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It’s called Operation Warp Speed. And — regardless of one’s politics, one’s level of concern about Covid-19, or one’s views of therapeutics and vaccines — it inarguably ranks as one of the most ambitious scientific endeavors in modern U.S. history.

Is it working?

Roughly five months after top U.S. health officials coalesced around the idea of a public-private effort to accelerate the development, manufacturing, and distribution of Covid-19 vaccines, therapeutics, and diagnostics, an answer to that question remains out of reach. But with billions of federal dollars already spent on the effort, it’s possible to take stock of the initiative’s progress, or lack thereof.

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Here’s an assessment of the work so far.

All in on vaccines

If all goes well, the fast-tracking of vaccine development, which normally takes years, will have been telescoped down to about a year. To date, the fastest a vaccine was ever developed was four years.

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Operation Warp Speed, or OWS, has already spent about $10 billion to help vaccine makers develop their candidates and build out production capacity to make vaccines at commercial scale. An innovation of this process: The vaccine makers are already producing doses, before they even know if the vaccines work. The idea is that if a vaccine is shown to be protective, use of it can start immediately. Moncef Slaoui, the scientific head of OWS, told STAT last week that the initiative has already started to stockpile upward of hundreds of thousands of doses. 

“That number will ramp up as the scale goes up, and that machine, if you wish, warms up,” he said.

Contracts with six manufacturers have been announced; another one or two may be coming, Slaoui said.

There have been ripple effects, however. In placing itself at the front of the line to receive vaccine doses from the OWS manufacturers, the United States has ignited a vaccine nationalism wildfire, which is reaching conflagration status. Wealthy governments have locked down more than 4 billion doses of vaccines so far, with the United States topping the list with commitments for 800 million initial doses and options on another 1.6 billion doses; new bilateral purchase agreements are announced almost daily. 

The World Health Organization and other global health agencies have argued that early access to vaccines should be shared across the nations of the world to help protect health workers, but the U.S. position has been that it will vaccinate Americans first, and share second. “We want to get our oxygen mask on first and then we’re going to help the people around us,” an unnamed administration official told Science in May.  

Richard Hatchett, CEO of CEPI — the Coalition for Epidemic Preparedness Innovations — acknowledged recently that the bilateral purchase agreements could snowball, if countries increasingly fear this is their only option. But he also believes the rest of the world will get vaccine sooner because of the investment the U.S. government has made.

I don’t think you can characterize the behavior of the country as being all one thing or another,” Hatchett told STAT. “They have invested … many billions of dollars in terms of funding the basic work and the clinical trials and the development of vaccines that will serve the needs of the world. They have invested more than all the rest of the world in aggregate.”

A modest impact on therapeutics

When it comes to therapeutics — which many observers believed would be important tools before the approval of any vaccine — OWS has had a far more modest impact. 

The initiative has made only one major investment in manufacturing: a $450 million payment to Regeneron to build up manufacturing for its monoclonal antibody treatment, which is still in clinical trials. OWS has also provided support to studies of a similar medicine being developed by Eli Lilly. It’s hoped that the antibodies will be able to be used both for treatment and prevention of Covid-19, but experts still worry about whether pharmaceutical companies can make enough of these treatments should they prove effective.

A major government-run study begun before OWS was involved showed that remdesivir, a drug developed by Gilead Sciences, shortened the time it took for patients to recover from Covid-19 by four days. This moderate effect is still the best seen by a new drug for Covid. A much older treatment — the steroid dexamethasone — was shown to have a big benefit late in Covid-19 by a study funded not by the United States but by the United Kingdom. 

A limited role on diagnostics

The inability to manufacture and provide widespread access to diagnostics has been one of the biggest failures of the U.S. response to the pandemic. Responsibility for that failure is spread across both the public and private sector.

On its site, OWS lists the development and testing of diagnostics as one of its five focus areas. The reality is that the initiative appears to have stayed largely on the sidelines, with the National Institutes of Health taking the lead.

An NIH effort, the Rapid Acceleration of Diagnostics (RADx), is funded with $1.5 billion, a sixth the OWS budget. By the end of the year, that program aims to have its awardees add 6 million tests per day to the number that can currently be conducted.

A big bet on materiel, with some risks involved

Manufacturing hundreds of millions of vaccine doses is a gargantuan challenge in and of itself. But the effort has set off a parallel scramble to avoid a comparatively low-tech bottleneck: potential shortages of the syringes and pharmaceutical-grade glass vials needed to transport and administer the vaccines, once they’ve been approved for use. 

