Short Wave - Fewer COVID Vaccine Doses Materialized Last Fall Than The U.S. Government Hoped

Episode Date: September 8, 2021

Manufacturers can expect to face unforeseen hurdles when they begin to mass-produce a brand new pharmaceutical product, and in a pandemic, there are bound to be supply chain problems as well. But in late 2020, Pfizer was delivering fewer doses than the government expected and then-federal officials told NPR they did not know why. See pcm.adswizz.com for information about our collection and use of personal data for sponsorship and to manage your podcast sponsorship preferences.NPR Privacy Policy

You're listening to Shortwave from NPR. Hey, everybody. Emily Kwong here with NPR's pharmaceuticals correspondent, Sydney Lupkin. Hi, Sydney. Hey. So you've got a look-back story for us about Operation Warp Speed. That was the Trump administration's crash vaccine program that cost billions of taxpayer dollars and was meant to make a vaccine available in record time. Yeah. It started in May of 2020.

and the initial promise was a few hundred million doses by the end of the year. But that didn't happen. We eventually got the doses, but later. And I just wanted to figure out why. Yeah, it's a really good investigative question. And it's an easy one to let slide, right? Considering where we are now, we're asking those who are vaccine hesitant to please consider the shot. But Sydney, only a few months ago, vaccine doses were scarce. And I remember there was a a ton of anxiety around when people would be able to get a shot. Totally. So I wanted to figure out why the promise far exceeded how many doses were actually available early on. So I've spent months digging through data and documents and then, you know,

made about a zillion phone calls. Yeah. It's a huge project. So where do you start figuring out something like this? Well, one of the first things that really got my attention was this interview on the Today Show. So I sort of focused on digging into this point, really. It was on November 10th, 2020, which I learned was 17 days before the first deadline in Pfizer's Operation Warp Speed contract. Then Secretary of Health and Human Services, Alex Azar, told the Today Show this. So the timeline is Pfizer will be producing and delivering to us approximately 20 million doses of vaccine each month, starting at the end of this month in November. But in reality, Pfizer wouldn't finish.

delivering those first doses until mid-January. Hmm. Okay. So did Azar know that Pfizer was behind when he made that promise on the Today Show? So I spoke to his chief of staff, Paul Mango, and asked the same question. I can assure you that Alex Azar always conveyed the truth as he knew it. It's just that the truth was being concealed from us. Oh, that's quite the allegation. Mm-hmm. Pfizer disputes it. The company says it was fully transparent with Operation Warp Speed,

plus the deadlines and the contract were designed to be flexible. Either way, as Pfizer's projections for what it could deliver to the United States dropped, COVID-19 cases were climbing. Today on the show, a detailed look at why Operation Warp Speed delivered far fewer vaccines last fall than initially promised. And what that tells us about vaccine contracts, the pitfalls of manufacturing, and the complicated relationship between the U.S. government and Pfizer. This is Shortwave, the Daily Science podcast from NPR.

Okay, Sydney, so let's start this story at the beginning when Operation Warp speed kicked off. It was May 15th, 2020. The country had been locked down for two months, and things were not looking great. At least 86,000 Americans had already died of the virus. Around this time, Trump administration said, enter office. Operation Warpspeed. Nobody's seen anything like we're doing now within our country. And enter vaccine veteran Monsef Slawe, who was introduced as the project's chief scientific advisor. He said this about vaccine data he'd seen earlier that day.

These data made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020. A few hundred million. That would have been huge, right? For sure, it could have changed the trajectory of the pandemic by Christmas. But producing that many doses that fast was a fantasy from the outset, according to pharmaceutical manufacturing consultant, John Avalonan. Anybody who was involved who had experience in this probably cautioned people to say, look, you know, you're making a big, ginormous assumption of everything going right,

which it's not going to in the middle of a pandemic. So in reality, Operation Warb speeds, contracts with pharmaceutical manufacturers turned out to be a lot more conservative. How much more conservative? So Pfizer and Moderna were only expected to deliver 55 million doses combined by the end of the year. And most of that, 40 million doses, was supposed to come from Pfizer. So a lot fewer. And as you said, Pfizer was already kind of behind in production.

Right. Pfizer actually only delivered 16 million doses by the end of the year. I learned after analyzing. data from the Centers for Disease Control and Prevention and running it past a few people to make sure I was doing it right. Wow. I mean, Sydney, what you found, none of this was readily apparent to the general public. Yeah, this information was in the CDC's allocation database, which doesn't quite jump out at you on the website. And we had to figure out how to count first versus second doses, when to include reserve doses, stuff like that. So it's not rocket science, but it definitely helps to do a little regular reporting with your data reporting.

