The vaccine safety monitoring system works. And, federal health officials take swift action when a rare but serious potential health complication surfaces.
Those are the important takeaways from a new and hopefully temporary halt on using the Johnson & Johnson COVID-19 vaccine. Early Tuesday, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention announced they are "recommending a pause" on giving the J&J shot after six people developed blood-clotting one to three weeks after inoculation. One of them died. These are unusual blood clots developing in the brain and other places in the body and associated with low platelet counts.
With 6.8 million J&J doses administered in the United States, the risk of this side effect is extremely low. While it's not clear yet if the shot caused the clotting, caution and transparency are warranted, particularly during the first few months of the vaccine's rollout.
The FDA and CDC made the right move. It's critical to note that the decision does not affect use of the Pfizer and Moderna vaccines.
The J&J pause spurred an energetic debate about whether this will broaden the ranks of those who are hesitant to get vaccinated against COVID or other diseases. That is indeed a risk. But there's a stronger argument that this move should bolster confidence in vaccines and safety monitoring.
The nation's surveillance system proved capable of picking up on an adverse event that may occur in roughly one out of a million people who get the J&J shot. The information was also quickly made public and will be examined by an expert panel during a livestreamed meeting on Wednesday.
Anyone with an internet connection can monitor this meeting. The transparency is at striking odds with a common anti-vaccine conspiracy theory — that side effects are covered up by mainstream doctors, federal health agencies and the news media.
In an interview Tuesday with an editorial writer, Mayo Clinic's Dr. Gregory Poland concurred with the FDA's pause. Poland is one of the world's leading vaccine researchers, and provides consulting to COVID vaccine manufacturers.
"Whenever a concern is raised like this, you pause in order to collect the data and be confident about what you're seeing or not seeing," Poland said. "This will be misinterpreted by people who don't understand these things, who are vaccine-hesitant, and of course it's ample ammunition for anti-vaxxers, but you know what? We go ahead and we do this knowing that risk because it's the right thing to do."
It is unclear how long the J&J pause will last, though the FDA's acting commissioner said at a Tuesday news conference that it could be a matter of days. Much will ride on the Wednesday expert advisory panel meeting.
A key question the panel will tackle: whether this blood clot is occurring more frequently in J&J vaccine recipients than the "background rate" (the incidence at which this condition happens naturally in those who haven't been vaccinated). In addition, the panel may consider whether the vaccine should be used in some groups but not others.
The FDA recommends that those who have had the J&J shot within the last three weeks should contact their doctor if they "develop severe headache, abdominal pain, leg pain, or shortness of breath." Poland also recommends that this group ask a physician about taking a daily low-dose aspirin during this time.
If the J&J shot is cleared for continued or limited use, federal and state health officials have work to do. They will need to proactively address lingering concerns and rehabilitate the shot's role in ending the pandemic. The public also has a responsibility to seek out credible sources of information.
Perspective is vital. Risk is inherent in everyday life, from climbing into a car to using other medications.
If the clot risk from the J&J vaccine seems high, consider that 1 in 3,000 women taking oral birth control pills develop a blood clot annually. The risk is much higher for those infected with COVID — 20 out of 100 people hospitalized develop blood clots, according to Poland.
"Whatever the theoretical risk from vaccine, it's orders of magnitude lower than the risk of COVID itself," he said.