Prime Minister Yoshihide Suga said Thursday that the government’s decision to suspend use of some 1.63 million doses of Moderna Inc.’s COVID-19 vaccine — a move that followed the discovery of foreign materials in one batch — will have little impact on its national vaccine rollout plans.
“I’ve received a report from the health ministry saying that it will not have a big impact,” Suga told reporters. “I have instructed the health ministry that safety is the top priority.”
Nonetheless, the incident is another bump in the road for Suga’s goal of completing both rounds of vaccination for 80% of all residents by early October.
Earlier in the day, the health ministry said that the foreign substance had been identified in 39 vials, all of which had the lot number 3004667, at eight workplace and large-scale inoculation sites in five prefectures — Aichi, Ibaraki, Gifu, Saitama and Tokyo — since Aug. 16. The ministry has decided to no longer use the around 570,000 doses with the lot number.
In addition, the use of 1.06 million doses with the lot numbers 3004734 and 3004956 has also been suspended as a precaution, as they were manufactured around the same time and on the same manufacturing line in Spain. The decision was made after the government consulted with Takeda Pharmaceutical Co., which is in charge of distribution in Japan on behalf of Moderna.
Some vials with one of the three suspended lot numbers have already been used, and it is not clear whether that includes any of the 39 vials with the foreign substance.
People who received the Moderna vaccine can check if they received one of the affected vials by looking at the lot number stamped on their proof of COVID-19 vaccination.
Takeda said it is working with the health ministry to supply replacement vials to minimize the impact on the vaccination rollout. As of Tuesday, 42.6% of the nation’s residents had been fully vaccinated, according to Cabinet Office data.
The affected vials had already been delivered to 863 vaccination centers across the nation. The government said it has urged a halt to their use, and asked those who have received shots with those lot numbers to go to a doctor if they have any health problems.
Chief Cabinet Secretary Katsunobu Kato said Thursday that there have been no reports of ill health from contaminated doses, or of foreign materials in other batches of the Moderna vaccine that have been distributed in Japan.
The government has signed a contract for 50 million Moderna shots by the end of September. So far, about 18 million Moderna doses have been used, mainly at mass inoculation centers run by the central government and prefectures, since it won the health ministry’s approval for emergency use in May. That compares with the 104 million Pfizer Inc. doses and 1,093 AstraZeneca shots administered as of Tuesday, according to the Cabinet Office data. Moderna and Pfizer’s messenger RNA vaccines have been authorized for use in Japan in people age 12 and older.
Takeda said Moderna has been conducting an investigation into the matter. The foreign substances are believed to be the size of a few millimeters, and their exact nature is unknown, Kyodo News reported. Pieces of rubber have been found in Moderna doses overseas, according to media reports.
"To date, no safety or efficacy issues have been identified," the Kyodo news agency quoted Moderna as saying, adding that the U.S. firm is "carefully assessing this matter and at this point does not have further comments on root causes."
Meanwhile, Japan Airlines Co. and All Nippon Airways Co. said they halted workplace vaccinations on Thursday, as their allocated supplies include vials with the affected lot numbers.
The Defense Ministry said Thursday that it has been told to suspend use of the relevant Moderna vials. It added that affected doses had been used for inoculations at the Self-Defense Forces-run mass inoculation center in Osaka between Aug. 6 and 20. The center has been checking for any abnormalities before using vials and added that there have so far been no reports of any safety incidents.
The SDF-run mass inoculation center in Tokyo was not allocated the affected vials, the ministry added.
In a time of both misinformation and too much information, quality journalism is more crucial than ever.
By subscribing, you can help us get the story right.