Johnson & Johnson vaccine, a contaminated batch in the US

One batch of the active ingredient in the Johnson & Johnson vaccine “was contaminated with materials intended for another vaccine manufactured at the same site” in the United States. This was announced by the European Medicines Agency – Ema, specifying that the contamination took place in a site in Maryland owned by Emergent Biosolutions and that “the lot in question was not destined for the EU market” “On the basis of the information available, vaccine batches released in the EU are not affected by cross-contamination. However, as a precaution and to safeguard the quality of vaccines – adds the EU regulatory body – the supervisory authorities have recommended not to release vaccine batches containing the active ingredient produced. around the same time as the contamination occurred. The European authorities are doing everything possible to safeguard the supply and limit the effects of any delays in the delivery of the vaccine “, assures Ema.” The Ema and the national authorities – continues the agency – are also aware of an inspection at the production site of Emergent Biosolutions, conducted by the US Food and Drug Administration (Fda). The authorities will continue to collaborate with the FDA and other international partners to ensure that vaccines in the EU meet the highest quality standards. “” The issue regarding production at Emergent Biosolutions – points out the European regulatory body – is not related to the recent review conducted by the EMA of very rare cases of blood clots and low platelet levels “.