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It was a constant theme of coverage of new Covid vaccines: a research and development process of several years has been condensed, via cutting-edge mRNA technologies, in a few months. Using the new platform was “a quick but risky, even controversial gamble,” reported The Washington Post; and led to the first human trials “orders of magnitude faster than any vaccine ever before,” said USA today. “Saint Mackerel,” Anthony Fauci told Atlantic.
Taking nothing away from mRNA vaccines – they are clearly incredible – but that account 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 United States is both more prosaic and more intriguing than one might think. Yes, their mRNA technology was new and different; and it is true that progress on Covid vaccines has been faster than anything we have seen before. But these two facts are not so closely related. In fact, without the specific means by 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 March 16, just months after the genome of the target virus was sequenced. But on the same day, the Chinese company CanSino Biologics gave the first injection in a trial of its vaccine without mRNA. Meanwhile, the first dose of Pfizer-BioNTech’s mRNA vaccine was not given in a clinical trial before more than a month later. At this point, two other Chinese biotechnology companies, Sinopharm and Sinovac, had already started the first human trials of old-school inactivated virus vaccines, based on the same approach used since the mid-twentieth century for polio and pertussis vaccination. A third vaccine in this so-called slow and obsolete “a bug, a drugAlso from Sinopharm, entered clinical trial just one week after Pfizer-BioNTech; while another high-level mRNA vaccine, from CureVac in Germany, has not been in a clinical trial before months later.
Clearly, the use of a revolutionary mRNA platform did not allow Pfizer-BioNTech and Moderna vaccines to enter clinical trials particularly faster than less technological methods did to other. So why were Pfizer-BioNTech and Moderna the first to reach the finish line and provide compelling evidence that their vaccines really worked? Three factors came into play. First, these vaccines are not only moderately effective in preventing Covid-19 – they excellent to do it. When there is such a dramatic difference between the vaccine and a placebo, it is faster and easier confirmation Success. The second factor was that these companies were successful in conducting phase 3 (late phase 3) trials of tour de force, recruiting thousands of participants very quickly. This is very difficult to do in a pandemic, because the profuse hiccups in tests of other companies have revealed. And finally, these well-conducted phase 3 trials took place in the United States and parts of Latin America, where the new coronavirus was rampant. In order to demonstrate their effectiveness, vaccine manufacturers need their clinical trial to include enough “events”, that is, people who contract Covid. Given the high rates of infection in the Americas, these have increased at a rapid rate.
In this third area, in particular, Chinese vaccine developers have found themselves at a major disadvantage. Having the coronavirus under control at home meant they had to search for partners in other countries for their Phase 3 trials. This added a major hurdle to starting trials, but any delays were quickly negotiated. Sinopharm has started the first phase 3 trial of its inactivated vaccines in the United Arab Emirates, July 16. It was two weeks before Pfizer-BioNTech and Moderna started theirs. The UAE had the infrastructure to conduct a major trial and a very ethnically diverse population, which would be essential for the development of a vaccine for use around the world. The coronavirus had also reached the Middle East early on. On the other side of the Persian Gulf, Iran had been hit hard: in mid-March, more than 1000 people there was death of Covid. At first things looked very good and there was no reason to believe that Sinopharm would be lagging behind other companies in reaching a conclusion.
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