Japan stops use of 1.63 million Moderna doses over contamination

Japan suspends 1.63M doses of Moderna over contamination
This June 14, 2021, file photo shows a Moderna COVID-19 vaccine vial that is being administered for flight attendants of Japan Airlines ar Haneda Airport in Tokyo. Japan's health ministry said Thursday, Aug. 26, 2021 that it is suspending use of about 1.63 million doses of COVID-19 vaccine produced by Moderna Inc. after contamination was found in portions of unused vials, raising concern of a supply shortage as the country desperately tries to accelerate vaccinations amid the surge of infections. Credit: AP Photo/Eugene Hoshiko, File

Japan will halt the use of 1.63 million doses of Moderna's COVID vaccine after reports of contamination in several vials, drugmaker Takeda and the health ministry said Thursday.

Takeda, which is in charge of sales and distribution of the Moderna shot in Japan, said it had "received reports from several vaccination centres that foreign substances have been found inside unopened vials".

"Upon consultation with the health ministry, we have decided to suspend the use of the vaccine" from three batches from Thursday, it added.

The firm said it had informed Moderna and "requested an urgent investigation".

In a statement, Moderna said the reported contaminations involved "one product lot distributed in Japan".

"Moderna believes the manufacturing issue was generated in one of the lines used at its contract manufacturing site in Spain," it added, saying so far "no safety or efficacy issues have been identified".

"Out of an abundance of caution, Moderna has put this lot and two adjacent lots on hold," it said, without specifying the nature of the contamination.

"We have not received reports of health problems stemming from the foreign object," top government spokesman Katsunobu Kato told reporters.

Japan suspends 1.63M doses of Moderna over contamination
This July 1, 2021, file photo shows syringes with the Moderna vaccine against COVID-19 disease for Tokyo Metropolitan Government employees at a newly opened vaccination center at the government building, Japan's health ministry said Thursday, Aug. 26, 2021 that it is suspending use of about 1.63 million doses of COVID-19 vaccine produced by Moderna Inc. after contamination was found in portions of unused vials, raising concern of a supply shortage as the country desperately tries to accelerate vaccinations amid the surge of infections. Credit: AP Photo/Eugene Hoshiko, File

"But we are asking people to consult their physicians if they experience any abnormality."

Contaminants were seen in 39 unopened vials at eight vaccination locations in central Japan, including Tokyo, according to national broadcaster NHK.

The defence ministry said doses from a suspended batch had been administered between August 6 and 20 at its mass vaccination centre in the western city of Osaka.

However, staff visually check vials for contaminants before injecting the formula, the ministry said, adding that its Tokyo vaccination centre was not affected.

Kato said there had been no "concrete reports" that doses confirmed to contain contaminants had been administered.

The reported contaminations involved batches of Moderna doses prepared by Spanish pharma company Rovi, Moderna's vaccine manufacturing partners outside the United States.

The Spanish health ministry said Rovi was "investigating the causes of these quality problems" under the supervision of Spain's medicines agency AEMPS.

Japan suspends 1.63M doses of Moderna over contamination
In this June 30, 2021, file photo, a health worker prepare a dose of the Moderna COVID-19 vaccine at Sumida ward of Tokyo. Japan's health ministry said Thursday, Aug. 26, 2021 that it is suspending use of about 1.63 million doses of COVID-19 vaccine produced by Moderna Inc. after contamination was found in portions of unused vials, raising concern of a supply shortage as the country desperately tries to accelerate vaccinations amid the surge of infections. Credit: AP Photo/Eugene Hoshiko, File

"All available information indicates that there are no other affected batches," it added in a statement.

Japan's health ministry said it would work with Takeda to secure alternative doses to avoid disruption to the country's vaccine programme, which has ramped up after a slow start.

Takeda declined to provide further details, citing Moderna's investigation. But a company spokesman said the firm encouraged the public to seek vaccine shots.

Around 43 percent of Japan's population has been fully vaccinated, as the country battles a record surge of virus cases driven by the more contagious Delta variant.

Over 15,600 people have died from COVID-19 in the country, and large parts of Japan are under virus restrictions.


Explore further

Japan gives preliminary OK to 2 more COVID-19 vaccines

© 2021 AFP

Citation: Japan stops use of 1.63 million Moderna doses over contamination (2021, August 26) retrieved 27 October 2021 from https://medicalxpress.com/news/2021-08-japan-163m-doses-moderna-contamination.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
13 shares

Feedback to editors