posted on 8/26/2021 1:22 PM / updated on 8/26/2021 1:36 PM
(credit: GUILLAUME SOUVANT / AFP)
Japan announced this Thursday (26) that it has suspended the use of 1.63 million doses of Moderna’s anti-covid-19 vaccine, after detecting impurities in some vials that, according to local press, were manufactured in Spain.
The Spanish Ministry of Health estimated, on Thursday (26), that the only batches of the Anticovid vaccine from Moderna produced in Spain and which contained impurities are those removed by Japan.
“All available data indicate that there are no other batches affected,” explained the Ministry of Health in a statement transmitted to AFP.
The ministry added that the impurity vaccine “has not been distributed to any other country.”
“Both the Japanese and Spanish authorities are assessing the risk of the presence of these particles and based on this analysis we will take the necessary measures,” said the Spanish ministry.
Health authorities stated that “ROVI is already working on investigating the causes of these quality problems” under the supervision of the Spanish Agency for Medicines and Sanitary Products (AEMPS).
ROVI shares fell more than 13% on the Madrid Stock Exchange.
“With regard to the particulate detection notification of certain vaccine vials distributed in Japan, we are currently conducting an investigation into what happened,” the company said in a statement.
In a statement, Moderna estimated that “the manufacturing problem occurred on one of the production lines used at its contracted manufacturing center in Spain”, saying that so far “it has not identified any safety or efficacy issues”.
In a statement, Japanese pharmaceutical group Takeda, which imports and distributes this vaccine in Japan, said it had received “reports from various vaccination centers that foreign bodies were discovered” in sealed vials.
“After consultation with the Ministry of Health, we decided to suspend the use” of all vaccines from three batches, or 1.63 million doses in total, the group added.
Takeda called the American laboratory Moderna to carry out an “urgent investigation” of these batches that, according to local media, were produced in Spain.
The impurities were detected in 39 vials at eight vaccination centers in Japan, according to public television broadcaster NHK.
The vials belonged to only one of the three designated lots. As a precaution, the other two were also removed, government spokesman Katsunobu Kato said on Thursday.
At a press conference, the spokesman assured that “nothing indicates” that the incriminated doses had been administered.
Medical personnel often inspect the vials before injecting the doses, said the Japanese Defense Ministry, which runs the immunization centers.
About 43% of the population is fully vaccinated in Japan, which is currently facing record daily levels of infections because of the delta variant.