Pandemic response: U.S. recommends pause for J&J vaccine over clots.
Reports of rare clots being investigated
WASHINGTON – The U.S. on Tuesday recommended a “pause” in using the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of rare but potentially dangerous blood clots, setting off a chain reaction worldwide and dealing a setback to the global vaccine campaign.
The Centers for Disease Control and Prevention and the Food and Drug Administration announced that they were investigating unusual clots that occurred six to 13 days after vaccination. The acting FDA commissioner said she expected the pause to last a matter of days.
The decision triggered swift action in Europe and elsewhere as the drugmaker and regulators moved to halt the use of the J&J vaccine, at least for now. Hundreds of thousands of doses of the vaccine were due to arrive in European countries this week. The European Union has been plagued by supply shortages, logistical problems and concerns over unusual blood clots in a small number of people who received the AstraZeneca vaccine.
Any slowdown in the dissemination of the shots could have broad implications for the global vaccination effort. The J&J vaccine held immense promise because its single-dose regimen and relatively simple storage requirements would make it easier to use, especially in less affluent countries.
The clots occurred in veins that drain blood from the brain and occurred to gether with low platelets, the fragments in blood that normally form clots. All six cases were in women between the ages of 18 and 48. One person died, and all of the cases remain under investigation.
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.
The FDA said the cases under investigation appear similar to the clots that European authorities say are possibly linked to the AstraZeneca vaccine, which is not yet cleared in the U.S. European regulators have stressed that the AstraZeneca risk appears to be lower than the possibility of developing clots from birth control pills.
Federally run mass vaccination sites will pause the use of the J&J shot, and states and other providers are expected to follow. But authorities stressed they have found no signals of clot problems with the most widely used COVID-19 vaccines in the U.S. – from Moderna and Pfizer. “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.
Speaking at a White House news conference, Dr. Anthony Fauci, the nation’s top expert on infectious disease, said the pause would allow the FDA and the CDC to investigate the clotting cases “to try and understand some of the mechanisms” and “to make physicians more aware of this.”
A CDC committee will meet Wednesday to discuss the cases, and the FDA has also launched an investigation.
FDA officials emphasized that Tuesday’s action was not a mandate. 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.