News: 1.6 million Moderna doses withdrawn in Japan over contamination (update: more contamination)

[Arcadia]

https://asia.nikkei.com/Spotlight/Coronavirus/1.6m-Moderna-doses-withdrawn-in-Japan-over-contamination
“TOKYO/ NEW YORK -- About 1.6 million doses of Moderna's coronavirus vaccine have been taken out of use in Japan because of contamination reported in some vials, the Ministry of Health, Labor and Welfare said early Thursday.

Several vaccination centers have reported that vaccine vials contained foreign matter, according to an announcement from the ministry, which added it will seek to minimize the impact of the withdrawal on the country's inoculation program.

…

"The company is investigating the reports and remains committed to working transparently and expeditiously with its partner, Takeda, and regulators to address any potential concerns," a Moderna spokesperson told Nikkei, saying the drugmaker believed a "manufacturing issue" at a plant in Spain was the cause.

The vaccine lot in question and two adjacent lots have been put on hold "out of an abundance of caution," the spokesperson said.

The ministry has not halted the use of Moderna vaccines in other batches, deeming them safe.”

Edited September 2, 2021 by Arcadia

[RootAnn]

Maybe 'dem 'der microchips finally got into a batch...

[fraidycat]

35 minutes ago, Arcadia said:

https://asia.nikkei.com/Spotlight/Coronavirus/1.6m-Moderna-doses-withdrawn-in-Japan-over-contamination
“TOKYO/ NEW YORK -- About 1.6 million doses of Moderna's coronavirus vaccine have been taken out of use in Japan because of contamination reported in some vials, the Ministry of Health, Labor and Welfare said early Thursday.

Several vaccination centers have reported that vaccine vials contained foreign matter, according to an announcement from the ministry, which added it will seek to minimize the impact of the withdrawal on the country's inoculation program.

…

"The company is investigating the reports and remains committed to working transparently and expeditiously with its partner, Takeda, and regulators to address any potential concerns," a Moderna spokesperson told Nikkei, saying the drugmaker believed a "manufacturing issue" at a plant in Spain was the cause.

The vaccine lot in question and two adjacent lots have been put on hold "out of an abundance of caution," the spokesperson said.

The ministry has not halted the use of Moderna vaccines in other batches, deeming them safe.”

While this is sucky and sad, and hopefully doesn't interrupt their vaccination progress too much...

30 minutes ago, RootAnn said:

Maybe 'dem 'der microchips finally got into a batch...

This is hilarious. 😂 Much needed levity. Good job!

[Arcadia]

49 minutes ago, RootAnn said:

Maybe 'dem 'der microchips finally got into a batch...

My first thought was German grammar 😂 (der Mikrochips)

[Ausmumof3]

Eek.  Hope this doesn’t impact progress too much and no one was hurt by the contaminated batch.  Public trust is so critical right now.

[Arcadia]

https://www.reuters.com/world/asia-pacific/japan-finds-another-moderna-vial-suspected-contain-foreign-substance-2021-09-01/
“TOKYO, Sept 1 (Reuters) - Japan reported a fresh contamination case involving Moderna's (MRNA.O) COVID-19 vaccine, the fourth such incident in less than a week, threatening to slow the country's sputtering inoculation campaign.

Kanagawa prefecture said on Tuesday several black particles in one Moderna vaccine vial were found upon checking for foreign substances before its use, and it has put the rest of the lot on hold.

Japan suspended the use of 1.63 million doses of Moderna shots last week after being notified of contamination in some of the supply. Moderna and Spanish pharma company Rovi (ROVI.MC), which bottles Moderna vaccines, have said the cause could be a manufacturing issue, and European safety regulators have launched an investigation.

… More Moderna shots were temporarily halted in two other regions this week. In some cases, foreign substances have been found in unused vials, whereas others appear to be caused when bits of the vials' rubber stopper break off when needles are incorrectly inserted.

Takeda did not immediately respond to a request for comment on the Kanagawa incident. The company posted a notice on its website on Wednesday saying that on rare occasions during manufacturing, rubber stopper material can get mixed into the vaccine solution.

Japan's health ministry, citing an investigation by Takeda, said on Wednesday that the vial sent to Kanagawa was from a different lot than the other lots, and rubber stopper material appears to have gone into it during the manufacturing process.

Rovi did not have an immediate comment to a Reuters' request for an update on its investigation.

Medical staff are advised to do a visual inspection of vials for discoloration or foreign materials before use, the notice said.”