Johnson & Johnson Vaccine FAQs

Johnson & Johnson Vaccine FAQs

The Centers for Disease Control and Prevention and the Food and Drug Administration on April 12 paused the administration of the Johnson & Johnson single-dose COVID-19 vaccine out of an abundance of caution related to blood clot disorders that were a side effect in six cases out of nearly 7 million doses administered. That pause was lifted on April 23.

Why was administration of the Johnson & Johnson vaccine halted?

The CDC and FDA reported that, as of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine had been administered in the U.S. The CDC and FDA were reviewing data involving six reported cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine, which resulted in one death and one critical illness.

In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant (blood thinner) 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.

The CDC convened a meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14, 2021, to further review these cases and assess their potential significance. The FDA reviewed that analysis as it investigated these blood clot cases, and recommended a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot. Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. Additionally, Gov. DeWine called for a pause in distribution of all Johnson & Johnson vaccines until the federal agencies offered additional guidance.

The CDC and FDA have recommended that use of the Johnson & Johnson COVID-19 vaccine resume in the United States, effective April 23, 2021. A review of all available data at this time shows that the J&J COVID-19 vaccine’s known and potential benefits outweigh its known and potential risks for those recommended to receive it. However, women younger than 50 years old should be aware of the rare but increased risk of blood clots with low platelets after vaccination, and that other COVID-19 vaccines are available where this risk has not been seen.

The pause allowed the CDC to communicate with healthcare providers and re-emphasize the importance of reporting severe events in people who have received this vaccine, as well as how to report such events. The pause also gave experts time to carefully review all available data and conduct a risk-benefit analysis around the use of this vaccine.

What should I do if I got a Johnson & Johnson vaccine?

Anyone who has received the shot more than a month ago is outside of the window when these complications have occurred. As with all vaccines, it is important to monitor oneself for any adverse reactions after a shot and seek medical attention at the DeWeese Health Center or from your healthcare provider if a reaction occurs.

Any students with concerns about the Johnson & Johnson vaccine should reach out to University Health Services with their questions.

How would I know if  I am developing a blood clot?

The most common type of blood clot is in the leg, known as deep vein thrombosis. Cerebral venous sinus thrombosis is rare and symptoms are severe headache and other neurological symptoms. Other symptoms of blood clots may be severe abdominal pain, leg pain or shortness of breath. These likely would occur within three weeks after vaccination. Anyone experiencing these symptoms should contact their healthcare provider.

Why was Kent State University Health Services giving out the Johnson & Johnson shot?

The vaccines were provided to Kent State and numerous other universities in Ohio as part of a program developed by Ohio Gov. Mike DeWine to vaccinate as many college students as possible before summer break. The goal of this vaccine push was to stop the spread of COVID-19 by college students as they departed their campuses for the summer. Gov. DeWine has expressed his confidence that the Johnson & Johnson vaccine, after its review, will once again be used as a key part of Ohio’s vaccination plan.

Is this a concern for the other COVID-19 vaccines?

These side effects have not been seen with either the Moderna or Pfizer brand vaccines, which require two doses to be fully effective.

These complications are similar to ones seen with the Astra-Zeneca vaccine, which has not yet received FDA approval for emergency use in the U.S. However, it has been approved for use in other countries.