J&J COVID Vaccine Paused For Very Rare, Possibly Unrelated Blood Clots

2019-ncov, Covid-19, Corona, Virus, Drug, Vaccine, Vials, Medicine, Bottles, Syringe
Coronavirus vaccines (Shutterstock)

The Centers for Disease Control and Federal Drug Administration recommended a pause in the use of the Johnson & Johnson Janssen COVID-19 vaccine Tuesday out of an abundance of caution, due to a very small number of blood clots that may or may not be connected to the vaccine. No such cases have occurred in the U.S. Virgin Islands, according to the V.I. Department of Health.

The other two conditionally approved vaccines: Moderna and Pfizer, do not show a similar, very rare, statistical anomaly and will continue to be available. According to the statement, of the 6.8 million Janssen COVID-19 vaccine doses administered in the United States to date, six cases of a type of blood clot called “cerebral venous sinus thrombosis” were seen in combination with low levels of blood platelets. That is fewer than one in a million and it is not at all clear if there is any causal connection to the vaccine.

For comparison, the Johns Hopkins Medicine website says this type of clot occurs in about five out of every million people every year, which would mean around 35 people would be expected to have such a stroke every year out of the 6.8 million who got that particular vaccine. But these six occurred after the vaccine was administered, so while it may be a statistical fluke, the CDC and FDA are taking a cautious approach.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday, April 14, to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

The Virgin Islands Department of Health reports it has taken immediate action to notify Janssen providers to mark inventory, continue to store the vaccines as previously instructed, and to continue to monitor and document storage unit temperatures.

To date, around 481 individuals have been vaccinated with the Janssen vaccine in the Virgin Islands, according to the Health Department. The department used a phased approach to vaccine distribution and administered the vaccine to mostly elderly individuals who are homebound. There have been no reported cases of adverse effects among the population that received the vaccine in the territory. All six cases in the United States occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. None of the individuals who received the Janssen vaccine in the territory are in the known risk group.

It appears that these adverse events are extremely rare. CDC and FDA have reassured the public that COVID-19 vaccine safety is a top priority for the federal government, and that they take all reports of health problems following COVID-19 vaccination very seriously.

The local health department encourages everyone who receives either the Pfizer, Moderna, or Janssen vaccine to monitor their symptoms after vaccination and report those symptoms using the V-safe app. V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. Visit
vsafe.cdc.gov/. This app lets you report any side effects you may experience. If you or your loved one have taken the Janssen vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination, you should contact your health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.
Department of Health staff are following up with individuals who have received the Janssen vaccine and are closely monitoring the situation nationally and locally. Though its mobile strike team has paused its efforts to deliver the Janssen vaccines to residents, its community vaccination centers are still operational. To schedule an appointment for the Pfizer or Moderna COVID-19 vaccine, visit covid19usvi.com/vaccines and choose from any vaccinating provider in the territory or click on the book appointment link to schedule an appointment for the community vaccination centers. You can also schedule an appointment for the community vaccination centers by calling (340) 777-8227.