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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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.
Based on the historical time between Phase III results and filing announcements, AstraZeneca is way behind the pace. The firm will soon have waited longer to submit its EUA to the US FDA than the three already-authorized products waited combined.