Sinovac Biotech announced preliminary study results. showing its experimental Covid-19 vaccine generated immune responses in patients and was safe — early data that suggest it might protect people against infections with the novel coronavirus.
The Beijing-based drug maker’s vaccine, called CoronaVac, induced neutralizing antibodies in “above 90%” of people who were tested 14 days after receiving two injections, two weeks apart. There were no severe side effects reported, the company said in a statement.
The preliminary results were from a 600-patient, placebo-controlled Phase 2 study. Sinovac is also conducting a 143-patient, placebo-controlled Phase 1 study.
There are currently more than two dozen research efforts underway to develop protective vaccines against the novel coronavirus that causes Covid-19. In May, Moderna, a Cambridge, Mass.-based biotech firm, announced early and encouraging immune-response results for its experimental Covid-19 vaccine — although vaccine experts criticized the company for not disclosing enough detailed data.
In similar ways, Sinovac’s statement was short on details about the extent of CoronaVac’s efficacy and safety. The company said it expects to submit a report on the Phase 2 study results in the “near future,” at the same time as it submits a design protocol for a Phase 3 clinical trial to China’s version of the Food and Drug Administration.
Earlier this week, Sinovac also announced a collaboration with a Brazilian drug maker to start a Phase 3 clinical study there.
“Our phase 1/2 study shows CoronaVac is safe and can induce immune response,” said Sinovac CEO Weidong Yin, in a statement. Sinovac is building a manufacturing facility intended to “maximize the number of doses available to protect people from COVID-19,” he added.
Sinovac’s CoronaVac vaccine candidate uses an inactivated version of the novel coronavirus. The company used the same technology to craft approved vaccines for hepatitis A and B; swine flu; avian flu; and the virus that causes hand, foot, and mouth disease.
Source: STAT News