There seems to be a few problems with the Johnson & Johnson COVID-19 vaccination and the U.S. government has recommended to “pause” using the single-dose shot. The Centers for Disease Control and Prevention and the Food and Drug Administration announced that they were investigating unusual clots that occurred six to thirteen days after the vaccination. The FDA commissioner said she expected the pause to last a matter of days.
According to The Associated Press, clots occurred in veins that drain blood from the brain and occurred together with low platelets, the fragments in blood that normally form clots. All six cases occurred in women between the ages of 18-48. One person died, and all of the cases remain under investigation.
The clotting problem, which appears to be extraordinarily rare, is similar to the one reported after use of AstraZeneca’s COVID-19 vaccine, which has not been authorized for use in the United States to date. It’s also similar to an event that occurred during Johnson & Johnson’s U.S.-based clinical trial, an event that led to a temporary pause during the trial phase.
More than 6.8 million doses of the J&J vaccine have been given in the U.S., the vast majority with little to no side effects.
“I’d like to stress these events appear to be extremely rare. However COVID-19 vaccine safety is a top priority,” acting FDA Commissioner Janet Woodcock said at a news conference.
A CDC committee will meet Wednesday to discuss the cases, and the FDA has also launched an investigation into the cause of the clots and low platelet counts. The FDA maintained that the “pause” was not a mandate and that doctors and patients could still use J&J’s vaccine if they decide its benefits outweigh its risks for individual cases, said Dr. Peter Marks to The AP.
The FDA also recommends that people who were given the vaccine should contact their doctor if they experience severe headache, abdominal pain, leg pain, or shortness of breath within three weeks. J&J said in a statement that it was aware of the reports of blood clots, but that no link to its vaccine had been established. The company also said it would delay the rollout of its vaccine in Europe as a precaution.
