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10 Feb 2021

CoronaVac received conditional marketing authorization from NMPA China

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Sinovac Biotech announced that the China National Medical Products Administration (NMPA) has granted a conditional marketing authorization (CMA) to Sinovac for CoronaVac, Sinovac’s Covid-19 vaccine in individuals aged 18 and above.

Sinovac began rolling submission to the NMPA since September 2020 and the NMPA carried out rolling reviews when the submission was made. As of February 4, 2021, the Company made more than 40 submissions to the NMPA. After obtaining the preliminary efficacy results, Sinovac formally filed for application of a conditional marketing authorization on February 3, 2021. The approval is based on the results of the two-month data of phase III clinical trials. The final results are not yet available, and the efficacy and safety results shall be further confirmed.

CoronaVac is being used under emergency use approval (EUA) in Indonesia, Brazil, Turkey and Chile. Sinovac is also actively seeking regulatory approval of CoronaVac in other countries and regions around the world in an effort to maximize global accessibility and affordability of the Covid-19 vaccine and to ensure global prevention and mitigate spread.

About CoronaVac:

  • CoronaVac (formerly PiCoVacc) is a formalin-inactivated and alum-adjuvanted vaccine developed by the China-based biotechnology company Sinovac Biotech.
  • The vaccine is administered in two doses 14-28 days apart.

Distribution of CoronaVac:

  • Brazil: The country has indicated it will purchase 46 million vaccine doses, while the state of São Paulo has ordered 60 million doses of the vaccine to be delivered by February. A production plant to manufacture 100 million doses of the vaccine is being built in São Paolo.
  • Chile: Science and Health ministers in Chile have reached an agreement for 20 million doses pending approval from regulators in Chile or Brazil.
  • China: A large production facility in Beijing, China, is being built to manufacture up to 300 million doses of CoronaVac per year.
  • Colombia: The country has reached an agreement with Sinovac for 2.5 million doses.
  • Indonesia: Bio Farma, a state-owned pharmaceutical company in Indonesia, is expected to manufacture up to 250 million doses of the vaccine in 2021 following a bulk purchase of 50 million doses from Sinovac. The vaccine has been shipped to Indonesia as of 9 December, with 1.8 million additional doses expected in January, according to the BBC.
  • Philippines: Up to 50 million doses of the vaccine have been ordered from the Philippines.
  • Malaysia: Pharmaniaga Berhad in Malaysia has signed an agreement for 14 million vaccine doses in the country.
  • Turkey: The country has signed an agreement for 50 million doses of CoronaVac.

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