We are getting an education in science and statistics after today’s news that the Food and Drug Administration recommended a pause in using Johnson & Johnson/Janssen vaccine.
The FDA’s recommendation – which will be viewed as an order by Delaware and other localities – comes after a rare blood clot type showed up in about one in a million vaccine doses.
The delay is another bump in the road in Delaware’s impressive vaccination effort that juggles first and second doses of Moderna and Pfizer vaccines.
Without an ample supply of J&J vaccine, the percentage of the state’s total population with at least one dose will struggle to move to the 50 percent threshold. Gov. John Carney said the figure now stands at 38 percent.
The current number is below the figure that many public health officials see as necessary to put a big dent in the recent uptick or as Carney calls a “mini-surge” in cases.
Of late, we have seen more calls for prioritizing getting the first doses out and delaying the second dose to get more people immunized. The emphasis in Delaware is on getting both doses and keeping the first vaccinations on the waiting list.
Granted, J&J vaccine supplies were tight with or without a pause. A manufacturing snafu had already led to a sharp reduction in J&J vaccine shipments during the next few weeks.
The question one might ask at this point is why wasn’t this problem detected in trials.
Trials of all three recommended vaccines involved tens of thousands of people, not the millions who have already received vaccines. The odds of detecting clots were low.
The risk can be seen in the Food and Drug Administration giving all vaccines an “emergency use” designation, a sign that not all questions have been answered.
A Centers for Disease Control and Prevention panel will meet on Wednesday to go over the findings and drill down into the nature of the cases.
My guess is that vaccinations will be allowed to resume once advisories are issued for population groups at risk, and side effects are examined further.
Based on current reporting, that group appears to include young to middle-aged women, a sizable chunk of the population.
The FDA’s decision is the right one but will come at a cost.
More will now shun the J&J vaccine, even though it is just as effective as others in preventing hospitalizations and deaths.
The pause also casts another shadow on the AstraZeneca two-dose vaccine, which has a similar formulation. AZ is expected to send findings from its trials to the FDA shortly. Similar blood clot reports have surfaced in nations administering the AZ vaccine.
Sadly, many people do not look at the odds and instead act on emotion or misleading or patently false information that shows up on social media and even cable news.
The message worth repeating by the business community and others is that regulators are watching out for us and even a one in a million chance of a severe side effect is too much without further defining the risk and acting accordingly. – Doug Rainey, chief content officer.