China’s Sinovac COVID-19 Vaccine Validated by WHO for Emergency Use

China’s CoronaVac COVID-19 vaccine, developed by the pharmaceutical company Sinovac was on Tuesday validated by the World Health Organization (WHO) for emergency use.

According to WHO’s Director-General, Tedros Adhanom Ghebreyesus, the Sinovac vaccine was given the organization’s Emergency Use Listing (EUL) after it was tested for safety, effectiveness, and quality assurance following two doses of the inactivated vaccine.

“The easy storage requirements of CoronaVac make it very suitable for low resource settings,” said Mr. Adhanom in a press briefing on Tuesday.

In response to the dire need for multiple COVID-19 vaccines across the globe, the WHO Assistant Director-General for Access to Health Products Mariangela Simao noted that to address the huge access inequity worldwide, manufacturers should participate in the COVAX Facility – a global union created to ensure fair and equitable access to COVID-19 vaccines around the world – and share their know-how and data and contribute to bringing the pandemic under control.

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The CoronaVac vaccine, much like the first COVID-19 vaccine from China, Sinopharm, is an inactivated vaccine developed by Sinovac Life Sciences Co., Ltd. a pharmaceutical firm based in Beijing. Sinopharm was validated by WHO for emergency use in early May.

Other COVID-19 vaccines listed for emergency use by the WHO so far include the vaccine developed by Pfizer/BioNTech, two versions of AstraZeneca/Oxford vaccine, the Janssen vaccine, and the Moderna vaccine.

“The Sinovac vaccine is recommended for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks,” noted the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE).

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Its efficacy results indicated that CoronaVac prevented severe COVID-19 and hospitalization in 100 percent of the studied population. This efficacy, however, could not be estimated efficiently in adults over 60 years as few such people were enrolled in the clinical trials.

WHO states there is no reason to believe that the vaccine has a different safety profile in older and younger populations, adding that SAGE is not recommending an upper age limit for the vaccine because data collected in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.

The Sinovac vaccine, as assessed by SAGE, had been authorized by 32 countries or jurisdictions for use in adults 18 years or older, where 260 million doses have been distributed to the public in domestic and overseas markets. No safety concerns have been identified from pre-clinical or repro/tox studies, while most adverse events were mild to moderate, such as pain at the injection site, headache, fatigue, and myalgia.

Currently, more than 80 percent of the COVID-19 vaccines used globally have been administered in high-and upper-middle-income countries while a mere 0.3 percent have made it to the low-income countries. The validation of the Sinovac vaccine is expected to accelerate vaccine roll-out in many low-and middle-income countries through purchase and delivery by the WHO-led COVAX international COVID-19 vaccine initiative.

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China has already committed to providing 10 million COVID-19 vaccine doses to the COVAX initiative to meet the urgent needs of developing countries.

“China believes that promoting the equitable distribution of and access to COVID-19 vaccines globally is crucial to outbreak prevention and control, and has fulfilled its commitment of providing COVID-19 vaccines as a public good by offering medical assistance to 80 countries, exporting vaccines to 43 countries, and supplying 300 million doses of vaccines worldwide,” said Yang Feng, the deputy director of Health Emergency Response Office affiliated with National Health Commission of China a Chinese delegate during the recently concluded  74th World Health Assembly.