US authorities want to pause Johnson & Johnson vaccine rollout due to extremely rare blood clots

Business Insider US
A nurse loads a syringe with a dose of Johnson & Johnson's COVID-19 vaccine on March 9, 2021 in Athens, Ohio.
  • The US health authority has asked for a pause in the roll-out of Johnson & Johnson's Covid-19 vaccine,
  • This after six women - out of seven million Americans who have received the Johnson & Johnson vaccine - developed clots.
  • The clots are extremely rare, said the FDA.
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The US Food and Drug Administration on Tuesday urged local health authorities to immediately pause the use of the Johnson & Johnson's single-dose Covid-19 vaccine, citing concerns over rare blood clots forming in vaccinated people.

Six women who had received the vaccine had developed the clots - out of the seven million Americans who have received the Johnson & Johnson jab. 

All six recipients were women between the ages of 18 and 48, according to The New York Times. One of the women died. 

The FDA said the step was taken “out of an abundance of caution.”

READ | Vaccine side effects are not uncommon - so, with J&J's jab: What are they, who gets them, and why? | Health24

“Right now, these adverse events appear to be extremely rare,” it said in a statement. Recipients who “develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider,” the FDA said.

US health authorities are concerned that doctors may not be trained to look for the rare disorder if recipients of the vaccine develop symptoms of it, The New York Times reported.

On Tuesday, TimesLive reported that there have been no cases of blood clots among the almost 300,000 health-workers already vaccinated with the Johnson & Johnson jab in South Africa.

South Africa has ordered more than 30 million of these vaccines, which are filled at an Aspen plant in Gqeberha in the Eastern Cape.

Europe had just started receiving doses of the Johnson & Johnson vaccine when the US announced it would be suspending its use to investigate cases of blood clots.

J&J is aiming to deliver 55 million doses of the vaccine to the 27 EU member states, plus Norway and Iceland, by the end of June, EU industry commissioner Thierry Breton has said.

For the following quarter, the target is 120 million doses. It is a single-shot vaccine, so requires half as many doses as the Pfizer, Moderna, or AstraZeneca shots.

Here is the situation in Europe with Johnson & Johnson:

  • Sweden said Tuesday it would review plans to use the vaccine in light of the US announcement.
  • The Dutch medical regulator said it would continue its rollout, arguing that the benefits outweigh the risks.
  • France received its first doses of the Johnson &Johnson vaccine on Monday, and will be offering the vaccine to everyone over the age of 55, France 24 reported on Monday.
  • Germany is expecting 275,000 doses this week, Health Minister Jens Spahn has said.
  • Spain expects 300,000 Johnson & Johnson shots on Wednesday, and will first administer the vaccines to those aged 70 to 79, DW reported.
  • Belgium is expected to receive 36,000 doses in the first shipment.
  • Ireland should receive 605,000 doses by the end of June.
  • The US CDC and FDA both recommended immediate suspension of the use of the vaccine while 6 reports of blood clots were being investigated. So far 6.8 million doses of J&J vaccine have been used in the US.

The European Medicines Agency (EMA) announced on Friday that it was closely reviewing the US cases.

Johnson & Johnson had initially planned to deliver its first doses in Europe in early April but faced production issues, Reuters reported. The vaccine was approved for use in Europe on March 11.

Australia, by contrast, has said that it would not be ordering doses of the Johnson & Johnson vaccine, because of its similarities to the AstraZeneca vaccine.

On Wednesday, the EMA listed unusual blood clots as a adverse side effect of the vaccine.

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