Two major U.S. health agencies recommended a pause in administering the Johnson & Johnson/Janssen Pharmaceuticals COVID-19 vaccine on Tuesday, and immediately faced questions over the low number of people who received the adverse reactions that led to the recommendation.
Six women in the U.S. between the ages of 18-48 experienced a rare and severe type of blood clotting after receiving the vaccine, according to the CDC. Nearly seven million people have been administered the J&J vaccine across the country as of April 12.
The Food and Drug Administration and Centers for Disease Control and Prevention reasoned that the pause was recommended “out of an abundance of caution.” At the same time, there have been more than 31.2 million cases of COVID-19 in the U.S., about 72,286 of which were reported on April 12, according to the New York Times.
One woman died and another is in critical condition, but the occurrences of serious blood clotting among people who have received the J&J vaccine is far below the risk of dying doing ordinary things such as driving a car, riding a bike, or even falling.
The U.S. National Safety Council puts your lifetime odds of dying in a motor-vehicle crash at one in 107, of dying while riding a bike at one in 3,825, and of dying from a fall at one in 106.
Dr. Patrick Jackson, an infectious disease expert at UVA Health, said it’s important to emphasize the low odds of having an adverse reaction to the Johnson & Johnson vaccine.
“Definitely your lifetime risk of being killed in a lightning strike far exceeds the risk of having this complication from the Johnson & Johnson vaccine,” Jackson told Fortune.
Dr. Jackson said, although the risks are low, he thinks the pause is appropriate while the possible link between the rare type of blood clots and the J&J vaccine is being investigated.
“On the other hand, I think that even if you saw, and were convinced that this is a true risk of receiving the Johnson & Johnson vaccine that the magnitude of risk might be so low that you would still recommend proceeding with vaccinating the general population,” Jackson told Fortune.
Some doctors point to the CDC and FDA pause as proof that regulatory oversight is working even as COVID-19 vaccines receive emergency use authorization, which fast-tracks a stringent approval process in emergency cases.
“That we were able to see our federal colleagues, recognize this, respond really quickly and make a call to action, I think, does provide reassurance to those who think that the system may not be as rigorous as it should be,” said Dr. David Wohl, a professor of medicine in the division of infectious diseases at the University of North Carolina School of Medicine in a Tuesday press conference.
Wohl said the decision for U.S. health officials to recommend a pause in administering the Johnson & Johnson vaccine could not have been an easy one.
“I’m sure there was heated debate about the balance of underreacting versus overreacting,” Wohl said.
Now that the decision has been made, there is no going back, for better or worse, said Wohl. Many states, including New York, Virginia, and North Carolina, among others, have already paused J&J vaccinations in line with the regulatory guidance.
Dr. Janet Woodcock, the acting Food and Drug Administration Commissioner, said in a Tuesday press conference that the pause recommendation is to help health care professionals make informed decisions about COVID-19 vaccines.
“In doing this, we feel we’re taking the route that will provide the most safety for the patient, by enabling health care professionals to recognize, to properly treat, and to properly report any of the events that might happen,” Woodcock said.
