This is about long-term trust and confidence in the system. We’re really fortunate to have multiple vaccines that look extremely good so quickly. We’re not going to eradicate COVID any time soon, if ever. In the short term this might cause some issues that may result in some people not getting vaccinated who would otherwise get vaccinated. You have to think about short term versus long term. Is this likely to hurt vaccine confidence and increase vaccine hesitancy? You don’t want to suspend something absent that reason, because it just confuses people, and potentially you’re not vaccinating people when you could. The decision to suspend it is a difficult judgment call. The systems are working because they identified something that looked unusual and they’re assessing it rapidly and making decisions from there.

What does this say about the systems in place to find, report, and investigate any adverse events? However, it’s a one to three per million chance, and the benefits of the flu vaccine are far, far greater than that. Guillain-Barre is a pretty serious neurological condition. For example, flu vaccine causes Guillain-Barre syndrome in one to three per million people vaccinated. Because at the end of the day, it’s all about risk versus benefits. If this is in fact a pattern, you need to look at the risk of these blood clots among women in this age group and how much risk it is, and then compare it to the benefit of the vaccine. The availability of other vaccines makes this decision easier. But with that said, they want to be careful with safety and that’s a good thing. Stopping the vaccine comes at a risk as well because those are people that aren’t getting vaccinated in the midst of a pandemic. What do you make of the pauses in administering these vaccines? we have two other highly effective vaccines to use that have not raised similar safety concerns. Ultimately, vaccine decisions are about weighing risks and benefits of the vaccine. The situation with the J & J vaccine really requires more data. What are your thoughts on how these two situations have played out so far? The Johnson & Johnson and AstraZeneca vaccines were paused for the same reason. The question is, is it because of the vaccine, and specifically more frequently after getting the vaccine? If, after you look at the data, you find that it still persists, usually you want to do a chart review and look for standardized case definitions and really do a more formal study. So, if we vaccinate a lot of people in a short amount of time, we have to anticipate that bad things will happen to them, hopefully at the same rate that would have happened anyway (except for the disease you’re vaccinating against, in this case COVID, which hopefully that happens less). How frequently these things happen depends on the population. And if you vaccinate people, these things will happen after people got the vaccine, by chance alone. People have heart attacks, people have strokes, people get infectious diseases, and chronic diseases, and cancer. How should we view these situations generally?īad things happen to people every day from a health perspective. This follows a similar move in Europe where several countries suspended use of the AstraZeneca COVID-19 vaccine because, of 17 million people in the EU and the UK who received the vaccine, 37 had CVST.ĭaniel Salmon, PhD ’03, MPH, a professor in International Health and director of the Institute for Vaccine Safety, shares his take on what to make of such pauses.

on April 13 paused use of the Johnson & Johnson COVID-19 vaccine because, of the nearly 7 million people who received the vaccine, six women under 50 developed a rare form of blood clots called cerebral venous sinus thrombosis, or CVST.

Fda pauses johnson and johnson vaccine