COVID-19 Update #103 for 10/7/2021

COVID-19 Vaccines
 
A 679 patient, British Phase IV trial found that a COVID-19 vaccine given with an influenza vaccine on the same day in different arms will not affect the immune response of either vaccine. Adverse events were similar in patients that received both vaccines on the same day and patients that received one of the vaccines three-weeks later. The Pfizer-BioNTech and AstraZeneca COVID-19 vaccines were used in the study.
 
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 10/26/2021 to discuss an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccines for children 5 through 11 years old.
 
COVID-19 Vaccine Booster doses
 
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 10/14/2021 to discuss an emergency use authorization (EUA) for the Moderna COVID-19 vaccines. On 10/15/2021, the committee will discuss an EUA for a booster dose of the Johnson & Johnson vaccine. On 10/15, VRBPAC will also discuss use of a different COVID-19 vaccine than a patient initially received, as a booster dose.
 
COVID-19 Antivirals
 
Merck announced interim results from 775 patients enrolled in the 29-day, 1,550 patient, Phase II/III, MOVe-OUT trial (NCT04575597), where 7.3% of patients treated with molnupiravir were hospitalized or died compared to 14.1% with placebo in outpatients with mild-to-moderate COVID-19 with at least one risk factor to progress to severe disease. Based on interim results from the MOVe-OUT study, Merck plans to file for an EUA and have 10 million doses available by the end of 2021.
 
COVID-19 Antibodies
 
In the 29-day, 1,035 patent, Phase III, BLAZE-1 trial (NCT04427501), 2.1% of patients treated with bamlanivimab 2800 mg plus etesevimab 2800 mg experienced the primary endpoint of COVID-19 related hospitalizations or death compared to 7% that received placebo in patients with mild to moderate COVID-19 who were at high risk for progressing to severe COVID-19 and/or hospitalization. No deaths occurred in the combination treatment group compared to ten deaths in the placebo group.
 
In the 21-day, 2,011 patient, Phase III, REMAP-CAP trial (NCT02735707), treatment with convalescent plasma did not improve organ support–free days or mortality compared to no convalescent plasma in critically ill adults with confirmed COVID-19.
 
AstraZeneca has requested an emergency use authorization (EUA) for, AZD7442 its monoclonal antibody combination of tixagevimab and cilgavimab, as prophylaxis of COVID-19.