Restaurant workers and restaurant delivery workers wait in line to sign up for Johnson & Johnson’s COVID-19 vaccine at a mobile vaccine site, Wednesday, April 7, 2021, in the Sunset Park neighborhood of New York. The mobile vaccination effort includes two buses equipped with four to six vaccinators each, delivering the COVID-19 vaccine directly to communities most in need. (AP Photo/Mark Lennihan)

Restaurant workers and restaurant delivery workers wait in line to sign up for Johnson & Johnson’s COVID-19 vaccine at a mobile vaccine site, Wednesday, April 7, 2021, in the Sunset Park neighborhood of New York. The mobile vaccination effort includes two buses equipped with four to six vaccinators each, delivering the COVID-19 vaccine directly to communities most in need. (AP Photo/Mark Lennihan)

U.S. recommends ‘pause’ for Johnson & Johnson vaccine over blood clot reports

More than 6.8M doses of the vaccine have been administered in the U.S., most with no or mild side effects

The U.S. is recommending a “pause” in using the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.

The Centers for Disease Control and Prevention and the Food and Drug Administration said Tuesday they were investigating unusual clots that occurred 6 to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48; there was one death and all remained under investigation.

The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca.

More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.

Federally run mass vaccination sites will pause the use of the J&J shot, and states and other providers are expected to follow. The other two authorized vaccines, from Moderna and Pfizer, make up the vast share of COVID-19 shots administered in the U.S. and are not affected by the pause.

“I’d like to stress these events appear to be extremely rare. However COVID-19 vaccine safety is a top priority,” FDA Acting Commissioner Janet Woodcock said at a news conference. “We expect it to be a matter of days for this pause.”

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

CDC’s Dr. Anne Schuchat said authorities have not seen similar clots after use of the Pfizer or Moderna vaccines, and that people should continue to get vaccinated with those shots.

The agencies are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.

J&J said in a statement it was aware of the reports of blood clots, but that no link to its vaccine had been established. The company also said it is delaying 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. “In this setting, administration of heparin may be dangerous and alternative treatments need to be given,” the FDA and CDC said.

European authorities investigating the AstraZeneca cases have concluded clots appear to be similar to a very rare abnormal immune response that sometimes strikes people treated with heparin, leading to a temporary clotting disorder.

While it’s not clear yet if the reports among J&J recipients are related, doctors would treat these kinds of unusual clots like they treat people who have the heparin reaction — with different kinds of blood thinners and sometimes an antibody infusion, said Dr. Geoffrey Barnes, a clot expert at the University of Michigan.

As authorities investigate whether the clots really are related to the J&J vaccine, Barnes stressed that it’s important Americans get vaccinated as soon as possible using the other two available vaccines, from Pfizer and Moderna.

“If you have a chance to get vaccinated with those, we strongly encourage it. The risks of COVID are real and they’re high,” Barnes said.

Jeff Zients, the White House COVID-19 response co-ordinator, said 28 million doses of the Pfizer and Moderna vaccines will be available for states this week, more than enough to keep up the nation’s pace of 3 million shots a day despite the J&J pause.

Asked if the government was overreacting to six cases out of more than 6 million vaccinations, Schuchat said recommendations will come quickly.

Because these unusual clots require special treatment, “it was of the utmost importance to us to get the word out,” she said. “That said, the pandemic is quite severe and cases are increasing in lots of places and vaccination’s critical.”

States and cities swiftly moved to implement the pause. New York state health commissioner Dr. Howard Zucker said people with Tuesday appointments for J&J vaccines at state-run mass vaccination clinics will instead get the Pfizer vaccine.

The city of Dallas had planned to begin an in-home vaccination program using the J&J vaccine for homebound or elderly people. The city said it will pause the program until more guidance is released.

The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the U.S. as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.

Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.

Only about 9 million of the company’s doses have been delivered to states and are awaiting administration, according to CDC data.

Until now concern about the unusual blood clots has centred on the vaccine from AstraZeneca, which has not yet received authorization in the U.S. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.

The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.

But the J&J and AstraZeneca vaccines are made with the same technology. Leading COVID-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.

The announcement hit U.S. stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of J&J dropped almost 3%

___

AP writers Emily Wagster Pettus, Karen Matthews and Jill Bleed contributed.

Zeke Miller, Lauran Neergaard And Matthew Perrone, The Associated Press

CoronavirusUSAvaccines

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Motorists breaking travel rules can be fined $230 for failing to follow instructions or $575 if the reason for travel violates the essential travel health order, at this Highway 3 check area near Manning Park. Photo RCMP
RCMP begin checking drivers on BC highways

Four check points are set up Thursday May 6 around the province

Similkameen Elementary Secondary School (google maps)
More potential exposures dates added to Keremeos school by Interior Health

The entire school week from April 26 to 30 now had a potential exposure

City Hall
Penticton council votes to shift tax burden to businesses

“The businesses staying afloat are what’s going to keep our community afloat,” said coun. Watt

Penticton Western News editor Monique Tamminga got her Astra Zeneca vaccine on Monday, May 3, 2021 at a Penticton pharmacy. Vaccines and appointments are available at most Penticton pharmacies this week.
More than 22K Penticton residents vaccinated

More than 35,000 people jabbed in South Okanagan so far

Weekly cases for the South Okanagan rose over April 25 to May 1, particularly in Summerland, according the map from the BC Centre for Disease Control. (BC CDC)
COVID-19 cases more than double in Summerland

Summerland currently has the highest per capita daily case rate

Protesters attempt to stop clear-cutting of old-growth trees in Fairy Creek near Port Renfrew. (Will O’Connell photo)
VIDEO: Workers, activists clash at site of Vancouver Island logging operation

Forest license holders asking for independent investigation into incident

Starting Tuesday, May 11, B.C. adults born in 1981 and earlier will be able to register for a vaccine dose. (Haley Ritchie/Black Press Media)
BC adults 40+ eligible to book COVID-19 vaccinations next week

Starting Tuesday, people born in 1981 and earlier will be able to schedule their inoculation against the virus

Kelowna City Hall. (Michael Rodriguez - Capital News)
New temporary outdoor shelter in Kelowna opens

The new area on Richter Street and Weddell Place replaces the Baillie Avenue site

Parks Canada and Tla-o-qui-aht Tribal Parks dig the washed up Princess M out from sand along the south shore of the Pacific Rim National Park Reserve. (Nora O’Malley photo)
Rescue attempt costs man his boat off Pacific Rim National Park Reserve

Coast Guard response questioned after volunteer responder’s speedboat capsizes in heavy swells

Al Kowalko shows off the province’s first electric school bus, running kids to three elementary and two secondary schools on the West Shore. (Zoe Ducklow/News Staff)
B.C.’s first electric school bus making the rounds in Victoria suburbs

No emissions, no fuel costs and less maintenance will offset the $750K upfront expense

Road sign on Highway 1 west of Hope warns drivers of COVID-19 essential travel road checks on the highways into the B.C. Interior. (Jessica Peters/Chilliwack Progress)
B.C. residents want travel checks at Alberta border, MLA says

Police road checks in place at highways out of Vancouver area

Victoria police say the photo they circulated of an alleged cat thief was actually a woman taking her own cat to the vet. (Black Press Media File Photo)
Photo of suspected cat thief released by Victoria police actually just woman with her pet

Police learned the she didn’t steal Penelope the cat, and was actually taking her cat to the vet

Most Read