NATIONAL NEWS - The South African Health Products Regulatory Authority (Sahpra) announced in a statement on Monday 22 November that the Emergent BioSolutions facility in Baltimore, Maryland, has been found to be compliant and therefore approved batches of the Janssen vaccine, that contains a drug substance manufactured at this facility, will again be allowed to be imported.

In June, Sahpra said that South Africa would not accept any product or ingredients made at the Emergent BioSolutions facility until the inspectorate has conducted an on-site/remote inspection.

After a joint inspection by Sahpra, the European Medicines Agency (EMA) and Health Canada, all three regulators found the facility to be compliant with good manufacturing practices (GMPs), said Sahpra. EMA and Sahpra participated remotely while Health Canada performed the inspection of the facility on site.

Sahpra, EMA and Health Canada’s compliant rating means Janssen will be able to import its vaccine that was made with the drug substance manufactured at the Emergent BioSolutions facility into South Africa, Europe and Canada. The three regulators are communicating with Janssen in the respective countries to confirm which lots of their Covid-19 vaccine they plan to distributet to the countries in the coming months. Only vaccine lots that meet these requirements will be released onto the South African and related markets.