The FDA narrowed its use authorization for Johnson & Johnson’s single-dose COVID-19 vaccine due to risks of severe blood clotting, a move that comes months after an initial warning from health officials.
The vaccine, produced by J&J subsidiary Janssen, should only be administered when an mRNA vaccine from Pfizer-BioNTech or Moderna is unavailable due to the risk of severe blood clotting known as thrombosis with thrombocytopenia syndrome, or TTS, the FDA announced Thursday.“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community.
Public health officials have been surveilling cases of the clotting disorder after receipt of the single-dose vaccine since spring 2021, soon after it was granted an emergency use authorization for adults 18 and older. Administration of the shots was placed on pause in April 2021 over concerns about cases of thrombosis in a handful of people.
The pause was lifted later that month. In December, the Centers for Disease Control and Prevention, which makes recommendations for or against FDA authorization, discouraged the use of the vaccine if an mRNA alternative is available. The FDA’s decision Thursday solidified the CDC’s earlier recommendation.
“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” Marks said. “We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.
Österreich Neuesten Nachrichten, Österreich Schlagzeilen
Similar News:Sie können auch ähnliche Nachrichten wie diese lesen, die wir aus anderen Nachrichtenquellen gesammelt haben.
Annual COVID-19 shot could be necessary, FDA officials sayWe may need to get a COVID-19 vaccine every year, the same way we do with the flu shot.
Weiterlesen »
FDA restricts J&J's COVID-19 vaccine due to blood clot riskWASHINGTON (AP) — U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to a rare but serious risk of blood clots. The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J's vaccine.
Weiterlesen »
FDA restricts Johnson & Johnson's COVID-19 vaccine due to rare but serious risk of blood clotsU.S. regulators on Thursday strictly limited who can receive Johnson & Johnson's COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.
Weiterlesen »
FDA puts strict limits on Johnson & Johnson Covid-19 vaccineThe US Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to people 18 and older for whom other vaccines aren't appropriate or accessible and those who opt for J&J because they wouldn't otherwise get vaccinated.
Weiterlesen »
FDA restricts Johnson & Johnson’s COVID-19 vaccine due to blood clot riskU.S. regulators have strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to a rare but serious risk of blood clots.
Weiterlesen »
FDA restricts Johnson & Johnson's COVID-19 vaccine due to rare but serious risk of blood clotsBREAKING NEWS: U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson's COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.
Weiterlesen »