The federal government has doled out several major contracts to companies rushing to ramp up manufacturing capacity for the essential glassware. In May, OWS awarded $138 million to ApiJect, a small company that makes an as-yet-unapproved product that would inject vaccine into syringes before shipment. The contract calls for 100 million prefillable syringes by the end of 2020 and another 500 million by the end of 2021. 

The Department of Health and Human Services and the Department of Defense also awarded roughly $350 million in June to two companies already in the business of manufacturing containers for vaccines and pharmaceuticals. Roughly $200 million went to Corning for a capacity expansion that would allow the company to churn out 164 million glass vials each year, and another $143 million went to SiO2 Materials Science to allow for the manufacture of 120 million glass-coated plastic containers each year. 

Some announcements have raised questions about the government’s procurement process and its methodology for awarding no-bid contracts. Before the Covid-19 pandemic, ApiJect had only manufactured its prefillable syringe in prototype form and limited quantities. And the company’s own executives have acknowledged there’s no precedent for using the technology en masse — especially not during a pandemic.  

Prefillable syringes “have to be precisely manufactured under the right conditions,” said Irwin Redlener, the director of the Pandemic Resource and Response Initiative at Columbia University. “It’s really unconscionable that a small company is being given this kind of responsibility.”

But contracts to expand capacity established manufactures like Corning and SiO2, he said, induce more confidence. 

“It’s nothing new for them,” he said, “and they’re well-established companies with good track records.”

Major questions on vaccine distribution plans 

When it comes to OWS plans to distribute vaccines when they become available, the initiative has not been forthcoming.

Groups that are normally responsible for last-mile planning — getting vaccine doses to the places where they’ll be administered — haven’t received a lot of information about the role they will or won’t play this time around. 

“There are still lots of big questions that remain, and it’s getting toward crunch time,” said Claire Hannan, executive director of the Association of Immunization Managers.

Some OWS skeptics in the public health world were heartened when the administration announced it had contracted with McKesson, one of the three largest pharmaceuticals wholesalers in the U.S., to be a “central” distributor of vaccines. McKesson plays this same role in the annual distribution of influenza vaccines.

The company’s role here has not been clearly defined, but it stands to reason the wholesaler will function as something of a hub in a distribution wheel, shipping containers to facilities around the country. STAT asked McKesson for more information, but has not yet received a reply.

Distribution, of course, is fraught with challenges, including some related to security. Although vaccine makers and wholesalers have long had procedures in place to thwart cargo theft, they will have to invest in additional sensors to track shipments around the country.

Beyond security, some of the pending questions can’t currently be answered, like how many vaccine doses will be available for use when the first one or two or three vaccines get approved. And the various groups working to prioritize who should get first access to the vaccines aren’t yet finished with their work, so granular planning around priority groups — Who is an essential worker in Omaha, Neb.? Tallahassee, Fla.? — can only go so far.

Planners also have to consider they may first be distributing a vaccine that requires ultra-cold storage. Pfizer’s vaccine, if it works, must be kept at -70 Celsius, which pretty much rules out administration in doctors offices. Or they may be distributing a couple of types of vaccines, with different cold-chain requirements. 

Low marks on transparency

Basic questions about what is being done and why are often not laid out. It’s not crystal clear, for instance, why OWS picked the vaccine projects to fund that it did, or how the process was handled. 

The trial protocols for the studies, which would explain what and how analyses are being done, have not been published. However, for the trial of Moderna’s vaccine, data on the diversity of the participants are being regularly made public.

Key public health professionals across the country have been in the dark about how Covid-19 vaccines, once available, will be distributed and administered.

Matthew Hepburn, a Defense Department official who heads the vaccines portion of OWS, ruffled feathers in June when he made a presentation to the Advisory Committee on Immunization Practices, an expert panel that develops vaccination guidance for the Centers for Disease Control.

ACIP presentations routinely involve data-rich slides. Hepburn said he hadn’t received clearance to present slides, but looked forward to liaising with ACIP in future. The group, which was at that point struggling to find out if — as would normally be the case — it would be tasked with determining which Americans should be at the front of the line for vaccines when they become available, was not impressed. Several members asked Hepburn pointed questions he pointedly did not answer. 

A careful balance with regulators

The Food and Drug Administration, which is playing a critical role in the response to the pandemic, has virtually no visibility into OWS — but that’s by design. 

Two senior FDA officials told STAT the agency couldn’t even explain the structure of OWS or when its leaders meet. The FDA has set up a firewall between the vast majority of staff and the initiative to separate any regulatory decisions from policy or budgetary decisions.  

