The Partnership That Made The First U.S. Covid Vaccine --- There are lessons in how Moderna and federal agencies combined to speed vaccine development -- and in how they clashed.

The history of vaccine development shows that the involvement of the modern state in the organization of new production is useful and necessary. The state reduces the risk of creating a new business, thereby involving an agile and energetic business that seeks profit and avoids risk. The development of Lithuanian biotechnology was also catalyzed by the state. The Russian state, which also ruled Lithuania at that time. Therefore, we now have biotechnology in Lithuania. 

 

 But that is not enough. The entire Lithuanian business needs to be reorganized in an innovative way. Unfortunately, we do not have our own state in Lithuania. We have a group of greedy, drowned in the search for pleasure from small amounts of drugs, people disguised as heads of state. As long as labor was cheap, we could tolerate it. The further, the less. You have to learn from the Americans:

 

 

In late 2019, just weeks before the world heard of Covid-19, scientists from the National Institute of Allergy and Infectious Diseases visited the new manufacturing plant of a small, 9-year-old biotechnology company called Moderna. The company's leaders boasted that the new plant in Norwood, Mass., could make a batch of a newly designed vaccine in 60 days -- rapid by standard timelines that usually take 12 months or more. NIAID and Moderna discussed a joint exercise in pandemic preparedness, which they dubbed the "stopwatch drill." They would pick a virus to target, NIAID would help Moderna design the vaccine, Moderna would make a batch and NIAID would conduct a clinical trial.

The initial target was a deadly virus called Nipah that can cause fever and breathing difficulty. But then the new coronavirus emerged in China. The stopwatch drill morphed into an urgent, real-world effort. "We viewed it as a proof of concept," John Mascola, then-director of the NIAID vaccine-research center, said later.

Moderna -- though it had raised big sums from private investors as a hot startup -- already owed its success in large part to help from the U.S. government. Partly due to its collaboration with federal researchers, Moderna -- which had never had a product approved before -- produced one of the first Covid-19 vaccines in record time. Billions of dollars in federal grants and supply contracts helped the company build a manufacturing network to supply the U.S. and other countries.

The partnership shows a potential way forward as the world braces for future pandemics. The disagreements between the company and the government along the way are instructive, too.

Infectious disease outbreaks are unpredictable, which makes it difficult for companies to rely solely on private investors to fund the costly research on medical countermeasures. Some have rushed to make vaccines only to see the need fade. Government help, both financial and scientific, can minimize the risk to companies, spurring them to respond to emerging threats more quickly.

Moderna and its CEO, Stephane Bancel, pursued such collaborations and grants for years to further the company's development of a technology it was pioneering using messenger RNA, a type of genetic material that can instruct human cells to make disease-fighting proteins. In 2013, Moderna got a grant for up to $25 million from the Pentagon's Defense Advanced Research Projects Agency. Three years later the Biomedical Advanced Research and Development Authority, which funds countermeasures to public health threats, pledged up to $125 million to fund Moderna's development of a vaccine targeting the Zika virus.

Although Moderna's initial Zika candidate disappointed during testing, the work convinced Dr. Anthony Fauci, NIAID's longtime leader, and other officials that mRNA was well-suited to rapid responses to outbreaks. The partnership steadily expanded, leading to the stopwatch drill that turned out to come at a pivotal moment. "This would be a great time to run the drill for how quickly can you have a scalable vaccine," Barney Graham, then the deputy director at NIAID's vaccine-research center, wrote to Mr. Bancel in January 2020.

Kizzmekia Corbett, a scientist working for Dr. Graham, helped comb through the new coronavirus's sequences the weekend they were published and saw that the virus had a hallmark spike protein on its surface. An mRNA vaccine could instruct human cells to make these spike proteins, inducing the immune system to build up antibodies.