Yeah. So your reporting showed that Pfizer delivered a lot fewer doses than Operation Warp Speed was expecting. But also, Operation Warp Speed officials told you that this wasn't clearly communicated, at least not early on to federal officials, including then Secretary of Health and Human Services, Alex Azar. Yeah, that's what I've been told. But there was a line that had been appearing toward the bottom of Pfizer's various press releases about vaccines. study updates. For months, it said the company was expecting to make 100 million doses globally by the end of the year. But right before Azar went on the Today Show, Pfizer issued a press release about their interim study results, and at the bottom, the line about global vaccine production

changed. What did it say? Instead of 100 million doses by the end of the year, it said 50 million doses. In other words, Pfizer was dropping its production estimates in half. Okay, so they were sort of transparent, but sort of not. Like, they said it, but they didn't issue a press release announcing the dropping dose expectations. Exactly. When I spoke to Paul Mango, Azar's chief of staff, he told me that transparency was a big issue. He says Pfizer lowered its productions multiple times and didn't tell Operation Warp Speed why. Again, Pfizer disputes this, saying it was transparent and didn't have to hit those delivery milestones exactly because they weren't hard and fast deadlines. They were just estimates. The company says government officials visited

three times in July, November, and December. But for comparison, Operation Warp Speed had folks in the other vaccine manufacturers factories daily. Pfizer was more at arm's length. So out of curiosity, how were things going at the other manufacturing facilities? I know that there were other companies involved in Operation Warp Speed like Johnson & Johnson, Moderna, Novavax. The manufacturing was definitely bumpy at times. Here's Paul Mango again. When you have all of that in motion, things happen. Equipment arrives and it doesn't work. Pipes are connected in the wrong direction. And plants, you know, all that stuff. Just, you know, is a function of a massive scale up that, in many cases, was the first time done in history.

And that's pretty normal. That's pretty expected. There was also a report from the government accountability office that identified multiple choke points, including limited production of a raw material that's not named. A domestic factory making it had a fire that delayed delivery between four and ten weeks, and a foreign facility making it had an explosion, prompting its manufacturing to shift to another facility entirely. A fire and an explosion. I mean, what this all tells me is the road to vaccine. scene delivery isn't always smooth. But does that give us insight as to why Pfizer may not have been able to deliver on its initial projections? Yeah, it gives you an idea of what can happen. It's not clear whether, for example, this mysterious raw ingredient was an issue for Pfizer, but a company spokesperson did tell me that the scale up of the raw material supply chain took longer than expected, and something along those lines certainly could have caused Pfizer's delays, too. But Mango says Pfizer never told Operation Warp Speed what went wrong.

So at that point, what could Operation Warp Speed do to get Pfizer to hit the targets? Or at least explain why it couldn't. Well, nothing, in essence. The contract doesn't have specific language giving the government the right to verify what went wrong. And Mango said, yeah, he basically had no leverage. The FDA granted an emergency use authorization or EUA for Pfizer's vaccine on December 11th, 2020. That meant the vaccine could start being distributed and administered, but shots were in shorter

supply than expected. What are we going to do? Refuse to take doses at any time from the only manufacturer as an EUA? That didn't make sense. It sounds like Pfizer had a ton of power in this situation because they were the only company at this point with an authorized vaccine. Yeah. Slawey, Operation Warp Speeds, chief scientific advisor, says that Pfizer's CEO told him the company was doing everything in its power to speed up manufacturing.

And to be clear, Slawey tells NPR he doesn't doubt that. But he wishes Pfizer had been more forthcoming. And when we were frustrated with Pfizer, it was more complicated to plan not knowing than knowing. It's just a fact. Got it. Well, Cini, I've got to ask, given where we are, now with more doses than people willing to take them. Help me understand why does knowing how all this went down matter? Hey, that's a good question. It depends on who you ask and how you look at it.

Slawey says the fact that any vaccine was available within a year of the virus's genetic code being sequenced was an unbelievable accomplishment. It usually takes a decade or so to develop a vaccine. That said, more vaccine early on might have helped alter the trajectory of the pandemic in the U.S. Here's what Dr. William Moss of Johns Hopkins had to say about it when I asked him. 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. But it is more than just having doses. Yeah, I mean, just having the doses in and of themselves isn't enough.

It took a while to get the small number of doses we did have late last fall into people's arms, making sure people are eligible, shipping the doses where they needed to be, staffing at clinics, etc. And Pfizer eventually came through. By mid-July, the company says it delivered 300 million doses to the United States government. More doses are expected starting later this fall for boosters. Pfizer is invested in its global supply chain to speed things up. It's doubled its batch sizes, started making its own raw materials like lipids, the fatty substance that coats the mRNA used in the vaccine, and it reduced its manufacturing timeline from 110 days to 60 days.

These are all good things. And this was unprecedented science that Pfizer and other manufacturers were carrying out. But it is worth thinking about how things could have been different. Exactly. understanding and analyzing what went right and what went wrong is always a good thing to do because we want to learn from it for future public health issues. Sydney, thank you for bringing this accountability reporting to Shortwave. We really appreciate it.

My pleasure. This episode was produced by Britt Hansen, fact-checked by Indy Kara and edited by Jasele Grayson. I'm Emily Kwong. Thanks for listening to Shortwave, the Daily Science podcast from NPR.