When Will The Johnson & Johnson Covid-19 Coronavirus Vaccine Be Approved?

When it comes to the Johnson & Johnson Covid-19 vaccine, remember what Guns N’ Roses said: “All we need is just a little patience.”

Last Thursday, Johnson & Johnson (J&J)  announced that they had submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its Janssen Covid-19 vaccine candidate. FDA officials will then review the submitted data, compile a report, and submit the report to an independent vaccine advisory committee. The committee will then meet on February 26 and make their recommendation, which means that the FDA could decide on a EUA by the end of February.

That would be a 22-day turnaround, which would be pretty darn quick, much quicker than the months that it can typically take for an FDA approval of a vaccine. Yet, even so, apparently this is not quick enough for everyone. For example, look at what Nate Silver, founder and editor-in-chief of FiveThirtyEight, tweeted:

Ummm, is that some premature anticipation? A 22-day wait would only be about two Scaramuccis, which ain’t a long period of time. That would be roughly in line with the 20 days that it took between the November 10 announcement of the December 10 meeting to discuss the Pfizer/BioNTech vaccine for its EUA and the actual meeting. It also would be only five days longer than the 17 days that transpired between the November 30 announcement of the December 17 meeting to discuss Moderna’s Covid-19 vaccine and the meeting itself. So why rush what’s already being rushed?

Sure, a National Institutes of Health (NIH) press release from January 29 included some very positive news about the Ad.26.COV2.S vaccine (otherwise known as the easier-to-remember JNJ-78436725 vaccine). Sure, the Phase 3 clinical study known as ENSEMBLE found that at 28 days after vaccination the vaccine was 66% effective at preventing moderate and severe Covid-19 and 85% effective at preventing severe/critical Covid-19. Sure, the study included participants who had been exposed to the more contagious variant of the Covid-19 coronavirus. Sure this adenovirus-based vaccine would be only one dose as opposed to the Pfizer/BioNTech and Moderna Covid-19 vaccines, which involve getting two doses. Sure, this vaccine has less stringent storage requirements than the other available Covid-19 vaccines and can remain in a standard refrigerator for months. Sure, all of this could make it a lot easier to supply, distribute, and administer Covid-19 vaccines. Sure, the initial Covid-19 vaccine roll out has gone about as well as the roll-outs of the Apply Newton, Harley Davidson perfume, and Cheetos Lip Balm.

But info from press releases is only the equivalent of a movie trailer for the ENSEMBLE trial. Anyone who watched the trailer for the movie Kangaroo Jack and was then convinced that the kangaroo would actually talk throughout the movie knows that trailers can be misleading. (By the way, the kangaroo hardly talks but does wear a hoodie in the film.) What’s been released about the ENSEMBLE Phase III clinical trial doesn’t really tell you the full story yet and what’s behind the results. FDA officials and the advisory committee will be reviewing a lot more. A little over three weeks is not a whole lot of time to carefully review data on 44,325 clinical trial participants from sites in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. Having to plough through loads of dense data certainly won’t be like reviewing a bunch of tweets or selfies.

Keep in mind too who will be reviewing the data and compiling the report. Highly paid folks with generous stock options surrounded with an unlimited supply of caviar? Genetically engineered people who don’t need to sleep and eat? Nope. It will be government officials who are on fixed salaries. Academics and other scientists will help out too by volunteering a fair amount of their time. And the time of academics can be like a pair of Spanx, stretched in many different ways.

Of course, a EUA would not be the same as full approval. EUAs occur only during public health emergencies when the FDA deems that risks from the emergency (in this case the Covid-19 coronavirus) outweigh the risks and unknowns of the new product. So the threshold for a EUA is lower. But it’s not as if the FDA should grant EUAs like some YouTubers endorse products. A health product that ends up being not as safe or effective as expected could end up costing lives.

Remember that haste makes waste, Rome wasn’t built in a day, you should look before you leap, and you should definitely lift up the toilet lid before you use the toilet. All of these saying emphasize the importance of patience. Rushing now can lead to bigger problems down the road. There are limits on how quickly you can push a vaccine through the regulatory process. Just because many are waiting for the J&J Covid-19 vaccine doesn’t mean that any important steps should be skipped. After all, Guns N’ Roses said did say, “sugar take the time cause the lights are shining bright.” Even if the vaccine has “got what it takes to make it,” a few extra weeks is going to be worth the wait.

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