Pfizer and BioNTech are evaluating BNT162b2 in a Pfizer funded, 44,000 patient, Phase II/III trial (NCT04368728) BNT162b2 will be administered as two 30 mcg immunizations given 21-days apart. The trial was expanded from its original 30,000 patients, in September 2020, to allow the vaccine to be tested in a larger more diverse population, including adolescents as young as 16 years of age and people with HIV, Hepatitis C, and Hepatitis B. Pfizer announced that as of 11/9/2020, 43,538 patients had been enrolled in the Phase III trial with 42% overall having diverse backgrounds. Interim data, from an analysis by the independent Data Monitoring Committee after 94 cases of COVID-19 developed in the population, found the vaccine to be 90% effective in preventing COVID-19. A final analysis of the vaccine’s efficacy is planned when 164 confirmed COVID-19 cases have accrued in the trial population. Pfizer estimates that two months of safety data will be available in the third week of November. If no safety issues are identified, Pfizer and BioNtech will request an emergency use authorization (EUA) and have 50 million vaccine doses available in 2020 and up to 1.3 billion doses in 2021. Pfizer also announced unblinded, interim data in September 2020, suggesting the most common adverse events with BNT162b2 are fatigue, headache, diarrhea, muscle pain, joint pain and chills. Adverse effects have been mild to moderate.
COVID-19 Monoclonal Antibodies
The FDA approved an Emergency Use Authorization (EUA) for bamlanivimab on 11/9/2020 for the treatment of patients, 12 and older with mild or moderate COVID-19, who are at high risk of progressing to a severe infection and who do not require hospitalization. Bamlanivimab is administered as a one-time intravenous dose. The FDA advised against using the drug in hospitalized patients, because a benefit has not been demonstrated.
Bamlanivimab will be distributed through an allocation program through AmerisourceBergen. The U.S. government has purchased 300,000 doses that will be distributed at no charge.
Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab 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 (English) (Spanish).
Novartis announced interim data from the 29-day, 454 patient, CAN-COVID trial (NCT04362813), where treatment with canakinumab did not decrease mortality without the need for invasive mechanical ventilation, compared with placebo in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome.
Humanigen announced interim data from 257 patients enrolled in a 28-day, 515 patient, Phase III trial, where treatment with lenzilumab reduced time to recovery compared to placebo in hospitalized COVID-19 patients not requiring ventilation. To improve the chance of the patient population experiencing 402 recoveries as recommended by the independent data monitoring board, Humanigen increased the patient population from 300 patients to 515. BARDA is funding consultants to assist in submitting an EUA and BLA for lenzilumab.