Considerations on the falsified vaccines

Given the recent regional and global alerts issued by NRAs in the Americas, and by WHO, on incidents involving falsification of COVID-19 vaccines, WHO is issuing the following recommendations for countries’ consideration.  

These falsified vaccines are difficult to detect, as they may appear indistinguishable from genuine vaccine. There is therefore a risk they could be illicitly or accidentally inserted into the regulated supply chain or authorized national immunization programs.  

Reused and refilled vials may sometimes be identified by physical examination. Some indicators that a vial is falsified and may have been illicitly refilled may include: labels show signs of damage; the metal cap is dented, scratched or broken; rubber seals are scratched or punctured; foreign materials/particles are visible inside the vial; visible signs that the expiration date has been changed or tampered with; the expiration date does not match the authentic batch number; and/or the product is available for private sale outside of authorized immunization programs.  

Due to the high risk of discarded vials being recovered, it is essential that they be safely disposed of at the site where they are used. Applying reverse logistics as a possible alternative, if the safe treatment and disposal of vaccine residues cannot be guaranteed, they could be transferred to a location established for that purpose. Failing that, consideration could be given to the possibility of discarded vaccine vials being crushed, if a safe way to do so is available. WHO requests increased vigilance within the supply chains of countries and regions likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies, and any other suppliers of medical products, as they could be affected by the introduction of falsified products.  

It is important to remind health professionals and the general public that all medical products, including COVID-19 vaccines, must be obtained from authorized providers and from national immunization programs. The products’ authenticity and physical condition should be carefully checked.  

National regulatory health authorities are advised to immediately notify WHO if these falsified products are discovered in their country. Any information concerning the manufacture, distribution, or supply of these products should be reported by contacting rapidalert@who.int.  

Sources:

1. World Health Organization. Medical Product Alert N°7/2021: Falsified COVID-19 Vaccine AstraZeneca. Available at: https://www.who.int/news/item/04-11-2021-medical-product-alert-n-7-2021-falsified-covid-19-vaccineastrazeneca.
2. World Health Organization. COVID-19 vaccination: supply and logistics guidance: interim guidance, 12 February 2021. Available at: https://www.paho.org/en/documents/covid-19-vaccination-supply-and-logistics-guidanceinterim-guidance-12-february-2021.