EU Stops Use Of Johnson & Johnson

( Last Friday, the European Union’s drug regulator announced that it will not use any batches of the Johnson & Johnson COVID vaccine made at Emergent Biosolutions in Baltimore, Maryland after manufacturing problems were reported at its facility.

In March 2021, a factory mix-up at the Baltimore plant resulted in a batch of the active substance used in the one-shot vaccine getting contaminated with materials for another vaccine also manufactured by Emergent Biosolutions. The mix-up delayed shipments of the J & J vaccine until the FDA could investigate the incident.

However, in announcing its suspension of the vaccine, the European Medicines Agency assured the public that none of the vaccines the EU obtained from Emergent Biosolutions were affected by this contamination. However, “as a precaution and to safeguard the quality of vaccines,” the EU would suspend the use of any J & J doses made at around the same time the contamination occurred.

According to anonymous sources, it was reported on Friday that up to sixty million doses of the J & J COVID vaccine are getting trashed due to possible contamination. It is believed that the EU’s decision was prompted by these reports.

However, neither the FDA or Johnson & Johnson have confirmed or denied what these anonymous sources have claimed.

The FDA, meanwhile, announced last Thursday that two batches manufactured at the Baltimore plant can still be used under the Emergency Use authorization. Several other batches, however, were not suitable for use and additional batches are still under review.

In the same press release, the FDA also announced that they have extended the expiration date for refrigerated doses of the J & J vaccine from three months to four and a half months.

After the mix-up was discovered, Emergent Biosolutions determined the contamination was caused by “human error.” That human error resulted in more than fifteen million doses of the Johnson & Johnson vaccine being ruined, and forced regulators to delay authorization of the plant’s production lines.

In addition to bulk manufacturing the Johnson & Johnson vaccine, Emergent Biosolutions also manufactures doses of the AstraZeneca vaccine as well.

The FDA has assured that none of the contaminated doses were ever distributed to the public.