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

These Douglas fir logs were recently found poached on Stoney Hill in North Cowichan’s forest reserve. (Larry Pynn/sixmountains.ca)
OPINION: Cowichan Valley’s Six Mountains Forest: War or Peace—The Choice is Ours

Icel Dobel writes in favour of protecting Cowichan Valley forests

North Cedar Volunteer Fire Department crews at the scene of a single-vehicle crash on Barnes Road near Holden Corso Road in Cedar. (Chris Bush/News Bulletin)
Jeep rolls over on wet afternoon in Cedar, occupants OK

Incident happened Monday, May 17, on Barnes Road

The former St. Joseph’s School converted to the St. Joseph’s Art Studios in 2019. (File photo by Don Bodger)
Former Chemainus St. Joseph’s School site sold to addictions recovery group

Diocese stresses the importance of a community outreach option in its decision

The bow-legged bear was seen roaming 2nd Avenue on Friday, May 7 and again in Brown Drive Park on May 13. (Submitted photo)
Bow-legged Ladysmith bear euthanized after vet examination

CO Stuart Bates said the bear had obvious health issues

The Arts Council of Ladysmith and District is working with several Vancouver Island art councils on the Digitial Innovation Group to improve digital skills for Island artists. (Submitted photo)
Digital Innovation Group supports digital literacy for Island artists

The goal is to leverage digital skills to promote Vancouver Island as an ‘arts powerhouse’

North Cedar Volunteer Fire Department crews at the scene of a single-vehicle crash on Barnes Road near Holden Corso Road in Cedar. (Chris Bush/News Bulletin)
Jeep rolls over on wet afternoon in Cedar, occupants OK

Incident happened Monday, May 17, on Barnes Road

Relief is coming for B.C.’s struggling tourism sector. (NEWS file photo)
B.C. officials set to announce more support for tourism sector hit hard by pandemic

Non-essential travel is restricted between three regional zones in B.C. until at least May 24

This image released by Universal Pictures shows Nathalie Emmanuel, left, and Vin Diesel in a scene from "F9." (Giles Keyte/Universal Pictures via AP)
The blockbuster movie is making a comeback this summer

Excitement in the industry is growing again for a return to a big-screen normal

More “strings of lights” were seen on May 15, 2021, in night sky over Vancouver Island. (File photo)
Sicamous RCMP Sgt. Murray McNeil and Cpl. Wade Fisher present seven-year-old Cody Krabbendam of Ranchero with an award for bravery on July 22, 2020. (Contributed)
7-year old Shuswap boy receives medal of bravery for rescuing child at beach

Last summer Cody Krabbendam jumped into the lake to save another boy from drowning

B.C. Health Minister Adrian Dix and provincial health officer Dr. Bonnie Henry update the province’s COVID-19 vaccine program, May 10, 2021. (B.C. government)
B.C.’s COVID-19 infection rate stays below 500 a day over weekend

14 more deaths, down to 350 in hospital as of Monday

Royal Bay Secondary School’s rainbow crosswalk was vandalized shortly after being painted but by Monday, coincidentally the International Day Against Homophobia, Transphobia and Biphobia, the crosswalk had been cleaned up and students had surrounded it with chalk messages of support and celebration. (Zoe Ducklow/News Staff)
B.C. high’s school’s pride crosswalk restored following ‘hateful’ graffiti attack

Hate terms, racial slur, phallic images spray-painted at Greater Victoria high school

Terrance Mack would have celebrated his 34th birthday on May 13, 2021. Mack’s family has identified him as the victim of a homicide in an apartment on Third Avenue in Port Alberni sometime in April. (SUBMITTED PHOTO)
Family identifies Ucluelet man as victim of Vancouver Island homicide

Terrance Mack being remembered as ‘kind, gentle’ man

Nathan Zuk had left his mother’s residence in Whaletown on Cortes Island in mid-December 2020 in a 14’ skiff rowboat and headed to an unknown location near the Pryce Channel, Deer passage, or Toba Inlet. Photo courtesy RCMP
RCMP need help finding man who set off from Cortes Island in 14-foot rowboat

Nathan Zuk left in December, may have been last seen in Toba Inlet approximately three weeks ago

Most Read