Explainer: What we know about Japan's contaminated Moderna COVID-19 vaccine supplies
30/08/2021 10:32
(Updates with vaccine lot number, ministry comment)
TOKYO, Aug 30 (Reuters) - Japan's COVID-19 vaccination push
has been dealt a blow by widening reports of contamination in
supplies of Moderna Inc's MRNA.O COVID-19 vaccine.
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Here are some key points in the issue so far.
WHEN WAS IT FIRST REPORTED AND HOW HAS IT WIDENED?
The first contamination was reported to Takeda
Pharmaceutical Co 4502.T , Moderna's local distributor, on Aug.
16. 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
shipped to 863 vaccination centres nationwide as a precaution.
It suspended the use of lot 3004667 that included those
vials and two similarly sized lots - 3004734 and 3004956.
On Sunday, a vaccination centre in Okinawa prefecture
reported that contaminants were found in Moderna vials from a
fourth lot, 3005293.
Black substances were spotted in syringes and a vial, while
pink substances were found in a different syringe, the health
ministry said.
Also on Sunday, a vaccine centre in Gunma prefecture, near
Tokyo, found a tiny, black substance in a Moderna vial from lot
3005236. urn:newsml:reuters.com:*:nL4N2Q108B
The affected lots from Okinawa and Gunma, accounting for
about 1 million doses, were temporarily suspended.
The health ministry said on Monday it appeared that some of
the cases were caused by needles being incorrectly inserted into
vials, breaking off bits of the rubber stopper. Other vials from
the Okinawa and Gunma lots can continue to be used, it said.
WHAT ARE THE CONTAMINANTS?
The contaminants that triggered suspensions of the first
three lots are believed to be metallic particles, public
broadcaster NHK reported, citing health ministry sources.
The ministry has not officially said what the particles are,
pending an investigation by Takeda, Moderna, and its Spanish
contract manufacturing partner Rovi ROVI.MC . Those companies
have also yet to comment on what the foreign material is.
IS THERE A SAFETY ISSUE?
Japan and Moderna have said no safety issues had been
identified.
Two men, aged 38 and 30, died this month within days of
receiving their second Moderna doses, the health ministry said
on Saturday. Each had one shot from one of the suspended lots,
3004734. The causes of death are being investigated.
Both men had a fever the day after their second dose and
died two days after getting the fever. 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 PFE.N /BioNTech, and 11 after
receiving Moderna's. No causality between the injections and the
deaths has been established, according to the health ministry.
About 500,000 people have had shots from the first three
suspended batches, Taro Kono, the minister in charge of the
vaccine push, told reporters on Friday.
ARE OTHER COUNTRIES ALSO AFFECTED?
Rovi, which bottles Moderna vaccines for markets other than
the United States, said last week the batch in question was
meant for distribution only in Japan.
South Korea, which also receives the Moderna vaccines
produced from sites in the United States and Spain, said it was
not affected.
The European Union drugs regulator said last week it was
investigating the incident but did not find reasons to seek a
temporary suspension of production after an initial assessment.
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(Reporting by Rocky Swift in Tokyo; Editing by Miyoung Kim and
Himani Sarkar)
((rocky.swift@thomsonreuters.com))