December 8, 2022

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COVID-19 Vaccine: What is the WHO Emergency Use List (EUL) ?

COVID-19 Vaccine: What is the WHO Emergency Use List (EUL) ?



 

 

COVID-19 Vaccine: What is the WHO Emergency Use List (EUL) ?   What is the emergency use list and what does being included in the list mean for China’s vaccines?

 

On May 7, the Director-General of the World Health Organization (WHO) Tan Desai announced that the WHO has included the COVID-19 vaccine developed by the Beijing Institute of Biology of China National Pharmaceutical Group (SINOPHARM) on the Emergency Use Listing (EUL).

 

Obtaining this authorization means that China will be able to provide more COVID-19 vaccines to other countries in need around the world through international multilateral mechanisms.

 

This is undoubtedly exciting news, because this is the first Chinese COVID-19 vaccine approved by the World Health Organization for emergency use and the first non-Western country’s COVID-19 vaccine approved by the World Health Organization.

 

According to Reuters, this will promote China to play an important role in global COVID-19 vaccination.

 

 

COVID-19 Vaccine: What is the WHO Emergency Use List (EUL) ?

 

 

 


1. What is the WHO Emergency Use List (EUL) ?

According to the WHO website, the emergency use list began with the Ebola epidemic and was named Emergency Use Assessment and Listing (EUAL). In May 2017, WHO simplified EUAL to EUL.

 

As a mechanism formed by WHO to assess the applicability of new health products in public health emergencies, the purpose of this list is to provide medicines, vaccines and diagnostic tools as soon as possible.

 

During the evaluation process, WHO will strictly review the data from the final phase of the second phase and the third phase of clinical trials of the vaccine, as well as a large number of additional data on safety, effectiveness, quality and risk management plans.

 

Vaccine manufacturers must commit to continuing to generate data until the vaccine is fully licensed and pre-certified by WHO. The WHO pre-certification program will evaluate more clinical data generated by vaccine trials and deployment in a rolling manner to ensure that the vaccine meets the necessary quality, safety and effectiveness standards, thereby expanding the vaccine supply.

 

According to the latest data released by WHO on May 4th, five domestic vaccines, including Kexing vaccine, Cansino vaccine, Zhifeilongkoma vaccine, vaccine from the Institute of Biology of the Chinese Academy of Medical Sciences, and the vaccine from the Wuhan Institute of Biology of the Chinese Medicine, are currently in emergency use In the list of candidates.

 

 

 

 


2. What is the impact of being included in the emergency use list on vaccines?

Prior to this, the WHO has included five new coronavirus vaccines on the emergency use list, namely Pfizer-Biontech vaccine, two AstraZeneca-Oxford vaccines, Johnson & Johnson vaccine and Moderna vaccine.


Sinopharm’s COVID-19 vaccine is the first inactivated vaccine to be included in the WHO’s emergency use list. Some commentators believe that this allows it not only to be included in the WHO’s “New coronavirus Pneumonia Vaccine Implementation Plan” (COVAX), but also to clear the barriers to its entry into the European Union.

 

In October 2020, China formally signed an agreement with the Global Alliance for Vaccines and Immunization to join the COVAX program. Foreign Ministry spokesperson Hua Chunying said that China’s participation in the plan is “to promote the fair distribution of vaccines with practical actions and ensure the supply of vaccines to developing countries.”

 

According to China Biotech, up to now, the Sinopharm China Biotech Covid-19 vaccine has been approved for registration or emergency use in 70 countries and regions and international organizations around the world. More than 100 countries and international organizations have put forward procurement requirements and have supplied more than 200 million doses at home and abroad. , The vaccination has covered 196 national populations.

 

What’s exciting is that on May 4, local time, the European Medicines Agency (EMA) also started a rolling trial of the Chinese Kexing vaccine to evaluate its effectiveness and safety. The first step of vaccination for member states.

 

EMA stated that the decision to start the review is based on preliminary results of laboratory and clinical studies, which show that the vaccine can trigger the production of antibodies against the new coronavirus and help prevent the new coronavirus caused by the virus. EMA did not disclose the time frame for the rolling approval of Kexing vaccine, but stated that it “should be less than the normal approval time.”

 

 

 

COVID-19 Vaccine: What is the WHO Emergency Use List (EUL) ?

(source:internet, reference only)


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