With J&J’s COVID Vaccine Pause Now Lifted, The Question Is How Well The System Worked
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.
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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.
Advisory committee says that clinical guidelines and other communications must include strong belief mRNA vaccines should be given over Janssen’s adenovirus vaccine.
US government does not have an adequate system to monitor vaccine safety in real time, Nicole Lurie, former assistant secretary for emergency preparedness says. Low-income countries sometimes do not receive same COVID product that FDA reviewed, a former agency official notes.