The federal Food and Drug Administration and Centers for Disease Control and Prevention on April 13 advised that states temporarily pause administration of the Johnson & Johnson Covid-19 vaccine. There’s no question that the cases of six women who suffered unusual blood clots — one of whom died — need to be monitored and considered closely.
This is certainly an alarming setback. But the abundance of caution exhibited does not mean the vaccine is unsafe for widespread use. Rather, it means that we are following a safety measure that was installed in the process to safeguard further patients who may be susceptible to clotting. This is what we want to see during the vaccination process, or for any medical treatment, for that matter.
In fact, this news demonstrates that the process is working. Safety has always been paramount to this massive vaccination effort, perhaps the largest clinical undertaking in centuries. This pause — and let me reiterate that it is only a pause for now — indicates that the U.S. is well organized to evaluate, and ideally prevent, these occurrences.
The Vaccine Adverse Event Reporting System is used by agencies to report the side effects of vaccines, an effective and seamless way for federal agencies to alert physicians to symptoms of these seldom-seen blood clots and treat them properly if they encounter them. In terms of J&J’s vaccine, more than 6.8 million people had already received the single-shot dose before the pause, so there was about one-in-a-million chance of this severe clotting to occur. And still, the six cases were enough to persuade clinical advisers to decide to review progress before moving forward.
The CDC’s Advisory Committee on Immunization Practices is meeting to investigate these cases closely to determine their cause, and whether vaccinations should continue. Their job is to openly discuss the safety and process moving forward. And in the age of misinformation, their work is critical to presenting the facts.
Bruce Farber, M.D., is the chief of the Division of Infectious Diseases in the Department of Medicine for North Shore University Hospital and Long Island Jewish Medical Center, and is a professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.