The fact sheet for Johnson & Johnson’s Covid-19 vaccine has been revised by U.S. regulators to warn of the risk of a rare bleeding disorder.
The Food and Drug Administration said in a letter to the company on Tuesday that adverse-event reports suggested an increased risk of immune thrombocytopenia, or ITP, during the 42 days following vaccination. Symptoms include bruising or excessive or unusual bleeding, according to the agency.
The changes to the fact sheet include recommendations to vaccination providers about giving the J&J shot to people with existing medical conditions, including those who have a low level of platelets, a type of blood cell that helps stop bleeding.
J&J said in a statement that “individuals who have been previously diagnosed with ITP should talk to their health-care provider regarding the risk of ITP and the potential need for platelet monitoring following vaccination.”
J&J’s vaccine has also been previously connected to rare but serious blood clots, a condition called thrombosis with thrombocytopenia syndrome, or TTS. Women ages 30 to 49 were at the highest risk, according to the Centers for Disease Control and Prevention.
So far, about 17 million Americans have been given the one-dose vaccine. Last month, the CDC recommended messenger RNA vaccines made by Moderna Inc. and Pfizer Inc. for use in adults over J&J’s shot.
The Push to Boost Every Person in the United States Proves Public Health Decisions Aren’t Data-Driven
@COVID19Up: The push to boost every person in the U.S. has a scientific problem. New data show that COVID-19 vaccine booster efficacy against getting COVID-19 can plummet to 35% with the Pfizer booster and 45% with the Moderna booster just 10 weeks after that third shot.
So will public-health officials recommend boosters every three months? The public has no appetite for that. Nor do many experts.
Antibodies represent one line of defense against early infection, but cellular immunity with B and T cells confers strong protection against severe disease. That’s why tracking antibody levels is a medically imprecise way to study immunity—and why public health officials must make decisions driven by data.
Dr. Vinay Prasad of the University of California this week nicely summarized the problem.
To date, the clinical benefit of boosters has not been reported in younger people or people with natural immunity from prior infection. A German population study found that no healthy child 5 to 17 years old died of COVID-19 over a 15-month period when the vast majority were unvaccinated.
Many have been alarmed by the CDC and FDA pushing boosters for young people, despite zero clinical data to support this recommendation and the risk of myocarditis, which can affect as many as one in 1,860 young men, ages 18 to 24.
Scientific discourse on the topic of boosters has been corrupted. Two top FDA officials already resigned over this very issue—political pressure to authorize boosters in young people.
Public health officials need to focus on real-world clinical outcomes.