No recall of batch of Janssen Covid-19 vaccine in St Lucia: WHO

St Lucia: The WHO released a statement on April 22, 2022, informing of a rapid alert issued by the Belgian Federal Agency for Medicinal and Health Products.

12th of May 2022

No recall of batch of Janssen Covid-19 vaccine in St Lucia: WHO

St Lucia: The World Health Organization released a statement on April 22, 2022, informing of a 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 the US FDA, WHO concluded that, at present, there is no evidence to question the safety, quality as well as 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 St Lucia is NOT among the recalled batches. Further, the drug product manufacturing site for the batch in St Lucia is Janssen Biologicals BV, Netherlands. In light of this, the Janssen COVID-19 vaccine administered here is safe.

During the past week, we noted an increase in the number of COVID-19 cases reported. The presence of both the Omicron variant and sub-variant has been confirmed in-country, both of which are highly transmissible. Let us take personal responsibility to protect ourselves and loved ones, especially the most vulnerable. Vaccines remain our best protection against COVID-19 and its complications. Therefore, a special appeal is being made to persons who are not yet vaccinated, are partially vaccinated or desire a booster to access COVID-19 vaccines at the wellness centres. “Act responsibly, and get vaccinated”, the ministry of health stated.

The government further asked the public to “Contact the Office of the Chief Medical Officer or the Epidemiology Unit, at 468-5309/468-5317 respectively.”