J&J COVID-19 Vaccine Pause Expected To Be Brief, But Subsequent Use May Be Restricted
CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.
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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.
Similarities to AstraZeneca blood clots are clear, but more research needed before any ‘class effect’ conclusions can be drawn.
Coronavirus Notebook: New EMA Review To Contextualize Blood Clot Risk From AZ Jab, EU Gets Earlier Access To More Pfizer Vaccines
Denmark has stopped using the AstraZeneca vaccine completely, while the Canadian regulator is not recommending restrictions in any specific populations. Can a new EMA review provide better context to guide the vaccine’s use in different age groups and gender?