Japanese health officials restricted distribution of Moderna‘s COVID-19 vaccine after a pharmacist reported a black substance inside one vial – now identified as stainless steel, likely added to the vial because of a factory error.
This is the second Moderna suspension in a week – Japan previously stopped distribution of 1.63 million doses, citing contamination concerns.
About 3,790 people were inoculated from this concerning batch. Two Japanese people have recently died following vaccination, but health officials say the deaths aren’t related to vaccine contamination.
The vaccine suspension is bad news as Japan is going through another Covid surge following the Tokyo Olympics. Under half of the nation’s population is fully vaccinated against Covid.
Japan has blocked the use of Moderna’s Covid vaccine for the second time in a week. Pictured: Moderna vials, pictured at a mass vaccination site in Lynchburg, Virginia, March 2021
Japan has blocked the use of Moderna’s Covid vaccine for the second time this week due to contamination concerns.
On August 26, the country halted the use of 1.63 million Moderna doses, when Takeda, the Japanese company distributing vaccines, reported contamination.
The vials were bottled by Rovi, a Spanish pharmaceutical company that partnered with Moderna on production for vaccine recipients outside the U.S.
Moderna and Rovi both suspect that a manufacturing error caused the contamination.
The new contamination case, announced Wednesday, is the fourth incident reported in the past week.
This report came from a pharmacist in Kanagawa prefecture, a coastal area on the country’s eastern border.
This pharmacist found ‘black particles’ in one vaccine vial when double-checking the Moderna vaccines for outside substances – as all medical staff are required to do before administering a dose.
Kanagawa leaders immediately put the remainder of Moderna vaccines from that batch on hold.
Takeda, the domestic distribution company, collected the ‘black particles’ vial for investigation.
Moderna and Takeda say the ‘black particles’ are stainless steel particles, likely added due to a factory error that occurred when machinery added rubber stoppers to the vials, according to Reuters and Japan Today.
Japan is currently seeing over 20,000 new Covid cases a day in the nation’s highest surge yet
‘The rare presence of stainless steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product,’ Moderna and Takeda said in a joint statement.
‘Stainless steel is routinely used in heart valves, joint replacements and metal sutures and staples,’ the two companies said.
‘As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk.’
About 3,790 people had received shots from the Kanagawa batch prior to the vaccines’ suspension.
While two vaccinated individuals have recently died, existing evidence doesn’t connect these deaths to the vaccine contamination.
Moderna and Japanese health officials continue to investigate the situation, however.
About 58 percent of Japanese residents have received at least one vaccine dose, as of September 1
The European Medicines Agency (EMA) is also investigating Japan’s contamination issues, as they could influence vaccine distribution in the European Union.
When announcing the August 26 suspension, Japanese health officials called this a precautionary measure, with no specific safety concerns identified yet.
But this suspension still caused some Japanese companies to cancel planned worker vaccination events, Reuters reported.
This is a worrying signal as case counts in Japan remain high following the Tokyo Olympics and the Indian ‘Delta’ variant’s takeover.
The country is currently seeing over 20,000 new cases a day – equivalent to about 16 daily new cases for every 100,000 residents.
It’s the highest surge that Japan has faced thus far in the pandemic.
Japan’s vaccination campaign has been slow and hindered by bureaucratic issues, falling behind the vaccination efforts of other high-income nations.
As of September 1, about 58 percent of Japanese residents have received at least one dose and 47 percent are fully vaccinated.