COVID Quick Takes: WHO clears Moderna vaccine, adding momentum to COVAX; plus Mesoblast, Brii
Friday’s emergency use listing by the World Health Organization of the COVID-19 vaccine from Moderna Inc. (NASDAQ:MRNA) will allow many countries to expedite their approval processes to import and administer the mRNA vaccine. The listing enables UNICEF and the PAHO Revolving Fund to buy the vaccine for distribution to countries in need, and is a prerequisite to supply COVID-19 vaccines to the COVAX facility, a global mechanism for pooled procurement and distribution. COVAX, which is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI); Gavi, the Vaccine Alliance; and WHO, alongside delivery partner UNICEF. The EUL is for individuals 18 years of age and older.
As of April 8, COVAX had delivered more than 38 million doses of vaccines from AstraZeneca plc (LSE:AZN; NASDAQ:AZN), the Serum Institute of India Pvt. Ltd. and partners BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE). Of the more than 100 economies that had received vaccines, 61 are among 92 lower-income economies receiving vaccines funded by the Gavi COVAX Advance Market Commitment (AMC). Ghana became the first to receive COVAX doses on Feb. 24.
Mesoblast cell therapy boosts survival in ventilated COVID patients
Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) plans to meet with FDA to discuss next steps for remestemcel-L based on Phase III data showing a 60-day survival benefit in a prespecified subgroup of COVID-19 patients under age 65. The culture-expanded mesenchymal stromal cells plus standard of care led to a 46% reduction in mortality vs. SOC alone in the 123-patient subgroup (HR=0.54, 95% CI: 0.286, 1.005, p=0.048). The company stopped the trial, which randomized 217 mechanically ventilated COVID-19 patients with moderate or severe acute respiratory distress syndrome, in December after a third interim analysis of data from 180 patients found remestemcel-L was unlikely to meet the primary endpoint of reducing 30-day mortality.
Brii’s mAb combo advances in ACTIV-2
BRII-196 plus BRII-198 from Brii Biosciences is heading to the Phase III portion of NIH’s ACTIV-2 COVID-19 outpatient trial after the mAb combo met the predefined Phase II endpoints. The international Phase III part will evaluate prevention of hospitalization or death.