The FDA adds new warning to Johnson & Johnson COVID-19 vaccine for rare side effect
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The FDA adds new warning to Johnson & Johnson COVID-19 vaccine for rare side effect
The US Food and Drug Administration will soon add a warning label to Johnson & Johnson COVID-19 vaccines after about 100 people out of 12.8 million vaccinated patients developed Guillain-Barré syndrome, a largely recoverable neurological condition, according to multiple reports. The Biden administration is expected to announce the new warning as early as Tuesday, according to The New York Times. Officials are still encouraging people to seek vaccination, as the possible side effects of vaccines are much less deadly than the effects of COVID-19.
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The FDA adds new warning to Johnson & Johnson COVID-19 vaccine for rare side effect
The New York Times
@nytimes
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17h
Breaking News: The FDA is planning to warn that the Johnson & Johnson coronavirus vaccine can increase the risk of a rare nerve condition known as Guillain-Barré syndrome.
F.D.A. Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine
Federal regulators found that the risk of developing the syndrome was low, but three to five times higher among Johnson & Johnson vaccine recipients than the general population.
nytimes.com
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"In a statement released Monday, the Centers for Disease Control and Prevention said the cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older." — The New York Times
The New York Times
@nytimes
·
17h
The regulators found the chances of developing the condition are low — officials have identified roughly 100 suspected cases — but the likelihood appears to be three to five times higher among J&J vaccine recipients than among the general U.S. population.
F.D.A. Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine
Federal regulators found that the risk of developing the syndrome was low, but three to five times higher among Johnson & Johnson vaccine recipients than the general population.
nytimes.com
Show this thread
"The Biden administration is expected to announce the new warning as early as Tuesday. European regulators may soon follow suit. No link has been found between Guillain-Barré syndrome and the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally authorized manufacturers. Those rely on a different technology." — The New York Times
The New York Times
@nytimes
·
17h
The FDA has concluded that the benefits of the vaccine in preventing severe disease or death from the coronavirus still strongly outweigh the risk, but it plans to include the warning in fact sheets about the drug for providers and patients.
F.D.A. Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine
Federal regulators found that the risk of developing the syndrome was low, but three to five times higher among Johnson & Johnson vaccine recipients than the general population.
nytimes.com
Show this thread
Reuters Health
@Reuters_Health
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14h
Johnson & Johnson in discussion with FDA regarding COVID-19 vaccine side effects
Johnson & Johnson in discussion with FDA regarding COVID-19 vaccine side effects
Johnson & Johnson (JNJ.N) said on Monday it was in discussions with the U.S. Food and Drug Administration about rare cases of a neurological disorder, Guillain-Barré syndrome, that have been...
reuters.com
More about Guillain-Barré and its link to the Johnson & Johnson vaccine
The FDA adds new warning to Johnson & Johnson COVID-19 vaccine for rare side effect
The FDA adds new warning to Johnson & Johnson COVID-19 vaccine for rare side effect
The US Food and Drug Administration will soon add a warning label to Johnson & Johnson COVID-19 vaccines after about 100 people out of 12.8 million vaccinated patients developed Guillain-Barré syndrome, a largely recoverable neurological condition, according to multiple reports. The Biden administration is expected to announce the new warning as early as Tuesday, according to The New York Times. Officials are still encouraging people to seek vaccination, as the possible side effects of vaccines are much less deadly than the effects of COVID-19.
Photo via @WebMDThe FDA adds new warning to Johnson & Johnson COVID-19 vaccine for rare side effect
Breaking News: The FDA is planning to warn that the Johnson & Johnson coronavirus vaccine can increase the risk of a rare nerve condition known as Guillain-Barré syndrome.
"In a statement released Monday, the Centers for Disease Control and Prevention said the cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older." — The New York Times
The regulators found the chances of developing the condition are low — officials have identified roughly 100 suspected cases — but the likelihood appears to be three to five times higher among J&J vaccine recipients than among the general U.S. population.
"The Biden administration is expected to announce the new warning as early as Tuesday. European regulators may soon follow suit. No link has been found between Guillain-Barré syndrome and the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally authorized manufacturers. Those rely on a different technology." — The New York Times
The FDA has concluded that the benefits of the vaccine in preventing severe disease or death from the coronavirus still strongly outweigh the risk, but it plans to include the warning in fact sheets about the drug for providers and patients.
Johnson & Johnson in discussion with FDA regarding COVID-19 vaccine side effects
More about Guillain-Barré and its link to the Johnson & Johnson vaccine
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