Moncef Slaoui

Moncef Slaoui's 30-plus career in biopharma included heading up GlaxoSmithKline's vaccine unit. (White House)

Moncef Slaoui wasn’t involved in Johnson & Johnson’s or AstraZeneca’s recent decisions to put their COVID-19 vaccine trials on hold, but as co-leader of the U.S. government’s Operation Warp Speed effort to rush a vaccine to market, he appreciated the companies’ urge to prioritize safety over speed.

For Slaoui, the holds also validated a strategy he helped set up in the early days of Operation Warp Speed. The effort is supporting a portfolio of eight companies working on vaccines that fall into four different technology platforms: mRNA, live non-replicating viral vector, adjuvant recombinant protein, and live replicating viral vector.

J&J and AstraZeneca are both developing live non-replicating virus vector vaccines, and both paused their trials due to unexplained illnesses in some participants. (Both trials are expected to resume soon.) Slaoui points to the portfolio approach as a good strategy for ensuring that those delays won't prevent Operation Warp Speed from meeting its goal.

“We wanted to hedge our bets and manage the risk that some vaccines could fail or be delayed,” Slaoui said in an interview with FiercePharma. “And there was a second dimension of risk management, which is that the strength of the immune response may be different in subpopulations. Elderly people may have a weak response to one vaccine, but that same vaccine might be very effective in young adults.”

Slaoui, the former head of GlaxoSmithKline’s vaccine unit, was appointed as chief advisor of Operation Warp Speed in May. In addition to funding COVID-19 vaccine development efforts, the program is fostering manufacturing and distribution plans, all in an effort to get at least one vaccine on the market by the end of the year.

The manufacturing side of the operation has proven challenging, given that Slaoui has been quite vocal about advising vaccine developers that they shouldn’t file for emergency use authorization with the FDA until they have enough doses on hand to immunize a large portion of their target patient base.

For example, Moderna has about a million doses of its mRNA vaccine ready now, Slaoui said, but that’s not nearly enough. “Say you’re filing for approval in elderly people, that’s 30 to 35 million people. Filing when you only have one million doses at hand will only exacerbate the problem.”

Moderna and the other vaccine developers have been locking up manufacturing deals in preparation for quick approvals. As a result, Slaoui predicts that by late November “we will be producing enough batches on an ongoing basis to be able to immunize sizeable populations, such as the elderly and healthcare workers.”

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The mRNA vaccines being developed by Moderna and Pfizer are widely believed to be in the lead now, and President Donald Trump has made no secret of his desire that a vaccine be approved before the November election.

As far as Slaoui is concerned, though, that timeline is unlikely, if not impossible. And that’s not just because the FDA recently released guidelines that suggested all trial participants be monitored for two months after getting their final vaccine dose.

Each company has to compile safety data on 30,000 or more trial participants, which the FDA has to review, Slaoui said. On top of that, the trials have to reach their primary endpoint, which requires that a certain number of people in the studies develop symptoms of COVID-19. An independent group has to validate those cases before the FDA can review any application for emergency use approval.

“This is a monumental amount of work,” Slaoui said. “That’s why I say an approval is going to take several weeks from the moment one says, ‘OK, the vaccine is efficacious.’” He can’t envision the process taking less than five weeks, which as of now would mean an approval after the election.

Slaoui came to operation Warp Speed backed by more than 30 years of Big Pharma experience, most of that spent at GSK. He was also a partner at life sciences investment firm Medicxi, and he served on the boards of several life sciences companies, including Moderna.

In fact, his role at Moderna prompted conflict-of-interest cries when he was first appointed to head up Operation Warp Speed. So in May he resigned his board seat, divested $12 million worth of stock options in the company and vowed to donate some of the proceeds to cancer research.

RELATED: 'Warp Speed' head Slaoui, challenged for 'huge conflict of interest,' sells off $12.4M in Moderna stock

Between the setbacks and the political pressure, Slaoui’s job has been anything but easy. But he still believes Operation Warp Speed has gone better than he expected it would when he took the job.

“There’s been instantaneous alignment and 100% support among all the parties involved, from HHS to the Department of Defense, to all the companies that are working at risk,” he said. “And it’s going super fast. I was confident we would get something by the end of the year. Now I’m pretty confident we’re going to get something in November.”

Moncef Slaoui