US recommends 'pause' for J&J shots in blow to vaccine drive

FILE - In this Thursday, April 8, 2021 file photo, the Johnson & Johnson COVID-19 vaccine sits on a table at a pop up vaccinations site the Albanian Islamic Cultural Center,  in the Staten Island borough of New York. The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots. (AP Photo/Mary Altaffer, File)
FILE - In this Thursday, April 8, 2021 file photo, the Johnson & Johnson COVID-19 vaccine sits on a table at a pop up vaccinations site the Albanian Islamic Cultural Center, in the Staten Island borough of New York. The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots. (AP Photo/Mary Altaffer, File)

WASHINGTON (AP) - The U.S. on Tuesday recommended a "pause" in use of 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 vaccination campaign.

The Centers for Disease Control and Prevention and the Food and Drug Administration announced they were looking into unusual clots in six women ages 18-48. One person died.

The acting FDA commissioner expected the pause to last only a matter of days. However, the decision triggered swift action in Europe and elsewhere as the drugmaker, regulators and providers moved to halt the use of the J&J vaccine, at least for now. Hundreds of thousands of doses were due to arrive in European countries, where vaccinations have been plagued by supply shortages, logistical problems and concerns over blood clots in a small number of people who received the AstraZeneca vaccine, which is not yet cleared for use in the U.S.

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, which happened six to 13 days after vaccination in veins that drain blood from the brain, occurred together with low platelets, the fragments in blood that normally form clots.

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.

"We know there are plenty of critics who say 'Why? It's just a couple of cases. Why don't we just move along?'" said Dr. Peter Marks, director of the FDA's vaccine center. He noted past episodes when health problems surfaced in people who got new vaccines, such as the debut of the polio vaccine in 1955 and a vaccination campaign against a new form of flu in 1976.

When medical countermeasures injure people in the United States, "we don't have a lot of tolerance for that, and that tends to undermine vaccine confidence. So we simply have to do whatever we can to minimize or eliminate issues that might be considered friendly fire."

The decision immediately upended some vaccine programs around the U.S.: In Atlanta, a mass vaccination event for public school teachers that was to have used the J&J vaccine was scrapped. St. Louis health officials said they would reach out to 1,800 people who got the shots to warn them of potential health issues. And in Montana, two colleges that had hoped to vaccinate students with J&J doses before they head home for the summer canceled clinics.

Authorities stressed they have found no sign of clot problems with the most widely used COVID-19 vaccines in the U.S. - from Moderna and Pfizer.

Seth Shockley, of Indianapolis, received the J&J vaccine Sunday and was initially worried when he heard about the potential side effects Tuesday. His concerns faded when he learned there were only six confirmed cases of blood clots.

"I would much rather take the risk with the vaccine - a much smaller risk - than to risk it with COVID," he said. Now he's more worried the reports could result in more people refusing to get vaccinated.

The FDA said the cases under investigation appear similar to the clots that are possibly linked to the AstraZeneca vaccine. European regulators have stressed the AstraZeneca risk appears to be far lower than the possibility of developing clots from birth control pills, which typically cause clots in about four of every 10,000 women who use them for a year.

Speaking at the White House, 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 and "to make physicians more aware of this."

A CDC committee will meet today to discuss the cases, and the FDA has launched an investigation into the cause of the clots and low platelet counts.

FDA officials emphasized 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, Marks said.

The agencies recommend people who were given the J&J vaccine should contact their doctor if they experience severe headache, abdominal or leg pain or shortness of breath within three weeks.

J&J said in a statement it was aware of the reports of blood clots, but 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.

U.S. health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin.

Even without J&J's vaccine, White House officials said they remain on track to have enough supplies to vaccinate most American adults by the summer.