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.

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.

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.

https://arstechnica.com/?p=1730750