The U.S. Paid Billions To Get Enough COVID Vaccines Last Fall. What Went Wrong?

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Then-Health and Human Services Secretary Alex Azar (left) and President Donald Trump listen as Moncef Slaoui of Operation Warp Speed speaks about the crash program to develop a COVID-19 vaccine in the White House Rose Garden in May 2020.

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Banks of ultracold freezers are used to store COVID-19 vaccines at Pfizer’s Kalamazoo manufacturing complex in Portage, Mich.

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«During the fall, during those meetings, the anticipated number of doses was going up and down,» said Claire Hannan, executive director of the Association of Immunization Managers. «I mean, I don’t think we ever actually had anything more than just estimates. And there really just wasn’t a good sense of how much vaccine would be available and when.»

Anytime a federal official said a new number during a press event, immunization managers would whip out their calculators to figure out how much they might get.

«It’s very difficult to plan a rollout or plan clinics or plan, you know, which providers are going to get doses if you don’t know how many you’re going to get,» Hannan said. «So, you know, that was very challenging.»

And then, a week or so after Azar’s optimistic Today show appearance on Nov. 10, Pfizer told the government it wouldn’t be able to meet the 40 million dose goal for the end of the year laid out in its contract, but it wasn’t yet clear how far behind the company was, according to several people familiar with the matter.

Pfizer spokesperson Castillo said the company was in «constant communication» with Operation Warp Speed, adding that government officials knew that fewer doses were coming and why.

«There were several factors which impacted the number of doses estimated to be available in 2020,» she said. «For one, scaling up a vaccine at this pace was unprecedented, and the scale-up of the raw material supply chain took longer than expected. In addition, the outcome of the clinical trial was somewhat later than the initial projection, requiring us to focus additional efforts on clinical trial production.»

Although the company didn’t deliver 40 million doses, she said that «it was always understood» the numbers in its contract and projections could change.

«The notion of flexibility was laced throughout the July 2020 agreement,» she said. «For example, the due date column in the deliverables table was labeled ‘Estimated Due Date.’ «

Pfizer «in the driver’s seat»

Although all the Operation Warp Speed agreements with vaccine makers were a little different, Pfizer’s stands out. As part of its eventual federal deal, Pfizer got a tailor-made contract awarded through Advanced Technology International.

In exchange for doing its research and development without government help, Pfizer got a contract that let it retain almost all of its intellectual property rights and forgo the taxpayer protection clauses found in most government contracts that fund inventions.

There were incremental targets in Pfizer’s original Operation Warp Speed contract to deliver 20 million doses a month starting in November and ending in March to hit 100 million eventually in all. But the contract said those requirements were «subject to change» based on a variety of factors outside the company’s control.

«They’re not hard and fast deadlines,» said Kathryn Ardizzone, a lawyer at Knowledge Ecology International who reviewed the vaccine contracts. Knowledge Ecology International is a nonprofit public interest group focused on intellectual property.

The contract doesn’t specifically give the government the right to verify Pfizer’s reasons for not meeting a delivery milestone. That’s apparent in the way the contract lays out how vaccines beyond the original 100 million doses would be purchased, Ardizzone said. It just said Pfizer «shall inform the government» how many additional vaccine doses it can make and on what timetable.

«So that seems like Pfizer is in the driver’s seat in terms of what the deadlines will be,» Ardizzone said. «The language of that just speaks to Pfizer telling the government about when it can accomplish certain goals, rather than the government having the right to verify that.»

Overall, the government had no leverage to enforce Pfizer’s November deadline once it learned those doses weren’t going to be ready, Operation Warp Speed’s Mango said.

«What are we going to do, refuse to take doses at any time from the only manufacturer under an EUA [emergency use authorization]? That didn’t make sense,» Mango said. «So at the time, remember, Moderna didn’t get its EUA until Dec. 21, and there was no guarantee on that either. So we had a very difficult, rocky relationship with Pfizer.»

Some of that friction arose because Pfizer CEO Albert Bourla said as early as August that the company would have top-line vaccine efficacy data by the end of October but didn’t announce it until days after the 2020 election. And Pfizer told the Biden team the good news before telling Operation Warp Speed officials, who were then still in office.

Mango said that Trump’s team had secured the needles, syringes and dry ice — not to mention a $2 billion federal contract with Pfizer — yet it felt like the last to know about the strong vaccine efficacy data: «How could we be happy with that?»

Dropping vaccine projections and finger-pointing

By the first week of December, Pfizer told Operation Warp Speed it would have just 22 million doses ready for distribution by the end of the year, several people familiar with the matter told NPR. Before the end of the month, that number dropped again — to 18 million doses.

