Sinovac Bio (NSDQ: SVA) announced conditional approval in China for CoronaVac, the Beijing company's COVID-19 vaccine. Sinovac has been conducting global trials of the inactivated vaccine since July. The company began making rolling submissions of data to China's NMPA in September 2020 and filed for approval on February 3, 2021. Sinovac has not yet published final efficacy and safety results for the vaccine, which have provoked controversy because various countries have reported a wide range of efficacy data.

The approval was based on data gathered two months after second administration of CoronaVac. Sinovac will continue to collect data from the trials and submit the results to the NMPA for final approval.

CoronaVac is being administered under emergency use protocols in Indonesia, Brazil, Turkey and Chile. Meanwhile, Sinovac is seeking regulatory approval of CoronaVac in other countries and regions around the world.

In December, Sinovac reported Sino Biopharma (HK:1177) of Hong Kong would invest $515 million in a Sinovac subsidiary to double production of the vaccine. Last month, Sinovac said it had the ability to produce 1 billion doses per year, though that was not for filled and finished vaccine doses.

Mr. Yin Weidong, Chairman, President and CEO of Sinovac, said, "Being granted a conditional marketing authorization for CoronaVac is a significant milestone for Sinovac after commencing development at the beginning of 2020. We show our respect and appreciation to the volunteers for their contribution to this research and thank all experts, scientists and partners who participated in this international collaborative project."

Sinovac's product portfolio includes vaccines for:

• enterovirus71 (EV71),
• hepatitis A and B,
• seasonal influenza,
• H5N1 pandemic influenza (avian flu),
• H1N1 influenza (swine flu),
• varicella vaccine and
• mumps.

The company is developing a number of new products including

• a Sabin-strain inactivated polio vaccine,
• pneumococcal polysaccharides vaccine,
• quadrivalent influenza vaccine and
• the SARS-CoV-2 (commonly referred to as COVID-19) vaccine.

See our other articles on Sinovac.

Disclosure: none.