December 8, 2022

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WHO has included SINOPHARM vaccine in the “Emergency Use List”

WHO has included SINOPHARM Covid-19 vaccine in the “Emergency Use List”

 

WHO has included SINOPHARM Covid-19 vaccine in the “emergency use list”.  The full text is here!  

WHO has included SINOPHARM Covid-19 vaccine in the "emergency use list"

 

WHO issued a statement announcing that the COVID-19 vaccine developed by the Beijing Institute of Biological Products of China National Pharmaceutical Group (SINOPHARM) will be included in the “Emergency Use List” (EUL).

On the 7th local time, the World Health Organization (WHO) issued a statement announcing that the COVID-19 vaccine developed by the Beijing Institute of Biological Products of China National Pharmaceutical Group will be included in the “Emergency Use List” (EUL).

The WHO Emergency Use List (EUL) is a prerequisite for the provision of vaccines to COVAX facilities. The list also allows countries to expedite their regulatory approvals to import and manage the COVID-19 vaccine.

The WHO stated in a statement that the WHO Strategic Advisory Expert Group on Immunization (SAGE) has also completed its review of the vaccine.

According to the WHO, based on all existing conditions, the WHO recommends that the vaccine be vaccinated at two-dose intervals, three to four weeks apart (in a manner) for adults aged 18 and over. If all age groups are combined, the effectiveness of the vaccine against symptomatic and hospitalized diseases is estimated to be 79%.

On the 6th, Chinese Foreign Ministry Spokesperson Wang Wenbin stated at a regular press conference, “China has always firmly upheld the “first attribute” of vaccine public products, and strives to improve the availability and affordability of vaccines in developing countries. Three countries and three international organizations provided vaccine assistance, exported vaccines to more than 40 countries, developed vaccine R&D, production and cooperation with more than 10 countries, actively participated in the WHO’s “New coronavirus Vaccine Implementation Plan (COVAX)” and promised the first batch Provide 10 million doses of vaccine for urgent needs in developing countries. We also announced the provision of vaccines to United Nations peacekeeping operations and the International Olympic Committee. China is implementing the concept of public vaccine products with tangible actions.

 

Included the Sinopharm vaccine in the “emergency use list”

The WHO stated that EUL assesses the quality, safety and effectiveness of the COVID-19 vaccine, as well as the applicability of risk management plans and procedures (such as cold chain requirements). The assessment is carried out by the product evaluation team, which is composed of regulatory experts and teams (TAGs) from all over the world, responsible for risk assessment, on “whether the vaccine can be listed as an emergency vaccine” and “if it can be listed as For emergency-use vaccines, independent recommendations will be made on issues such as “under what conditions”.

The WHO stated in the statement that for the Sinopharm vaccine, the WHO organization’s assessment also includes on-site inspections of production facilities.

According to the WHO, the Sinopharm vaccine is an inactivated vaccine called SARS-CoV-2 vaccine. The vaccine is easy to store, which makes it ideal for resource-poor environments.

At the same time, Sinopharm Vaccine 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 health workers know whether the vaccine can be used safely.

As mentioned earlier, SAGE has completed its review of the vaccine. The WHO also pointed out that very few elderly people (over 60 years old) participate in clinical trials, so the efficacy of this age group cannot be estimated.

Nevertheless, the WHO does not recommend setting an upper age limit for the vaccine, because preliminary data and supporting immunogenicity data indicate that the vaccine is likely to have a protective effect on the elderly.

According to the WHO, theoretically, there is no reason to believe that the vaccine has different safety profiles between the elderly and the young. Therefore, the WHO recommends that countries where the vaccine is used by the elderly should conduct safety and effectiveness monitoring to enhance the strength of this recommendation.

Prior to this, on May 3, WHO had released an evaluation report on the Beijing Biovaccine BBIBP-CorV and other vaccines of China National Pharmaceutical Group.

At that time, the WHO confirmed in the report that the BBIBP-CorV vaccine has a high protective effect (78.1%) for people aged 18 to 59 years old. The evidence of vaccine effectiveness is “highly credible”, the effectiveness of preventing hospitalization is 78.7%, and the evidence of safety is “Medium credibility.”

 

WHO emergency use list

The EUL program assesses the suitability of new sanitary products in public health emergencies. Its purpose is to provide medicines, vaccines and diagnostic methods as soon as possible to respond to emergencies, while complying with strict safety, efficacy and safety. The evaluation process should weigh the emergency situation, the benefits of using the product, and any potential risks.

The EUL path involves rigorous evaluation of data from late phase II and phase III clinical trials, as well as a large amount of additional data on safety, effectiveness, quality, and risk management plans. These data are reviewed by independent experts and a WHO organization team, who will consider the evidence base of the vaccine currently under consideration, as well as plans for how to monitor its use and conduct further research.

As part of the EUL process, the company that produces the vaccine must commit to continuing to generate data to facilitate the full approval of the vaccine and prequalification by the WHO.

The WHO prequalification process will conduct a rolling evaluation of additional clinical data generated from vaccine trials and deployment to ensure that the vaccine meets the necessary quality, safety, and efficacy standards for wider availability.

Previously, WHO included Pfizer/BioNTech’s vaccine on the emergency use list on December 31, 2020; on February 15, 2021, two COVID-19 vaccines from AstraZeneca/Oxford University were included on the list. The two vaccines are respectively. Produced by AstraZeneca-SKBio in South Korea and Serum Institute of India; on March 12, 2021, the WTO will list Ad26.COV2.S, a COVID-19 vaccine developed by Johnson & Johnson

 

(source:internet, reference only)


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