Jackson Jambalaya

 When history is written about the Covid-19 pandemic in the distant future, Operation Warp Speed will hopefully receive the credit it deserves.  The vaccine breakthroughs that were announced a few weeks ago are simply unprecedented in human history.  The New York Times dived into the weeds last week and published a pretty good article about Operation Warp Speed.  The newspaper reported:

Dr. Bourla had chosen from the start to keep Pfizer and its research partner, the German firm BioNTech, at arms length from the government, declining research and development money from the crash federal effort, called Operation Warp Speed.

Mr. Bancel, with a far smaller company, made the opposite bet, embracing the assistance of a government led by a science-denying president. Moderna got nearly $2.5 billion to develop, manufacture and sell its vaccine to the federal government and teamed up with the National Institutes of Health on the scientific work, a highly successful partnership that managed to sidestep the political meddling by Mr. Trump and his aides that had bedeviled other efforts to confront the virus...

Still, both companies, in their own very different ways, have pulled off a remarkable feat: developing a vaccine that appears safe and effective in a matter of months, rather than the years or decades that such developments usually take. They were aided by a confluence of three factors. A new method of developing vaccines was already waiting to be tested, with the coronavirus a perfect target. Sky-high infection rates accelerated the pace of clinical trials, the most time-consuming part of the process. And the government was willing to spend whatever it took, eliminating financial risks and bureaucratic roadblocks and allowing mass production to begin even before the trials were done.

Their apparent success showed that in an era of polarized politics, science was able to break down barriers between government, countries and industry to produce one of the few pieces of good news in a year of suffering and division.

Unlike older, slower ways of developing vaccines, which involve stimulating the body’s immune system by injecting inactivated or weakened viruses, Moderna and other companies created platforms that work like the operating system on a computer, allowing researchers to quickly insert new genetic code from a virus — like adding an app — and create a new vaccine.

The method employs a synthetic form of a genetic molecule called messenger RNA, or mRNA, to cause human cells to make a harmless viral protein called a spike, which then stimulates the immune system to make antibodies and immune cells that can recognize the spike quickly and counterattack when needed....

Moderna’s goal was to get from a vaccine design to a human trial in three months. The design came quickly. “This is not a complicated virus,” Mr. Bancel said.

Dr. Graham said that after China released the genetic sequence of the new virus, the vaccine research center zeroed in on the gene for the virus’s spike protein and sent the data to Moderna in a Microsoft Word file. Moderna’s scientists had independently identified the same gene. Mr. Bancel said Moderna then plugged that data into its computers and came up with the design for an mRNA vaccine. The entire process took two days.

N.I.H. scientists were “really hot” on the mRNA approach, Dr. Fauci said. But it was not Moderna’s alone....

As the economy shuddered to a halt last spring and deaths mounted in New York, Detroit and Chicago, administration officials proposed a coordinated effort to develop tests, treatments and vaccines for what was now clearly the gravest public health crisis in a century.

Operation Warp Speed was the brainchild of Dr. Peter Marks, the top vaccine regulator for the Food and Drug Administration. A collaboration between the Pentagon and the Department of Health and Human Services, it was devised to support pharmaceutical and biotechnology companies with the full breadth of the government’s expertise from clinical trials to logistics. The goal for a vaccine was October, according to an early memo.

The operation, working out of a seventh-floor suite and a second-floor operations center at the Health and Human Services headquarters, had a military flavor. Its leaders discussed the book “Freedom’s Forge,” an account of how American industry armed the military in World War II, and imposed what they called a “battle rhythm” of meetings, including a daily 8 a.m. session on vaccines. Dozens of military officers reported to work in uniform.

The biggest decision, Dr. Slaoui said, was which vaccine candidates to back out of almost 50 possible contenders. His team decided on three types of vaccines, each to be pursued by two companies in case one firm failed. Federal officials referred to the finalists as “horses,” a nod to the race between them....

Pfizer signed a $1.95 billion agreement in July to sell the federal government 100 million doses of its vaccine if it was successful, guaranteeing it a buyer, no small incentive. It also called on the Trump administration a few times to get access to manufacturing supplies. Otherwise it was on its own.

Moderna had no qualms about government help. “Guys, we don’t have a balance sheet like Pfizer,” Mr. Bancel said he told federal officials.

Nearly $2.5 billion in federal funds helped Moderna buy raw materials, expand its factory, and enlarge its work force by 50 percent. In return, it promised to deliver 100 million doses to the federal government.

It got expertise, too. Operation Warp Speed had created six teams of around 15 clinical trial specialists, epidemiologists and budget experts, each assigned to a different vaccine maker.

Senior leaders convened weekly check-ins with companies’ clinical trial heads, tracking recruitment of trial participants and covering whiteboards with potential distribution plans.

When Moderna discovered this summer that an air handling unit for its factory could not be delivered over a weekend because of Covid-19 limitations on interstate trucking, the major’s team stepped in. Warp Speed officials arranged a law enforcement escort to accompany the massive piece of equipment from the Midwest to its Massachusetts manufacturing plant.

The team again sprang into action when Moderna discovered that a specialized pump, needed to make the first batches of vaccine for the clinical trials, was marooned in a rail car and was not going to be delivered on time. Federal workers tracked down the train and rummaged through it until they found the pump.... Rest of article.