Sinopharm vaccine approved for emergency use by World Health Organisation

Listing represents an important endorsement of the vaccine

China's Sinopharm vaccine has been approved for emergency use by the World Health Organisation.

It recommended the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks.

The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products, a subsidiary of China National Biotec Group.

"This afternoon, WHO gave emergency use listing to Sinopharm Beijing's Covid-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality," the UN health agency's director general Tedros Adhanom Ghebreyesus told a news conference.

“This expands the list of vaccines that Covax can buy and gives countries confidence to expedite their own regulatory approval and to import and administer a vaccine.”

World Health Organisation Director General Tedros Adhanom Ghebreyesus says Sinopharm has been approved for emergency use. Reuters
World Health Organisation Director General Tedros Adhanom Ghebreyesus says Sinopharm has been approved for emergency use. Reuters

It can now be added to the Covax programme, which provides equitable access to vaccines against Covid-19, paving the way for millions of the doses to reach needy countries.

The WHO’s Strategic Advisory Group of Experts on Immunisation reviewed the vaccine and found its efficacy for symptomatic and hospitalised disease was estimated to be 79 per cent.

“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 Simao, the WHO's 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.”

Its easy storage requirements make it highly suitable for low-resource settings. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that changes colour as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.

The listing represents an important endorsement of the vaccine, which has yet to release data from late-stage trials in a medical journal.

The Sinopharm vaccine was registered by the UAE Ministry of Health and Prevention on December 9 following a large-scale local trial.

It has since been approved for use in more than 30 countries, including Hungary, Serbia and several countries across Asia, Africa and South America.

A study conducted in Abu Dhabi, where the vaccine has accounted for the bulk of Covid-19 shots administered since the start of the mass vaccination campaign, found it was 100 per cent effective against death.

It was also 93 per cent effective in preventing hospitalisation and 95 per cent effective against admission to intensive care.

Its overall efficacy is 79 per cent, said Sinopharm.

The listing will help guide countries’ regulatory agencies, but it does not mean approval will automatically be granted.

Some regulators, including those in the EU, US, and the UK, require manufacturers to apply directly by submitting detailed trial data on the quality, safety and efficacy of vaccines, which is assessed before a decision is made on whether to grant a vaccine approval.

The WHO has previously given emergency approval to Covid-19 vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, and, last week, Moderna.

The vaccine is produced locally in the UAE at Emirati drug maker Julphar's plant in Ras Al Khaimah under the brand name Hayat-Vax.

Production of the vaccine is also expected to begin in Serbia later in the year.

Updated: May 9, 2021 01:21 PM

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