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FDA’s top vaccine regulator, Vinay Prasad, is known for overruling scientists.
Vinay Prasad Credit: Getty | Marvin Joseph
Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided to refuse to review Moderna’s mRNA flu vaccine, overruling agency scientists, according to reports from Stat News and The Wall Street Journal.
Stat was first to report, based on unnamed FDA sources, that a team of career scientists at the agency was ready to review the vaccine and that David Kaslow, a top career official who reviews vaccines, even wrote a memo objecting to Prasad’s rejection. The memo reportedly included a detailed explanation of why the review should proceed.
The Wall Street Journal confirmed the report with its own sources, who added that FDA scientists attended an hourlong meeting with Prasad in early January, in which they laid out their objections to Prasad’s plans to block the vaccine review. They reportedly told Prasad—a political appointee known for causing turmoil and espousing anti-vaccine rhetoric—that it was the wrong approach.
Prasad’s objection was not based on any potential problem with Moderna’s experimental mRNA vaccine; rather, it was with the existing licensed vaccine Moderna used for a comparison in a Phase 3 clinical trial that enrolled nearly 41,000 adults aged 50 and older. The FDA reviewed Moderna’s trial plans on multiple occasions prior to the company’s submission, without objection.
While Moderna acknowledged that FDA scientists had suggested using a different vaccine comparator for trial participants aged 65 years and older—who are eligible for a high-dose flu shot—they highlight that the agency concluded that Moderna’s plan was “acceptable.”
Still, while Moderna largely stuck with its plan to use a standard dose for all participants, it altered its plans based on the feedback. Specifically, it added a comparison of a high-dose vaccine to some older participants and provided the FDA with an additional analysis.
This wasn’t enough for Prasad, who, according to the Journal’s sources, told FDA staff that he wants to send more such refusal letters that appear to blindside drug developers. The review staff apparently pushed back, noting that such moves break with the agency’s practices and could open it up to being sued. Prasad reportedly dismissed concern over possible litigation. Trump’s FDA Commissioner Marty Makary seemed similarly unconcerned, suggesting on Fox News that Moderna’s trial may be “unethical.”
A senior FDA official suggested to Stat, meanwhile, that the door might not be entirely closed for Moderna’s flu vaccine. The official said that the company could toss the data for the 65 and up participants and, perhaps, grovel.
“It is entirely feasible that if they come back, maybe even show some humility and say, ‘
, we didn’t follow your recommendation. Just take a look at the 50 to 65 group, where there’s a little more equipoise,’” the official told Stat. “Then the review team could say, ‘We’ll consider that cohort.’”
The Journal notes that Moderna is at least the ninth company to have received a surprise rejection from Prasad and his team. The unpredictability is raising fears about the industry’s ability to obtain investments and innovate.
Prasad, a blood cancer specialist who has no expertise or experience in vaccine regulation, is also facing internal problems at the agency. His management style has created an environment “rife with mistrust and paranoia,” according to Stat. The Journal reports that several complaints have been filed against him, including some involving sexual harassment, retaliation against subordinates, and verbally berating staff.
Vinay Prasad Credit: Getty | Marvin Joseph
Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided to refuse to review Moderna’s mRNA flu vaccine, overruling agency scientists, according to reports from Stat News and The Wall Street Journal.
Stat was first to report, based on unnamed FDA sources, that a team of career scientists at the agency was ready to review the vaccine and that David Kaslow, a top career official who reviews vaccines, even wrote a memo objecting to Prasad’s rejection. The memo reportedly included a detailed explanation of why the review should proceed.
The Wall Street Journal confirmed the report with its own sources, who added that FDA scientists attended an hourlong meeting with Prasad in early January, in which they laid out their objections to Prasad’s plans to block the vaccine review. They reportedly told Prasad—a political appointee known for causing turmoil and espousing anti-vaccine rhetoric—that it was the wrong approach.
Prasad’s objection was not based on any potential problem with Moderna’s experimental mRNA vaccine; rather, it was with the existing licensed vaccine Moderna used for a comparison in a Phase 3 clinical trial that enrolled nearly 41,000 adults aged 50 and older. The FDA reviewed Moderna’s trial plans on multiple occasions prior to the company’s submission, without objection.
While Moderna acknowledged that FDA scientists had suggested using a different vaccine comparator for trial participants aged 65 years and older—who are eligible for a high-dose flu shot—they highlight that the agency concluded that Moderna’s plan was “acceptable.”
Still, while Moderna largely stuck with its plan to use a standard dose for all participants, it altered its plans based on the feedback. Specifically, it added a comparison of a high-dose vaccine to some older participants and provided the FDA with an additional analysis.
This wasn’t enough for Prasad, who, according to the Journal’s sources, told FDA staff that he wants to send more such refusal letters that appear to blindside drug developers. The review staff apparently pushed back, noting that such moves break with the agency’s practices and could open it up to being sued. Prasad reportedly dismissed concern over possible litigation. Trump’s FDA Commissioner Marty Makary seemed similarly unconcerned, suggesting on Fox News that Moderna’s trial may be “unethical.”
A senior FDA official suggested to Stat, meanwhile, that the door might not be entirely closed for Moderna’s flu vaccine. The official said that the company could toss the data for the 65 and up participants and, perhaps, grovel.
“It is entirely feasible that if they come back, maybe even show some humility and say, ‘
, we didn’t follow your recommendation. Just take a look at the 50 to 65 group, where there’s a little more equipoise,’” the official told Stat. “Then the review team could say, ‘We’ll consider that cohort.’”The Journal notes that Moderna is at least the ninth company to have received a surprise rejection from Prasad and his team. The unpredictability is raising fears about the industry’s ability to obtain investments and innovate.
Prasad, a blood cancer specialist who has no expertise or experience in vaccine regulation, is also facing internal problems at the agency. His management style has created an environment “rife with mistrust and paranoia,” according to Stat. The Journal reports that several complaints have been filed against him, including some involving sexual harassment, retaliation against subordinates, and verbally berating staff.
