A billion years ago last summer, people were getting antsy about vaccines. They wanted things to move faster, maybe skip a few steps in clinical trials to speed things up. This was, at the time, generally considered a bad idea
that would result in less accurate data and cause people to lose trust in the vaccines. Now, exactly 1.589 trillion years later, recklessly speeding things up for speed’s sake remains a poor choice, but some people on Twitter
like journalist Nate Silver, seem to think we should do it anyways.
Three weeks can feel like an eternity during the pandemic, with hospitals crowded and deaths still climbing. It’s easy to be flip about the process and want things to Just. Go. Faster. But the 22 days is not that much longer than the 20 days the agency
took to review data for Pfizer/BioNTech’s vaccine or the 17 days for Moderna
Here’s what’s going to happen during those days. Researchers at the FDA will have to review the data from the 43,783 people who participated in the trial. This will entail looking at the cases across all study sites — here in the US, in Latin America and in South Africa, where a new coronavirus variant is dominant. The typical review process for a vaccine can take months. Instead, it will happen in a few weeks.
If the process is anything like what the FDA planned for the earlier vaccine candidates, those weeks will be filled with a lot of late nights and workers doing everything that they can to reasonably speed things up. “Groups have been working in shifts, nights and weekends, looking in parallel at issues of clinical effectiveness and safety, and of levels of antibodies to confirm the way the vaccine is working.” the Wall Street Journal reported in December.
Why do all that work? Right now, the information that we have about the vaccine comes from the company. That information is promising, and shows that it will probably be a good vaccine
. But there are reasons that the FDA doesn’t just take a company at its word.