The Corona Pandemic

Away End - General Chat
5475

A 60 second search on Google

HEALTH AND SCIENCE

U.S. puts J&J in charge of plant that botched Covid vaccine, removes AstraZeneca

PUBLISHED SUN, APR 4 20215:02 PM EDTUPDATED MON, APR 5 20211:43 PM EDT

Reuters

SHAREShare Article via FacebookShare Article via TwitterShare Article via LinkedInShare Article via Email

KEY POINTS

  • The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.
  • J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.
  • AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca from using the facility, a senior health official said on Saturday.

J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.

The Department of Health & Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

White House officials did not immediately respond to a request for comment.

The development, first reported by the New York Times, further hampers AstraZeneca’s efforts in the United States. The government has criticized the drugmaker for using outdated data in the results of its vaccine trial. It later revised its study.

All of this wrongly insinuates that the blame lay with AstraZeneca itself. You have to read on further before the article says it was the fault of factory workers mixing up ingredients but how many people even read beyond the headline or the “Key Points”?

1 Like
5476

I still don’t see where it suggests that AZ were responsible for the fuck up (I only googled for about 50 secs).
It’s clear that the facility fucked up and an alternative facility is being sought for AZ who don’t come out of it tarnished in any way IMO.
Maybe some are a bit hyper sensitive and over protective now of AZ given what’s passed.

1 Like
5477

Nobody can read what I’ve quoted and honestly say that, when it is reported that AstraZeneca had been:

  • “removed”,
  • that the U.S. had put “Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca from using the facility”, and J&J saying it was now “assuming full responsibility”,
  • with a spokesperson fuelling the negative speculation by asking not to be named due to the “sensitivity of the matter”,
  • all then juxtaposed with reference to the [unusually public and disproportionately severe] criticism of AstraZeneca’s reporting of trial data.
5478

Yes they can, if they haven’t become so invested in the debate to the point of obsession.

2 Likes
5479

To be fair to that facility, if medicine agencies checked plants without prior notice, most of them would be closed down or at least hit with observations.

5480

You have two children. You find them fighting over playing with lego. You remove one and tell that one that they’re not allowed to play there anymore and go find somewhere else. You let the other kid continue playing with the lego, having it all to themselves.

What message are you sending (intentionally or otherwise) about who you think was responsible for the fight in the first place? Particularly if you also say, almost as an aside, that you’ve had trouble before with the kid you removed.

5481

You politely find another toy for the kid that comes from down the street and let your own kid play with the lego.

5482

One of my friends who works in R&D for J&J, he’s frustrated on the focus of the phrase “taking responsibility”, making it seem like they were at fault for the screw up. I guess if you’ve got a vested interest in how people will interpret these very dry reports you can easily read into it things that others aren’t seeing.

5483

Yes, that phrase could be understood that way if it wasn’t clear that J&J were taking (on) responsibility for the future operation of the factory. But that is clear. And every report I’ve read so far leaves the reader in no doubt that this is the case given the corresponding references made to AstraZeneca. I’ve not read a single headline that would insinuate J&J, as opposed to AstraZeneca, were responsible for the mistake.

5484
5485

Warning about coronavirus vaccine and clots is a sign that the system is working

Tom Whipple

, Science Editor

Tuesday April 06 2021, 1.35pm, The Times

Share

The efficacy of a vaccine programme is not just a percentage figure. It is not just about antibodies and T-cells. It is also about something far more elusive and far more fragile: faith.

After the clinical trials had finished, we were never going to find a high number of serious side effects. By definition, anything that did appear once mass vaccination started had to be rare enough that it had not been spotted in trials of tens of thousands of people.

This means that, on a purely utilitarian basis, the vaccine was always going to do vastly more good than harm. Covid-19 kills 1 in 150 of those infected. These rare blood clots, even if they really are caused by the vaccines, affect far fewer than a thousandth that number — and kill even less.

According to UK figures, fewer than one in two million vaccinated people have died of them, and according to German figures the number is about 1 in 300,000.

These risks, though, are not evenly distributed. A woman in her thirties has an extremely low risk of dying from Covid-19. It also appears she may have a very slightly raised risk of suffering this severe side effect from the jab — possibly because, very occasionally, it induces an immune response that causes her body to attack its own platelets.

Both those risks are, when written down, essentially zero. But only with the latter one is there a theoretical chance it is caused by the vaccine itself. And the emphasis is still on theoretical — the truth is this condition is rare enough we are still not certain of its expected prevalence. The European Medicines Agency (EMA) puts it at between 2 and 16 cases per million people per year, and laments our understanding is poor.

This is the calculation the regulators, who are not utilitarians, have to make. Is it ethical to give a vaccine to someone who does not need it for themselves, if doing so could cause them harm?

There is much that is uncertain. Separating out true side effects from sheer random chance is extremely hard when the events are this rare.

Working out the mechanism itself would also be extremely useful — particularly when deciding what vaccine to give instead.

No such clusters of cerebral clottings have been seen with the Pfizer-BioNTech vaccine, despite millions of doses. If this side effect is indeed caused by the Oxford-AstraZeneca vaccine, though, could the Russian Sputnik and Johnson & Johnson vaccines, which use a similar “adenovirus” technology, also have the same effect?

There is a final consideration that is, rightly, beyond the bounds of the medical regulators: confidence.

What is being decided this week by the EMA and the MHRA will affect the population of the UK and the world. In the UK, modellers are certain we will see another wave once we open up. How big it is depends on how many people are vaccinated. In particular, if vaccine confidence is low in younger age groups, and fewer of them go for their jabs, then that wave will be worse and more people — in all age groups — will die.

