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

Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty Images

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.

Here’s what else is happening this week.

Research

Scientists want to know if vaccinated people can still become COVID-19 long-haulers
Data from trials has shown that COVID-19 vaccines have done a stellar job at preventing severe cases of disease. But it’s still unclear whether they can prevent chronic COVID-19 symptoms. (Nicole Wetsman/The Verge)

The Pandemic Broke the Flu
The flu appears to have taken the year off. While COVID-19 has dominated the planet, our regular seasonal virus appears to have mostly stayed home. It’s not clear what will happen (Katherine J Wu/The Atlantic)

Indigenous Americans dying from Covid at twice the rate of white Americans
One in every 475 Native Americans has died of COVID-19, a rate that is higher than any other community in the US. The toll is especially brutal for smaller communities, who face disproportionate losses. (Nina Lakhani/The Guardian)

Development

New Vaccine Puzzle: Who Should Get Which Shot?
Some places in the world are already juggling three different vaccines — and distributing them is getting very complicated. (Benjamin Mueller and Rebecca Robbins/The New York Times)

With a seductive number, AstraZeneca study fueled hopes that eclipsed its data
A study of Astra Zeneca’s vaccine found that people who were vaccinated were less likely to carry the virus. That statistic got misinterpreted as proof that the vaccine decreased transmission of the virus. It might, but that hasn’t been proven yet. (Matthew Herper and Helen Branswell/STAT)

So you got the vaccine. Can you still infect people? Pfizer is trying to find out.
People are still trying to understand how vaccines affect transmission, but it’s incredibly complicated. Here’s why. (Antonio Regalado/MIT Tech Review)

After a Rocky Start, Novavax Vaccine Could Be Here by Summer
Novavax’s vaccine candidate has gotten off to a slower start than many of its competitors, but it is now well on its way. (Katie Thomas/The New York Times)

Perspectives

I had my espresso with foamed milk, even though coffee is disgusting to me now. I do not enjoy the taste. But I have a cup of coffee almost every morning. It’s like ritual, right? I enjoy the process of making it, and the warmth, and the caffeine. So I keep doing it, and I keep hoping that it will taste good to me at some point. I feel like I’m using my imagination when I eat, trying to use my memory of how things smell and taste to recreate the experience, because otherwise I would not want to eat.

—Meema Spadola tells Eater’s Jenny Zhang. Zhang interviewed people whose sense of taste and smell had not recovered after contracting COVID-19

More than numbers

To the more than 105,485,261 people worldwide who have tested positive, may your road to recovery be smooth.

To the families and friends of the 2,301,169 people who have died worldwide — 459,571 of those in the US — your loved ones are not forgotten.

Stay safe, everyone.

Comments

Very well said. All it takes is for one vaccine to go horribly wrong and normal people will be afraid of all of them regardless of the differences.

I hadn’t thought of that angle but you are so right, especially in this environment, they’ve got to be super cautious and really fast at the same time.

Another angle in all this, it isn’t as if J&J has 100 million doses ready to go and their waiting – that is not the case. Once the approval comes through they’ll have a couple of million ready from what I understand – so the 3 weeks isn’t going to really be much this way or that.

A shout out to all the workers both at the vaccine makers and the FDA who are doing weekends and overtime to literally save the lives of their fellow citizens by doing this as quickly as possible. Once we get through all this the President should recognize them.

22 days, or we’ll just call it three weeks, seems actually pretty dang fast in the first place.

The pandemic would only be exacerbated if 1) the vaccine caused widespread and harmful side effects which would lead to 2) people not trusting and therefore not utilizing the vaccine in the first place.

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.

Please Mary Beth Griggs, when you see a political pundit ask questions, please just quote them this statement. Also this Tweet nails this sentiment

The one thing I hope the J&J estimates show that it’s more effective by FDA standards and that we can get it to all countries sooner than later.

I just got my first dose of the Moderna shot on Feb 1, 2021 so far I feel fine. My arm was a little sore for 2 good days afterwards though.

Good for you and nice to hear someone getting it. Here in the U.S. I think we’re at 30 million vaccinated so far (about 10% of the population….making progress).

The New York Times reports, as of me writing this, that 9.1% of Americans have gotten one jab and 2.5% are fully vaccinated. Of course these numbers will go up, hopefully rapidly.

I’m amazed that the vaccines were announced and approved weeks if not months ago —and yet we’re still at sub-10% vaccinated in February. Initially I was scared because I thought there would be cut-throat competition between states and citizens alike. But it’s almost like the vaccines are just now being rolled out in earnest. (Even though I know that’s not true …it’s just been a logistical nightmare.)

Fantastic article Ms. Griggs, really.

Excellent article, I thoroughly agree in the necessity of proper consideration being given to any treatment before approval of use. Ee simply cant afford for one of these vaccines to go wrong and cause people to reject them wholesale.

And now, I condemn you to burn in hell for putting that Billy Joel song in my head.

From what I understand, the review process only involves a simple statistical analysis that could be completed in hours, not weeks. Source: https://thedispatch.com/p/fda-career-staff-are-delaying-the

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.

The more appropriate analogy would be inspecting the lifeboats after the crash already occurred.

The comparisons to thalidomide seem reckless in this case. There are of course, legitimate risks risks associated with a virus that need to be evaluated but they’re not the same sort you see with drugs. There’s no need to fear monger about birth defects.

I don’t think J&J’s vaccine is going to be a game changer though. Despite the one dose benefit it isn’t nearly as effective and with new strains on the way it might be a poor choice. NovaVax is a lot more likely to be able to ease supply problems and scale up while delivering high efficacy needed to deal with new strains.

It’s not fear-mongering about birth defects. Thalidomide is used as the classic example of the need to thoroughly evaluate safety in any new medicine during the approval process. In reply to Jordan Hunt, the review process does not only involve a simple statistical analysis. The safety analyses is time-consuming and requires careful review of all adverse events captured during a trial. With biologics and vaccines, the manufacturing process also needs to be reviewed.

22 days is approximately 2.2 million new infections (at the now-lower daily rate, thank god). Of those 2.2 million, rough estimate of 11,000 people will die. Understanding the necessity of getting the vaccine right, I would submit that even the worst-case scenarios outlined in the article are better than 11,000 people dying.

As noted in one of the Twitter threads linked above, "(the) FDA doesn’t invite companies to submit an EUA unless/until they anticipate approving it"

Except if we release a faulty vaccine, then a lot of people are going to stop trusting ANY vaccine and far more than those 11,000 will die.

Maybe, maybe not. The 1976 Swine Flu vaccine was a disaster, obviously. But this situation is very different. There’s no reason to think the J&J vaccine is unsafe—there were questions about the basic efficacy of the 1976 swine flu vaccines before it even shipped.

Kind of supporting DrBenji’s point, I see we have about 3000 US Covid deaths per day recently. And the States and counties are now distributing vaccines faster than they are receiving them, so vaccine supply rate is the limiting step now. And I see from the article that FDA reviewed the first vaccine in 20 days, and the second one in 17 days, so one might expect a continued sense of tremendous urgency, and the benefit of experience to kick in, and for them to thereby review the J&J vaccine in 17 or less days. If they can’t do that for some reason(s), then at least the article could have explained those reasons, instead of what it did do, which was to cut them a journalistic break by merely saying basically ‘22 days…yeah, that’s about the same as 20 or 17 days’. I wonder if the families of the 15,000 people who will die in the extra 5 days FDA will take to review the J&J vaccine would feel a 22-day review is ‘about the same’ as 17-day review.

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