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

Just Posted

Plans to restore the ecology of Sidney Island include the eradication of fallow deer first introduced in the early 1900s. (Parks Canada/Submitted)
Parks Canada proposal calls for eradication of fallow deer on Sidney Island

Proposed eradication part of a larger plan to restore local ecology but obstacles remain ahead

A dramatic four-vehicle crash at the intersection of Government and Herald streets brings standstill in downtown Victoria on May 18. (Jake Romphf/News Staff)
UPDATE: Downtown Victoria intersection reopens after 4 car crash injures passengers, slowed traffic

Traffic impacted after crash closes Government and Herald streets

The entrance to one of the tiny homes in Victoria’s Tiny Home Village. (Kiernan Green/News Staff)
Victoria Tiny Home Village resident evicted for lighting small fire

No damage or injuries, but zero-tolerance rule stands

A forest of dance-protesters outside the BC Legislature on April 11. These participants were doing the Dance for the Ancient Forest in support of the Fairy Creek blockade and against old-growth logging. (Zoë Ducklow/News Staff)
Arrests begin at Fairy Creek blockade on Vancouver Island

Five protesters arrested as RCMP begin to enforce injunction

A prowling coyote proved no match for a stray black cat who chased it out of a Port Moody parking lot Friday, May 14. (Twitter/Screen grab)
VIDEO: Little but fierce: Cat spotted chasing off coyote by Port Moody police

The black cat is seen jumping out from under a parked car and running the wild animal out of a vacant lot

A thunderstorm pictured in Fraser Valley in 2021. (Black Press Media/Jaimie Grafstrom)
Wildfire concerns sparked after 320+ lightning strikes blasted B.C. yesterday

Approximately one-quarter of the province is currently listed as being at moderate risk of fire

A restaurant server on White Rock’s Marine Drive serves customers on a roadside patio. Indoor dining and recreational travel bans have been in effect since late March in B.C. (Peace Arch News)
B.C.’s COVID-19 infection rate falls to 411 cases Tuesday

360 people in hospital, up slightly, two more deaths

The Banff National Park entrance is shown in Banff, Alta., Tuesday, March 24, 2020. THE CANADIAN PRESS/Jeff McIntosh
Minister asks Canadians to camp carefully in national parks as season starts

Kitchen shelters in Banff National Park closed, trails on Vancouver Island will only be one-way

Names of those aboard the ship are seen at Komagata Maru monument in downtown Vancouver, on Tuesday, May 18, 2021. The City of Vancouver has issued an apology for its racist role in denying entry to 376 passengers aboard a ship that was forced to return to India over a century ago. Mayor Kennedy Stewart says discrimination by the city had “cruel effects” on the Sikhs, Hindus and Muslims aboard the Komagata Maru, which arrived in Burrard Inlet on May 23, 1914. THE CANADIAN PRESS/Darryl Dyck
Vancouver mayor says sorry for city’s role in turning away South Asians in 1914

Kennedy Stewart has declared May 23 as the annual Komagata Maru Day of Remembrance

A crew of WestCoast WILD Adventures employees tackled an onslaught of litter left at the ‘Locks of Love’ fence at Wally Creek on May 2. (Anne-Marie Gosselin photo)
Litter woes consume popular ‘Locks of Love’ fence on B.C.’s Pacific Rim

Popular view spot near Tofino plagued by people hanging masks and other unwanted garbage

A game camera near the Klahoose reservation on Cortes Island caught this glimpse of a truck leaving the woodlot at around 2:30 on Sunday morning. Photo supplied by Klahoose First Nation
Indigenous cutblock vandalised on Cortes Island, anti-logging element suspected

Ribbons pulled down, gravel poured into gas tank at Klahoose First Nation site

Announced Tuesday, May 18 by Public Safety Minister Mike Farnworth, the province added gyms, dance and fitness studios to its list of places where face coverings are mandatory. (AP/Steven Senne)
Masks now required at all times inside B.C. gyms, including during workouts

Those who disobey could be subject to a $230 fine

Reinhard “Bud” Loewen of Abbotsford has now been charged with 21 counts of sexual assault related to his massage business. (Facebook photo)
Former Abbotsford masseur now faces 21 counts of sexual assault

Bud Loewen of Bud’s Massage Therapy initally faced three charges

Most Read