On 11/23/2020 AstraZeneca announced interim data from two trials involving 22,690 patients after 131 cases of COVID-19 developed in the population. The COV002 trial (NCT04400838) enrolled 12,390 volunteers in the U.K., and the COV003 trial (NCT04536051) enrolled 10,300 participants in Brazil. An analysis of two trials by the independent Data Safety Monitoring Committee found the average efficacy for both dosing regimen of the vaccine to be 70% in preventing COVID-19, two weeks after the second dose of the vaccine. Giving a half dose as the first immunization and a full dose four weeks later resulted in 90% efficacy (n=2,741), while giving a full dose at both immunizations resulted in 62% efficacy (n=8,895). The vaccine can be stored, transported and handled at 2-8 degrees Celsius for at least six months.
The FDA approved an Emergency Use Authorization (EUA) for the combination of casirivimab (REGN10933) and imdevimab (REGN10987)(REGEN-COV2, Regenron) on 11/21/2020, for the treatment of patients, 12 and older and weighting at least 40 kg, with mild or moderate COVID-19, who are at high risk of progressing to a severe infection and who do not require hospitalization. Casirivimab and imdevimab are administered as a one-time intravenous dose. The FDA advised against using the drug in hospitalized patients, because a benefit has not been demonstrated. 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. Regeneron has an agreement with Roche to increase manufacturing capacity and distribution of REGN-COV2. Regeneron will distribute the drug in the U.S. and Roche will handle distribution outside the U.S. The combined manufacturing capacity will increase production to at least 2 million doses per year. Regeneron has 80,000 doses available and forecasts 200,000 by the beginning of the 2021 and 300,000 by the end of January 2021. The U.S. government has purchased 300,000 doses that will be distributed at no charge.