The World Health Organization released a statement on 22 April, 2022, informing of rapid alert issued by the Belgian Federal Agency for Medicinal and Health Products on April 12 of a Class II recall of some Janssen COVID-19 Vaccines. This recall is in keeping with Pharmaceutical Inspection Convention and Pharmaceutical Inspection co-operation Scheme (PIC/S) standards.
This recall is based on a precautionary measure and related to lots produced at the drug substance manufacturer located in USA and drug product batches manufactured between March and July 2021. After consulting US FDA, WHO concluded that at present there is no evidence to question quality, safety and efficacy of the vaccine. However, as a precautionary measure, WHO recommends a temporary suspension of the use of batches of Janssen COVID-19 vaccines, manufactured using drug substance lots from the specific site.
The Ministry of Health has reviewed the information arising from the alert and recognized that the current batch of Janssen COVID-19 vaccines circulating in Saint Lucia is NOT among the recalled batches. Further, the drug product manufacturing site for the batch in Saint Lucia is Janssen Biologicals B.V, Netherlands. In light of this, the Janssen COVID-19 vaccine administered here is safe.