US Restricts Use of J&J's COVID Shot

2022-05-07

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1
  • American health officials have placed strong restrictions on the use of Johnson & Johnson's COVID-19 vaccine.
  • 2
  • The treatment carries a risk of rare but serious blood clots.
  • 3
  • The United States Food and Drug Administration, or FDA, said the J&J shot should only be given to adults who cannot or will not accept a different COVID vaccine.
  • 4
  • U.S. health officials have suggested for months that Americans get Pfizer-BioNTech or Moderna shots instead of J&J's vaccine.
  • 5
  • FDA vaccine chief Dr. Peter Marks said the agency acted after examining the data on the risk of life-threatening blood clots.
  • 6
  • The FDA found that the risk is limited to J&J's shot in the first two weeks after vaccination.
  • 7
  • "So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn't an issue," Marks said.
  • 8
  • "But," he added, "compared to no vaccine-- this is still a better option."
  • 9
  • The FDA approved J&J's shot in February last year for adults.
  • 10
  • The vaccine was considered an important tool in fighting the pandemic because it required only one shot.
  • 11
  • But the single-shot vaccine proved less effective than those from Pfizer and Moderna.
  • 12
  • In December, the U.S. Centers for Disease Control and Prevention suggested Moderna and Pfizer shots over J&J's because of its safety issues.
  • 13
  • As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that resulted in death.
  • 14
  • That amounts to 3.23 blood clot cases per 1 million J&J shots.
  • 15
  • The problem is more common in women under 50, where the death rate was around 1 in one million shots, Marks said.
  • 16
  • The J&J COVID vaccine will carry a warning about possible "long-term and debilitating health consequences" of the side effect.
  • 17
  • Under the new FDA orders, J&J's vaccine could still be given to people who had bad reactions to the other COVID vaccines.
  • 18
  • J&J's shot could also be given to people who refuse to receive the mRNA vaccines from Pfizer-BioNTech and Moderna.
  • 19
  • A J&J spokesman said in an emailed statement: "Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults when compared with no vaccine."
  • 20
  • The blood clot problems were first reported last spring, with the J&J shot in the U.S. and with an AstraZeneca vaccine used elsewhere.
  • 21
  • At that time, U.S. health officials decided the benefit of J&J's vaccine outweighed what was considered a very rare risk.
  • 22
  • Symptoms of the rare blood clots include severe headaches, a week or two after the J&J vaccination, as well as stomach pain and nausea.
  • 23
  • Pfizer and Moderna have provided a large majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies' two-shot vaccines while less than 17 million Americans got the J&J shot.
  • 24
  • I'm Caty Weaver.
  • 1
  • American health officials have placed strong restrictions on the use of Johnson & Johnson's COVID-19 vaccine. The treatment carries a risk of rare but serious blood clots.
  • 2
  • The United States Food and Drug Administration, or FDA, said the J&J shot should only be given to adults who cannot or will not accept a different COVID vaccine. U.S. health officials have suggested for months that Americans get Pfizer-BioNTech or Moderna shots instead of J&J's vaccine.
  • 3
  • FDA vaccine chief Dr. Peter Marks said the agency acted after examining the data on the risk of life-threatening blood clots. The FDA found that the risk is limited to J&J's shot in the first two weeks after vaccination.
  • 4
  • "So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn't an issue," Marks said.
  • 5
  • "But," he added, "compared to no vaccine-- this is still a better option."
  • 6
  • The FDA approved J&J's shot in February last year for adults. The vaccine was considered an important tool in fighting the pandemic because it required only one shot. But the single-shot vaccine proved less effective than those from Pfizer and Moderna.
  • 7
  • In December, the U.S. Centers for Disease Control and Prevention suggested Moderna and Pfizer shots over J&J's because of its safety issues.
  • 8
  • As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that resulted in death. That amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was around 1 in one million shots, Marks said.
  • 9
  • The J&J COVID vaccine will carry a warning about possible "long-term and debilitating health consequences" of the side effect.
  • 10
  • Under the new FDA orders, J&J's vaccine could still be given to people who had bad reactions to the other COVID vaccines. J&J's shot could also be given to people who refuse to receive the mRNA vaccines from Pfizer-BioNTech and Moderna.
  • 11
  • A J&J spokesman said in an emailed statement: "Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults when compared with no vaccine."
  • 12
  • The blood clot problems were first reported last spring, with the J&J shot in the U.S. and with an AstraZeneca vaccine used elsewhere. At that time, U.S. health officials decided the benefit of J&J's vaccine outweighed what was considered a very rare risk.
  • 13
  • Symptoms of the rare blood clots include severe headaches, a week or two after the J&J vaccination, as well as stomach pain and nausea.
  • 14
  • Pfizer and Moderna have provided a large majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies' two-shot vaccines while less than 17 million Americans got the J&J shot.
  • 15
  • I'm Caty Weaver.
  • 16
  • The Associated Press reported this story. Hai Do adapted the story for Learning English.
  • 17
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  • 18
  • Words in This Story
  • 19
  • option - n. opportunity or ability to choose something
  • 20
  • debilitating - adj. making someone very weak
  • 21
  • profile - n. a representation of information relating to something
  • 22
  • benefit - n. good result or effect