FDA Limits , Johnson & Johnson’s COVID-19 Vaccine , Emergency Use Authorization.
CNN reports that on May 5, the U.S. Food and Drug Administration (FDA)... .
... announced the company's vaccine will now only be available to those who are 18 and older... ... announced the company's vaccine will now only be available to those who are 18 and older... ... who can't receive other COVID-19 vaccines or who choose the one-shot inoculation because they wouldn't get vaccinated otherwise.
The change is due to the rare risk of thrombosis with thrombocytopenia syndrome (TTS), a serious clotting condition.
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, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, via statement.
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, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, via statement.
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.
, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, via statement.
Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, via statement.
CNN reports that the updated authorization applies to booster shots as well.
The FDA maintains that the benefits of J&J's vaccine outweigh the risks , for people who are allergic to or can't access mRNA COVID vaccines or who would remain unvaccinated without it.
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According to the CDC, as of May 5, over 18.7 million doses of J&J's COVID vaccine have been administered in America
