The World Health Organization (WHO) has authorized the inclusion of the coronavirus vaccine developed by the Chinese pharmaceutical company Sinopharm in its emergency use list, thus becoming the sixth to receive this validation.
This was announced this Friday by the director general of the WHO, Tedros Adhanom Ghebreyesus, at a press conference, where he assured that this vaccine is "safe and effective" and that, therefore, the agency has included it in its list of emergency.
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This list serves to evaluate the quality, safety and efficacy of vaccines against covid-19 and, in turn, allows countries to accelerate their own regulatory approval to import and administer the vaccines, which must be included in this list in order to be administered through the Covax mechanism, reports Ep. It is an especially useful mechanism for developing countries that do not have regulatory agencies and that usually use the endorsement of the WHO to start with the use of medicines.
“The addition of this vaccine has the potential to rapidly accelerate access to the covid-19 vaccine for countries seeking to protect healthcare workers and populations at risk. We urge the manufacturer to participate in the Covax installation and contribute to the goal of a more equitable distribution of vaccines ”, said the deputy director general of Access to Health Products of the WHO, Mariângela Simão.
In the case of the Sinopharm vaccine, the WHO assessment has included on-site inspections of the production facility. It is an inactivated vaccine and its "easy storage requirements" make it "very suitable" for low-resource settings. It is also the first vaccine to carry a vaccine vial monitor, a small sticker on vaccine vials that changes color as the vaccine is exposed to heat, allowing healthcare workers to know if the vaccine can be use safely.
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. Based on all the available evidence, this body recommends the vaccine for adults over 18 years of age, in a two-dose schedule with an interval of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined.
Finally, the WHO advises against an upper age limit for the vaccine because preliminary data and supporting immunogenicity data suggest that it is likely to have a protective effect in older people. “There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations. Therefore, we recommend that countries that use the vaccine in older age groups monitor its safety and efficacy so that the recommendation is more robust, ”the agency has settled.