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April 15, 2020

Sinovac gets regulatory approval to assess Covid-19 vaccine

China-based Sinovac Biotech has secured regulatory approval to perform a clinical trial of an inactivated SARS-CoV-2 vaccine candidate to protect from Covid-19.

China-based Sinovac Biotech has secured regulatory approval to perform a clinical trial of an inactivated SARS-CoV-2 vaccine candidate to protect from Covid-19.

The company started developing the vaccine candidate at the end of January this year. It conducted preclinical studies in alliance with academic research institutes in China.

Findings from an animal challenge study revealed that the Covid-19 vaccine candidate protects animals with no antibody-dependent enhancement (ADE).

The candidate can also neutralise virus strains from various countries. This characteristic indicates the potential use of the vaccine to prevent disease spread worldwide.

Sinovac Biotech chairman, president and CEO Weidong Yin said: “At present, the whole world is facing an unprecedented public health crisis. It is a matter of urgency to develop an effective vaccine to control the spread of Covid-19 globally, as quickly as possible.

“Sinovac has been working closely with the regulators in China in order to make this happen. Sinovac has always been committed to developing vaccines for global use when facing pandemics.”

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The company also announced that the ongoing Covid-19 pandemic has affected its daily operations.

The vaccinations suspension by the Chinese CDC since February this year impacted the company’s domestic sales, while exports have been hindered because of cargo flight cancellations and an increase in freight costs.

Further interference to Sinovac’s clinical trials, suppliers or contract manufacturers is expected to delay regulatory approvals or commercialisation of existing or future products.

The company added that some Chinese provinces and cities are lifting select restrictive measures and vaccine delivery is gradually resuming in the country.

China commenced a Phase I clinical of a vaccine candidate against Covid-19 in March this year. The candidate is a recombination vaccine developed by biotechnology company CanSino Biologics in alliance with a research team from the PLA Academy of Military Medical Sciences.

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