FDA officials are still allowed to interact with companies developing products for OWS, but they’re barred from sitting in on discussions regarding other focuses of OWS, like procurement, investment or distribution.

Even FDA Commissioner Stephen Hahn is removed from the day-to-day workings of OWS, an FDA spokesperson confirmed to STAT. 

Helen Branswell, Matthew Herper, Lev Facher, Nicholas Florko, Ed Silverman, and Damian Garde contributed to this report.

  • Approx. 10 years ago the exec I worked with at McKesson went to jail, and Charlie McCall the then CEO was convicted of fraud. Since then McKesson has been implicated in the opioid crisis. This is hardly a company whose ethics I trust with a COVID vaccine.

  • The technical basis for vaccine distribution should be based on early vaccination of high risk groups in all countries, and not on early vaccination of everyone in developed countries. There is a naive assumption that the populations of US, UK and Australia will protect the populations of those countries. That would be true in a world where neither people nor pathogens fly across national borders. That never-never world does not exist. If all countries do not get early access to the vaccines, then neither morbidity nor mortality will remain durably low in any country.

  • It seems that Anticoagulants, commonly known as blood thinners, which have proven quite helpful for treatment, are also on short supply, including for patients that need them for their traditional purposes. Maybe they had been deemed too “common” to make any problems ever. At least that looks like a shortfall of OWP not to address production capacity of these as well.

  • They might have added that: any President has access to more information than any one else. But every time this President mentions any positive findings on any method or medicine, or phase trial, that finding is attacked by big media as being incomplete or not totally proven. Or painted as worse, dangerous, because it doesn’t have a one year or two year track record of safety for this use. This creates confusion and doubt. People on both, or no, political side get scared to accept an existing drug or accept the viability of whatever vaccine might hit the mark first. Thank you New York and Washington media. For misleading us all.

    • The president knows all? Injecting or drinking Clorox? Shoving a UV light down one’s throat? Hydrochloroquine? If the media had not exposed the idiocy of Trump’s quack cures, you’d have 30% of the US population die from poisoning themselves. You’ve gotta be kidding me about taking the lead from our president.
      Please leave it to Fauci et al.

  • Horrible journalism. The authors should be reassigned to fact-checking for a year so they get an idea of information vs. adjectives.

    The unhelpful article reads as if it was written by a 6th grader who skimmed 5 months of WaPo headlines then added the clickbait title to impress her teacher.

  • Odd title referencing vaccine progress that includes “lack thereof” then chronicles massive progress. The incidental meanderings about a “lack of transparency” is the stuff of politics.

  • Everybody, imagine if worrywart Anthony Fauci were running this operation instead of folks with a “get things done” business mentality?

    The question answers itself.

    Traditional vaccine development TAKES TOO LONG, especially Phase 3. By the time we go the traditional route, the viral infection of interest will have run through the population and the vaccine will be too late to the party. That even may be the case now with Covid, after 8 months.

    The article bemoans the proportion of funds to therapeutics — not too long ago the President was on record that he thought getting therapeutics was preferable.

    But therapeutics are way more complex and time consuming to test, given all the confounding variables — such as the stages of disease progression, specific yet varied physiological reactions to infection, accompanying co-morbidities — among many others.

    Vaccines, in contrast, are simpler — they either produce antibodies, or not, and they trigger memory T cells, or not. It makes total sense to get the vast majority of resources devoted to vaccines.

    I believe that OWS is a huge game changer in Pharma development. This process will not be perfect — large scale, high speed, multi-layered development processes are never perfect. But the rewards far outweigh the problems.

  • This article would have benefited from more balanced information about McKesson and vaccine distribution.

    FYI: McKesson was the centralized distributor for the H1N1 vaccine during 2009 and 2010. McKesson delivered about 126 million doses of this vaccine to nearly 70,000 locations. It handled 330,000 total shipments, with 95 percent of shipments received within 48 hours of ordering. (Source: https://drugch.nl/3bD4yqp)

    McKesson’s performance gives me confidence for the 2020-21 rollout of the COVID-19 vaccine.

  • 5 authors but only 2 links/citations. As a news source that claims “Some of the best-sourced” science, health, and biotech journalists” work for STAT (statnews.com/about), I would think they would include more of their sources. I dont disagree with anything in the article, I just wish there was a quick news source that had some citations.

    • Agreed. I was thinking the same thing. The Conversation has extensive citations in every post, and is free.

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