In the wider world, the effects of a loss of confidence are more serious still. The UK is lucky because it has a growing choice of vaccines, but across the planet this year there will not be enough vaccines. When it passed its trials, the Oxford-AstraZeneca jab was described as a “vaccine for the world”.

If the world begins to perceive it, instead, as a “vaccine for the third world”, as a vaccine that the west is hesitant about, then that will only exacerbate a growing sense of unfairness and discontent — at just the point where it is imperative, for everyone, that the global pandemic is brought under control.

The fact that regulators are doing their job, that they are teasing out and analysing these extremely rare signals in the data, should boost our faith in the system: this is a sign it is working. The paradox is it might do the reverse.

1 Like
5486

Even if the vaccine was the cause, and this is still not proven, the numbers suggest around one death in every 2.5 million people vaccinated in the UK.

:roll_eyes: Nick Triggle bending the truth again. We aren’t talking about the UK dick for brains. We are talking about a heightened risk in a particular age and gender group that the UK hasn’t even started vaccinating on yet.

1 Like
5487
5488

You save the princess and progress onto Lvl 2

3 Likes
5489

Many more women in the relevant age group have been vaccinated with AstraZeneca in the UK than any other country (with the possible exception of India) :roll_eyes:

https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2021/04/COVID-19-weekly-announced-vaccinations-1-April-2021.xlsx

[Don’t read any of this if you’re interested in facts.]

5,513,253 vaccine doses have been administered to women under the age of 55 in England (not even the whole UK) up to 28 March 2021, the majority of whom have been vaccinated with AstraZeneca.

In total England had vaccinated 9,584,241 people under the age of 55 as at 28 March 2021 (57.5% of whom are women).

In total, as at 21 March, 15.8 million first doses of AstraZeneca had been administered in the UK across the entire population (10.8 million first doses of Pfizer).

The total doses of AstraZeneca administered to everyone [under the age of 65] in Germany, both male and female, was 2,596,248 to date.

https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#distribution-tab

It’s a fact that the UK has administered more doses of AstraZeneca to women under the age of 55 than any other country has administered AstraZeneca doses in total with the possible exception of India. More than Germany, more than France, more than Italy.

People need to stop spreading false information.

5490

The government being referred to here is the Australian government.

5491

Both the MHRA and EMA are making statements today about AstraZeneca at 3pm UK time.

5492

A couple of things to note about the potential link between the AstraZeneca vaccine and bloodclots. There is a weaker correlation between sex and the blood clots than the age. 7/9 of the deaths in Germany attributed to bloodclots following the AstraZeneca vaccine have been in women but the AstraZeneca vaccine has been given to women in greater numbers in Germany (and also in the UK, as I set out above). It is estimated that 2/3rds of those vaccinated in Germany with AstraZeneca were women so a proportion of 7 out of 9 deaths does not look massively out of line.

I do not know the breakdown of the 4 deaths mentioned in the UK. This number has also been reported as 7 but that must either refer to information not yet published or it also includes deaths from thrombocytopenia as well as CVST. There are a total of 7 reported deaths from CVST and/or Thrombocytopenia as at the most recent update (1 April). 4 CVST following AstraZeneca, 2 Thrombocytopenia following AstraZeneca and 1 Thrombocytopenia following Pfizer.

It is reported that the majority (if not all) of the deaths from CVST and/or Thrombocytopenia have occurred in those under the age of 55. We await a more detailed breakdown.

However, I have seen someone attempt a modelling exercise:

As you can see, these are a huge range of estimates based, I think, on a hypothetical range of ages that the reported deaths have occurred. This is hypothetical at the moment and I think may slightly underestimate the number of vaccinations given but it’s a starting point whilst we await more detailed information.

As you can see, it hypothesises the risk of a fatality from coronavirus as opposed to a bloodclot following AstraZeneca vaccination as being anywhere between 10x and 90x more likely for those aged between 15 and 24. [Apologies, it is described as lives saved, so this may be a combination of providing protection from covid for the vaccinated individual as well as the larger societal benefit of that individual being vaccinated and therefore not potentially passing on the infection to others more at risk]

For those aged between 25 and 44 the estimate is you are between 85 and 720 times more likely to die from coronavirus than you are from a bloodclot following AstraZeneca vaccination. The risk of dying from coronavirus rather than a bloodclot following AstraZeneca continues to increase substantially the older you are.

This is only a hypothesis so far but it’s the only attempt I’ve seen to try and estimate the breakdown in the risk. This assumes that there is a causal link (CVST is more prevalent in younger people anyway). Hopefully more information will be given by the MHRA or EMA later today.

5493

If there is a chance/connection established with blood clots causing death in those who receive a covid vaccine, should the question really be which covid vaccine is least likely to cause clots leading to death and what is the ratio between those vaccines.

2 Likes
5494

Yes, where it is possible to provide an alternative that must be the appropriate course of action.

What is slightly odd here is that it is this very comparison that seems to be elevating the perception of risk from AstraZeneca.

It has been suggested that the number of deaths from CVST following AstraZeneca appear to be very similar to what you might otherwise expect in the general unvaccinated population for the particular age groups concerned. The number of reactions (let alone deaths) from CVST following Pfizer are much lower.

So it might not be a case of AstraZeneca causing these fatalities but rather AstraZeneca not preventing them in the way that Pfizer might be doing.

Hopefully more information will be given soon to add some much needed clarity.