Getting America vaccinated at Warp Speed

In the early days of the pandemic, many worried about the status of their hospitalized loved ones and hoped that treatments for their symptoms would emerge. But health officials were already beginning to look further than simply therapeutics for COVID-19 symptoms: in January 2020 during the Trump administration, they established a project called "Operation Warp Speed" (OWS), aiming to develop the first COVID-19 vaccine as soon as possible.

In Heinz College on Monday, April 25, Paul Mango talked to KDKA Anchor Jon Delano about Operation Warp Speed in an interview titled "The Untold Story of the Race to Save the World from COVID-19." Mango, formerly Deputy Chief of Staff at the U.S. Department of Health and Human Services, was tasked with overseeing OWS on behalf of United States Secretary of Health and Human Services Alex Azar. After interviewing several of the people involved during the Trump and Biden administrations, Mango wrote the book "Warp Speed: Inside the Operation That Beat COVID, the Critics, and the Odds," describing how OWS delivered vaccines to the public in the span of about eight months.

OWS was relatively behind the scenes during the Trump administration. Most press-centered coverage around Vice President Pence's Coronavirus Taskforce, which held press conferences more regularly and was more focused on formulating policy between agencies. The task force was very deliberative, but OWS "could not afford to invest that much time in what we were doing," Mango said. "So we sequestered the Operation Warp Speed team over in the [Hubert H.] Humphrey Building with a completely separate governance structure."

"When we needed something I called Jared [Kushner], Jared gets the president and says, 'Come on over here in two hours.' President makes a decision," Mango said. "So what normally takes weeks, months maybe in the federal government, we'd get done in hours."

In the interview, Mango describes that while the vaccine was distributed in December 2020, it had been created close to the beginning of the pandemic's onset in the U.S. in January 2020, albeit untested. In January, Moderna had already been working closely with the National Institute of Health (NIH) to develop a cancer vaccine. Once a draft DNA sequence of the coronavirus was published around January 11, Moderna and the National Institute of Allergy and Infectious Diseases of the NIH, which Anthony Fauci heads, decided to create a mRNA COVID-19 vaccine., According to Mango, they completed the vaccine 10 days later. BioNTech, Pfizer's partner in Germany, used similar technology to create their own mRNA vaccines soon after, which became the first mRNA vaccine to gain FDA approval in the U.S. "We didn't know it. It hadn't been tested and hadn't gone through clinical trials," Mango said. "But what Moderna had on January 20, 2020 was the same vaccine it distributed December 21, 2020."

These were notable developments, not only because of how quickly the vaccine was created, but also because before the pandemic, mRNA vaccines were simply not extensively used outside the Ebola outbreak in Africa. However, COVID-19 allowed mRNA vaccine technology to create a name for itself and gain more commercial success in the U.S.

The federal government wanted to invest in as many vaccines as they could. During the pandemic, the FDA narrowed 95 vaccine candidates down to 14. Head of OWS Moncef Slaoui and Chief Operating Officer Gustave Perna decided to cut the list of vaccines to just six. Their primary reasons were that each vaccine had specific conditions to be kept in, such as temperature as well as different sized syringes and needles. In their cumulative probability analysis, they found that the six vaccines would give them around a 75 percent chance of having at least one vaccine, manufactured at scale, safe and effective in those over age 65 by the end of the year.

There were a number of troubles along the way. After developing the vaccine, OWS hesitated to promote it before it received FDA approval, as they feared the public would think they were trying to influence the FDA's decision. They also worried that once the public knew of the vaccine, there would be more demand than supply. Delaying promotion of the vaccine contributed to the public's hesitancy to accept it. The government also did not have a great social media presence, particularly on Facebook, which their primary audience of those over 65 tend to frequent.

They also found that people were hesitant to take the vaccine because it had been developed so quickly, reinforced by the project name “Operation Warp Speed.”

"And that name stuck, but we did have some regrets about that afterwards, because our intent was to express a sense of urgency," Mango said. "But of course, you know, people receive that message differently, like, 'Oh, they're going to cut corners.'" Mango emphasized that the standards for the vaccine were higher than that of others, but it was difficult to dissuade the public otherwise once the name caught on.

Another challenge was deciding whether to work with private partners to distribute the vaccine or to rely on the public healthcare system. While the CDC advocated for distributing the vaccine through the public healthcare system, OWS decided that the private sector was probably the better choice, as public health agencies were already overwhelmed. Private partners simply had more resources and capability to implement processes, such as requiring those getting their first vaccine dose to make an appointment for their second dose.

One interesting challenge that OWS ran into was handling the transition between the Trump and Biden administration. "I can see the dilemma they were in because Joe Biden had run against Donald Trump on his incompetence of dealing with COVID-19," interviewer Delano said. "So here they come into power, and they can't automatically turn around the dime and say, 'Hey, by the way, Trump was nuts on this stuff, but he actually did a great job on the vaccine.'"

After President Joe Biden was inaugurated into office, "his team was quoted in the paper as saying three things: they left us a mess, we had to start from scratch, and they had no plan," Mango said.

"And as political appointees, we just said that's politics. They're lowering the bar so they can look good," Mango said. "But the real issue was there were about 300 individuals, career officials in the Humphrey Building at that time, who were seven days a week, 16 hours a day, working to get this done. And you can imagine the morale impact of your new boss basically saying, 'You guys didn't do anything the last 10 months.'"

However, the Biden administration did ultimately follow the OWS game plan. "And just to be fair, they did a spectacular job of picking up the ball and running with it and getting America vaccinated," Mango said. "I think we had 25 million shots at the end of January, by when we left basically, and they had 200 million by the spring."