US federal agencies have told multinational Johnson and Johnson that around 60 million doses of their Janssen vaccine cannot be administered due to the risk of possible contamination, sources associated with the conversation told the New York Times.
The cans were made at an Emergent BioSolutions facility in Baltimore, which was closed for two months due to an investigation after it was discovered that its employees mixed the wrong ingredients in making a batch of vaccine.
Exactly ten million doses of Emergent are part of the package of vaccine donations that the United States intends to make available to the international community. Johnson and Johnson have not yet commented on this information.
While the FDA has confirmed that this particular batch is fit for use, it must be accompanied by a notice that regulators cannot confirm that Emergent followed “good recommended practices” in manufacturing the vaccine.
The FDA has determined that several other batches are unsuitable for use, but additional batches are still being investigated and the agency will inform the public of the completion of these tests.
Additionally, the FDA extended the expiration date of the Janssen COVID-19 chilled vaccine after reviewing the information submitted and determining that the vaccine can be stored at 2-8 degrees Celsius for four and a half months instead of three.
For its part, the European Medicines Agency (EMA) announced this Friday about its findings on a batch of the active ingredient in the Janssen COVID-19 vaccine that is “contaminated with materials for another vaccine manufactured at the same location” and is targeting Baltimore Factory, “has indicated that the batch in question is not intended for the EU market.”
According to the information available, the EMA points out that the Janssen vaccine batches in the EU “were not affected by cross-contamination”, but “as a precautionary measure and to ensure the quality of the vaccines”, the supervisory authorities do not recommend processing batches “at about the same time as the contamination “.