The FDA approved a booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines for all patients 18 and older on 11/18/2021. On 11/19/2021, the CDC recommended booster doses of both vaccines for the same group of patients. All patients have already been approved to receive a booster of the J&J vaccine.
Pfizer and BioNTech announced that follow-up data from their COVID-19 vaccine teen study (NCT04368728) demonstrated 100% efficacy from seven days after the second dose through four months.
A Norwegian case–control study examined first-trimester pregnancies in 13,956 women from registry data and found no evidence of an increased risk for early pregnancy loss after Covid-19 vaccination.
In the 28-day, 2,052 patient, Phase III, PREPARE-IT 2 trial (NCT04460651), treatment with icosapent ethyl did not reduce hospitalization or death compared to placebo (13.69% vs 11.16%) in nonhospitalized Argentinian COVID-19 patients.
AZ announced that after six months 4,991 patients enrolled in the PROVENT trial, no cases of severe COVID-19 or COVID-19-related death occurred in patients that received AZD7442 compared to five cases of severe COVID-19 and two COVID-related deaths with placebo.
In the 15-day, 511 patient, Phase III, C3PO trial (NCT04355767 treatment with convalescent plasma did not reduce emergency treatment, hospitalization or death in high-risk outpatients with COVID-19.
In the 29-day, 583 patient, Phase III, COMET-ICE trial (NCT04545060), 1% of patients treated with sotrovimab
were hospitalized or died compared to placebo in outpatients with COVID-19 who were at high risk of progression to severe disease.
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.
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.
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.
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.
Pfizer and BioNTech COVID-19 vaccine approved for use in children 5 to 11 years of age.
Researchers analyzed historical and current data from Olmsted County, Minnesota and found the incidence of cerebral venous sinus thrombosis (CVST) had increased in females who received the J&J COVID-19 vaccine. The highest incidence of CVST was in women 40-49, followed by women aged 30 to 39 years.
CDC analysts compared the outcomes of 20,101 fully vaccinated immunocompromised adults to 69,116 fully vaccinated immunocompetent adults and found vaccine effectiveness to prevent COVID-19 related hospitalizations to be 77% for immunocompromised adults compared to 90% for immunocompetent adults. This decrease in effectiveness was present regardless of the type of vaccine used, patient’s geographic location, prevalence of the Delta variant or underlying cause for the immunocompromised state.
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