COVID-19 Update #85 for 6/2/2021

COVID-19 Vaccines
 
A pre-print draft of a 12,675 patient, British observational study described the effectiveness of COVID-19 vaccines against the B.1.617.2 (Indian) variant. The effectives of the Pfizer-BioNTech COVID-19 vaccine was estimated to be 87.9% after two doses and the AstraZeneca vaccine was estimated at 59.8% efficacy in a cohort of 1,054 patients with an infection with the B.1.617.2 variant.
 
The CDC provides advice on myocarditis and pericarditis in adolescents and young adults who received an mRNA COVID-19 vaccine. Most cases have occurred in male patients 16 and older and patients responded well to treatment. The CDC continues to recommend vaccination of all patients 12 years and older due to the greater risk for complications from COVID-19.
 
An analysis of patients with immune-mediated inflammatory diseases who were receiving immunomodulatory treatments found that use of methotrexate decreased the immune response from the Pfizer-BioNTech COVID-19 vaccine. Over 90% of patients that were receiving a TNF blocker achieved a robust antibody response compared to only 62.2% of patients that were receiving methotrexate that achieved an adequate response.
 
The FDA may not review additional COVID-19 vaccines for emergency use if the sponsoring company is not already in discussions with the FDA. Novavax, Medicago and Astra Zeneca have discussed approval with the FDA. Other vaccine developers would need to seek full authorization.
 
In a 2,260 patient, Phase III trial (NCT04368728), no cases of COVID-19 developed in patients immunized with the Pfizer-BioNTech COVID-19 vaccine compared to 16 cases in the placebo group for 100% efficacy in patients 12 to 15.
 
In a 77-day, 40,382 patient, Phase III trial (NCT04510207), efficacy was estimated to be 72.8% with Sinopharm’s WIV04 COVID-19 vaccine and 78.1% with the HB02 vaccine in healthy adults in the United Arab Emirates and Bahrain.
 
COVID-19 Antibodies
 
HHS has paused distribution of Lilly’s monoclonal antibody combination bamlanivimab and etesevimab in Illinois and Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington because the combined incidence of the P.1 variant (Brazil) and B.1.351 variant (South Africa) exceeds 10% of COVID-19 cases. In vitro data suggest that bamlanivimab and etesevimab administered together are not active against these variants. HHS recommended Regeneron’s REGN-COV2 a combination of casirivimab and imdevimab be used when a monoclonal antibody is needed in these states.
 
The FDA granted an Emergency Use Authorization (EUA) to sotrovimab (VIR-7831) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with COVID-19, who are at high risk for progression to a severe infection. Healthcare providers should review the Fact Sheet for information on the authorized use of casirivimab and imdevimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers.
 
COVID-19 Anti-inflammatories
 
In the 28-day, 146 patient, open-label, Phase III, STOIC trial (NCT04416399), 3% of patients treated with inhaled budesonide added to usual care required urgent care or hospitalization compared to 15% with usual care alone in outpatients with COVID-19. Clinical recovery was also one-day less with budesonide.
 
In the 30-day, 4,488 patient, Phase III, COLCORONA trial (NCT04322682), treatment with colchicine did not reduce hospitalizations or mortality compared to placebo in outpatients with COVID-19 diagnosed by PCR testing or clinical criteria, who were at least 40 years old and had at least one risk factor for more severe disease. Among the 4,159 patients with PCR confirmed infection there was a small benefit with colchicine with 4.6% of patients requiring hospitalization or dying compared to 6% with placebo.