CBER Director Hopes for COVID-19 Vaccine In Nine Months

The FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks said Wednesday that he hopes the center can help expedite vaccine development to lead to a COVID-19 vaccine in nine months.

Meeting this ambitious timeline requires eliminating “dead space” in the process, including manufacturing a vaccine before it’s proven safe and effective, Marks said.

Marks, speaking at an online event hosted by Axios, also said the FDA will consider every option to approve a vaccine that is proven to be safe and effective, including emergency use authorization and accelerated approval.

“It would all depend on what the data showed at the time, and what we needed to do to make sure the population had access,” he said.

Marks said that there will be a better understanding by mid-summer of whether the agency is on track with its aggressive timelines.

“In this particular crisis, we need to try to move things through quickly to get there — working meticulously — because there is just so much at stake here,” he said.

But not everyone is so optimistic about the timeline. Former FDA Commissioner Scott Gottlieb said he thinks there’ll be enough promising COVID-19 vaccines to begin late-stage trials by the fall, which means a vaccine won’t be available until much later than some of the more optimistic timelines being discussed by many experts.

Gottlieb said vaccine candidates could be headed into phase 3 trials by the fall, assuming they demonstrate safety and immunogenicity in early and mid-stage trials.

The former FDA chief, speaking at a webinar Wednesday sponsored by The Washington Post, said these trials could be designed for intervals of the population to get vaccinated at different times to determine if when they get vaccinated affects their probability of getting the virus.

Gottlieb said he also expects the Trump administration to discuss what it can do in terms of supporting clinical development and manufacturing for therapeutics and vaccines as it plans to “reopen America.”

“The more that we can do these things in parallel, the more likely we are able to secure sufficient doses of a vaccine in time,” he said.

Zeke Emanuel, vice provost of the University of Pennsylvania, agrees with Gottlieb that it could take longer than hoped for to get a vaccine available to the public. He noted that even if large-scale trials start in the fall, production and distribution of the vaccines still has to be figured out.

“I’m looking at the fall 2021, maybe January 2022,” he said. “If everything goes well, that’s when we could have a vaccine.”

Emanuel, a former White House adviser for health policy, is also not optimistic that a therapeutic would be available by January of next year. He said the best chance is a drug or combination of drugs designed specifically for COVID-19.

“For a lot of these viruses, like HIV and hepatitis C, we need more than one drug,” he said. “It’s very likely for COVID-19, the same will be true.” — Jordan Williams