And a recent study that has yet to be peer reviewed suggests that it’s even more prevalent in people with COVID-19.

It typically happens in 5 out of every 1 million people in the world every year. In mid-April, the Centers for Disease Control and Prevention (CDC) and the FDA announced that they were investigating reports of a serious and rare blood clot called cerebral venous sinus thrombosis (CVST) in people who had received the Johnson & Johnson vaccine.ĬVST is a type of blood clot in the brain’s veins that stops blood from draining out, resulting in a stroke. Why was the Johnson & Johnson vaccine paused?

This was the case with the Johnson & Johnson vaccine, which we’ll cover next. In some cases, product use may be paused as a precaution until the risk is evaluated. With something as wide-reaching as the COVID-19 vaccines, it’s important to take these reports seriously and act quickly in the public interest. If serious adverse events occur, they are investigated to see if they are linked to the vaccine - meaning that there is a causal relationship - or if they are due to something else. But just because something happens after getting a vaccine doesn’t mean that it was caused by it. This is why the CDC encourages the use of V-safe - the side effect tracking smartphone app - and the Vaccine Adverse Event Reporting System (VAERS) for people and providers to report events that happen after vaccination. In the case of COVID-19, over 8 billion vaccine doses have been given so far, so we would expect to see any potential rare adverse events pop up. Some adverse events may be uncovered in clinical trials, whereas others, especially if they are very rare, might surface down the road as more people get vaccinated. Safety monitoring after authorizationĪs with any vaccine, it’s important to monitor adverse events to protect the public from potential harm. Events are also tracked as the general public gets the vaccine, which is where rare events may come to light. And while there were several blood clot events in both the vaccine and placebo groups, researchers couldn’t determine if the vaccine directly caused them since they may have been the result of underlying conditions.Īs part of the emergency use authorization (EUA), the company is required to report serious adverse events - unexpected problems that may be associated with the product - to the FDA for ongoing safety monitoring in the study population. In the case of the Johnson & Johnson vaccine, which was tested for safety and efficacy in over 40,000 people in clinical trials, most side effects were mild to moderate and only lasted a few days. The recommendation came after new data suggests that there may be a higher risk for the rare blood clotting condition than previously thought. While Johnson & Johnson’s vaccine is still available, the CDC recommends that adults get the Pfizer and Moderna vaccines instead. This is what the FDA evaluates when approving or authorizing a new vaccine. Almost everything has risks, but the question is whether or not the benefits outweigh the risks. It’s important to understand that when we say a vaccine is safe, it doesn’t mean it’s risk-free. Here we’ll cover why the Johnson & Johnson vaccine was paused, why it’s available again, and what you need to know if you decide to get it. But it’s still available for people who prefer a different option or have severe allergic reactions to the Pfizer and Moderna vaccines. In fact, the Centers for Disease Control and Prevention (CDC) now recommends the Pfizer or Moderna vaccines for initial and booster shots over the Johnson & Johnson vaccine. Given that over 1 million COVID-19 vaccine doses are given every day in the U.S., it’s important to quickly identify and address rare problems that may occur as a result. Some may view the pause as an extreme measure, but it’s a sign that the safety monitoring processes are working to protect the public. The decision came after government agencies investigated the issue and concluded that the benefits of the vaccine outweighed the risks. After a temporary 10-day pause in the United States, the Johnson & Johnson vaccine is back - but with a new warning about a rare but serious blood clotting condition possibly linked with the shot.

Fda pauses johnson and johnson vaccine