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

The mighty Fraser during freshet on May 2, 2021 at Island 22 Regional Park. A new B.C. coalition representing 25 organizations, and 273,000 people, is calling on B.C. to reverse decades of wildlife and habitat declines. (Jennifer Feinberg/ The Chilliwack Progress)
Coalition calls on B.C. to invest in wildlife stewardship and habitat protection

Representing 25 organizations, and 273,000 people, they seek to reverse decades of declines

Terry Driver as he looked around the time of the killing of Tanya Smith and the attempted murder of Misty Cockerill in Abbotsford in October 1995. No current photos are available of Driver.
‘Abbotsford Killer’ Terry Driver denied parole, deemed ‘high risk’ to re-offend

Driver murdered Tanya Smith, 16, and seriously injured Misty Cockerill, 15, in 1995

Boats in the Fraser River launched from Barrowtown and Ft. Langley on May 12 to search for the missing fisherman. (Steve Simpson)
Boats search the Fraser River for missing Abbotsford fisherman

Anyone with ‘a boat, time, or a drone’ to help bring Damian Dutrisac home was asked to help

Mina Shahsavar is a fourth-year student in the bachelor of science in nursing program at University of the Fraser Valley and is an employed student nurse at Abbotsford Regional Hospital. (Submitted photo)
Nursing student in Abbotsford plans for career in critical care

Mina Shahsavar inspired during hospital stays as a child

The Canadian Forensic Health Corporation, made up of (left to right) Kirstin Simpson, Adrienne Fershau, Tiffany Kafka, Susan Short and Cole Bruce, are changing the game for the forensic nurse occupation. (Submitted)
Abbotsford nurses create Canadian Forensic Health Corporation

Tiffany Kafka, Susan Short, Kirstin Simpson, Cole Bruce and Adrienne Fershau teaching new generation

B.C. Labour Minister Harry Bains in the B.C. legislature, May 13, 2019. (Hansard TV)
VIDEO: B.C. to provide 3 days of sick pay for COVID-19 absences

Province will support employers on cost, labour minister says

New homes are built in a housing construction development in the west-end of Ottawa on Thursday, May 6, 2021. THE CANADIAN PRESS/Sean Kilpatrick
Budget’s foreign-homebuyers tax could bring in $509 million over 4 years, PBO says

Liberals are proposing a one per cent tax on vacant homes owned by foreign non-residents

A Canadian flag patch is shown on a soldier’s shoulder in Trenton, Ont., on Thursday, Oct. 16, 2014. The Canadian Forces says it has charged one of its members in the death of an army reservist from British Columbia during a training exercise at a military base in Alberta last year. THE CANADIAN PRESS/Lars Hagberg
Canadian Forces member charged in death of army reservist during training exercise

Cpl. Lars Callsen has been charged with one count of negligence

Health Minister Adrian Dix looks during a press conference in the rotunda at Legislature in Victoria, B.C., on Wednesday May 6, 2020. THE CANADIAN PRESS/Chad Hipolito
B.C. to use remaining AstraZeneca vaccine for 2nd doses

Health officials say the change is due to the limited availability of the vaccine

A youth plays basketball in an otherwise quiet court in Toronto on Saturday April 17, 2021. The Canadian Civil Liberties Association is urging the federal and provincial governments to fight COVID-19 pandemic by focusing on proven public health policy interventions including paid sick leave, and education rather than punitive enforcement measures. THE CANADIAN PRESS/Chris Young
Provinces issued more COVID-19 tickets during 2nd wave: CCLA report

‘A pandemic is a public health, not a public order, crisis,’ reads the report

Capt. Arpit Mahajan of the Canadian Forces Snowbirds - Snowbirds 2 - shows off his ‘Jenn Book’ dedicated to Capt. Jennifer Casey. Zoom screenshot
Homecoming for B.C.-raised Snowbirds pilot training in the province

Capt. Arpit Mahajan flies Snowbird 2 in his first year as a solo pilot with the team

BC Housing minister David Eby. (THE CANADIAN PRESS/Chad Hipolito)
Eby jabs back against Penticton mayor’s ad urging BC Premier to intervene in shelter dispute

Eby writes that Penticton’s ‘serious’ social issues won’t improve under leadership of the mayor

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

What3words was first created in the U.K. in 2013 and is credited to saving the lives of outdoor enthusiasts around the world. (Contributed)
‘This is a life saving tool’: App helps paramedics find capsized canoeists near Revelstoke

What3words pinpoints the person’s phone location to a three-meter range

Most Read