FDA Restricts J&J Covid-19 Shot Due to Risk of Blood Clots
May 5, 2022 20:21:03 GMT -5
Post by maybetoday on May 5, 2022 20:21:03 GMT -5
FDA Restricts Johnson & Johnson Covid-19 Shot Due to Risk of Blood Clots
By Jim Hoft
Published May 5, 2022 at 6:04pm
The U.S. Food and Drug Administration announced on Thursday that it would limit who can receive the Johnson & Johnson/Janssen Covid-19 shot due to the serious risk of blood clots.
The FDA announced that it would limit the authorized use of J&J Covid-19 shot to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
The change is being made after the investigation revealed that there is a risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets following administration of the Janssen Covid-19 shot.
“In making the determination to limit the authorized use of the Janssen COVID-19 Vaccine, the agency considered that reporting rates of TTS (thrombocytopenia syndrome) and TTS deaths following administration of the Janssen COVID-19 Vaccine are not appreciably lower than previously reported. Furthermore, the factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown,” according to the news release.
“The FDA also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate. The agency also considered the availability of alternative authorized and approved COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS.”
The FDA also confirmed that individuals experienced an anaphylactic reaction after taking an mRNA Covid-19 shot.
Continued at link
By Jim Hoft
Published May 5, 2022 at 6:04pm
The U.S. Food and Drug Administration announced on Thursday that it would limit who can receive the Johnson & Johnson/Janssen Covid-19 shot due to the serious risk of blood clots.
The FDA announced that it would limit the authorized use of J&J Covid-19 shot to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
The change is being made after the investigation revealed that there is a risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets following administration of the Janssen Covid-19 shot.
“In making the determination to limit the authorized use of the Janssen COVID-19 Vaccine, the agency considered that reporting rates of TTS (thrombocytopenia syndrome) and TTS deaths following administration of the Janssen COVID-19 Vaccine are not appreciably lower than previously reported. Furthermore, the factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown,” according to the news release.
“The FDA also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate. The agency also considered the availability of alternative authorized and approved COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS.”
The FDA also confirmed that individuals experienced an anaphylactic reaction after taking an mRNA Covid-19 shot.
Continued at link
