Rejecting FDA Advice, ACIP Defers J&J COVID Vaccine Blood Clot Decision Until It Gets More Data
US FDA suggested potential risk could be managed though a change in the fact sheet, but CDC committee wants more data, which could come within a week or so, to get a better sense of the frequency of the adverse events.
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Unlike its response to incidents of blood clots with J&J’s vaccine, the US FDA is not calling for a pause in its administration following reports of about 100 cases of Guillain-Barré syndrome. CDC advisory panel is to discuss the issue at an upcoming meeting.
Number of deaths and ICU admissions that may have been prevented without the pause is ‘striking,’ CDC advisory committee member says; ACIP votes to reaffirm use of J&J’s vaccine in persons 18 and older based on positive risk-benefit analysis and reports of only nine additional cases of TTS.
US FDA’s Search For Class-Wide Vaccine Blood-Clot Effect Makes Scientific Sense, But Raises Questions
Several adenovirus vaccine developers say the products cannot be compared, potentially complicating the US FDA and CDC’s decision on ending the recommended pause in the use of Janssen’s vaccine.