AstraZeneca approval in the US

Do you think it unwise to pause the AZ vaccine for people under 50?

At current rates of infection it looks like the risk/benefit calculation is still on the side of the AZ vaccine for anyone over 30.

If that calcuation changes my opinion will change

The calcualtion also changes depending on whether such a pause means no vaccination and remaining unprotected, or whether a different vaccine can be substituted immediately.

OK, well that is properly addressed in the article I linked to.

I don’t know about that. A healthy 25 yr old woman might be safer “unprotected” over taking the AZ shot.

OK, hour 12 was painful. I’m zero for 3 on vaccines. Got hit pretty hard with joint pain which is consistent with the reaction I’ve had with flu shots. Your mileage may vary.

IANAD but If this is your general response to flu shots then consider taking an anti-inflammatory before you need it.

If that is true it is only very slightly true at very low rates of covid infection. It doesn’t take much of a rate increase to tip that balance in favour of the vaccine for all age groups.
In any case the risk presented by the vaccine is unlikely to rise to the level of, say, the contraceptive pill.

Right, but you don’t hear a lot of people talking about birth control passports.

What have they failed to do? The sort of competent pharmacovigilance that allowed several European countries to identify this adverse event before the UK did. What makes it far worse is that the UK has had much more exposure to the vaccine for much longer, compared to these other countries, and should therefore have had access to much more data much earlier - and still we lagged hopelessly behind.

What should they have done differently? It doesn’t help anyone when the UK position is: there’s nothing; the rate in vaccinated people is lower than you’d expect in the general population; there’s five cases; well, thirty; well, seventy-nine with nineteen people dead; if you’re under thirty, you might like to consider a different vaccine; and hold that trial, could you?

There was a time when the MHRA - MCA as it was then - considered itself to be one of the best, if not the best, at pharmacovigilance. I recall being lectured that it was the MCA that pinpointed the improbable-sounding link between tetracycline use and Achilles tendon injury - pinpointed it because their PV was so damn good. Well, on the evidence of this, not any more.

j

Thank you. And thanks to @wolfpup too.
I don’t know what it is about COVID-19, but it seems like everything feels so dire about it. I’m more chill now. I get JnJ tomorrow.

They got called out for submitting older, more favorable efficacy data to the US. They either missed or hid the data about this complication, while actively disparaging the experts in other countries who were raising valid concerns.

At best, they were lying about how very vigilant they were. They dragged down the WHO and the European Medicines regulator, who both put out statements saying there was no evidence of a link to a blood clot problem, presumably on the basis of false data that was supplied to them.

I wonder if this quote is reflective of an overall attitude. This is from an article about the two leaders of the Oxford team that developed the vaccine, and was in the context of the debunking of the claim that it was ineffective for people over 65.

“I think we really need people to make positive statements about vaccines to build confidence. Negative comments pose the risk of undermining that confidence,” Pollard told the Observer last week.

Sounds like a potentially problematic attitude, especially for a person in charge to have. I’m not saying he’s the source of the problem, but it could be reflective of an attitude.

Quote from here: Life savers: the amazing story of the Oxford/AstraZeneca Covid vaccine | Coronavirus | The Guardian

Has it actually been pinned down that people getting clots were particularly at risk of blood clots before the vaccine? If this is some kind of vaccine generated autoimmune issue there might be completely different risk factors.

See posts 243 and 238.

This is the best/most recent source I have seen in re risk factors. There’s a suggestion that some risk factors to do with health status are involved. I think that’s the best you can say right now.

j

I think the answer to that question depends on the prevalence of covid and the availability of other vaccines in the region. As i don’t know what region is “pausing AstraZeneca for those under 50”, let alone the answers to the other two questions, i can’t say.

Here in the US it hasn’t even been approved, yet, apparently because they haven’t yet asked for approval.

Germany has paused it for <60, Canada&France <55, UK <30.

Thank you, @Treppenwitz.

cite?

cite?

The articles are already posted. If you want to nitpick something, go ahead, but I’m not going to play.

Numbers in France are pretty high. I’m dubious.
UK has driven the incidence of covid down pretty far, largely by previously giving AZ vaccine to other people, but yeah, it looks like they can afford to delay vaccination of of the under-30 crowd who are at lower risk any way. Germany and Canada? They both a facing critical shortages of vaccine, and numbers are increasing. But maybe they need to prioritize their elders anyway, so maybe that “pause” for younger people doesn’t have a lot of real-world impact. Perhaps the same is true in France – a “pause” for the less-at-risk is not as big a deal as a total pause, especially if you were going to give most of your vaccine to the more-at-risk.

So… maybe it’s makes sense. I’m glad it’s not my call, honestly.

I’m not sure that the UK is delaying any vaccinations. They have Pfizer now, and will start getting the newly approved Moderna this week. It sounds like it’s just a shift of who gets what vaccine.

Those aged under 30 are to be offered the Moderna or Pfizer-BioNTech jabs as an alternative to the Oxford-AstraZeneca vaccine due to evidence linking it to rare blood clots.

Health Secretary Matt Hancock has said there is “more than enough of the Pfizer or Moderna vaccine” for the 8.5 million people under 30 who are yet to be vaccinated to have two doses.

I believe the UK is still only vaccinating people 50 and older, so the numbers of people under 30 who are eligible for vaccination now will be limited to those who have some other qualification.

You are making a claim that Astra Zeneca have knowingly lied to the regulatory agencies.

That is hyperbolic in the extreme and I’ve seen no evidence that that is the case.

If you knew who I worked for you’d maybe be surprised that I back AZ so strongly here but I do find it depressing that AZ are getting so much grief.
This a company who have acted so quickly to create a vaccine that is very effective, very cheap, easy to distribute, being provided at zero profit and has already saved untold thousands of lives and yet they are still being painted as some sort of villain.

I don’t think people are trying to sink AZ’s ship. But they were sponsored to develop their vaccine so the “very cheap” price is due in part to the research money they received. Their zero profit is admirable and worthy of your support.

As has been posted already, they have had problems with accurately reporting their numbers.