Rovi has starred in a new manufacturing error with Moderna’s vaccines. The affected sera have been detected in several European countries and the American biotech company has acknowledged that 764,900 doses could have been affected, although it also said that the withdrawal was as a precaution and not because it had already verified contamination. The affected countries have been Spain, Sweden, Norway, Poland and Portugal.
The Spanish Medicines Agency has hastened to withdraw them from circulation in our country. The agency under the Ministry of Health issued yesterday the order to withdraw batch 000190A due to the presence of a foreign body inside a vial. “The affected vial was identified in a vaccination center, it was segregated and it was not administered to any patient,” says the Agency.
The entity explains that the withdrawal was adopted “as a preventive measure, since the incidence has only been detected in a single unit, and it is not expected that there will be more affected units in the lot.” Rovi says it is carrying out investigations to determine the cause of the problem and prevent its recurrence. In statements to El Economista, they rule out that the incident has anything to do with the incidence they suffered in the summer with some doses that arrived in Japan and that he received a large bill on the stock market.
On that occasion, the most probable cause of the particles identified was related to friction between two metal pieces installed in the capping module of the production line due to incorrect installation. The investigation carried out by the pharmaceutical companies involved (Rovi, Moderna and Takeda, in charge of distribution in Japan) was closed, ruling out the contamination produced by the two deaths that occurred.
Aemps has already carried out inspections at the manufacturing plant to verify that the control measures are adequate and thus guarantee the correct development of the investigation. “The manufacture of vaccines is carried out under highly standardized and internationally regulated conditions (Rules for the Correct Manufacture of Medicines) to minimize the risk of this type of event and, in the event that they occur, allow their detection before they occur.” its release to the market.
However, despite these precautions and their low frequency, these events can happen given the very high number of doses manufactured,” says the agency dependent on Health.
Currently, Moderna has put more than 900 million doses on the market worldwide. The Agency stresses that there is no reason to panic. “The available data allow us to conclude that there is no risk for patients who have received any dose of the batch, so it is not necessary for them to adopt any type of special measure,” stresses the health entity.
A long-term collaboration
The relationship between Moderna and Rovi has been consolidated for the long term. When the incident with Japan occurred, the American biotech already assured that its relationship with the Madrid company had not changed at all.
The vaccine has meant a before and after for Rovi in its income statement. The evolution of its manufacturing business for third parties has gone from billing 91.6 million euros in 2020 to 264.7 million last year, almost triple. Of course, Rovi was not unknown in 2019, but today it is one of the 35 most relevant companies in the country.
A few months ago, the Madrid pharmaceutical company announced that it was expanding its collaboration with Moderna for the next ten years. Therefore, beyond the Covid, Rovi will be one of the main manufacturers of the new drugs of the American biotech.
Facebook Comments
Disqus