WHO approves China's Sinopharm COVID-19 vaccine for emergency use

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Beijing/Geneva: In a big relief for China, the WHO on Friday finally granted the conditional approval to its Sinopharm COVID-19 vaccine for emergency use, a move that could help Beijing step up its vaccine diplomacy amid the surge in coronavirus vaccines in several countries.

China has approved about five of its vaccines for emergency use and especially using Sinopharm and Sinovac vaccines for both at home and abroad.

The Sinopharm vaccine was authorised by 45 countries and jurisdictions for use in adults, with 65 million doses administered, according to official media reports. But many countries hesitated using the vaccine as it has not secured recognition from the World Health Organisation.

While WHO has listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen vaccines for emergency use, the Chinese vaccine got delayed recognition due to data related issues.
China was eagerly awaiting the global health body's nod for it to aggressively push the vaccine among different countries.

A press release issued by WHO in Geneva on Friday listed the Sinopharm COVID-19 vaccine for emergency use, a first for a Chinese vaccine, giving the green light for this vaccine to be rolled out globally.

The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG).

The two jab vaccine is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). Its easy storage requirements make it highly suitable for low-resource settings, the WHO press release said.

It is also the first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change colour as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used, it said. 

Sinopharm vaccine efficacy for symptomatic and hospitalised disease was estimated to be 79 per cent, all age groups combined, the WHO said. The efficacy is, however, below the efficacy rates of other WHO vaccines which are in the range of 90 per cent. However, the WHO has okayed Sinopharm usage from 18 years and above, clarifying lingering doubts about its usage for people above 59 years. China itself listed the vaccine for people in the age group of 18 to 59 years which raised doubts about its efficacy in the senior citizens population.

Clarifying this issue, WHO said, ?Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons."

"There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations," it said.

"The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk," said Dr Mariangela Sim'o, WHO Assistant-Director General for Access to Health Products.

"We urge the manufacturer to participate in the COVAX facility and contribute to the goal of more equitable vaccine distribution," he said.

China has committed to provide 10 million vaccines to the UN-backed COVAX facility to be distributed among the developing countries. But it could not deliver it as it required WHO approval for its vaccines.

COVAX aims to send vaccines for free to 92 lower-income countries and to help another 99 countries and territories procure them.