April 8 (Reuters) – Moderna Inc (MRNA.O) said on Friday it was recalling 764,900 doses of its COVID-19 vaccine made by its contract manufacturer Rovi (ROVI.MC) after a vial was found contaminated by a foreign body.
No safety issues have been identified, Moderna said about the lots that were distributed in Norway, Poland, Portugal, Spain and Sweden in January.
The drugmaker said the contamination was found in just one vial, and it was recalling the whole lot out of “an abundance of caution”. It did not disclose what was found in the vial.
Japanese authorities last year suspended the use of some doses of the vaccine, which Moderna later recalled, after an investigation found stainless steel contaminants in some vials. read more
Over 900 million doses of the Moderna COVID-19 vaccine have been administered worldwide to date.
Moderna said on Friday it did not believe the contamination posed a risk to other vials in the lot.
I can say from past experience that if a foreign body is found in only one vial of vaccine, FDA does not require that the whole lot be recalled. Instead, a certain number of vials must be visually inspected, i.e., looked at.