US lifts pause, allowing J&J COVID-19 vaccinations to resume

FOX 2 - U.S. health officials have lifted an 11-day pause on Johnson & Johnson vaccinations following a recommendation by an expert panel. Advisers to the Centers for Disease Control and Prevention said Friday the benefits of the single-dose COVID-19 shot outweigh a rare risk of blood clots.

Panel members said it's critical that younger women be told about that risk so they can decide if they'd rather choose another vaccine. The CDC and Food and Drug Administration agreed. European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J's shot.

U.S. health advisers on Friday urged resuming COVID-19 vaccinations with Johnson & Johnson’s single-dose shot, saying its benefits outweigh a rare risk of blood clots — in line with Europe’s rollout.

Federal health officials uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized.

Advisers to the Centers for Disease Control and Prevention said while J&J’s vaccine is important for fighting the pandemic, it’s also critical that younger women be told about that risk in clear, understandable terms — so they can decide if they’d rather choose an alternate vaccine instead.

The panel voted 10-4 to lift an 11-day pause in use of the J&J shot while adding warnings that women and health workers would see in leaflets at vaccination clinics. The group debated but ultimately steered clear of outright age restrictions.

"This is an age group that is most at risk (of the clotting) that is getting vaccine predominately to save other peoples’ lives and morbidity, not their own. And I think we have a responsibility to be certain that they know this," said Dr. Sarah Long of Drexel University College of Medicine, who voted against the proposal because she felt it did not go far enough in warning women.

The CDC and Food and Drug Administration will weigh Friday’s recommendation in deciding whether to end the pause; the CDC typically follows the recommendation of its advisers and CDC Director Dr. Rochelle Walensky has promised swift action.

European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J’s shot.

At issue is a weird kind of blood clot that forms in unusual places, such as veins that drain blood from the brain, and in patients with abnormally low levels of the platelets that form clots. The CDC and Food and Drug Administration initially spotted six people who developed such clots one to three weeks after J&J vaccination. On Friday, health officials said nine more cases came to light in the last week or so.

The needle-in-a-haystack reports raised alarm because European regulators already had uncovered similar rare clots among recipients of another COVID-19 vaccine, from AstraZeneca. The AstraZeneca and J&J shots, while not identical, are made with the same technology.

European scientists found clues that an abnormal platelet-harming immune response to AstraZeneca’s vaccine might be to blame -- and if so, then doctors should avoid the most common clot treatment, a blood thinner called heparin.

The Associated Press contributed to this report