Foreign Substance

at

This morning.

Via Reuters:

Japan reported a fresh contamination case involving Moderna’s (MRNA.O) COVID-19 vaccine, the fourth such incident in less than a week, threatening to slow the country’s sputtering inoculation campaign.

Kanagawa prefecture said several black particles in one Moderna vaccine vial were found upon checking for foreign substances before its use, and it has put the rest of the lot on hold.

Japan suspended the use of 1.63 million doses of Moderna shots last week after being notified of contamination in some of the supply. Moderna and Spanish pharma company Rovi (ROVI.MC), which bottles Moderna vaccines, have said the cause could be a manufacturing issue, and European safety regulators have launched an investigation.

Moderna has said no safety or efficacy issues had been identified from the issue.

Japan finds another Moderna vial suspected to contain foreign substance (Reuters)

Yesterday: Teen Spirit

Meanwhile…

Good times.

Meanwhile…

Sponsored Link

20 thoughts on “Foreign Substance

    1. alickdouglas

      I have little doubt the Japanese authority will make public what they find, but I suspect that they will take some time. The most likely (stress on likely, not the only) source is a broken vial or a broken piece of the fill/finish machine itself: the process is high-speed and when things break they get ground up into small, difficult to recognise bits. While QC systems should reject vials with particles (or, batches where it exceeds a threshold), the QC system in Europe is heavily automated and driven by cameras rather than manual inspection. It’s over 10 years since I’ve had any invovlement with vaccines for Japan, but back then all vials (every single one) were inspected by hand by the Japanese health authority, and they rejected a lot of vials that passed EU inspection thresholds.

        1. alickdouglas

          Tricky one that. QC is mainly driven by the notion that anything that can go wrong will go wrong and QC departments try to test for everything, with backups. The last line of defence is usually a weasel statement in the package insert that instructs the vaccine administrator to shake the vial, check the color and check for particles.

          From my experience I’d say that particles are found from time to time, and that they do get reported to license holders. Particles should be vanishingly rare, but I’d hazard that on the occasions they are present (we are talking millions of doses so even rates <1% manifest from time to time), the Japanese system is the most likely to catch them, report them, and publicise that because their public health authority has the system in place to formalize the in-country QC and has an obligation to report to the general public.

          1. E'Matty

            Thanks for the reply. It seems from what you’re saying, and correct me if I am misinterpreting it as I don’t wish to put words in your mouth, that the Japanese have the more stringent and effective quality control system which has on this ocassion detected these particles, but similar could quite easily have been present in other batches worldwide and gone completely undetected. Lesson might be, get your vaccinations in Japan (if your minted enough to make the journey). Would be very interested to know if any other regulatory bodies are now re-assessing Moderna tand checking again for these particles or similar, but haven’t heard much of anything in that regard. It will be quite interesting to find out what these particles actually are. Hopefully something uttterly benign and harmless.

          2. alickdouglas

            It’s a more stringent system, and the upside is that it catches more deviations. The downside is that it slows down the delivery of vaccines to patients, strains the cold chain (you have to take the vaccines out of the fridge to look at them), and adds to the cost overall. So there is a cost/benefit to it. There are those who would say that for the extremely limited number of deviations it catches, the system is too ‘expensive’ (both cash and time). I would of course rather not get a metal shaving or piece of rubber stopper injected into myself or anyone else, but then we just get back into a discussion on acceptable risk.
            If I rember right, the batches came out of a contract manufacturer in Spain If the Guardian article cited below is correct and the particles are steel shavings, I imagine they will be getting audited by EMA imminently and changes would be expected at the plant. While Moderna are the license holder, I’d say there’ll be much finger pointing at the contract manufacturer.

          3. E'Matty

            yes, an audit imminent one would think and likely some serious litigation coming between Moderna and the producer, that’s for sure. The reputational damage to Moderna has been pretty significant, and on such a global stage. Would be interesting to find out what other markets received Moderna vaccine supplies from that same producer. Any sign of others being flagged or a recall?

            Yes, always a bit of a balancing act and cost benefit analysis required. Faster to market may save countless lives. Identifying a serious defect may also do the same. Which is best may shift from one occasion to the next. It would be great if people could personally choose which system they wished to receive their drugs through. The “lob into me boss” crew would be happy with early delivery, and the “we’re not entirely sure about this” crew would have greater assurances.

          4. SOQ

            The “lob into me boss” crew would be happy with early delivery, and the “we’re not entirely sure about this” crew would have greater assurances.

            Isn’t that what has happened? There is still half a million of us in the second category of course.

      1. Fearganainm

        “Contaminants found last week in suspended Moderna vaccines were particles of stainless steel, Japan’s health ministry has said, adding that it did not expect they would pose health risks.

        Japan suspended the use of 1.63 million doses of the Moderna vaccine last Thursday after being notified of contamination. In a joint statement reported by Reuters, domestic distributor Takeda Pharmaceutical Takeda and Moderna said:

        Stainless steel is routinely used in heart valves, joint replacements and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk.”

        Three lots of Moderna vaccines were suspended after 39 vials were found to be contaminated. Though all the vials came from one lot, two others were also halted as a precaution as they all came from the same manufacturing line.

        It is believed that the particles came from friction caused by pieces of metal in the machinery that puts stoppers on the vials, Takeda said. The three suspended lots were the only ones affected by the manufacturing issue and Rovi, the Spanish pharmaceutical company that bottles the vaccines, has taken corrective measures, the statement said.”

        Source: https://www.theguardian.com/world/live/2021/sep/01/coronavirus-live-news-who-monitoring-new-mu-variant-stark-covid-divides-could-shape-europe-for-generations-study?page=with:block-612f85fb8f083528f0f50ef6#block-612f85fb8f083528f0f50ef6

  1. one username per user please

    What’s the point of these anti-vaxx articles? If Japan wants to self destruct that’s their business, scientists looked into the vaccines and said they’re safe, end of.

      1. chris

        Sounds more like they’re lashing out in denial. Expect to see a lot more of it. I think the weight of the coming realisations will cause as much damage as these ‘vaccines’.

    1. E'Matty

      Safe, end of? So, how can you say with any certainty that these particles are not harmful? You do realise the trials would not include these particles, right?

      1. Micko

        Well hopefully it will be a great success and regardless of it’s mechanism of operation, it’s not going to be given to 90% of the adult population.

        And of course it won’t be given to children.

        So the two aren’t comparable.

    1. SOQ

      Well if there is a link between that and the unexplained magnets thing then you can be very certain the issue is much wider than a few contaminated batches in Japan.

Comments are closed.

Sponsored Link
Broadsheet.ie