The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found the AstraZeneca COVID-19 vaccine causes a rare adverse event of thrombosis in combination with thrombocytopenia. PRAC reviewed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis and concluded the thrombi are most likely to occur within the first two weeks after administration in women younger than 60. PRAC advises the benefits of the vaccine continue to outweigh the risks and the vaccine is effective at preventing COVID-19 and reducing hospitalizations and deaths. The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has recommended that while prompt vaccination with the AZ vaccine outweigh the risk of thrombosis, patients under 30 should be offered an alternative vaccine. The World Health Organization has stated that a causal relationship between the rare event of thrombosis in combination with thrombocytopenia had not been proven, but surveillance and investigation should be continued.
Researchers from NIAID, Emory University, Moderna and others report that antibody titers remained high in 33 patients 200 days after receiving the second Moderna COVID-19 vaccine.
Lilly announced that in the 1,525 patient, Phase III, COV-BARRIER trial (NCT04421027), adding baricitinib to standard of care did not decrease the need for ventilation (non-invasive or mechanical) or death compared to standard of care alone in hospitalized patients with COVID-19.