EDITORIAL: J&J pause highlights importance of vaccine transparency, context about risk

Apr. 26—The BDN Editorial Board operates independently from the newsroom, and does not set policies or contribute to reporting or editing articles elsewhere in the newspaper or on bangordailynews.com.

An important tool in the continued fight against COVID-19 is back in the tool box. After an 11-day pause on the Johnson & Johnson vaccine to look into its link to a rare form of blood clot, the U.S. Centers for Disease Control and Prevention and U.S. Food and Drug Administration are once again recommending the use of this one-shot vaccine.

This is an encouraging step, even if it took too long to materialize. Because the Johnson & Johnson vaccine (also sometimes referred to as the Janssen vaccine, after a company subsidiary) only requires one dose, it can be a great equalizer in terms of getting vaccines out to more isolated and vulnerable populations.

"We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older," Acting FDA Commissioner Janet Woodcock said in a statement on Friday. "We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider."

Following review from the CDC's Advisory Committee on Immunization Practices, the resumption includes a new warning as part of the Johnson & Johnson fact sheet for vaccine recipients and health care providers. The warning to recipients notes that blood clots along with low levels of platelets have occured in some patients, mostly women between the ages of 18 and 49. "The chance of having this occur is remote," that warning stresses.

At question here were an initial six cases of people developing this rare type of blot clot, all women, after receiving the Johnson & Johnson vaccine. Over the course of the pause and the investigation, that number grew to 15. All of those cases were women, between the ages of 18 and 59, with a median age of 37.

That is 15 cases — three deaths, seven current hospitalizations, and five people discharged back to their homes — out of roughly eight million people in the U.S. who have received the Johnson & Johnson vaccine. According to the advisory committee's analysis, that works out a rate of seven cases per one million doses in women under age 50 (with women ages 30 to 39 having the highest risk), and less than one case per one million doses respectively for women over 50 and men of all ages.

For some perspective, as others have already pointed out, the risk of blood clots is greater for COVID-19 patients, especially in more severe cases, than it is for people who received the Johnson & Johnson vaccine. According to the president of the American Society of Hematology, "147,000 in 1 million hospitalized COVID-19 patients experience clot."

The people who experience vaccine complications, just like the people who experience complications from COVID-19, are much more than a number. They are human beings, with other human beings who care for them and rely on them. With that in mind, it's still important to keep the numbers in context.

"I don't mean to minimize the effect of the clots on the people who get them, because obviously for those people it's a devastating consequence," Yale Medicine hematologist Dr. Robert Bona said. "But this is going to be infrequent, while the clotting rate is going to be much higher among those who have a COVID-19 infection."

It's easy for us to back-seat drive and Monday-morning quarterback this situation, but the risk-benefit analysis involved in the Johnson & Johnson decision has looked clear for a week.

We've been all aboard the caution train for the past year. Moving forward, however, leaders must not let caution turn into inaction. A pause can't become institutional paralysis, perceived or otherwise.

"Initial pause by FDA on Tuesday was a close call. But I supported it," Ashish Jha, the dean of the School of Public Health at Brown University, tweeted on April 14. "A few days to alert people, begin [the] process of collecting more data, advise physicians — all made sense. Now [the] advisory panel wants to return in 7-10 days to discuss further. The risk-benefit here is all wrong."

On Friday, Jha called the unpausing "obviously the right answer," and welcomed the additional warning as more transparency for the system.

Transparency is key as public health officials work to bolster vaccine confidence, and so is keeping the risks in perspective. To again borrow from Jha, the Johnson & Johnson pause, at least for the last week, looked more like a punt. It didn't stop efforts to reach more rural and vulnerable populations, like Maine's mobile vaccination clinic, but it certainly added complications. And it came at a bad time in terms of vaccine hesitancy, though fears about it fueling more hesitancy may have been overblown.

Potential Johnson & Johnson vaccine recipients should look at the results of the pause, and feel confident that the vaccine safety system has done its due diligence. And public health officials should strive to have the system work faster and keep risks in better context for the general public. Those two thoughts may seem contradictory, but we think they go hand-in-hand.

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