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Finger-pointing abounds as states get fewer vaccines than planned

 3 years ago
source link: https://arstechnica.com/science/2020/12/vaccines-ready-but-no-distribution-operation-warp-speed-meets-speed-bumps/
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Need for speed —

Finger-pointing abounds as states get fewer vaccines than planned

Pfizer: We have "millions more doses" with no shipping instructions from Feds.

John Timmer - 12/18/2020, 11:59 PM

Fake highway sign showing the USS Enterprise hitting a speed bump
Enlarge / Operation Warp Speed hits a speed bump.
Aurich Lawson / Getty Images


As we're waiting for word on the authorization of a second vaccine for use in the US, glitches have been striking the distribution of the first through the federal government's "Operation Warp Speed." This week, the US saw the first use of the vaccine developed by a Pfizer/BioNTech collaboration. But immediately afterward, many states started saying that orders for shipments in the ensuing weeks were being cut. After some in the federal government had indicated that the problem might be in production, Pfizer issued a statement indicating that it had doses in its warehouse ready to ship out but no indication of where to ship them to.

All in all, it's about what you'd expect in the first weeks of a massive undertaking like this.

State of denial

One of the first states to report problems was Illinois, where its governor, J.B. Pritzker, said that it had indications it would only be receiving half the expected doses of the Pfizer/BioNTech vaccine next week. Since then, over a dozen states have indicated that they'll be receiving fewer doses than planned in the second week (this article seems to have a fairly comprehensive list).

Aside from the obvious problem of fewer vaccinated people, this creates issues for states that are working through vaccinating a set of populations using risk-based priorities. For example, the availability of doses for health care workers will determine when vaccinations can be shifted to nursing home populations; planning on when to change the target population will be critical for a quick and effective shift. Without knowing when sufficient vaccines will be available, it's much harder to manage these transitions.

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When it comes to why the orders are being cut, we're hearing multiple excuses. At a press conference on the distribution effort, Secretary of Health and Human Services Alex Azar pointed the finger at Pfizer, which is manufacturing the vaccine in the US. “We have recently been informed by them, finally, of various challenges that they might have in their manufacturing, and we will ensure that by whatever mechanism, that we provide them full support to ensure that they can produce for the American people,” Azar said.

But Azar's isn't the only story being given out by the government. The Washington Post was told that the issue was a matter of when the week's doses were determined. Originally, that had been planned for Friday, when the full week's manufacturing run had completed; it has since been shifted to Tuesday when fewer doses would be completed. That would necessarily cut down on the availability numbers given to states.

Unfortunately, neither of these seems to be entirely true. In response to this news, Pfizer has issued a statement in which it says it is having no production issues. "This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. Government to the locations specified by them," the statement reads. "We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses."

Given that BioNTech joined up with Pfizer in part because of the latter's manufacturing abilities and due to clear credibility issues with the Trump administration on the topic of COVID-19, it's likely that Pfizer's statement is closer to the truth.

Not all bad news

Warp Speed is a large and complex project in which multiple vaccine manufacturers will eventually be shipping doses to the federal government, which will then distribute them to states, each of which has to plan to get them to populations according to different priorities. It's not at all surprising that there would be some growing pains. Hopefully, they can be ironed out while there's a single vaccine supplier, which limits the complexity somewhat.

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But the single supplier status may change as early as today, based on the decision of an FDA advisory board that a vaccine from Moderna is effective. Based on preliminary figures, Moderna expects that it will supply substantially more vaccine as soon as it receives a formal Emergency Use Authorization from the FDA, which will complicate distribution but ease supply bottlenecks.

Longer term, there are indications of other opportunities to increase vaccine supplies. After having declined an offer from Pfizer to purchase additional doses of the vaccine earlier this year, the federal government may be close to a deal to purchase more. Pfizer had worked with the suppliers of its raw materials to determine how much vaccine it could produce; when the US turned it down, the company simply found other countries to sell doses to. Now, it's indicating that if the US government can ensure enhanced supply of its vaccine ingredients, it will sell the additional doses to the country.

As of right now, the US only has commitments to buy enough vaccine to cover half of its population by the middle of 2021, making additional doses essential. Last week, the government did manage to get a commitment from Moderna for another 100 million doses of its vaccine. Major pharmacy chains are expecting widespread availability this spring, indicating a confidence that additional supplies will be sorted out.

One small help for the present supply constraints that has become apparent this week is that the normal "overfill" found in vaccine bottles is sometimes enough to allow an extra dose to be extracted from a five-dose bottle of Pfizer vaccine. While it won't handle the big-picture supply issues, it will undoubtedly help individual facilities get more of their staff protected in the early days of the vaccination program.

Promoted Comments

  • eric102 wrote:
    Am I the only one worried about the "extra dose" in the vials? Does this mean that people are getting underdosed? Is there a manufacturing problem?
    With such a scarce resource you'd expect tight manufacturing controls. Not a loosey goosey "maybe you get 20 percent more for free..."
    Not in the slightest. There is variability in automated filling, so you calibrate to guarantee that every vial has at least the promised number of doses. This means some vials will have mild overfill.
  • johnsonwax Ars Tribunus Angusticlavius
    jump to post
    So, I'm a state govt worker, and government work is difficult, arduous, and boring. NASA might be sexy but the rest of it isn't. One reason why government feels inefficient is that, well, it is - mostly by the nature of what it is. See, we don't have the luxury of saying 'it's not worth our time to send a check for $0.47 to some one out in East Jesus'. We're government. It's your $0.47 and we're going to send it to you.

    One reason why government is so easy to criticize is that when your job is serving 100% of the people, many of whom express no interest in your help, it's easy to find our failures. Apple more or less gets to choose which 300 million customers they serve. They can price some out, they can not put stores in their communities, they can simply not make the product you insist you want (clue for the over the top Apple critics - maybe their products are unappealing to you because Apple doesn't want to deal with you). But government gets none of that.

    That means that we approach problems in a very different manner. It's embarrassing when Sony can't find a way to let me buy a PS5, but it's a catastrophe when you can't get your drivers license renewed at the DMV or your social security check doesn't arrive, or you are unable to cast a vote. So those of us who believe in a benevolent government grind out the process to make those things work - plans, contingency plans, tests, trial runs, simulated problems. Those episodes of Parks and Rec when Leslie needs to lead the group through a simulated disaster - we do that. All the time.

    So when it comes to a vaccine distribution, you have plans, you have plans when the truck doesn't arrive, you have plans when the truck is hijacked, you have plans when shipment is to go out at the same time a blizzard is about to reach the recipient, you have plans for when Pfizer is having a production issue but Moderna is not, you have plans for when someone who recently took the vaccine dies from a heart attack and it hits the news with 'Is the Covid vaccine fatal?'. You have plans for everything and you keep your finger on everything. You talk to the drug companies every day, even if you have nothing to talk about. You make it a routine because you'd be surprised at how often the offhanded 'I'm not sure if this is important but' comment turns out to be super fucking important. That way you also know if the guy responsible for shipping to Boise is out sick, or has an undertrained stand-in or whatever. A hell of a lot of the job is simply being on it, all the time, 24/7. But those of us who have made a career of this really love doing it. The act of doing it may be arduous and sometimes soul-crushing, but at the end of the day saying you helped make sure every person in the greater Des Moines area received their tax refund is surprisingly gratifying.

    Government is about visiting every mailbox in the United States, every day, on the off chance that you wanted to send a letter to your grandma. It is not efficient, but it's really damn important. And we're currently being led by a bunch of fuckers who don't see the importance of it and are simply too lazy to do the work. Those of us who hire can see those people a mile away. It's not for everyone.

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