Moderna trial investigator worries about political pressure in vaccine approval process

Dr. Carlos del Rio, an investigator in Moderna's clinical trials, told CNBC on Thursday he is worried abo

توسط ELEMENTORSITE در 28 شهریور 1399

Dr. Carlos del Rio, an investigator in Moderna's clinical trials, told CNBC on Thursday he is worried about political pressure interfering in the regulatory approval process for any potential coronavirus vaccine.  

"Politics have already impinged on science," del Rio said on "Power Lunch," referring to a pair of previous developments during the coronavirus pandemic that did not involve vaccine approvals. 

Del Rio, an infectious diseases professor at Emory University School of Medicine in Atlanta, pointed to the timing of the Food and Drug Administration granting emergency approval to use convalescent plasma to treat hospitalized Covid-19 patients. The announcement arrived a day before the start of the Republican National Convention. 

He also referenced recent reporting by Politico, which said communications officials within the Department of Health and Human Services pushed to review or change reports on the coronavirus issued by the Centers for Disease Control and Prevention.

The reported efforts to change the highly regarded reports are "something that none of us ever thought could potentially happen," del Rio said. "I think there's already plenty of evidence of political interference in science, so if that has happened up to now, why would it not happen again?" he added, referring to a vaccine approval. 

In addition to del Rio, others across the scientific community, as well as other Americans, are worried President Donald Trump's administration may try to influence the regulatory process for a vaccine. Trump has often claimed a vaccine may be ready prior to the Nov. 3 presidential election, triggering concerns about political priorities being placed ahead of safety and effectiveness.

But Dr. Stephen Hahn, who leads the FDA, has repeatedly pushed back against these worries. Last week, Hahn said he has "no intention" of overruling career scientists at the agency, while adding, "I have complete and absolute confidence in the scientists at the FDA and the decision-making that they have here." 

Del Rio also said he believes strongly the FDA's career officials "are there to do the right thing." He also referenced the letter issued earlier this month by major U.S. and U.K. drugmakers, which expressed their assurances that they would uphold scientific principles during the course of their vaccine trials. Moderna, Pfizer and AstraZeneca were among the statement's signatories. 

"My only hope is that Dr. Hahn and the political appointees in the FDA stand up and basically say, 'No, we cannot have political pressure lead the FDA into making a decision. It has to be science that leads the decision,'" said del Rio, who also is co-director of the Emory Center for AIDS Research. "The American public's health depends on the FDA doing their job."

Moderna and the FDA did not immediately respond to CNBC's requests for comment on del Rio's remarks. 

Earlier Thursday, Moderna CEO Stephane Bancel told CNBC the company should have enough data from its late-stage trial to know whether its vaccine works in November. He said on "Squawk Box" that it would be unlikely for the company to have enough data in October.

Dr. Scott Gottlieb, the former FDA commissioner under Trump, told CNBC on Wednesday the American public would find out if there was political interference in the approval of a vaccine. 

"I think you'll see resignations, and you'll see something very public. I know the folks who are going to be engaged in this, and they have a lot of integrity and they jealously guard that process," said Gottlieb, a board member at Pfizer, which is developing a potential vaccine. 

"If the process is preserved, and they feel they haven't been leaned on and they've had their ability to make independent decisions here and their prerogatives have been maintained, you're going to know that, too," he added on "Squawk Box." "I'm pretty confident that we're going to have transparency into how this decision gets made." 

Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic testing start-up Tempus and biotech company Illumina. He also serves as co-chair of Norwegian Cruise Line Holdings′ and Royal Caribbean's "Healthy Sail Panel."
آخرین مطالب
مقالات مشابه
نظرات کاربرن