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Sinovac reveals positive preliminary data for COVID-19 vaccine

Plans protocol application for phase 3 study

coronavirus vaccine

Beijing, China-based Sinovac Biotech has announced that early results from its phase 1/2 clinical trials of its COVID-19 vaccine have demonstrated preliminary promise.

Sinovac’s candidate – dubbed CoronaVac – induced a positive immune response against COVID-19, according to a statement released by the Chinese biotech company.

The early-stage trials tested the candidate in 743 healthy volunteers between 18 and 59 years of age. That included 143 participants in a phase 1 trial and 600 volunteers in a phase 2 trial.

In the 600-patient phase 2 study, CoronaVac induced neutralising antibodies in ‘above 90%’ of volunteers who were tested 14 days after receiving two doses of the vaccine, two weeks apart.

According to Sinovac, the vaccine did not demonstrate any severe side effects among the volunteers across both trials.

Following the initial results, Sinovac plans to submit a phase 2 clinical study report and a phase 3 clinical study protocol to China’s National Medical Products Administration (NMPA). The company also expects to begin applications for phase 3 clinical trials outside China.

That includes a collaboration with Instituto Butantan in Brazil, for the preparation and conducting of a phase 3 clinical trial in the country.

“Our phase 1/2 study shows CoronaVac is safe and can induce an immune response. Concluding our phase 1/2 clinical studies with these encouraging results is another significant milestone we have achieved in the fight against COVID-19,” said Weidong Yin, chairman, president and chief executive officer of Sinovac.

CoronaVac works by utilising an inactivated version of the novel coronavirus, known as SARS-CoV-2, and has been in development since January, in partnership with leading academic research institutes across China.

Sinovac’s candidate is just one potential vaccine among a number that are currently in development across the world. This includes an mRNA-based vaccine being developed by Moderna, which has also revealed early results demonstrating immune-response against COVID-19.

AstraZeneca has also partnered with Oxford University for rights to manufacture the latter’s COVID-19 vaccine candidate, and has also pledged to make the vaccine at a low cost for the duration of the pandemic and provide it free to low-income countries.

Article by
PMGroup

15th June 2020

From: Research, Healthcare

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