THE World Health Organization (WHO) has granted emergency use listing (EUL) to the Sinopharm vaccine against coronavirus disease 2019 (Covid-19), facilitating its approval for emergency use worldwide and possible participation in the Covax Facility to promote vaccine equity.
The Sinopharm inactivated vaccine, called Sars-CoV-2 Vaccine (Vero Cell), is the sixth to receive WHO validation for safety, efficacy and quality, after those developed by Pfizer/BioNTech, AstraZeneca/Oxford (two vaccines), Serum Institute of India, and Janssen Pharmaceuticals (Johnson & Johnson).
It is the first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.
This was the vaccine administered to President Rodrigo Duterte on May 3, 2021 based on a compassionate special permit issued by the Food and Drug Administration (FDA).
In a statement issued Friday, May 7 (Geneva time), the WHO said its Strategic Advisory Group of Experts on Immunization (Sage) has recommended the Sinopharm vaccine for adults 18 years and older, with a two-dose schedule three to four weeks apart.
Vaccine efficacy for symptomatic and hospitalized disease was estimated at 79 percent, all age groups combined.
Efficacy in adults over 60 years could not be estimated because only a few were enrolled in clinical trials.
Despite this, the WHO said it 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,” the WHO said.
Nonetheless, WHO suggested that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust.
The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG).
“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. 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.
The EUL is a prerequisite for Covax vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
The EUL assesses the quality, safety and efficacy of Covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.
The assessment is performed by the product evaluation group, composed of regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment.
In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility. (Marites Villamor-Ilano / SunStar Philippines)