Vaccines not procured through government purchases from certified providers and offered by authorized national immunization circuits are presumed to be counterfeit and dangerous to health.
WASHINGTON, DC - The Pan American Health Organization (PAHO) urges people to get vaccinated against COVID-19 only through national immunization programs and officially authorized mechanisms and warns that doing so outside these channels can be dangerous to their health.
The recommendation comes in response to reports of counterfeit or unauthorized vaccines in some Latin American countries, such as Bolivia, Colombia, and Mexico, and to press reports of vaccines being administered outside authorized national immunization programs. In March, WHO issued a global alert on the counterfeit Pfizer/BioNtech vaccine in Mexico.
People are advised to use only authentic vaccines as directed by national authorities, to seek the advice of a health professional if in doubt, and, if they know of any suspicious incidents, to report them to the authorities so that the products can be identified and withdrawn from circulation.
The COVID-19 pandemic has led to an increase in incidents of substandard, counterfeit, and unregistered medical products worldwide. In particular, the limited availability of vaccines appears to be contributing to the emergence of products in illegal channels, ranging from Internet sales offers to customs seizures to retail trade.
Substandard, counterfeit, and unregistered vaccines can lead to increased prevalence of COVID-19, potential adverse and even toxic or fatal events, and loss of trust in the health system, as well as social and economic consequences of unpredictable magnitude.
Recommendations to regulatory authorities
PAHO urges strengthening coordination between health, law enforcement, and customs authorities regarding prevention, detection, and response to incidents of substandard, counterfeit products. PAHO also urges increased comprehensive surveillance of the COVID-19 vaccine supply chain from the manufacturer or certified supplier to the patient or site of administration.
Health authorities are also advised to keep vaccines in their original secondary packaging during storage and transport to protect the QR and bar codes, which allow verification of product information throughout the distribution chain. Increased surveillance of illegal offers of COVID-19 vaccines, especially on the Internet, social networks, and retail outlets is also recommended.
Other recommendations are to implement strategies for the destruction and/or final disposal of packaging, containers, vials, boxes, and labels of legitimate vaccines used in national immunization schemes; to ensure a robust traceability mechanism for COVID-19 vaccines to minimize the risk of detour from the legal channel; and to immediately notify WHO - through the rapid alert system - of any suspected or confirmed vaccine counterfeiting.
PAHO, through cooperation with countries, and the operation of the Network of Focal Points of National Regulatory Agencies for the Prevention, Detection, and Response to substandard, counterfeit or unregistered Medical Products - comprising more than 20 countries in the region - promotes the exchange of information and supports decision-making in this field.