When the enormity of the pandemic became clear in March, few would have dared hope that three vaccines would have proved effective in clinical trials by now and that one would be approved for UK use by early December. Vaccines usually take years to develop and indeed, on the basis of talks with experts, I wrote a Prospect essay (“Shot of Hope,” April 2020) suggesting that 18 months was the likely minimum.
Yet after less than half that time, here we are. A trio of Covid-19 vaccines has now been developed by Pfizer (and BioNTech), Moderna, and AstraZeneca (with Oxford researchers). There have also been reports of vaccines ready for rollout in Russia and China, although less is known about their trials.
What made this all happen so quickly? Anti-vaccination forums buzz with talk of dangerous corner-cutting. This is simply wrong. Exactly the same procedures have been followed as are required for any other vaccine.
So what was different? “There’s a single answer to that,” says Beate Kampmann of the London School of Hygiene and Tropical Medicine: money. The sheer scale of the Covid-19 toll, economic as well as human, meant that governments and funding bodies were ready to commit vast sums. These “got people to think what could they do individually, together, and very fast.”
Once a candidate vaccine has been developed in the lab, it must go through three stages of clinical trials. In Phase 1 it is tested on a small number of healthy people, primarily to assess safety. Phase 2 involves testing on more people (perhaps up to 100) for effectiveness. Phase 3 then involves testing on hundreds or thousands of people, so even rare side effects may become apparent. The Pfizer Phase 3 trials had around 43,000 participants, larger than is common for new drugs.
“As soon as the stuff goes into humans, things get really expensive,” says Kampmann. Phase 3 trials typically cost millions—and usually take several years.
But in this case the massive funding meant companies could take the risk of conducting tests in parallel, rather than sequentially. “Usually you do things serially so you don’t spend money on things that aren’t going to work,” says Barney Graham of the US National Institute for Allergy and Infectious Diseases, who worked with Moderna on its vaccine. “This time a lot of money was spent on things that may or may not have worked.”
As far as money—but not safety—was concerned, everyone was “allowed to take gambles,” says Kampmann. “I’ve never seen a situation where people were producing millions of doses of a product that nobody had seen even Phase 2 data for.”
Furthermore, it was easier to find labs that could conduct the large-scale trials. “In the UK alone, there were over 30 sites,” says Kampmann. “There were people already doing this kind of work, and it was a matter of throwing money at them and saying ‘stop everything else.’”
Recruits were particularly easy to find with infection so widespread, and regulatory agencies have been flexible. The first vaccines will most probably be given “emergency use authorisation” (EUA)—Pfizer’s already has been in the UK. This is still rigorous, but obliges companies to conduct post-marketing surveys of efficacy and side effects. EUA procedures are well established and have been used before, including for treatments for Ebola virus.
The rapid pace of progress has also been enabled by long-term investment in the science. For example, the Pfizer and Moderna vaccines use a new technology in which the viral protein that elicits an immune response is produced directly in the body by injecting molecules of RNA (similar to DNA) that encode its structure. This approach has been in development for years, and it’s not mere good fortune that it was ready just in time.
The bottom line is you get what you pay for. The story of how we make vaccines has been rewritten without compromising safety, but only because we decided the price was worth it.