On Jan. 13, 2020, Dr. Graham and other NIAID scientists agreed with Moderna on a vaccine design incorporating these insights. But the collaboration had tensions. Moderna would later say in a patent dispute in 2021 that only its own scientists -- not NIAID scientists -- should be listed on a U.S. patent application as inventors of the vaccine's mRNA sequence. NIAID said its scientists helped invent the sequence. Moderna dropped its patent application late last year as the two sides try to resolve the dispute.

After Moderna made a small batch of vaccines for testing, NIAID ran animal tests and then the first study in human volunteers. In April, Moderna received $483 million for Covid-19 vaccine development from the same agency that had funded its Zika research. For Moderna, much smaller than industry giants like Pfizer Inc., it was much-needed funding. For the U.S. government, it ensured access to resulting vaccine doses.

Operation Warp Speed, the Trump administration's multiagency effort to hasten Covid-19 medicines, took the collaboration to a new level in May. The U.S. funded and helped Moderna design and conduct a 30,000-person clinical trial. The government also helped Moderna bulk up its manufacturing.

One Friday afternoon in August, the company was expecting delivery of large air-handling units to help expand production at its factory. Moderna had hired construction cranes to lift the tractor-trailer-sized units onto the roof of its plant. But delivery was delayed because the supplier lacked all the state permits needed to transport oversize cargo from the Midwest to Massachusetts. If the units didn't get there by Sunday, Moderna would lose the cranes and a week of production.

Frantic, Moderna executives called Warp Speed officials. They gave the job to an Army colonel, who leaned on state officials, who in turn sent state police with sirens blaring to escort the delivery to their state line and then hand off the convoy to a new escort. The precious cargo rolled into Moderna's plant on Sunday morning, in time for the cranes.

The much larger and older Pfizer, meanwhile, mostly opted out of Operation Warp Speed for fear it would slow the company down. As for Moderna's collaboration, it generated enough friction to make the company's chief medical officer during 2020, Tal Zaks, question at times whether it was worth it to accept the federal assistance.

Dr. Zaks had wanted to use a private contract research organization to run the whole trial, but NIAID officials wanted their clinical-trial network involved. Eventually, Dr. Zaks backed off, and both entities participated. "I realized we were at an impasse, and I was the embodiment of the impasse," Dr. Zaks said.

Next, when Moderna's 30,000-person study began enrolling volunteers in July 2020, the subjects weren't racially diverse enough. Moncef Slaoui, who led Warp Speed's vaccine efforts, and Dr. Fauci began holding Saturday Zoom calls with Mr. Bancel and other Moderna leaders to "help coax and advise Moderna how to get the percentage of minorities up to a reasonable level," Dr. Fauci recalled.

Drs. Fauci and Slaoui wanted Moderna to slow down overall enrollment, to give time to find more people of color. Moderna executives resisted at first. "That was very tense," Dr. Slaoui said. "Voices went up, and emotions were very high." Moderna ultimately agreed, and the effort worked, but it cost the trial about an extra three weeks. Later, Mr. Bancel called the decision to slow enrollment "one of the hardest decisions I made this year."

The large study showed that Moderna's vaccine was 94.1% effective at preventing symptomatic Covid-19, clearing the way for government authorization in December 2020. Within days, Dr. Fauci was on stage at an NIH auditorium with the White House's other top health officials. In a livestreamed event, they rolled up their sleeves to receive their first injections of the Moderna vaccine that their agencies had helped birth.

And the original plan for the stopwatch drill, subsumed by Covid? Earlier this month, the NIH started the first human study of an experimental Nipah vaccine manufactured by Moderna.

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Mr. Loftus is a reporter for The Wall Street Journal. This essay is adapted from his new book, "The Messenger: Moderna, the Vaccine and the Business Gamble That Changed the World," published by Harvard Business Review Press." [1]

1. REVIEW --- The Partnership That Made The First U.S. Covid Vaccine --- There are lessons in how Moderna and federal agencies combined to speed vaccine development -- and in how they clashed.
Loftus, Peter. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 30 July 2022: C.5.