Sinovac Makes Headway In Coronavirus Vaccine Race With Positive Preliminary Phase 1/2 Results

Chinese biopharma Sinovac Biotech, which is one of 10 companies doing human testing of a vaccine candidate for SARS-CoV-2, the virus that causes COVID-19, announced positive preliminary data Monday from Phase 1/2 clinical trials.

What Happened: The company said its vaccine candidate CoronaVac showed favorable immunogenicity and safety profiles.

The Phase 1/2 trials were designed as randomized, double-blinded and placebo-controlled trials and enrolled 743 healthy volunteers ages 18-59.

Of that group, 143 were enrolled in the Phase 1 trial and 600 in the Phase 2 trial.

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Favorable Safety, Efficacy Profile: Sinovac said the Phase 2 trial showed that the vaccine induced neutralizing antibodies 14 days after vaccination, with a neutralizing antibody seroconversion rate above 90%, suggesting that CoronaVac can induce a positive immune response.

The company said no adverse events were reported in either of the studies.

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What's Next: Sinovac said it expects to submit a Phase 2 study report and Phase 3 study protocol to China's National Medical Products Administration in the near future. It also expects to commence application of Phase 3 clinical trials outside of China.

"We have started to invest in building a manufacturing facility so that we can maximize the number of doses available to protect people from COVID-19," Weidong Yin, Sinovac's chairman, president and CEO, said in a statement.

Sinovac has an ongoing collaboration with Instituto Butantan in Brazil to prepare and conduct a Phase III clinical study.

Last week, U.S. vaccine maker Moderna Inc MRNA said it has finalized the Phase 3 protocol for its vaccine candidate mRNA-1273.

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