How the U.S. Laid the Groundwork for a Covid-19 Vaccine
Vaccines will be a story of the process working the way it’s supposed to (and how good people get it done)
With the vaccine progress today, is Operation Warp Speed for real? It’s a great story but not what it appears.
First, let’s be clear on our accomplishment. From January 11, when the sequence for the virus arrived from China, to around December 13, when needles will start to enter arms, only 11 months will have passed. Vaccine development can typically be a seven-year process or worse— HIV and the common cold have no vaccine.
Operation Warp Speed has had phases. The idea, the planning, the decisions, and the work. This was hatched by Peter Marks of the U.S. Food and Drug Administration (FDA). When the story of the pandemic and our response is written, he will be one of the great heroes.
In 2017, the man who ran the government agency Biomedical Advanced Research and Development Authority (BARDA), Rick Bright, began investing in a new technology called mRNA in the private sector. When Covid-19 hit, he was ready. Good people like Bright, who was thinking ahead, always attribute success to luck. It’s luck that there are people like Bright.
Marks decided he wanted to cut time from the longest part of the vaccine development process: the approvals and back and forth with developers and the FDA. So he dreamed up the idea to imbed National Institutes of Health, FDA, and BARDA people inside the companies with the five to six most promising vaccines.
Bright worked with them to get them to invest in concurrent manufacturing and got the money out of Congress. Bright, Marks, and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, pitched this approach, and it worked. Everything was accelerated.
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Operation Warp Speed then entered into a second, more visible phase where it was managed as part of the White House. Marks was invited to be a part of it; something most people would jump at. After a day or two, he decided to go back to the FDA and focus on the approval process.
Maybe he foresaw the politics taking over, or maybe he just knew what the country needed. But the beautiful thing is that the man who did more to speed up drug approval than anyone then did more to slow it down when Donald Trump pushed to get a vaccine out before the election.
So three days after NIH had the virus, it was stabilized and made available. The FDA and BARDA found the companies, helped with the trials, and assisted with production. The next time someone bad-mouths career civil servants, think of them.
Was it a success? Without a doubt. Did we need it? Well, Pfizer didn’t participate and still got it done in the same amount of time. And the mRNA platform wasn’t the only thing that worked. Oxford’s vaccine also appears to have worked. But you can’t evaluate in hindsight.
Investing heavily in six candidates, taking small flyers on dozens of others, investing in concurrent manufacturing so we would be ready to go, and slowing down when the politics looked like they were taking over—that’s success.
Who deserves credit? Everyone. But the people who conceived of this were the career team. But Congress funded it. And the political leaders supported it.
Why did it work, and what did we learn? Aside from the process, the spike protein turned out to be a good target. And while it creates antibodies, it wasn’t known until very recently that those antibodies prevented disease.
This is a story about how government works. About how good people get it done. About how early investments can pay off when a crisis hits. About how when you do good work, you get lucky. About the reason you don’t create single points of failure.
It’s also a story about why it doesn’t pay to be cynical. Nothing ever gets done by the critics. So many things we do don’t pay off. But they’re still worth doing. Because they make us smarter.
There’s been teamwork and quiet leadership in the background while the lies, distortions, and political pressure were going in the White House.
We’re not all the way there yet with the vaccines, and science won’t always come to our rescue — unless we keep investing in it, honoring it, and believing in expertise. Even when experts are wrong.
Starving our government by cutting taxes is also not the answer. Neither is the government doing everything itself without the private sector. Ideology goes out the window when it comes to solving problems.
For all the people I didn’t mention who work behind the scenes every day in our government, take abuse, and deliver as a career civil servant for this country, thank you.
(This is pulled and lightly edited from my November 23 Twitter thread.)