On April 13, both the Centers for Disease Control and Prevention and the United States Food and Drug Administration recommended a pause in the use of the Johnson & Johnson’s Janssen COVID-19 vaccine “out of an abundance of caution.” The CDC and FDA are reviewing data after six people out of the nearly 7 million Americans who received the Janssen vaccine experienced a rare and severe type of blood clot. Here is what we know so far.
What are the CDC and FDA doing during this pause?
Although the vaccine is still authorized for use, the CDC and FDA recommend this vaccine not be given to anyone until we know more. This gives scientists a chance to review the data and decide if recommendations on who should get the vaccine need to change. As of now, all 50 states, Washington, D.C., and Puerto Rico have stopped administering the vaccine. The pause is important to help ensure that health care providers are aware of the potential side effects and prepared to administer the unique treatment required for CVST with low levels of platelets.
Is the Janssen vaccine only causing blood clots in women?
All reports occurred among women between the ages of 18 and 48. One of the women died, and another was hospitalized in critical condition. However, no data has been released yet determining women as the only group vulnerable to such blood clots. Other factors such as age, sex, gender, race, ethnicity, and medical history need to be reviewed to identify the cause of blood clots.
What are the blood clots caused by the vaccine?
The FDA and CDC are reviewing the reports of a low level of platelets in the blood in combination with a rare and severe type of blood clot called cerebral venous sinus thrombosis (CVST). Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given. This is why the pause is important for health practitioners to plan for proper recognition and management of this condition.
What if I got the Janssen vaccine?
In all cases reported so far, symptoms of blood clots occurred six to 13 days after vaccination. According to CDC recommendation, people who received the vaccine more than three weeks ago have a very low risk of developing a blood clot. For those who received the vaccine within the last three weeks, the risk of developing a blood clot is still very low. But the CDC recommends patients be on the lookout for possible symptoms which include: severe headache, blurred vision, fainting, seizures, pain in the abdomen, chest or stomach, leg pain or swelling, and shortness of breath. The symptoms are very different from the commonly reported side effects experienced in the first few days following inoculation such as headache, fatigue, and muscle aches.
Are other COVID-19 vaccines such as Moderna and Pfizer causing similar side effects?
As of April 19, the CDC said about 132.3 million people have received at least one dose of a COVID-19 vaccine – with about 85.4 million people who have been fully vaccinated by Johnson & Johnson’s single-dose vaccine or the two-dose series made by Pfizer-BioNTech and Moderna. So far, no cases of this blood clot issue were reported among the people who received the Pfizer-BioNTech or Moderna vaccines. While Johnson & Johnson initially claimed all COVID-19 vaccines might cause blood clots, experts who studied the vaccines refuted that claim. Dr. Eun-Ju Lee, an assistant professor of medicine at Weill Cornell Medical College who studied Moderna and Pfizer’s vaccines told CNN they didn’t find anyone with blood clots in their study. “We didn’t find any of those scary things that are happening with Johnson & Johnson,” Dr. Lee said.
However, similar CVST cases were found in the European Union in individuals who received the AstraZeneca vaccine, which is not available in the U.S. yet.
What will be the consequences of pausing the Johnson & Johnson vaccines?
While in the U.S. two other vaccines are still available, some worry about the impact on the rollout of the vaccine. Because the Janssen vaccine was only authorized in February, it played a minor role in the U.S. vaccination campaign and most Americans who had signed up to receive it were quickly switched to the two other vaccines, Los Angeles Times writes. However, the pause might make it more difficult for some harder to reach populations to get a vaccine. Mass vaccination sites and mobile vans that administer vaccines on the go tend to use the Janssen vaccine as it only requires to be kept in a standard refrigerator. People experiencing homelessness too relied heavily on the one-dose vaccine.
The pause in the Jonhson & Johnson vaccine is also damaging the public’s trust in vaccines and surveys already show the huge impact on the perceived safety of vaccines.
Will the Janssen vaccine be administered again in the future?
The Advisory Committee on Immunization Practices (ACIP) will hold its second virtual emergency meeting to discuss the Janssen COVID-19 vaccine on April 23. During an interview with Meet the Press, Dr. Anthony Fauci, the nation’s leading infectious disease expert, said he anticipated that the public will get more information after the emergency meeting and that the vaccine might be administered again, with some restrictions.
