ROVI informs on the evolution of the investigation of particulate matter having been seen in certain drug product vials of the Moderna COVID-19 vaccine distributed in Japan

Laboratorios Farmacéuticos ROVI, S.A. has announced that a formal investigation is continuing to determine what happened in the filling and finishing process of the affected batches

Following the public relevant information published on 26 of August 2021 with registered number 11377, Laboratorios Farmacéuticos ROVI, S.A. (ROVI), in compliance with the information duties set out in article 227 of the Revised Text of the Securities Market Act, as an entity participating in the manufacturing process of Moderna’s vaccine against Covid-19, and in relation to the notification of particulate matter having been seen in certain drug product vials of the vaccine distributed in Japan, informs that the investigation on this event continues to be conducted to determine what happened in the drug product fill/finish manufacturing process of the related batch.

As reported publicly by the laboratory owning the vaccine, Moderna, and the company in charge of distributing the vaccine in Japan, Takeda, unfortunately, the death of two individuals who had received the Moderna covid-19 vaccine have been reported. There is no evidence up-to-date that these deaths are caused by the Moderna covid-19 vaccine. In any event, there is a formal investigation underway to determine whether there is any connection.

As recently reported, the detection of this particulate matter in certain drug product vials is an event that is in the process of being investigated by ROVI in coordination with Moderna, Takeda and the health authorities. ROVI will continue to proactively assist in the investigation of this matter, waiting for its finalisation and the publishing of the relevant conclusions by Moderna and Takeda, of which ROVI will inform in due course.

No votes yet
Madrid, 19th July 2022 The European Investment Bank (EIB) is providing Laboratorios Farmacéuticos Rovi (ROVI) with a new EUR 50 million...
4 min
ROVI REPORTS OPERATING REVENUE GROWTH OF 57% AND NET PROFIT GROWTH OF 123% • Operating revenue increased by 57% to 205.6 million euros...
2 min
Madrid – 08 April, 2022 - Moderna and ROVI Pharma Industrial Services, S.A.U. today announced a recall of one lot (lot #000190A) of the...
2 min