Why the FDA is taking 22 days to look over J&J’s data

Sometimes it’s worth double-checking your work
Why the FDA is taking 22 days to look over J&J’s data
Why the FDA is taking 22 days to look over J&J’s data

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.

They take particular issue with the fact that while Johnson and Johnson submitted their data from their giant clinical trial this week, the Food and Drug Administration will take until February 26th to review the data.

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’s candidate.

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.

Let’s turn to noted scientific historian Billy Joel, and the “children of thalidomide.”

Thalidomide was a sedative that was given to pregnant people in the 1960’s as a cure for morning sickness. It caused birth defects in thousands of children across the world. In the US, pregnant women were given the drug in clinical trials, but unlike other countries, it wasn’t approved for sale at the time, thanks to Frances Kelsey. Kelsey was a drug reviewer at the FDA who looked over data from the company trying to sell the drug and found it unconvincing. The incident led to new laws that let the FDA determine a drug’s safety and effectiveness.

Taking the time to review a vaccine during a pandemic might seem like rearranging deck chairs on the Titanic — but it’s actually inspecting the lifeboats before you leave port. We have procedures and protocols for a reason. When we launch something big, like a rocket, engineers don’t just push a button and send it soaring. They go through detailed pre-flight checklists, making sure that every bit of a spaceship is sound. We’ve learned the hard way that disregarding safety procedures can cost lives.

Pushing out a third vaccine quickly might help save lives, yes. But only if people are willing to take it. Some healthcare workers are already hesitant to take the vaccine. They worry that the process is rushed. Rushing the process more isn’t likely to convince them — people who generally are not opposed to vaccines — that the process is safe and secure.

I get it. Waiting sucks. But when you’re injecting people with a new treatment and the trust of billions of people is on the line, sometimes it’s worth taking the time to double-check your work.