JAPAN HALTS

1.6 MILLION MODERNA VACCINE

AFTER DISCOVERING

METAL FOREIGN SUBSTANCES

By

Søren Nielsen

2021

Key facts.

According to Kyodo News, foreign substances—a few millimeters in size—were confirmed in at least 39 unused vials of the vaccine, with their elements being unknown.

As a precaution, Moderna is suspending the supply of about 1.63 million doses that it suspects were manufactured on the same production line in Spain.

The vaccine maker claims that only 565,400 doses were part of the same production lot as the contaminated doses, but decided to also put a hold on two adjacent lots "out of an abundance of caution."

Moderna is now conducting an investigation into the nature of the foreign materials, the Japanese ministry said.

Japanese pharma giant Takeda, which handles the sales and distribution of the vaccine in the country, said it has yet to see any reports of safety concerns.

Takeda, however, has informed medical institutions and other entities to not use any doses which appear abnormal or show any signs of contamination, including doses not subject to the suspension.

Key Background.

The vaccine setback comes at a time when Japan is witnessing its worst outbreak of the entire pandemic. 

Fueled by the highly infectious delta variant, the country is reporting an average of around 23,000 new cases every single day. 

The one bright spot in Japan’s pandemic management has been the recent speed of its vaccine rollout. 

After a sluggish start, Japan has now fully inoculated nearly 43% of its population. 

On Wednesday, Prime Minister Yoshihide Suga said that the country is on track to inoculate around 60% of its population by the end of September and it has enough vaccine doses in reserve for a potential booster dose if that is needed.

Japan’s Ministry of Health, Labour and Welfare suspended the use of more than 1.6 million doses of Moderna’s Covid-19 vaccine Thursday following reports of contaminated vials at multiple vaccination sites there.

Takeda Pharmaceuticals, which distributes the vaccine in Japan for Moderna, said it notified the ministry after several vaccination sites reported an unspecified foreign object found in one specific lot.

"We requested that Moderna, the product owner and manufacturer, conduct a thorough investigation to determine the precise root cause of the issue," Takeda said in a statement.

Takeda also said that it is not aware of any "significant safety concerns" stemming from the contaminated doses.

Moderna said it’s been notified of the problem and is looking into it.

"The company is investigating the reports and remains committed to working expeditiously with its partner, Takeda, and regulators to address this," Moderna wrote in a statement.

Moderna said it believes the manufacturing issue was generated in one of the lines used at its contract manufacturing site in Spain, adding that it didn’t appear to affect the safety or efficacy of the shots.

"Given the company’s priority to assure quality, and out of an abundance of caution, Moderna has put this lot and two adjacent lots on hold," the company said.

Rovi, the Spanish pharma company that bottles Moderna vaccines, said it is investigating the situation and that the contamination seems to be limited to some batches meant to be distributed to Japan, according to Reuters. 

Rovi shares dropped 13% in midday trading.

Takeda discovered the contaminated vials on Aug. 16 and reported it to Japanese officials on Wednesday, according to NBC News. 

The company said the delay was because the contamination of the vials and affected countries needed to be confirmed.

Japan’s chief cabinet secretary, Katsunobu Kato, told reporters Thursday that contaminated doses were administered to an unknown number of Japanese residents, though there have been no reports of ill effects, according to The New York Times.

Doses from the contaminated lot were administered between Aug. 6 and Aug. 20 at a vaccination site in Osaka run by Japan’s defense ministry, according to Reuters, but it is unclear if any of the doses used were contaminated.

Doses from the contaminated lot were set to be used at mass vaccination sites at large companies and universities, but all have been halted, according to Reuters.

All of the contaminated vials were manufactured in Spain. 

It is still unclear if other countries besides Japan have been affected, though the European Medicines Agency said it’s also looking into the issue.

"EMA is investigating the matter and has requested the marketing authorisation holder to provide information on any potential impact on batches supplied to the EU in addition to details on the ongoing root cause investigation," the agency said in a statement to Reuters.

Moderna told CNBC there is "no evidence" that other countries could have been affected because "the lot comes from a batch that was manufactured exclusively for Japan."

Moderna said there is no "expected timeframe for completion" of the investigation into the contaminated doses but that it is working with its contract manufacturer, its distributor and the government.