Moderna Inc said on Wednesday it has withheld supply of about 1.63 million doses of its COVID-19 vaccine in Japan after a report of contamination of vials with particulate matter, which it suspects involves a production line in Spain.
Although Moderna said no safety or efficacy issues had been identified, the suspension is a fresh setback for the firm, whose partners had production delays last month that disrupted supplies to countries, including South Korea.
That has prompted some Japanese companies to cancel worker vaccinations planned for Thursday, as most of doses in question have been supplied to mass vaccination sites and workplaces in Japan.
"Moderna confirms having been notified of cases of particulate matter being seen in drug product vials of its COVID-19 vaccine," Moderna said in a statement.
"The company is investigating the reports and remains committed to working expeditiously with its partner, Takeda, and regulators to address this," it added, referring to Japan's Takeda Pharmaceutical.
It said the contamination could be due to a manufacturing issue in one of the production lines at its contract manufacturing site in Spain.
It was not immediately clear whether the issue impacted supplies to other countries.
Moderna did not immediately respond to a Reuters' request for comment. Spain's Rovi, which bottles or "fills and finishes" Moderna vaccines for markets other than the United States, was not immediately available to comment.
The vaccine lot with complaints had 565,400 doses and Moderna said that "out of an abundance of caution" it had put the lot on hold and two adjacent ones.
Takeda said it conducted an emergency examination after particulate matter was found in a lot of vaccine vials at an inoculation site in Japan.
Japan's health ministry has decided to withdraw some doses as a precaution after consultation with Takeda but it said it would strive to minimize the impact of the withdrawal on its inoculation plans.
Chief cabinet secretary Katsunobu Kato said there had been no cases reported of health issues related to contaminated shots administrated.
Between Aug. 6 and Aug. 20, vaccines from the lot in question were used at a mass public vaccination centre in Osaka, according to the defence ministry, which operates the centre. The ministry did not said how many people were affected.
Japan Airlines said it had cancelled some COVID-19 vaccinations for its employees on Thursday after receiving Moderna vaccines with particulate matter.
Another Japanese carrier, ANA, also held off on its vaccinations on Thursday according to Kyodo news agency.
Prime Minister Yoshihide Suga said on Wednesday that about 60% of the public will be fully vaccinated by end September and that the country had enough vaccines to provide booster doses if such a decision is taken.
Reuters
Thu Aug 26 2021
Moderna said the contamination could be due to a manufacturing issue in one of the production lines at its contract manufacturing site in Spain. - REUTERS
Pro-Palestinian NGOs seek court order to stop Dutch arms exports to Israel
The Dutch state, as a signatory to the 1948 Genocide Convention, has a duty to take all reasonable measures at its disposal to prevent genocide.
How quickly can Trump's Musk-led efficiency panel slash US regulations?
Moves by Trump and his appointees to eliminate existing rules will be met with legal challenges, as many progressive groups and Democratic officials have made clear.
2TM: Consultations on PTPTN loans, admission to IPTA at MOHE booth
Consultations on PTPTN loans and admission to IPTA are among services provided at the Higher Education Ministry booth.
Kampung Tanjung Kala residents affected by flooded bridge every time it rains heavily
Almost 200 residents from 60 homes in Kampung Tanjung Kala have ended up stuck when their 200-metre (m) long concrete bridge flooded.
COP29 climate summit draft proposes rich countries pay $250 billion per year
The draft finance deal criticised by both developed and developing nations.
Bomb squad sent to London's Gatwick Airport after terminal evacuation
This was following the discovery of a suspected prohibited item in luggage.
Kelantan urges caution amidst northeast monsoon rains
Kelantan has reminded the public in the state to refrain from outdoor activities with the arrival of the Northeast Monsoon season.
Former New Zealand PM Jacinda Ardern receives UN leadership award
Former New Zealand prime minister Jacinda Ardern was given a global leadership award by the United Nations Foundation.
ICC'S arrest warrants for Netanyahu, Gallant an apt decision - PM
The decision of the ICC to issue arrest warrants against Benjamin Netanyahu and Yoav Gallant is apt, said Datuk Seri Anwar Ibrahim.
KTMB provides two additional ETS trains for Christmas, school holidays
KTMB will provide two additional ETS trains for the KL Sentral-Padang Besar route and return trips in conjunction with the holidays.
BNM'S international reserves rise to USD118 bil as at Nov 15, 2024
Malaysia's international reserves rose to US$118.0 billion as at Nov 15, 2024, up from US$117.6 billion on Oct 30, 2024.
Findings by dark energy researchers back Einstein's conception of gravity
The findings announced are part of a years-long study of the history of the cosmos focusing upon dark energy.
NRES responds to Rimbawatch press release on COP29
The Ministry of Natural Resources and Environmental Sustainability (NRES) wishes to offer the following clarifications to the issues raised.
Online Safety Bill and Anti-Cyberbullying Laws must carefully balance rights and protections
The Online Safety Advocacy Group (OSAG) stands united with people in Malaysia in the fight against serious online harms.
Malaysia's inflation at 1.9 pct in Oct 2024 - DOSM
Malaysia's inflation rate for October 2024 has increased to 1.9 per cent, up from 1.8 per cent in September this year.
Saudi Arabia showcases Vision 2030 goals at Airshow China 2024
For the first time, Saudi Arabia is participating in the China International Aviation & Aerospace Exhibition held recently in Zhuhai.
King Charles' coronation cost GBP 71mil, govt accounts show
The coronation of Britain's King Charles cost taxpayers GBP72 million (US$90 million), official accounts have revealed.
Couple and associate charged with trafficking 51.9 kg of meth
A married couple and a man were charged in the Magistrate's Court here today with trafficking 51.974 kilogrammes of Methamphetamine.
PDRM to consult AGC in completing Teoh Beng Hock investigation
The police may seek new testimony from existing witnesses for additional insights into the investigation of Teoh Beng Hock's death.
Thai court rejects petition over ex-PM Thaksin's political influence
Thailand's Constitutional Court rejects a petition seeking to stop Thaksin Shinawatra from interfering in the running the Pheu Thai party.