By Natalie DeCoste
American authorities recommend that the distribution of the Johnson & Johnson vaccine be put on pause after reports of adverse reactions.
The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention announced that the Johnson & Johnson vaccine was linked to a type of blood clot called cerebral venous sinus thrombosis (CVST).
“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,” read the start of the announcement.
The agencies report that all six cases occurred in women between the ages of 18 and 48, and the symptoms of the clots appeared 6 to 13 days after vaccination.
The issue with the CVST clot, according to the agencies, is that treatment of this specific type of blood clot is distinct from the treatment that is typically administered for a blood clot. Usually, an anticoagulant drug called heparin is used to treat blood clots. However, in this case, administration of heparin may be dangerous to the patient, and alternative treatments need to be given.
In response to the reports of the blood clots, the CDC and FDA are convening an advisory committee to look further into the situation. In the interim period, the agencies are recommending that the distribution of the vaccine be paused.
“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday 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,” read the announcement.
Pausing vaccine distribution will also allow for health care providers to prepare to treat and report any cases of this clotting issue, according to Anne Schuchat, principal deputy director of the CDC.
The Johnson & Johnson vaccine makes up only a small portion of the vaccine doses given to Americans. According to White House COVID-19 coordinator Jeff Zients, the Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date.
Zients also said that the administration was working with state and federal partners to get people who were scheduled to receive the J&J shot signed up for a Pfizer or Moderna vaccine.
The European Medicines Agency announced it was also reviewing the Johnson & Johnson vaccine after receiving reports of four clotting cases in Europe. On April 13, the company said it would delay the rollout of the vaccine shot in Europe while the investigation is underway.
