Vaccines Face Uncertain Approval, Reviews With New FDA Official

The appointment of a vocal critic of expedited approvals of vaccines, Vinay Prasad, to run the FDA’s office responsible for those drugs presents a challenge for the pharmaceutical industry.

Prasad on May 6 was named the new director of the FDA’s Center for Biologics Evaluation and Research, taking the reins of a high-profile position that oversees the safety and efficacy of vaccines, complex gene therapies, blood supply, and other cutting-edge treatments.

The hematologist-oncologist, frequent YouTuber, and podcast host brings a public record of opinions with him that signals how he could run the center. He’s criticized mRNA and Covid-19 vaccines, questioned current clinical trial practices, and repeatedly attacked the decisions of his predecessor, Peter Marks, who resigned from his post in March after holding opposing viewpoints from US Health Secretary Robert F. Kennedy Jr., a vaccine skeptic.

The pharmaceutical industry and medical leaders expect changes at CBER after his appointment, including how the the agency interacts with the industry and influences business decisions. Those changes could start to take shape as soon as this week, as the center prepares a framework to guide industry on the FDA’s thinking about vaccines.

“He is a fairly polarizing figure, and I think it really signals a change in direction at CBER,” said Richard H. Hughes IV, a member at Epstein Becker & Green PC, who represents some vaccine makers. “This is going to be a huge obstacle and a huge change in direction for the agency with respect to vaccines and clinical trials.”

Shares of manufacturers for vaccines and immunotherapies plunged shortly after Prasad’s appointment on concerns he would crack down on approvals. Vaccine development, which is known to be less attractive for investors, is likely to be influenced by his assessments and could lead to less incentives to take risks and develop new products.

“This has the potential to slow vaccine development and potentially limit access,” said Emily Martin, an epidemiology professor at the University of Michigan School of Public Health. “His statements don’t take into account decades of advancements on how to do this work well and how to be efficient with government resources.”

Despite industry skepticism, the former epidemiology professor signaled that changes at CBER won’t be as dramatic as some may expect.

“We will continue to be flexible,” Prasad said May 8 in a conversation with FDA Commissioner Marty Makary the agency streamed online. “There’s not going to be a light switch change here.”

Prasad did not respond to request for comment.

Vaccines, Clinical Trials

His comments about the FDA’s vaccine regulation and other therapeutics give a glimpse of his vision for CBER, which likely contrasts from how the center operated in the past nine years under Marks.

Marks was a key figure in Operation Warp Speed, a plan initiated by the first Trump administration that accelerated the development of safe and effective Covid-19 vaccines. His work, which received both praises and critiques, championed treatments for rare diseases and advocated for flexibility in the regulatory approval process.

Prasad called Marks “one of the most dangerous, pro-pharma regulators of the 21st century.” He opposed Marks’s moves to rubberstamp Covid-19 boosters and criticized his decision to approve Sarepta Therapeutics’ Duchenne’s muscular dystrophy drug, despite reviewers concerned about the benefits of the treatment.

“He fits in with the current structure of doubting vaccines, especially covid vaccines,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “I worry that over time there will be a gradual erosion in vaccines.”

Prasad, nonetheless, pushed back in his conversation with Makary on comments that he’s anti-vaccine.

“Vaccines are like drugs, which is that when given at the right time, in the right moment to the right person, they’re life saving,” Prasad said. “But just like drugs, they need to be evaluated on a case-by-case basis.”

“We love vaccines when done right, when given appropriately, when based on solid evidence,” he said.

His vision for how clinical trials should be executed is also likely to shake up CBER’s expectations, industry watchers say. He’s advocated for randomized placebo-controlled trials in vaccine testing, where one group would receive the treatment and the other group receives the placebo.

The US Department of Health and Human Services said it will require all new vaccines to be tested in placebo-controlled trials before they’re approved, but critics of the new policy say routine vaccines were already being tested against placebos.

This requirement could change the threshold for approval of vaccines and biologics. What currently is sufficient to meet a safety or potency standard could no longer be enough to gain FDA approval, industry watchers say.

“He’s been calling for pharmaceutical companies to generate more data than what FDA has generally required,” said Ana Santos Rutschman, a law professor at Villanova University. “I think that we’ll see CBER guidance on clinical trial data change.”

Makary on May 15 said CBER plans to release in the coming days a framework to guide vaccine makers on how the agency is approaching vaccines.

Industry Interactions

Prasad’s previous attacks on the industry and its relationship with the FDA are expected to influence how he’ll interact with vaccine and gene therapy makers.

He’s not one to favor accelerated access to treatments, arguing that the flexibility in accelerated approval may have led to a “low-bar for approval for drugs that are unlikely to produce data that is clinically meaningful.”

He’s said the FDA can limit the number of “me-too drugs it grants accelerated approval, after all, the ‘unmet need’ has closed.”

He’s also criticized gene therapy innovations, appearing to be restrictive of treatments that may have more more nuanced risk and reward for patients, according to an analysis from BMO Capital Markets.