Tuesday, October 26, 2021

WHO grants Sinopharm’s COVID-19 vaccine emergency approval

The World Health Organization (WHO) has approved Sinopharm’s COVID-19 vaccine for emergency use, making it the first jab developed by a non-Western company to gain this recommendation.

So far, the WHO has approved vaccines from Pfizer/BioNTech, AstraZeneca/Oxford University, Johnson & Johnson (J&J) and Moderna.

“This expands the list of COVID-19 vaccines that COVAX can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine,” said Tedros Adhanom Ghebreyesus, director-general of the WHO.

A WHO emergency use listing (EUL) was granted following an assessment by a technical advisory group (TAG), which assesses the quality, safety and efficacy of COVID-19 vaccines.

Sinopharm’s vaccine is an inactivated vaccine, with ‘easy’ storage requirements that make it suitable for low-resource settings, the WHO said in a statement.

The vaccine has an efficacy of 79% against symptomatic and hospitalised COVID-19 disease across all age groups – the WHO approved the jab for use in adults aged 18 years and older on the basis of this evidence.

However, the WHO added that as a result of small numbers of older adults having been enrolled in clinical trials, efficacy could not be estimated in this age group.

Even still, WHO is not recommending an upper age limit for the Sinopharm vaccine as preliminary data and supportive immunogenicity data suggest the vaccine is ‘likely’ to have some sort of protective effect in people aged 60 years and older.

In addition to signalling the safety and efficacy of a vaccine, a WHO EUL is also a prerequisite for the COVAX Facility vaccine sharing mechanism.

“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 Mariângela Simão, 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,” she added.

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