COVID-19 Update #77 for 4/9/2021

COVID-19 Vaccines 
 
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.
 
SARS-CoV-2 Variants
 

• Israeli researchers administered a single dose of the Pfizer-BioNTech COVID-19 vaccine to six patients that had recovered from a COVID-19 infection with the original Wuhan virus. Antibodies taken after recovery, but before vaccination were able to neutralize the original virus and the B.1.1.7 (U.K.) and P.1 (Brazil) variants, but not the B.1.351 (South African) variant. After vaccination, antibody titers were greatly increased and neutralized all strains of the virus.

 

• South African researchers tested the neutralizing activity of COVID-19 antibodies from 89 patients that had recovered from an infection with the B.1.351 (South African) variant. The antibodies were effective against both B.1.351 and P.1 (Brazil) variants. The researchers recommend that vaccines targeted at B.1.351 may offer cross-reactive neutralizing antibody responses to other known SARS-CoV-2 strains.

 

• Researchers from two vaccine manufacturers, Duke University and NIAID tested the neutralizing activity of antibodies from 14 recovered patients, 26 patients that received the Moderna COVID-19 vaccine and 23 patients that received the experimental Novavax COVID-19 vaccine. The researchers found that while neutralizing activity was modestly lower for the B.1.429 (California) variant, the activity was strong enough to neutralize the variant. The large magnitude of resistance observed with the B.1.351 (South African) variant was cause for concern.

COVID-19 Anti-Inflammatories
 
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.