Moderna and NIAID initiated an NIAID funded, 30,000 patient, Phase III, COVE trial (NCT04470427) for COVID-19 vaccine candidate mRNA-1273 on July 27. The vaccine is administered as two 100 mcg immunizations given 28 days apart. Moderna announced the 30,000 patient goal was met on 10/22/2020. On 11/16/2020, interim data was announced based on over 30,000 patients, from an analysis by the independent NIH-appointed, Data Safety Monitoring Committee, after 95 cases of COVID-19 developed in the population. The vaccine achieved 94.5% efficacy in preventing COVID-19, two weeks after the second dose of the vaccine was given. No severe cases of COVID-19 developed in the vaccine group, compared to 11 cases in the placebo group. The study population included 42% over the age of 65 or who were at increased risk for severe COVID-19. The study population also included 37% with diverse backgrounds. If no safety issues are identified after the two-month safety data is available, Moderna will request an emergency use authorization (EUA) and have 20 million vaccine doses available in 2020 and up to 1 billion doses in 2021. Moderna said that based on data from the interim report, the most common adverse events with mRNA-1273 are injection site pain and redness, fatigue, myalgia, arthralgia, headache and general pain. Adverse effects have been mild to moderate. Moderna announced that mRNA-1273 is stable for 30 days at 2 to 8 C and for six-months at -20 C. This will make the vaccine easier to ship and use in pharmacies, clinics and small hospitals.
BioNTech announced that the COVID-19 vaccine it is developing with Pfizer, BNT162b2, can be stored for up to five-days at 2 to 8 C. The shipping container will keep the vaccine viable for up to ten days if stored at 15 to 25 C without opening and up to 15 days if opened and then re-iced with dry ice. The vaccine is stable for up to six months at -70 C.
Johnson and Johnson is initiating a 30,000 patient, Phase III, ENSEMBLE 2 trial (NCT04614948), to evaluate a two doses of JNJ-78436735 given 57 days apart compared to placebo. BARDA is giving J&J an additional $454 million and J&J is providing $604 million, for the ENSEMBLE Phase III program. The Phase III, ENSEMBLE trial (NCT04505722) is evaluating a single dose of JNJ-78436735 in a 60,000 patient trial.
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