COVID-19 Update #109 for 11/10/2021

​COVID-19 Vaccines
 
In a final analysis of the 30,451 patient, Phase III COVE trial (NCT04470427), vaccine efficacy was 93.2% to prevent COVID-19 and 98.2% to prevent severe disease with the Moderna COVID-19 vaccine.
 
In a 2,268 patient, Phase II/III trial (NCT04816643), two 10 mcg doses of the Pfizer-BioNTech COVID-19 vaccine given 21 days apart, to children 5 to 11 years, produced antibody titers comparable to the levels seen with two 30 mcg adult doses in adolescents and young adults age 16 to 25 years. Vaccine effectiveness was 90.7% one month after the second injection.
 
COVID-19 Antivirals
 
Pfizer announced interim data from 1,219 patients enrolled in the 28-day, 3,000 patient, Phase III, EPIC-HR trial (NCT04960202), where 0.8% of patients treated with the combination of PF-07321332 and ritonavir were hospitalized or died compared to 7% with placebo in unvaccinated patients with mild-to-moderate COVID-19 at risk to progress to severe illness. Due to the 89% reduction in COVID-19-related hospitalization or death, the FDA agreed with Data Monitoring Committee, the trial could be stopped. Pfizer plans to submit the data as part of a rolling NDA.
 
The United Kingdom Medicines and Healthcare products Regulatory Agency approved molnupiravir for the treatment of mild-to-moderate COVID-19 in adults at risk to develop severe illness.
 
COVID-19 Anti-inflammatories
 
In the seven-day, 203 patient, Phase II, CONTAIN trial (NCT04435795), treatment with inhaled and intranasal ciclesonide did not improve symptom resolution compared to placebo in low-risk, Canadian outpatients with COVID-19.
 
COVID-19 Antibodies
 
In a long term extension of the Phase III, PREVENTION trial, patients that received REGEN-COV had an 81.6% reduction in developing symptomatic COVID-19 compared to placebo after eight months.