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WHO validates China’s Sinovac COVID-19 vaccine for emergency use

Abstract : The World Health Organization (WHO) validated on Tuesday the CoronaVac COVID-19 vaccine developed by Chinese pharmaceutical company Sinovac for emergency use.

GENEVA, June 1 (Xinhua) — The World Health Organization (WHO)
validated on Tuesday the CoronaVac COVID-19 vaccine developed by Chinese
pharmaceutical company Sinovac for emergency use.

“I am happy to announce that the Sinovac coronavirus vaccine has been
given WHO Emergency Use Listing (EUL) after being found to be safe,
effective, and quality assured following two doses of the inactivated
vaccine,” WHO Director-General Tedros Adhanom Ghebreyesus said at a WHO
press briefing on Tuesday.

“Furthermore, the easy storage requirements of CoronaVac make it very suitable for low resource settings,” he added.

In an official press release, WHO Assistant Director-General for
Access to Health Products Mariangela Simao 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 know-how and data and contribute to bringing the pandemic under
control,” she said.

COVAX is a global coalition that works to ensure fair and equitable access to COVID-19 vaccines around the world.

The CoronaVac vaccine, developed by Sinovac Life Sciences Co., Ltd.
based in Beijing, is also an inactivated vaccine, like the other and the
first COVID-19 vaccine from China — the Sinopharm vaccine, which was
validated earlier last month for WHO emergency use.

Apart from the two Chinese vaccines, WHO has previously listed the
COVID-19 vaccine developed by Pfizer/BioNTech, two versions of
AstraZeneca/Oxford vaccine, the Janssen vaccine, and the Moderna vaccine
for emergency use.

According to WHO’s Strategic Advisory Group of Experts on
Immunization (SAGE), 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.

The vaccine efficacy results showed that the Sinovac vaccine
prevented severe COVID-19 and hospitalization in 100 percent of the
studied population.

However, as few people over 60 years old were enrolled in clinical
trials, SAGE said the Sinovac vaccine’s efficacy could not be estimated
in this age group.

“There is no reason to believe that the vaccine has a different
safety profile in older and younger populations,” the WHO statement
said, 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.

As in the cases of previously validated vaccines, WHO recommends that
countries using the Sinovac vaccine in older age groups conduct safety
and effectiveness monitoring to verify the expected impact and
contribute to making the recommendation more robust for all countries.

Assessment by SAGE has shown that the Sinovac vaccine 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.

As more than 80 percent of the COVID-19 vaccine doses globally have
been administered in high-and upper-middle income countries and just 0.3
percent in low-income countries, according to WHO’s statistics, the two
Chinese vaccines, with WHO’s validation for emergency use, are 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.

China has already decided to provide 10 million COVID-19 vaccine
doses to the COVAX initiative to meet the urgent needs of developing
countries, a concrete step to deliver on the promise to make vaccines a
global public good.

Addressing the 74th World Health Assembly that has just concluded,
Chinese delegate Yang Feng, also deputy director of Health Emergency
Response Office affiliated with National Health Commission of China,
said, “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.”

“China will continue to make its own contribution to promoting the
accessibility and affordability of vaccines in developing countries,” he
added, calling for global solidarity and cooperation in building a
community with a shared future for mankind. Enditem

About Xinhua Silk Road

Xinhua Silk Road (en.imsilkroad.com) is the Belt and Road Initiative (BRI) portal.China’s silk road economic belt and the 21st century maritime silk road website,includes BRI Policy, BRI Trade, BRI Investment, Belt and Road weekly, Know Belt and Road, and the integrated information services for the Belt and Road Initiative (BRI).

Source: WHO validates China’s Sinovac COVID-19 vaccine for emergency use

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