1. ACIP votes to halt the pause on J&J vaccine as previously approved with special warning language in the EUA regarding clots in women <50.
2. Syndrome will now be referred to as TTS. Thrombosis with thrombocytopenia Syndrome. Unusual, rare and potentially dangerous cerebral venous sinus clot with low platelets
3. 10-15 cases per million doses in women average age 35. Severe headache most common presenting symptom. Detect and treat early with IVIG and non-heparin anti-coagulant. Median onset is 10 d following vaccine (5-24 days later). So don’t worry if your vaccine was > a month ago.
For every 1M people vaccinated with the J&J vaccine we avert 2000 deaths & 6000 hospitalized with possible 2 TTS cases.
5. CVST alone is seen in COVID disease at about 6 cases per million infections. CVST + low plts in Covid disease is rare.
6. No ACIP voting or non-member advocated for the option of “recommendations against the use in all persons”. Strong support to reinstate the J & J vaccine as the benefit to prevent deaths, disability from COVID disease outweighed the risk.
7. Discussion was around language to alert clinicians and the public of rare but serious TTS in women <50 and will go into EUA, provider education, clinical COCA calls, MMWR next week etc with note that vaccine options are available.
8. I am honored to be a liaison (non-voting) member of #ACIP representing @NAPNAP & could not be more proud of the US Vaccine Safety program today. The pause was needed, but brief. Data brought to us to consider was thoroughly presented & transparently discussed for all to hear.
9. My comments were around urgency to get J & J back due to its effectiveness against rising variants in US & globally, that clinicians will inform of risks/benefits, public will be more aware with clear communications.
End. The ACIP discussion was a live, real-time scientific method & PH master class with global transparency bar none. My hope is in the long run it increases vaccine confidence in the vaccine approval & safety monitoring process. #CovidVaccine #VaccinesWork
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