6 cases out of 6 million causes a pause for J&J vaccine

6 women out of 7 million people who have received the Johnson & Johnson 1-shot vaccine have developed serious blood clots that need to be treated in a special way. One woman has passed away, and one is in serious condition in a hospital in Nebraska. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. The clot condition is a rare CVST – cerebral venous sinus thrombosis. The CDC said that “the 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”.

Rhode Island and Massachusetts have followed suit in “pausing” the vaccine, as most states also did. RI has administered 37,000 J&J vaccines, so far, with no adverse side effects reported.

Out of an abundance of caution, the CDC and FDA have “paused” the use of the Johnson & Johnson vaccine. In most cases, these vaccines were used as part of the federal vendor program, which is primarily the national pharmacy chains. A quick look yesterday at the national CVS registration site, for one, showed “no availability” for any appointments in any state. This morning, appointments are available with this notice: “Per CDC/FDA guidance, we are pausing the use of Johnson & Johnson (Janssen) vaccine until further notice. We will provide information as we learn more. CVS Health will continue to offer the Moderna and Pfizer-BioNTech vaccines.”

The Johnson & Johnson vaccine was thought of as a “game-changer” in that it would be good for those who were resistant to the vaccine, fearful of needles, or unlikely to return for their second vaccine, as is required with the Moderna and Pfizer vaccines. Colleges were particularly interested in the convenience of a one shot vaccine, without a refrigeration issue. Approximately 300 individuals scheduled for a J&J shot in Rhode Island will be immediately either rescheduled by local pharmacies, or have their vaccine switched out when they get to their location, and a second date set up.

In Europe a few weeks ago, some countries “paused” the use of the Oxford University-AstraZeneca vaccine after a very small number of people suffered CVST blood clots. The AstraZeneca vaccine uses the same type of technology as the Johnson & Johnson shot. The blood clots were thought to be extremely rare. Moderna and Pfizer use a different technology. Dr. Fauci said yesterday that there have been no complications reported with either of those vaccines.

Statement of Johnson & Johnson:

Johnson & Johnson is known as the Jansson vaccine. Johnson & Johnson said it “was aware that blood clots had been reported with some Covid-19 vaccines, but that ‘no clear causal relationship has been established between these rare events’ and its shot. We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public. We have made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants.”

Statement from the CDC and FDA on Johnson & Johnson COVID-19 Vaccine:

The following statement is from Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research

“As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. 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 6 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 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.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) TODAY to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care 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. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their 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.htmlexternal icon.

Officials stress that if people have received the vaccine more than 2 weeks ago, their reason for concern is very, very low – within the last two weeks, they should be aware of headaches, lightheadedness, abdominal or leg pain, etc., and contact their physician with any concerns.

In a press conference yesterday officials said that the length of the pause will depend on what is learned, and could go from a matter of days to permanent withdrawal, which was thought to be unlikely. The vaccine may be “contraindicated” for some groups such as young women or women under the age of 50. A causal relationship with women taking birth control pills was also discussed. Notably the risk of women getting serious blood clots on oral contraceptives is thought to be 1 in 1,000, much higher than the 6 in almost 7 million with the J&J vaccine.

Probable cause may be an immune response that occurs very rarely – the response leads to activation of platelets and parts of coagulation system. The type of clotting problem is not only CVSTs, but two clotting problems occurring together.

Dr. Ashish Jha has said that the “pause” demonstrates that “the system is working”.

When questioned as to why a nationwide “pause” was warranted with such a small complication number, several experts have said it was done primarily as a way to immediately get the attention of the medical community about identification of this particular type of blood clotting problem and that it needs to be treated in a very different way than it might normally be treated. The normal heparin treatment for blood clots could create more clots and make matters worse in this type of dual clotting condition.

More than 6.8 million doses of the J& J vaccine have been given in the U.S., the vast majority with no or mild side effects.

In Rhode Island, this pause of the one vaccine is not expected to impact availability of the vaccine for any Rhode Islander wanting to be vaccinated.