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J&J vaccine pause means safety checks work


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.

Vaccines are the biggest weapon in the fight against Covid-19, and in a timely way, because timing does matter. It matters in places like Michigan, which is now seeing a fourth surge in coronavirus cases and hospitalizations. It matters for countries like Thailand, which until now have been able to contain the virus. And it certainly matters for the loved ones of the women who suffered the blood clots.
I can almost hear the faint calls of those who have been hesitant or resistant to being vaccinated. They will likely mislabel these rare side effects as common, distorting them into reasons to skip the inoculations. That would be a grave mistake and miscalculation.
With Covid-19 stubbornly hanging on as the third-leading cause of death in the U.S., we cannot afford to simply eliminate this type of vaccine from our anti-pandemic arsenal without the most careful consideration, nor can we afford for nine million recently shipped doses to go unused.
Let’s not mince words about the need for this vaccine. The World Health Organization reported that more than four million people were recently diagnosed with Covid-19 in a single week. In that context, our federal agencies bear a heavy burden as they evaluate whether these unusual medical occurrences are vaccine-related.
Let’s push forward with the use of the other vaccines while we place some trust in the agencies charged with investigating the safety of the Johnson & Johnson vaccine. For all of us, I hope for a better understanding of why the women suffered the severe clotting, and the establishment of parameters so we can safely resume the use of the vaccine in the near future.

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.