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What do we know about the Sinopharm vaccine's approvals and clinical trials?

This article was published on
April 21, 2021

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As of February 19, 2021, the World Health Organization (WHO) has approved the Pfizer/BioNTech COVID-19 vaccine (December 31, 2020) and two versions of the AstraZeneca/Oxford COVID-19 vaccine (February 15, 2021) under its Emergency Use Listing (EUL).  The Sinopharm inactivated virus COVID-19 vaccine is being developed and produced in conjunction with the China National Biotec Group and the Beijing Institute of Biological Products. The vaccine is in phase three trials in Argentina, Jordan, Egypt, Bahrain, and United Arab Emirates. Sinopharm is pursuing emergency approval and, according to WHO records dated January 20, 2021, Sinopharm submitted study data and safety, efficacy, and quality information to the WHO in December 2020. The assessment is ongoing and a decision could be made as early as March. Another Sinopharm COVID-19 vaccine is being tested in conjunction with the China National Biotec Group and the Wuhan Institute of Biological Products. This vaccine is currently in phase three trials in Jordan, Egypt, Bahrain, Morocco, Peru, and United Arab Emirates. According to WHO documentation dated January 20, 2021, there has not been a pre-submission meeting or further pursuit of emergency approval for this vaccine. 

As of February 19, 2021, the World Health Organization (WHO) has approved the Pfizer/BioNTech COVID-19 vaccine (December 31, 2020) and two versions of the AstraZeneca/Oxford COVID-19 vaccine (February 15, 2021) under its Emergency Use Listing (EUL).  The Sinopharm inactivated virus COVID-19 vaccine is being developed and produced in conjunction with the China National Biotec Group and the Beijing Institute of Biological Products. The vaccine is in phase three trials in Argentina, Jordan, Egypt, Bahrain, and United Arab Emirates. Sinopharm is pursuing emergency approval and, according to WHO records dated January 20, 2021, Sinopharm submitted study data and safety, efficacy, and quality information to the WHO in December 2020. The assessment is ongoing and a decision could be made as early as March. Another Sinopharm COVID-19 vaccine is being tested in conjunction with the China National Biotec Group and the Wuhan Institute of Biological Products. This vaccine is currently in phase three trials in Jordan, Egypt, Bahrain, Morocco, Peru, and United Arab Emirates. According to WHO documentation dated January 20, 2021, there has not been a pre-submission meeting or further pursuit of emergency approval for this vaccine. 

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What our experts say

As of February 19, 2021, the World Health Organization (WHO) has approved the Pfizer/BioNTech COVID-19 vaccine (December 31, 2020) and two versions of the AstraZeneca/Oxford COVID-19 vaccine (February 15, 2021) under its Emergency Use Listing (EUL). 

The Sinopharm inactivated virus COVID-19 vaccine is being developed and produced in conjunction with the China National Biotec Group and the Beijing Institute of Biological Products. The vaccine is in phase three trials in Argentina, Jordan, Egypt, Bahrain, and United Arab Emirates. Sinopharm is pursuing emergency approval and, according to WHO records dated January 20, 2021, Sinopharm submitted study data and safety, efficacy, and quality information to the WHO in December 2020. The assessment is ongoing and a decision could be made as early as March.

Another Sinopharm COVID-19 vaccine is being tested in conjunction with the China National Biotec Group and the Wuhan Institute of Biological Products. This vaccine is currently in phase three trials in Jordan, Egypt, Bahrain, Morocco, Peru, and United Arab Emirates. According to WHO documentation dated January 20, 2021, there has not been a pre-submission meeting or further pursuit of emergency approval for this vaccine. 

Context and background

The World Health Organization (WHO) may approve medications, vaccines, or other health products for Emergency Use Listing (EUL) during public health emergencies, with the goal of making these new therapies available as soon as possible. The approval process includes a very strict review of safety, efficacy and quality as well as the potential risks and benefits of the product’s potential use.

During the COVID-19 pandemic, WHO emergency approval is required before the vaccine can be considered for COVAX Facility vaccine supply. The WHO emergency approval also allows “countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.”

Even once a vaccine has received emergency approval from the WHO, the WHO will continue to monitor and assess data from vaccine trials and vaccine use in the general population. This monitoring and assessment process is to ensure that the vaccines meet required quality, safety, and efficacy standards.

Resources

  1. WHO lists two additional COVID-19 vaccines for emergency use and COVAX roll-out (WHO)
  2. The COVID-19 candidate vaccine landscape, version dated February 19, 2021 (WHO)
  3. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process, version dated 20 January 2021 (WHO)

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