FDA Restricts Use Of J&J Covid Vaccine
After review of rare cases of blood clots, the FDA limits the parameters for who can get Johnson & Johnson's one-dose shot to adults who cannot get either of the approved mRNA covid vaccines.
Politico:
FDA Dramatically Narrows Use Of Johnson & Johnson Covid-19 Vaccine
The Food and Drug Administration has restricted the use of the Johnson & Johnson Covid-19 vaccine to adults who are unable or unwilling to get the Pfizer-BioNTech or Moderna mRNA shots. The decision comes after the agency completed an updated risk analysis of developing thrombosis with thrombocytopenia syndrome, or TTS, a rare and possibly fatal combination of blood clots and low platelet counts one to two weeks after receiving the vaccine, the agency said Thursday. (Foley and Gardner, 5/5)
Stat:
FDA Limits Use Of Johnson & Johnson's Covid-19 Vaccine
Peter Marks, the FDA’s vaccines lead, told STAT the agency reached its decision after a recent review of the data on the vaccine revealed another person in this country had died after receiving it — the ninth such death — in the first quarter of the year. The vaccine is made by J&J’s vaccines division, Janssen. (Branswell, 5/5)
AP:
FDA Restricts J&J's COVID-19 Vaccine Due To Blood Clot Risk
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. U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine. FDA’s vaccine chief Dr. Peter Marks said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine. ... The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.” (Perrone and Neergaard, 5/6)
Bloomberg:
J&J’s Covid Shot Restricted By FDA On Rare Clotting Disorder
Uptake of the J&J vaccine has paled in comparison to those made by Pfizer Inc. and Moderna Inc., which require two doses for a full regimen. Hundreds of millions of their messenger RNA shots have been administered. While some 18.7 million doses of J&J’s vaccine have been administered to U.S. adults, according to the Centers for Disease Control and Prevention, almost 31 million doses have been delivered to vaccine sites, suggesting a surplus of unused shots. The agency decided to limit the authorized use of J&J’s shot after conducting an investigation and analysis of reported cases of blood clots in combination with low levels of blood platelets, known as thrombosis with thrombocytopenia syndrome, or TTS, that occurred one to two weeks following administration of the shot. (Griffin, 5/5)
The New York Times:
The F.D.A. Further Limits The Use Of Johnson & Johnson’s Covid Vaccine.
The F.D.A. said that weighing the risks of Johnson & Johnson’s vaccine against the benefits, it had decided to limit its use to adults who cannot access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be people who experienced an extreme allergic reaction to the other two vaccines, the agency said.It said the vaccine could also be given to adults who “would otherwise not receive a Covid-19 vaccine.” (LaFraniere, 5/6)
