The FDA limited the authorized use of the J&J COVID-19 Vaccine to when mRNA vaccines are not accessible or clinically appropriate or for patients who choose to receive the vaccine and would otherwise not receive a COVID-19 vaccination. The FDA considers the known and potential benefits of the vaccine to outweigh the known and potential risks of receiving it. The restriction was due to the rare occurrence of thrombosis with thrombocytopenia syndrome (TTS). TTS is estimated to have an incidence of 3.23 cases per million vaccinations and 0.48 deaths per million. Risk factors for TTS associated with the J&J vaccine have not been identified and prompt diagnosis and treatment of TTS may not prevent deterioration of the condition.
A pre-print draft of an Israeli analysis examining SARS-CoV-2 antibodies during pregnancy, found antibodies levels were too low to provide protection by delivery in 34.6% of patients who experienced a first trimester infection and 9.1% who experienced a second trimester infection. A single dose of the Pfizer COVID-19 vaccine induced protective antibody titers for both mother and infant with modest adverse effects.
The FDA has provided additional information about use of Paxlovid in a new posting. The FDA addresses reports of rare infection recurrences after completing a course of the drug combination. A re-analysis of Paxlovid data found that while 1-2% of patients may test positive after treatment, it was unclear whether this was a drug effect, because the same results were seen in placebo patients (tested negative, then tested positive). However, the FDA stated there is no evidence to support use of the drug beyond five days.
COVID-19 Convalescent Plasma
In a 28-day, 1,181 patient, Phase II trial (NCT04373460), 2.9% of patients treated with high titer convalescent plasma, within nine day of symptom onset, were hospitalized for COVID-19 compared to 6.3% with placebo in outpatients with recent onset of COVID-19. Over 80% of patents were unvaccinated.
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