Credit Operation Warp Speed in part for Novavax’s stunning vaccine success

Jazz mentioned in his thread this morning about Novavax’s impressive trial results that it’s a product of Operation Warp Speed but that subject deserves more attention. Why? Because Novavax was a longshot when the feds threw $1.6 billion at it for its COVID vaccine last year. Economist Alex Tabarrok knows:

Not only is Novavax a small company, it hadn’t successfully brought a vaccine to market in more than 30 years of trying when it won its contract with the feds under OWS. Its setbacks from having some of its other vaccine candidates go bust during trials led it to lay off a third of its staff at one point and nearly saw Nasdaq delist its stock. It even sold its manufacturing facilities to a competitor when it needed cash. That’s not an obvious racehorse for the federal government to bet big on. In fact, this NYT piece from last summer about Novavax’s huge contract — bigger even than the one given to AstraZeneca — strongly implied that the company may have drummed up interest from the feds via cronyism, as much by trying to pull strings with friends in the industry as for the promise of its COVID vaccine.

When asked this week why Novavax has received more than anyone else, a Trump administration official said that smaller companies needed more federal investment in manufacturing compared to large pharmaceutical firms, which have an established track record for mass-producing vaccines…

The Biomedical Advanced Research and Development Authority, or BARDA, which makes deals with drug manufacturers during public health emergencies and is one of the federal agencies carrying out Operation Warp Speed, has been headed by two former Novavax executives. One of them would later complain that the company crossed ethical lines when it approached him about receiving funding this spring.

Novavax also tapped into a longstanding relationship with the Gates Foundation, which had previously provided it with funding and is one of the most powerful global players in the vaccine world…

Mr. Trizzino said the company did nothing wrong. “We did what we thought was prudent and reasonable under the circumstances of a pandemic and the need to move very quickly,” he said.

Confidence in Novavax grew a few months ago when a trial for the company’s flu vaccine also produced promising results but today’s data feels like vindication, making Warp Speed’s lavish support for Novavax look less like a corrupt bit of favoritism for tapped-in underachievers than a canny bet on an underdog with real potential. (There’s some talk of Novavax’s COVID and flu shots being combined.) Their COVID vaccine process relies on moth cells to crank out copies of SARS-CoV-2’s spike protein, which are then adapted for incorporation into the vaccine. That process is fast, the Times noted in its piece last year, which is why the Trump administration and other governments mired in a raging pandemic took an interest in it.

But speed in production isn’t its only virtue. Novavax’s vaccine doesn’t require deep-freeze temperatures for storage. Also, the technology to manufacture the “recombinant protein” type of vaccine they’ve produced is well-known and can be scaled to produce huge quantities. Novavax may also cause fewer side effects than Pfizer’s or Moderna’s vaccines do, which is part of the argument for why it’s an especially strong candidate to become a booster shot in the fall here in the U.S.

[T]he protein-based technology used in the Novavax vaccine may do a particularly good job at amplifying protection, even if people have previously been vaccinated with a different formulation…

Researchers gave Beta boosters to baboons that had been vaccinated with the original version of the Novavax vaccine in experiments a year ago. The researchers found that the baboon’s immunity against Covid-19 shot up after this booster, protecting them against Beta, Alpha and the original version of the coronavirus.

“When you boost, you see a very high recall response,” said Matthew Frieman, a virologist at the University of Maryland School of Medicine and a co-author of the new study. The study has not yet been published in a scientific journal.

Boosters are tricky because scientists are looking to maximize the immune boost while minimizing the side effects. Adenovector vaccines like AstraZeneca may see diminishing immune returns from additional doses; on the other hand, the side effects from mRNA vaccines like Pfizer and Moderna may become debilitating or even dangerous (e.g., heart inflammation) after a third or fourth shot. Novavax may be the sweet spot. And it’s apparently simple for the company to adapt its vaccine to combat new variants as they emerge, making it well suited for a booster role. Not surprisingly, the company is currently participating in a “mix and match” UK trial to see how well its product does to boost immunity in people who have received a different type of COVID vaccine for their first two doses.

But boosters may be merely a sidenote to its true role in the pandemic. As Ed noted a few months ago, given the problems Johnson & Johnson’s vaccine has had with manufacture and side effects, Novavax may become a vaccine of choice for poorer countries looking for an easy-to-store option instead of J&J. The sooner we can get shots into arms in the third world, the lower the risk of new immune-resistant variants like B.1.617 developing abroad and then migrating back here to haunt us at home. Novavax may be one of the world’s best hopes to do that once it’s approved.

Without Operation Warp Speed, the company may have never found the funding it needed to get off the ground. It may end up being one of Trump’s most meaningful achievements.

Here’s the CEO touting his company’s progress on Fox this afternoon.

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