Sinopharm product is an inactivated organism, called SARS-CoV-2 vaccine (Vero Cell). Its easy storage requirements make it very suitable for resource-poor environments.
Mexico City (APRO). -The World Health Organization (WHO) authorized the emergency use of the new drug Sinopharm Group (CNBG) for covid-19 produced by the Beijing Institute of Biological Products Co., Ltd., a Chinese company under the China National Biotechnology Group.
Supplementing this vaccine has the potential to rapidly accelerate the use of the covid-19 vaccine for countries seeking to protect health workers and people at risk,” said Mariângela Simão, Deputy Director of the Agency for Access to Health Products.
The WHO Emergency Use List (EUL) is a prerequisite for the provision of vaccines from COVAX facilities. It also allows countries to expedite their own regulatory approvals to import and manage the covid-19 vaccine.
EUL assesses the quality, safety and efficacy of the covid-19 vaccine, as well as the applicability of risk management plans and procedures, such as cold chain requirements. The evaluation is carried out by a product evaluation team (composed of regulatory experts from all over the world) and a technical advisory group (TAG), which is responsible for conducting risk-benefit assessments to make independent recommendations on whether vaccination is possible, including use in emergency situations, if so , And under what circumstances.
For Sinopharm vaccines, WHO’s assessment includes on-site inspections of production facilities.
Sinopharm product is an inactivated organism, called SARS-CoV-2 vaccine (Vero Cell). Its easy storage requirements make it very suitable for resource-poor environments. It is also the first vaccine with a vaccine bottle monitor. The small label on the vaccine bottle will change color when the vaccine is exposed to heat, so that medical staff can know whether the vaccine is safe to use.
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) also completed a review of the vaccine based on all available evidence. Therefore, it is recommended to use the vaccine in 18 doses, two doses, with an interval of three to 20 years old. All around. In the sum of all age groups, the vaccine efficacy against symptomatic and hospitalized diseases is estimated to be 79%.
Few elderly people participate in clinical trials, so it is impossible to estimate the efficacy of this age group.
However, the WHO does not recommend the upper age limit for the vaccine, because preliminary data and supporting immunogenicity data indicate that the vaccine may have a protective effect on the elderly.
?? There is no theoretical reason to believe that the vaccine has different safety in the elderly and young people. Therefore, WHO recommends that countries that use the vaccine in older people monitor its safety and effectiveness to make this recommendation more robust. ”He says.
The WHO also listed Pfizer/BioNTech vaccines for emergency use on December 31, 2020; on February 15, 2021, two AstraZeneca-SKBio (Republic of Korea) and Serum Institute of India produced two kinds of AstraZeneca-SKBio (Republic of Korea) and Serum Institute of India. Sleek/Oxford covid-19 vaccine; and the covid-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) on March 12, 2021.
It also includes Pfizer/BioNTech, AstraZeneca-SK Bio, Serum Institute of India, Janssen and Moderna vaccines.