11th May 2022

No recall of the batch of Janssen COVID-19 vaccine in Saint Lucia

By Ministry Of Health

The World Health Organization released a statement on 22 April, 2022, informing of a rapid alert issued by 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.

During the past week, we note an increase in the number of COVID-19 cases reported. The presence of both the Omicron variant and sub-variant has been confirmedin-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; partially vaccinated or desire a booster to access COVID-19 vaccines at the wellness centers. Act responsibly, get vaccinated.

For more information please contact the Office of the Chief Medical Officer or the Epidemiology Unit, at 468-5309/468-5317 respectively.

TO RECEIVE NEWS NOTIFICATIONS And Covid NEWS VIA WHATS APP PLEASE SAVE OUR NUMBER AND SEND US A MESSAGE AT 7584896261 AND WE WILL ADD YOU TO OUR LIST