COVID-19 Vaccines: With Narrowed Authorization For Janssen, US FDA Catches Up To CDC
Citing risk of thrombosis with thrombocytopenia syndrome, FDA restricts adenovirus-based vaccine to adults for whom other vaccines are not accessible or clinically appropriate, or who would not otherwise get a vaccine; action comes almost five months after CDC decided to preferentially favor the mRNA vaccines from Pfizer/BioNTech and Moderna.
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Johnson & Johnson reported disappointing Q1 sales for its COVID-19 vaccine but called the Carvykti launch solid and discussed plans for further diversification of its multiple myeloma portfolio.
Advisory committee says that clinical guidelines and other communications must include strong belief mRNA vaccines should be given over Janssen’s adenovirus vaccine.
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.