Before Covid-19 few people had heard of Moderna. A 10-year-old pharmaceutical minnow that had no products on the market, it was on borrowed time with investors. Talent, leaps of faith and dogged determination brought it to world attention in 2020 in its successful bid to develop an mRNA vaccine that has subsequently saved millions of lives.
Wall Street Journal reporter Peter Loftus provides the inside track on the company in The Messenger, an engagingly pacy yet detailed narrative that traces the scientific origins of the Moderna story through the various dramas that led to the licensing of the vaccine in December 2020.
Moderna’s big bet was a new way of making drugs by harnessing the power of genetic information known as messenger RNA into a vaccine. It had a good working relationship with the National Institute of Allergy & Infectious Diseases (NIAID), headed by Dr Anthony Fauci, a figure who saw promise in its technology and who was to prove a faithful ally in its journey to producing a vaccine.
In early 2020 Moderna was preparing a trial on a vaccine for a potentially deadly virus called Nipah, which like Covid-19 also caused fever and breathing difficulties, when news spread from China of the scale of the emerging coronavirus disease. Moderna’s French chief executive Stephane Bancel spotted the opportunity, engaged with NIAID and persuaded his chairman and colleagues to switch their focus to the emerging disease.
Speed and calculated risk-taking are a recurring theme in this book. Fauci believed it would take up to 18 months to create a safe vaccine, which would have been an impressive feat given that it normally takes 10 years. In the end, it was done in about half the time Fauci anticipated.
That time compression involved the novel approach of trialling on humans at the same time as monkeys, getting an $484 million (€475 million) funding pipeline from federal drug research agency BARDA and starting high-scale production before the drug was licensed. With additional market funding also secured, Moderna’s manufacturing plant worked 24/7 but it didn’t have the capacity required. It outsourced much of its production to a Swiss firm called Lonza, that had a global network of 50 sites. Another risk was taken here. Though it was an established contract drug manufacturer, Lonza had never produced a vaccine before.
The high stakes bets paid off but it was not all plain sailing.
In August Trump tweeted — without evidence — that the Food and Drug Administration agency was delaying authorisation of vaccines until after the election
In May a 29-year-old trial participant became ill after receiving his second vaccine dose. Ian Haydon was admitted to the emergency department with nausea, chills and a high temperature. Treated with intravenous fluids and Tylenol, he was discharged but fainted at home. He recovered quickly and it emerged that he had been given the highest dose of the vaccine, about 250 micrograms, a dose researchers promptly removed from the trials.
News of the case reached the media and was amplified by anti-vaxxers, sowing doubts about safety in sections of the public.
That same month, however, researchers were able to report that the vaccine induced the production of antibodies which prevented the virus from infecting cells by blocking or interfering with the spike protein’s ability to attach itself inside cells. The potency was better than expected and Moderna knew it had cracked the code.
Politics played a key role in the vaccine story. An August 2020 poll found that 35 per cent of Americans said that they wouldn’t take a free vaccine. This figure rose to 47 per cent among Republican supporters, despite the fact it was a Republican administration that had launched Operation Warp-speed, an initiative that prioritised removing roadblocks to deliver a vaccine.
Former president Donald Trump nonetheless believed an earlier roll-out of the vaccine would have provided a powerful campaign boost before the November 2020 election. This was illustrated in his meeting with Bancel and rival pharma bosses in the White House, along with Fauci, in early March 2020, which Loftus reports in detail.
When Bancel confirmed to the president that Moderna could have a vaccine developed in two months, Fauci intervened to make sure Trump understood that this meant a vaccine that would go into testing, a process that would take it well into 2021 before a vaccine would be approved for widespread use. “I like the sound of a couple of months better, I must be honest with you,” Trump responded.
Drug companies issued a joint statement pledging to adhere to the highest ethical standards and scientific principles in bringing their vaccines forward, in a clear warning they were not going to let politics override public safety
In August Trump tweeted — without evidence — that the Food and Drug Administration agency (FDA) was delaying authorisation of vaccines until after the election. In early September he said a vaccine could be delivered by the end of October.
Moderna and other vaccine producers faced a dilemma. They were in a race to produce a vaccine but this haste risked undermining public confidence in the safety of the treatment, which could result in vaccination hesitancy or refusal and prolong the pandemic.
As Loftus adds: “They also had to walk a fine line between describing their progress without agitating the unpredictable Trump who could jeopardise the help and money they were getting from federal officials.”
In September the drug companies took matters into their own hands, notwithstanding their intense rivalry in the race to produce the first vaccine. They issued a joint statement pledging to adhere to the highest ethical standards and scientific principles in bringing their vaccines forward, in a clear warning they were not going to let politics override public safety.
In the end it was Pfizer that produced the first licensed vaccine, by a matter of days. Moderna might have won that race had it not slowed down trial enrolment to achieve greater diversity in its participants. It didn’t matter in the end. The efficacy rates of Moderna at 94.5 per cent exceeded expectations and Fauci, a key supporter, was one of the first to receive its licensed vaccine before the world’s media on December 22nd, 2020.
The subsequent roll-out of the vaccine in 2021 was not without its hiccups, especially outside the US in the second quarter of the year. Skilled labour shortages at a number of plants were cited as a key factor.
The logistics of making and supplying the vaccine worldwide are also highly complex, requiring total synchronisation in the supply chain. About 600 items are required to make a batch. If one is missing, you cannot make it.
Loftus would have had a neater end for the story were it not from Omicron. As Moderna planned a party for employees in December 2022 and looked forward to shifting its focus to the other treatment possibilities its platform offered, a new wave struck, crucially involving a new variant. Covid-19 was far from defeated and an exhausted Bancel and his team would have to go back to the drawing board.
Nonetheless, Moderna’s achievements cannot be overstated. The 10-year upstart had developed and delivered a powerful new vaccine in a previously unimaginable timescale. It also validated its science and technology platform and it is now poised to make further ground-breaking advances in disease treatment in the years ahead.
Money may not have been the key focus during a global pandemic that was killing millions of people but, as Loftus notes, one interesting yardstick of success is that a big pharma company aims to produce revenue of about $1 million per employee. While a direct comparison with larger competitors is perhaps unfair, it is interesting nonetheless to note that Moderna’s corresponding figure is closer to $10 million. Its story is just beginning.
The Messenger, Moderna, the Vaccine and the Business Gamble That Changed the World by Peter Loftus is published by Harvard Business Review Press