FDAnews
www.fdanews.com/articles/197983-sinovacs-covid-19-vaccine-moves-into-phase-3-trials

Sinovac’s COVID-19 Vaccine Moves Into Phase 3 Trials

July 8, 2020

The race to develop a COVID-19 vaccine continues.

Beijing-based Sinovac has received approval from Brazil’s Health Regulatory Agency to begin phase 3 trials of CoronaVac, its COVID-19 vaccine candidate, and said it plans to begin enrollment this month.

The phase 3 study will include 9,000 healthcare professionals across 12 clinical sites.

Sinovac got Chinese regulatory approval to conduct phase 1 and 2 trials of its vaccine candidate in April. According to recently reported preliminary results, no serious adverse events were reported after vaccinating 743 healthy adults, and a phase 2 trial showed that more than 90 percent of participants developed antibodies after receiving a two-dose vaccination.

Another phase 2 study of elderly participants is under way, with child and adolescent groups next in line for study. That trial is slated to conclude at the end of the year, the company said.

AstraZeneca and another Beijing company, Sinopharm, are currently conducting phase 3 studies for their coronavirus vaccine candidates. Moderna is not far behind with plans to launch a phase 3 trial this month. — James Miessler