GIF denies reports of quality defects in Janssen's XD955 vaccine series

Covid-19 vaccines are registered in a central procedure. This means that the European Medicines Agency (EMA) has taken over supervision of their safety. In turn, inspections at the vaccine manufacturer are carried out by the agency from the country where the production facility is located.

The EMA has exchanged information on the safety of these medicinal products with the drug agencies of EU member states throughout the SARS CoV-2 virus pandemic. One of the EMA's communication platforms with national drug agencies is the Rapid Alert System. We explain how the drug agencies communicated through this system in the case of Janssen's vaccine with batch number XD955.

April 2021

In April 2021, the FDA (U.S. Food and Drug Administration) conducted an inspection at the facility,
, where the active ingredients used in Janssen's vaccines were manufactured. The inspectors conducting the inspection raised concerns about insufficient control over the conditions under which the active ingredient of one of the vaccines was manufactured. The FDA then obliged the manufacturer to implement clarifying and corrective actions. This action was reported by the FDA to the EMA, which forwarded the information to national drug agencies.

The EMA also informed the agencies that the FDA had identified 1 batch of the active substance for which a quality defect (cross-contamination) was found, but that the batch was not intended for the EU market.

In addition, the EMA conveyed that it would be assessing possible additional risks for the XD955 series, which was the only one distributed on the European market. It then communicated to the member countries' drug agencies in the Rapid Alert system (the information, not the Rapid Alert document) that in the absence of evidence of contamination of the batch of active ingredient used to manufacture the XD955 vaccine series, it does not recommend withholding the administration of the vaccine series in question to patients.

The GIF, like other drug agencies in Europe, has implemented the EMA guidelines.

Rapid Alert or Rapid Alert information?

The Rapid Alert System operates continuously, 24/7; if there was any information
as part of the investigation of the risk assessment for this batch, the EMA would send the information to the drug agencies. Procedures are in place at the GIF for staff to monitor the Rapid Alert System at all times; in addition, a phone number is provided within the Rapid Alert System for 24/7 contact with a GIF representative.

We make a clear distinction between the information in the Rapid Alert system and the Rapid Alert itself as a document that obliges drug agencies to take action according to the deadlines imposed by the EMA.

The content in the public space, saying that the GIF did not take action despite receiving a Rapid Alert, is itself contradictory, because that Rapid Alert was not there. And it wasn't there because the API batch for which the quality defect (cross-contamination) was found was not intended for the EU market. Therefore, there was no reason or basis to implement additional investigations on the Polish side - other drug agencies acted in exactly the same way. There were no health risks to patients from taking the XD955 series of Janssen vaccine.

The actual and first Rapid Alert of April 2022 was issued by the Belgian drug agency, and other agencies followed the recommendation, preemptively withdrawing all vaccine series made with active ingredients from Janssen. Why? Because concerns from a year ago about inadequate control over the manufacturing conditions of this vaccine were upheld. No quality defect was ever found for the XD955 series, which was taken by Polish patients.

Source: GIF