The CDC and FDA announced Friday that the pause put in place on use of Johnson & Johnson’s COVID-19 vaccine has been lifted.
The Biden administration paused the recommendation of the vaccine on April 13 after six cases of rare blood clots were detected in the nearly seven million American recipients of the shot. Health officials announced the lifting of the pause after the CDC’s Advisory Committee on Immunization Practices (ACIP) voted ten to four, with one abstention, to re-approve its original recommendation of the J&J shot.
The ACIP did recommend that the FDA add a warning label to the vaccine, explaining that in rare instances the vaccine caused clots in women under age 50. Johnson & Johnson and the FDA have reportedly agreed on wording for a new warning to be added to the vaccine fact sheet. (RELATED: Poll: Americans No Longer Confident In Johnson & Johnson Vaccine After CDC Pause)
This is the warning that could appear on the EUA fact sheet given to patients getting the J&J vaccine, if it is allowed to resume. pic.twitter.com/H1k8XJ79sY
— Brandon Richard (@BrandonLRichard) April 23, 2021
However, the panel did not add any label or new information to its original recommendation. Members debated one option that would amend the original recommendation to include the warning information about blood clots but opted not to.
23. The two options on the table now are laid out here. pic.twitter.com/Vi4PoiMGCz
— Helen Branswell (@HelenBranswell) April 23, 2021
This means that, after a nearly two-week pause, all that will have changed is a brief warning added to the vaccine fact sheet. (RELATED: COVID Is Far More Likely To Cause Blood Clots Than Vaccines Are, Study Finds)
New evidence of the link between the vaccine and rare blood clots was presented at the ACIP meeting. Tom Shimabukuro, a vaccine safety expert with the CDC, said there were now 15 known cases of clotting. All the confirmed cases have been in women, and there have been three confirmed deaths. Data was presented during the meeting that suggested a continued pause of the vaccine would result in far more deaths than the potential blood clots, particularly if women under age 50 increasingly choose to get another vaccine.
The lifting of the pause will open up access to the roughly 10 million currently distributed doses of the shot.