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Sunday, May 19, 2024

The Race for a Covid Vaccine Was More About Luck Than Tech

It’s been a constant theme in coverage of the new Covid vaccines: A years-long process of research and development has been condensed, via breakthrough mRNA technologies, into a matter of months. Using the new platform was “a speedy but risky—even controversial—bet,” reported The Washington Post; and led to first-in-human trials “orders of magnitude faster than any vaccine ever before,” said USA Today. “Holy mackerel,” said Anthony Fauci to The Atlantic.


Not to take anything away from mRNA vaccines—they’re clearly amazing—but this narrative just doesn’t fit the facts. The reality of what happened here, and how Pfizer-BioNTech and Moderna came to win the vaccine race in the US, is both more prosaic and more intriguing than it’s been made to seem. Yes, their mRNA technology was new and different; and it’s true that progress on the Covid vaccines was more rapid than any that we’ve seen before. But those two facts aren’t so tightly linked. In fact, but for the specific ways in which the coronavirus has progressed around the world, we could have ended up with a very different set of options at this point.

Moderna began the first clinical trial of its mRNA vaccine on Mar. 16, just a couple of months after the genome of the target virus had been sequenced. But on the very same day, the Chinese company CanSino Biologics gave the first injection in a trial of its non-mRNA vaccine. Meanwhile, the first dose of Pfizer-BioNTech’s mRNA vaccine wasn’t given in a clinical trial until more than a month later. By that point, two more Chinese biotech companies, Sinopharm and Sinovac, had already started first-in-human trials of old-school, inactivated virus vaccines—ones based on the same approach that has been used since the middle of the 20th century for vaccinating against polio and pertussis. A third vaccine in this supposedly slow and obsolete “one bug, one drug” category, also from Sinopharm, went into clinical trial just a week after Pfizer-BioNTech’s; while another high-profile mRNA vaccine, from Germany’s CureVac, didn’t make it into a clinical trial until months later.


Clearly the use of a revolutionary mRNA platform didn’t get Pfizer-BioNTech and Moderna’s vaccines into clinical trials particularly faster than lower-tech methods did for others. So why were Pfizer-BioNTech and Moderna the first to reach the finish line, and deliver convincing proof that their vaccines really worked? Three factors came into play. First, these vaccines aren’t just moderately effective at preventing Covid-19—they’re excellent at doing so. When there’s such a dramatic difference between the vaccine and a placebo, it’s quicker and easier to confirm success. The second factor was that these companies managed to run tour-de-force phase 3 (late stage) trials, recruiting many thousands of participants very quickly. That’s very hard to do in a pandemic, as the plentiful hiccups in other companies’ trials have revealed. And finally, those well-run phase 3 trials took place in the US and parts of Latin America, where the new coronavirus was running rampant. In order to show efficacy, vaccine-makers need their clinical trial to include enough “events”—i.e. people who get sick with Covid. Given the high rates of infection in the Americas, these turned up at a rapid pace.

In this third domain, in particular, the Chinese vaccine developers found themselves at a major disadvantage. Having the coronavirus under control at home meant they had to seek out partners in other countries for their phase 3 trials. That added a major hurdle to getting trials off the ground, but any delays were soon negotiated. Sinopharm got started on the first phase 3 trial for its inactivated vaccines, in the United Arab Emirates, on July 16. That was two weeks before Pfizer-BioNTech and Moderna began theirs. The UAE had the infrastructure to run a major trial, and a very ethnically diverse population, which would be critical for the development of a vaccine intended to be used around the world. The coronavirus had reached the Middle East early, too. On the other side of the Persian Gulf, Iran had been hit hard: By mid-March, more than 1,000 people there had died of Covid there. At first, things were looking very good, and there was no reason to believe that Sinopharm would lag behind the other companies in reaching a conclusion.

Indeed, the UAE trial, called 4Humanity, was a triumph of management and community mobilization. A convention center in Abu Dhabi was converted into a recruitment and vaccination hub open for long hours. Politicians and other prominent citizens signed up for the trial, and social media were awash with people’s #4Humanity stories and pics. Within a month, Sinopharm’s UAE partners had recruited 15,000 people to test the two vaccines; by the first week of October, they had 31,000. Thousands were outfitted with wearable devices that could supposedly track signs of Covid in your breathing patterns while asleep; and according to media reports, participants were getting tested for infection every two weeks. We don’t know for sure exactly how this work was carried out, because the protocol for the trial hasn’t been released. One thing’s certain, though: the amount of data is potentially enormous. When the UAE began offering the vaccines to its frontline workers and others under an emergency use authorization in September, it came with strict requirements: You had to agree to make follow-up visits every couple of days for more than a month, and then check in from time to time by phone for half a year.

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There was just one hitch. The UAE kept the coronavirus under control. The country’s Covid mortality rate is substantially less than one-tenth of that seen in the US; and it’s running more Covid tests, per capita, than almost any other nation in the world. That’s good news for the Emiratis, but it also dashed any hopes of getting rapid trial results for the Sinopharm vaccines. They kept expanding their trial, in Bahrain, Egypt, and Jordan, till they had 45,000 participants. But if there had been as much coronavirus circulating in the UAE since July as there was in the US and Brazil, the 4Humanity trial could well have been the first to report its findings to the public.

What’s more, those results might have ended up looking pretty good. On Dec. 9, the UAE issued full approval to one of the Sinopharm vaccines on the basis of an interim analysis, reporting that its efficacy was 86 percent with a low rate of adverse events. The results to back that up haven’t yet been released, and it’s not clear when they might be public. Sinovac, too, reportedly had interim results in November, and the results from a trial in health care workers in Brazil are due to be made public today.

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In other words, the efficacy of at least one inactivated vaccine from China could be close to Pfizer-BioNTech and Moderna’s. The Chinese vaccines also have the advantages of being made by conventional vaccine facilities, easier to distribute and less prone to causing unpleasant side effects. (Sometime in the future, mRNA vaccines might be easier to produce, but not yet.) And crucially, if inactivated vaccines are able to prevent disease, that fact might have been known first—the clinical research already completed—but for the happenstance that Covid was well-controlled in the UAE, and tragically unchecked in the US. If things had gone the other way, even more of the world would be scrambling to get inactivated vaccines and wondering (prematurely) what had gone wrong with the new-fangled mRNA vaccines and why Europe and America had “failed.”

For the moment, though, the American and European media are mostly focused on a white-savior vaccine narrative. Even as the first doses of the Pfizer-BioNTech and Moderna vaccines are given out, many more are now (or soon will be) in phase 3 trials. Almost half of these candidates come from China, India or Japan; and many are inactivated vaccines. These simpler vaccines have their drawbacks, especially when it comes to biosafety: There’s a risk of not-completely-inactivated batches if quality control isn’t adequate, for example, or of virus containment breakdown at a manufacturing facility. A slower timeline for development, though, did not stand in the way.

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