Castillo, Pfizer’s spokesperson, said the company let Operation Warp Speed know earlier that fall that a lower number of doses would be arriving by the end of the year. In November, Operation Warp Speed made planning numbers available to jurisdictions based on an assumed 22.5 million Pfizer doses by the end of the year, she said.

However, not everyone seems to have been briefed at the same time. Some people NPR spoke with said they knew there would be around 22 million doses in November. Others said Pfizer didn’t tell them until December.

Slaoui said he remembers it being «quite late.»

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Boxes containing Pfizer’s COVID-19 vaccine were prepared for shipment at the company’s Kalamazoo, Mich., plant in December.

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On Dec. 14, Sandra Lindsay, an intensive care nurse at Long Island Jewish Medical Center in the Queens borough of New York City, became the first person in the U.S. to receive the Pfizer COVID-19 vaccine after the Food and Drug Administration authorized it for emergency use.

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Gen. Gustave Perna speaks at a Senate committee hearing in February. Perna took personal responsibility for miscommunication about the supply of COVID-19 vaccine doses at a press briefing on Dec. 19.

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Gen. Gustave Perna speaks at a Senate committee hearing in February. Perna took personal responsibility for miscommunication about the supply of COVID-19 vaccine doses at a press briefing on Dec. 19.

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«Gen. Perna apologized and we supported him, and it was not at all because the distribution did anything wrong,» Slaoui said. He explained that providing a precise number of doses from week to week is incredibly difficult, given the hurdles of early manufacturing.

Perna’s apology seemed to help defuse some of the tension. Pfizer and the government came to an agreement for another 100 million doses for $2.05 billion on Dec. 22.

And this time, the U.S. government would use the Defense Production Act to get Pfizer some supplies it needed. Until then, the other five Operation Warp Speed vaccines had at least some help from the federal government under the Defense Production Act, which allowed the vaccine makers to be at the front of the line when they needed certain supplies, equipment, ingredients or more from third-party vendors. Now Pfizer would have that advantage, too.

By the end of the month, Pfizer delivered 16 million vaccine doses to the United States. It was 2 million short of its latest lowered projection and 24 million short of its contractual targets.

Pfizer becomes the dominant vaccine supplier

By late February, Pfizer got its vaccine manufacturing humming and — with Moderna — delivered vaccine doses in high volumes to help bring case counts down. Because it takes so long to make each batch, many of those doses were in production even before Trump and Operation Warp Speed officials left.

But before vaccines could bend the pandemic’s curve downward, another 243,000 people would die from COVID-19 from December through February, according to data from Johns Hopkins University.

It was in February that vaccines finally started to have an impact, particularly on nursing home populations, said Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health.

«I think if we had more doses earlier, we may have been able to have an impact on the mortality rates, I think, in the nursing home population in particular,» he said. «But it is more than just having doses.»

It’s possible that even if the United States had all 55 million vaccine doses expected under the contracts by the end of the year, it wouldn’t have had the infrastructure in place to distribute them and get them into people’s arms.

Johnson & Johnson, the third COVID-19 vaccine supplier in the U.S., only got the FDA’s authorization in late February, and the company has struggled to supply it in volume because of manufacturing issues.

Pfizer said it released all of the 300 million doses it had committed to the U.S. by the middle of July. The company has invested in its global supply chain to make this happen, including doubling its batch sizes, producing its own lipids (the fatty substance that coats the mRNA used in the vaccine) and dry ice and reducing the manufacturing timeline from 110 days to 60 days, spokesperson Castillo said.

In late July, Pfizer agreed to supply the government with an additional 200 million vaccine doses for delivery between October 2021 and April 2022, which would support the government’s plan to provide booster shots.

As of Aug. 25, 73% of adults have had at least one dose of the Pfizer, Moderna or the Johnson & Johnson vaccine, according to data from the CDC. And Pfizer is the dominant supplier, accounting for about 57% of the doses administered overall.

«I think it’s a good news, bad news story,» Yale’s Omer said. «The good news is that we eventually got to a pretty substantial number of doses by spring, etc. But I did think that some of their [Operation Warp Speed’s] pronouncements … there seems to be a lack of overlap between what the government officials were assuming versus what was happening.»

Slaoui said he doesn’t want to minimize the fact that Operation Warp Speed could have immunized millions of people a few weeks earlier had Pfizer met its goals on time, but overall, his team — and Pfizer’s — did what they set out to do.

«There was always in the mind of everybody in the operation that the big picture is to have vaccines,» Slaoui said. «The very small picture was whether it was 1.5 million this week or 1.8 million.»

You can contact NPR pharmaceuticals correspondent Sydney Lupkin at [email protected].

• COVID-19 vaccine
• operation warp speed
• Pfizer Inc.