J&J vaccine to remain in limbo while officials seek evidence

Full Screen
1 / 2

Copyright 2021 The Associated Press. All rights reserved.

FILE - In this March 3, 2021, file photo, Johnson & Johnson COVID-19 vaccine is held by pharmacist Madeline Acquilano at Hartford Hospital in Hartford, Conn. U.S. health officials are weighing next steps as they investigate unusual blood clots in a small number of people given the vaccine -- a one-dose shot that many countries hoped would help speed protection against the pandemic. (AP Photo/Jessica Hill, File)

Johnson & Johnson's COVID-19 vaccine will remain in limbo for a while longer after government health advisers declared Wednesday that they need more evidence to decide if a handful of unusual blood clots were linked to the shot — and if so, how big the risk really is.

The reports are exceedingly rare — six cases out of more than 7 million U.S. inoculations with the one-dose vaccine. But the government recommended a pause in J&J vaccinations this week, not long after European regulators declared that such clots are a rare but possible risk with the AstraZeneca vaccine, a shot made in a similar way but not yet approved for use in the U.S.

At an emergency meeting, advisers to the Centers for Disease Control and Prevention wrestled with the fact that the U.S. has enough alternative shots to vaccinate its population but other countries anxiously awaiting the one-and-done vaccine may not.

“I continue to feel like we’re in a race against time and the variants, but we need to (move forward) in the safest possible way,” said CDC adviser Dr. Grace Lee of Stanford University, who was among those seeking to postpone a vote on the vaccine.

Authorities have studied the clots for only a few days and have little information to judge the shot, agreed fellow adviser Dr. Beth Bell of the University of Washington.

“I don’t want to send the message there is something fundamentally wrong with this vaccine,” Bell said. “It’s a very rare event. Nothing in life is risk-free. But I want to be able to understand and defend the decision I’ve made based on a reasonable amount of data."

These are not run-of-the-mill blood clots. They occurred in unusual places, in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets. The six cases raised an alarm bell because that number is at least three times more than experts would have expected to see even of more typical brain-drainage clots, said CDC's Dr. Tom Shimabukuro.

“What we have here is a picture of clots forming in large vessels where we have low platelets,” Shimabukuro explained. “This usually doesn’t happen,” but it’s similar to European reports with the AstraZeneca vaccine.