Falsified Covishield vaccine identified in Africa and Asia
WHO urges supply chain stakeholders to be vigilant, after falsified Covishield COVID-19 vaccines were identified in Uganda, India and Myanmar.
The World Health Organization (WHO) has issued a Medical Product Alert (N°5/2021) for a falsified Covishield (ChAdOx1 nCoV-19 Corona Virus Vaccines [Recombinant]) COVID-19 vaccines in the WHO Africa Region and WHO South-East Asia Region.
The WHO stated that the falsified products were reported in July and August 2021, and that the Serum Institute of India – the genuine manufacturer of Covishield – has confirmed that the products are indeed falsified. The products have been reported at the patient level in Uganda, India and Myanmar.
Genuine Covishield vaccine is indicated for active immunisation of individuals 18 years or older for the prevention of COVID-19, the disease caused by the SARS-CoV-2 virus.
Falsified COVID-19 vaccines pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems. It is important to detect and remove these falsified products from circulation to prevent harm to patients.
The products identified in the N°5/2021 alert are confirmed as falsified on the basis that they deliberately/ fraudulently misrepresent their identity, composition or source:
- Batch 4121Z040 – the expiry date (10.08.2021) on this product is falsified
- COVISHIELD 2ml – the genuine manufacturer does not produce Covishield in 2ml (4 doses).
- Batch 4126Z079 – the batch number on this product is falsified and the product name ‘COVISHELD’ is spelt incorrectly
The WHO recommends increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products.
They stated that these falsified products should not be used and that, if they have been used, recipients should seek immediate medical advice from a qualified healthcare professional and report the incident and any adverse events to the National Regulatory Authorities/National Pharmacovigilance Centre.
National regulatory or health authorities are advised to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, the WHO asks that you contact [email protected].
Table 1: Products subject of WHO Medical Product Alert N°5/2021