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

Photo: RCMP
Rossland pedestrian dies after being pinned between 2 vehicles

RCMP Sgt. advises that victim services is available for anyone requiring help

Dani Evans with her brother Alex, 9, and George, her buddy dog (a guide dog for children). Photo: Bill Metcalfe
Visually impaired girl walks for Nelson Friends of the Family

Dani Evans is raising money through the month of May

Pharmacist Barbara Violo shows a vile of the Oxford-AstraZeneca COVID-19 vaccine. Photo: THE CANADIAN PRESS/Nathan Denette
Castlegar pharmacies gets additional AstraZeneca vaccines

Several Castlegar pharmacies list appointment openings this week

FILE - In this April 19, 2021, file photo, Keidy Ventura, 17, receives her first dose of the Pfizer COVID-19 vaccine in West New York, N.J. States across the country are dramatically scaling back their COVID-19 vaccine orders as interest in the shots wanes, putting the goal of herd immunity further out of reach. (AP Photo/Seth Wenig, File)
5 more deaths, 131 new cases of COVID-19 in Interior Health over the weekend

Those 18-years and older in high-transmission neighbourhoods can register for the vaccine

Castlegar City Hall. (Photo: Kristen Lawson)
City of Castlegar finance reports for 2020 show revenue losses

Some losses were offset by savings and grants

A bullet hole is seen in the windshield of an RCMP vehicle approximately 4 km from Vancouver International Airport after a one person was killed during a shooting outside the international departures terminal at the airport, in Richmond, B.C., Sunday, May 9, 2021. THE CANADIAN PRESS/Darryl Dyck
Homicide team IDs man in fatal YVR shooting as police grapple with spate of gang violence

Man, 20, charged in separate fatal shooting Burnaby over the weekend

Kelowna resident Sally Wallick helped rescue a kayaker in distress a week and a half ago. (Sally Wallick/Contributed)
VIDEO: Kelowna woman rescues capsized kayaker in Okanagan Lake

Sally Wallick is asking people to be prepared for the cold water and unpredictable winds

Dr. Bonnie Henry talks about phase two in B.C.’s COVID-19 immunization plan. THE CANADIAN PRESS/Chad Hipolito
All of B.C. will eventually ease out of COVID-19 restrictions at same time: Henry

People who have received two doses of a vaccine can’t yet return to post-pandemic activities with each other, she says

Winnipeg Jets’ Andrew Copp (9) and Edmonton Oilers goaltender Mike Smith (41) watch an incoming shot during second period NHL action in Winnipeg, Monday, April 26, 2021. THE CANADIAN PRESS/Fred Greenslade
‘Very jealous’: Canadian teams can’t take advantage of NHL’s relaxed COVID-19 rules

League eased some tight COVID-19 health and safety protocols over the weekend for fully vaccinated clubs

Cannabis bought in British Columbia (Ashley Wadhwani/Black Press Media)
Is it time to start thinking about greener ways to package cannabis?

Packaging suppliers are still figuring eco-friendly and affordable packaging options that fit the mandates of Cannabis Regulations

A map of Huu-ay-aht-owned forestry cutblock. (SUBMITTED PHOTO)
B.C. First Nations restrict access to territory in wake of forestry standoffs

Huu-ay-aht set up checkpoints after heated and dangerous incidents on southwest Vancouver Island

RCMP are searching for Philip Toner, who is a ‘person of interest’ in the investigation of a suspicious death in Kootenay National Park last week. Photo courtesy BC RCMP.
RCMP identify ‘person of interest’ in Kootenay National Park suspicious death

Police are looking for Philip Toner, who was known to a woman found dead near Radium last week

Vancouver Canucks goaltender Thatcher Demko (35) makes a save on Winnipeg Jets’ Nate Thompson (11) during second period NHL action in Winnipeg, Monday, May 10, 2021. THE CANADIAN PRESS/Fred Greenslade
Vancouver Canucks see NHL playoff hopes dashed despite 3-1 win over Winnipeg

Montreal Canadiens earn final North Division post-season spot

The southern mountain caribou, an iconic species for the Splatsin First Nation, is threatened with extinction, much to the dismay of the First Nation. (Province of B.C. photo)
Okanagan First Nation band concerned over dwindling caribou herd

Southern mountain caribou at risk of extinction, much to dismay of Splatsin First Nation near Enderby

Most Read