The vaccine has been recommended for use in people aged 18 years and above
The European Medicine Agency (EMA) has also started the rolling review of CoronaVac. (Credit: Arek Socha from Pixabay)
China-based biopharmaceutical company Sinovac has received the World Health Organization (WHO) Emergency Use Listing (EUL) for its Covid-19 vaccine CoronaVac.
CoronaVac is an inactivated Covid-19 vaccine developed by Sinovac Life Sciences, a subsidiary of the company, validated by the WHO for emergency use.
The international agency has granted the EUL based on recommendation of its Strategic Advisory Group of Experts on Immunization (SAGE).
WHO assistant-director general for access to health products Mariângela Simão said: “The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe.
“We urge manufacturers to participate in the COVAX Facility, share their knowhow and data and contribute to bringing the pandemic under control.”
Sinovac had submitted clinical and non-clinical research data, along with manufacturing and control (CMC) data, to the WHO review group to evaluate the quality, safety, efficacy data and risk management plan of CoronaVac.
In February this year, the agency has conducted an on-site inspection of CoronaVac manufacturing facilities and its quality management system.
Upon conducting a systematic review of CoronaVac, WHO’s SAGE has concluded that the Sinovac’s inactivated vaccine has more benefits compared to the known risks, and recommended the use of CoronaVac in people aged 18 years and above.
Furthermore, the European Medicine Agency (EMA) has started the rolling review of CoronaVac, which marks the first step in obtaining the regulatory approval for use in the EU.
Sinovac chairman, president, and CEO Weidong Yin said: “The phase III clinical research and follow-up real-world studies in Brazil, Turkey, Indonesia and Chile represent good examples of the collaborative, global action against the pandemic.
“These studies have provided a solid scientific foundation for CoronaVac to be approved by more than 40 countries, as well as the WHO. These achievements could not have happened without the efforts of global partners and scientists.
“As the Covid-19 pandemic persists, SINOVAC will continue to participate in pandemic prevention and control actions, acknowledging the value of China’s Covid-19 vaccine as a global public good and contributing to the international triumph over the Covid-19 pandemic.”
In February, WHO has granted EUL for two versions of the AstraZeneca’s Covid-19 vaccine, in people aged 18 years and older, including those above 65 years.