.

Bright has become a whistle-blower and prominent Trump critic after he was removed from his job last month and transferred to a position at the National Institutes of Health. He says the White House retaliated against him for resisting the president’s effort to promote an untested treatment for Covid-19, the malaria drugs chloroquine and hydroxychloroquine.

“There is a lot of hope. But that doesn’t make a vaccine,” he told members of a House health subcommittee on Thursday.

From the U.S. to China, biopharmaceutical companies and academic institutions are racing to develop and produce a vaccine against the novel coronavirus. More than 100 experimental shots are currently in development, though most of the programs are in their early stages, meaning gold-standard clinical trials with “blinded” placebo and therapeutic groups are still far off.

Operation Warp Speed seeks to accelerate a process that is typically years long into a matter of months. Some health experts have cast skepticism at the idea that a vaccine could be ready for emergency use in at-risk populations by the end of the year, while others like billionaire Bill Gates said a vaccine could be ready within months.

In April, the U.S. National Institutes of Health launched a partnership among government health agencies and 16 biopharmaceutical companies with the goal of expediting development and production of coronavirus treatments. Known as Activ, or Accelerating Covid-19 Therapeutic Interventions and Vaccines, the group’s efforts appear to closely resemble Operation Warp Speed.

Slaoui said early data from one trial made him feel even more confident about having vaccine doses by end of 2020.

“We will do the best we can to do that,” Slaoui said.

Members of the White House coronavirus task force, including Anthony Fauci, have said a vaccine could be developed in 12 to 18 months. Bright said even that timeframe is unrealistic, much less Trump’s goal to produce hundreds of millions of doses by year’s end.

The president dismissed Bright on Thursday as “an angry, disgruntled employee” who “didn’t do a very good job.”

In Slaoui, the president selected a former executive with 30 years of experience at a major pharmaceutical company who has been credited for overseeing the development of vaccines such as Rotarix, used to prevent diarrhea in infants, and Cervarix, which guards against a viral infection that could lead to cervical cancer.

Slaoui said in an interview with the New York Times published Friday that it would be “a very aggressive timeline” to produce a vaccine within 12 to 18 months, but that doing so by January is a “credible objective.”

Government watchdog groups have raised alarms about potential conflicts of interest because Slaoui sits on the board of Moderna Inc., a biotechnology company which has a drug in trials that Fauci has said represents one of the best hopes for a coronavirus vaccine.

Slaoui plans to depart his board seats upon taking his role leading Operation Warp Speed, according to a person familiar with the matter.

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