Why Trump's Operation Warp Speed is credited with helping race for COVID-19 vaccine

Operation Warp Speed, a Trump administration initiative to manufacture COVID-19 vaccines as fast as possible,should be lauded as a successful endeavour in what has otherwise been a poor effort to deal with the coronavirus, experts say.

"No doubt, Operation Warp Speedis a huge success," saidTinglong Dai, associate professor of Operations Management andBusiness Analytics at Johns Hopkins UniversityCarey Business School in Baltimore.

"You can like or hate the Trump administration, but nodoubt, it's a huge successunprecedented success."

Jesse Goodman, the former chief scientist of the U.S. Food and Drug Administration, agreed that the U.S.government deserves credit for the high priority placed on Operation Warp Speed.

"This is a bright spot in the pandemic response. I mean, the rest of it has been dismal," said Goodman, who is also director of Georgetown University'sCenter on Medical Product Access, Safety and Stewardship.

Anthony Fauci, director of the U.S. National Institute ofAllergy and Infectious Diseases, also lauded Operation Warp Speed for being a "success certainly in the arena of vaccines, it's been a success" in his remarks at a recentvirtual summit organized by the medical news site Stat.

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Launched in May, Operation Warp Speed (OWS) is a government initiated private/public$10 billion US programto help provide support to companies in the development, manufacturing and distribution of300 million doses of COVID-19 vaccine, with the aim of havinginitial doses readyby January2021.

Pfizer, Moderna announce potential vaccines

On Wednesday, pharmaceutical company Pfizer Inc. announced that new test results showits coronavirus vaccine is 95 per cent effective, is safe and also protects older people most at risk of dying.

Earlier this week, biotech firm Moderna Inc. also announced similar effectiveness of its ownvaccine candidate.

The experts agree that Operation Warp Speed played a significant role in Moderna's development of a potential vaccine.

"WithoutOWS, there would be no Moderna vaccine. Period," Dai said.

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Allison Winnike, president of the Texas-basedImmunization Partnership, an organization providing advocacy and information about immunization initiatives, saidthat Moderna benefited tremendouslyfrom Operation Warp Speed, in part, by receiving close to $1 billion to support its vaccine developmentand clinical trials.

"That really got them to where they are today," she said.

As well, the U.S. governmentsigned an agreement with Modernaas part of theWarp Speed initiative committingto the purchase of 100 million doses once a vaccine wasapproved.

The clinical trial network to testModerna's vaccinewas also funded by money that came from WarpSpeed,Goodman said.

As for the role the fundingplayed in the development ofPfizer's vaccine,that'sa bit fuzzier. Last week, when the company announced it had developed a vaccine that was more than 90 per cent effective, U.S. President Donald Trump said that Pfizer was suggesting "it wasn't part of Warp Speed, but that turned out to be an unfortunate misrepresentation."

Pfizer self-funded

Indeed, Pfizer'sCOVID-19 vaccine development and manufacturing costs have been entirely funded by the company. However, it did strike a deal with OperationWarp Speed for the U.S. government to buy about $2billion of itsvaccine, or 100 million doses, once it gets approved.

"Pfizer is a very large company with substantial cash reserves," Goodman said."I'm sure that [OWS]was helpful.I'mnot sure about[whether] it wouldn'thave happened without it."

But Walter Orenstein, a former director of the U.S. Immunization Program and former deputy director for immunization programs at the Bill & Melinda Gates Foundation, said Operation Warp Speed has played a major role byguaranteeinga marketto Pfizer so it can begin developing its procedures for distribution.

And that has takensome of the financial risk out of the process for companies such asPfizer, he said.

He agreed that the policyinitiative is an exception to how the Trump administration hashandled the pandemicand thathis "personal opinion is [OWS] has helped substantially."

"I've never seen an effort like this before," he said. "Never in my lifetime or my career certainly [have I]seen anything proceed this quickly.

"I can't see this large an effort by this many companies going forward in this fashion without substantial support that has come [through]Operation Warp Speed."

Initiative done in anything but warp speed

However, Dai saidthat even without OperationWarp Speed, companies such asPfizer would already have an incentive to be the first to market.

But he believes the initiativedeserves credit for spurring on competition byits"seemingly impossible due date."

"OWS effectively changed the entire narrative of vaccine development timeline and prompted vaccine manufacturers to pool all their resources to meet the impossible due date," Dai said.

While Goodman said Operation Warp Speedis certainlya success,he criticized the Trump administration for being in denial about the pandemic and downplaying its seriousness. Indeed, getting OWSoff the ground was done in anything but warp speed, he said.

It took months, he said, before the U.S. government got investing in vaccines in earnest.

"Can you imagine where we could have been hadthese billions of additional dollars and investment had started kicking in January?" he said.

"I think we could be significantly further along if there hadn't been that really kind of desire to just wishthe pandemic away."

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Early missteps

Winnikesaid, by its own metric, Operation Warp Speedwon't have succeeded in meeting its goal ofdelivering 300million doses of thevaccine by the beginning of thenew year. At most, she said, it would be able to deliver 20 million doses.

Winnike also criticized the program for being secretive and not transparent.

"Ithink one of their major missteps early on is that they were secretive about who was involved in the process for choosing the vaccine candidate, and they were secretive about how they were making those decisions," she said.

She said that secrecy "planted a flag on the growing distrust in the vaccine development process in the United States."