The World Health Organization (WHO) has approved Sinopharm’s Vero Cell COVID-19 vaccine for use in emergencies, making it eligible for use worldwide. Vero Cell is manufactured by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG).
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) completed its review of the Vero Cell vaccine and recommended it for adults aged 18 years and older on a two-dose regimen administered 3 to 4 weeks apart;
The efficacy of Vero Cell COVID-19 against symptomatic disease and hospitalization was estimated at 79% for all age groups combined. Few adults over 60 years of age were included in the clinical trial, so efficacy could not be evaluated in this age group. However, WHO does not recommend an upper age limit for the vaccine because preliminary and maintenance immunogenicity data suggest that the vaccine is likely to have a protective effect in older adults. There is no theoretical reason to believe that the vaccine has a different safety profile for older and younger adults.
Inclusion on the WHO Emergency Use List is a prerequisite for vaccine supply under the COVAX program. This assesses the quality, safety and efficacy of the vaccine, as well as risk management plans and programmatic suitability, such as cold chain requirements. According to WHO, Sinopharm’s Vero Cell has simple storage requirements, making it very suitable for resource-limited settings. It is also the first vaccine that will have a vaccine vial monitor, a small sticker on the vials that changes color when the vaccine is exposed to heat so that health workers know if it is safe to use.
COVID-19 vaccines included in the WHO Emergency Use List:
- Comirnaty vaccine, Pfizer and BioNTech.
- AstraZeneca vaccines
- SKBio – COVID-19 (ChAdOx1-S [recombinant]) vaccine
- Serum Institute of India Pvt Ltd – COVID-19 (ChAdOx1-S [recombinant]) vaccine – COVISHIELD™.
- Vaccine Janssen COVID-19 (Ad26.COV2.S).
- Vero Cell vaccine (inactivated).
Immediately after the vaccine was placed on the WHO Emergency Use List the European Medicines Agency (EMA) announced that it is launching its floating review, during which it will evaluate all data on the efficacy, safety and quality of the vaccine as they become available. The EMA will also assess Vero Cell’s compliance with routine EU standards and decide whether the benefits of using the vaccine outweigh the possible risks. Once enough data has been accumulated, Sinopharm will be able to submit a formal application for approval of the vaccine in the EU.
Shutterstock/FOTODOM UKRAINE photos were used
