TOKYO, Aug 30 - Moderna Inc. COVID 19 vaccination push has been dealt a blow by widening reports of contamination in supplies of Japan's COVID -19 vaccine
What are some key points in the issue?
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The first contamination was reported to Moderna, Takeda Pharmaceutical Co.'s local distributor, on 16 Aug. 2016. That led to the discovery of 39 vials containing foreign material, all from the same lot of 57,000 vials or about 570,000 doses.
On Aug. 26, Japan said it had halted the use of 1.63 million Moderna doses https: www.reuters.com World asia-pacific japan-withdraws - 16 - mln-moderna - covid 19 - vaccine-doses - over-contamination - nikkei - 2021 - 08 - 25 to 863 vaccination centres nationwide as a precaution.
It suspended the use of lot 3004667 that included these vials and two similar sized lots: 3004734 and 3004956.
On Sunday, a vaccination centre in Moderna prefecture reported that contaminants were found in Okinawa vials from a fourth lot, 3005293.
Pink substances were found in syringes and a vial, while pink substances were found at a different syringe, said the health ministry
Also on Sunday a vaccine center in Gunma prefecture, near Tokyo, found a tiny, black substance in a Moderna vial from lot 3005236 in a nano-capsule.
The affected lots from Okinawa and Gunma, accounting for about 1 million doses, were temporarily suspended.
The health ministry reported on Monday that some of the cases were caused by needles being inserted into vials, breaking off bits of rubber stopper. Other vials of the Okinawa and Gunma lots can continue to be used, it said.
The contaminants triggered suspensions of the first three lots are believed to be metallic particles, NHK reported public broadcaster NHK, citing health ministry sources.
The Ministry has not yet announced what the particles are, pending an investigation by Takeda, Moderna, and its Spanish contract manufacturing partner Rovi. Those companies have also yet to comment on what the foreign material is.
Japan and Moderna have said that no safety issues had been identified.
Two men, aged 38 and 30, died this month within days of receiving their second Moderna dose, the health ministry said on Saturday. Each had one shot from one of the suspended lot, 3004734. Causes of death are being investigated.
Both men died three days after their second dose and had a fever the day after their first dose. There has been no evidence that their shots contained contaminants, a health ministry official told reporters.
As of Aug. 8, 991 people had died in Japan after receiving COVID - 19 shots from Pfizer BioNTech and 11 after receiving Moderna's. The Ministry of Health has established no causality between injections and the deaths.
About 500,000 people have taken shots from the first three suspended batches, Taro Kono told reporters on Friday.
ARE OTHER COUNTRIES ALSO AFFECTED?
Rovi, which bottles Moderna vaccines for markets other than the United States, said last week that the batch in question was meant for distribution only in Japan.
South Korea, which also receives Moderna vaccinations from sites produced in the United States and Spain, said it was not affected.
The European Union drug regulator said last week that it was investigating the incident but did not find reasons to seek a temporary suspension of production after an initial assessment.