The fact that people have died following having had either the AZ vaccine or the Pfizer vaccine is incredibly disappointing. I was hoping they’d make us immortal.
By “political” I believe he means that it’s a decision for the politicians. I don’t think he necessarily means that it is about “politics”.
Been, had the jab, only side effects are, drink more strong tea and eat chocolate!!!
There are two issues as I see it:
1. Is there evidence to support a link between the vaccine and this side effect?
If the health authorities in Iceland, Norway, and EU who identified this are still gathering evidence into whether there is a link, I find it laughable that the common public or the media can say one way or the other yet. Shouldn’t we be waiting on evidence? Some may be ok with the EMA, WHO, AZ giving template press statements to implore the public to not take the suspension out of context ( the smart thing to do). AZ have shown a lower risk of blood clots, but which batch? Which country? What were the health characteristics of the population? I want to see numbers and figures proving or disproving the connection from the country that identified it. And I’ll wait until that point.
2. Now assuming 1 to be true, is a suspension of a life-saving vaccine in proportion to the likelihood and severity of this side-effect? Should a suspension be the go-to choice when investigating?
This is a seriously tough question. Especially when we are talking about a vaccine perceived to be inferior around the world, and especially when talking about a population in Europe generally hesitant in getting vaccinated. It’s just piling on misery.
I think we are all ok with getting vaccinated knowing that there are side effects that are likely but with low severity, like having a temperature, or swelling at the site of the vaccine. But when you have something with high severity and very low likelihood, like in the case of CVST, then how do you handle that? Steam ahead as normal and hide it from the public? If the public find out, public trust in the government is shattered forever. If you make the public aware, how do you portary that the risk of blood clotting in the brain is incredibly low but is still connected to the vaccine? The public image of the vaccine will be the difficult part to turn around if this is true.
If we found out today that the Pfizer vaccine caused gangrene from the shoulder down in 1:5m vaccinated people, would the health authorities consider this risk adequate for the benefits of the vaccine? Would the public be happy to take on this risk? Where do you create the threshold for what side effect is tolerated and what is not, both from the health authorities and from the public? How do you sell an essential vaccination that has far more benefits than negatives, but that in a very small number of cases could kill you? How do you sell that risk to an 90yo lady that remembers when Thalidomide was used for morning sickness? That’s the difficult question if the evidence in fact points to a connection with the AZ vaccine. Could be some very tough days ahead.
As for whether suspension should take place while investigating, would the public continue to go in and get vaccinated while investigation is taking place? Would the public be happy to be injected with something that the health authorities are still unsure of what it can do to you?
I personally think a suspension is the correct approach to take during investigation if the potential side effect is significant enough to halt vaccination if the connection is found. Ie. When Norway discovered this, the question from that point should be ‘would we stop AZ rollout altogether if there is a link?’. If yes, then suspend and investigate, if no then still investigate but don’t suspend. Whether CVST would be that side effect, well, it’s an unenviable position to be in making that decision.
It’s either been accidentally or deliberately smart by the UK media to paint this as feeding into the EU-UK war, as it essentially insulates the UK population being hesitant about getting their AZ vaccine.
I think the issue here is there is a difference to what the regulators are responding to and how the data are being reported. The risk of general thromboembolism appears to be no different, but within that category they have identified several cases of a rare form of it. It’s still difficult to see how this justifies suspension, but it does change the narrative a bit away from “the risk is no greater than in the general population.”
Yes, you’re right. I have no issues with analysing data and focusing on abnormal anomalies of concern to see if there is anything causing them which could then be mitigated so that particular side effects are counteracted or avoided entirely.
I guess my issue is in not letting perfect be the enemy of good. The numbers overwhelmingly show that all vaccines currently approved are saving thousands of lives. I cannot then see the justification in suspending one particular vaccine, which will only add to the vaccine hesitancy generally but specifically with regard to AZ.
As I said earlier, it does feel like they are being overly cautious with AZ for whatever reason when it is showing greater efficacy than Pfizer and only marginally more severe side effects for a very, very small minority.
It does come back to the remark @ISMF posted a few weeks back. The stance appears to be “your vaccine is terrible, and such small portions”. With AZ being the main vaccine used in India I do worry how damaging these steps may be to the perception of that vaccine within that population (and elsewhere).
The AZ vaccine has been proven to work very well at combating the most serious effects of covid, but if there is the possibility that it can cause the death of people who would not have died from blood clots now had they not taken the vaccine then it is the right thing to do to at least suspend the program until it is proved one way or another.
At this rate there’s the chance that the number of excess deaths might be negative next week.
This is relatively surprising and forthright language from one of the scientists on the JCVI
https://twitter.com/HugoGye/status/1371805823861673990
AstraZeneca vaccine: Public will need reassurance on perfectly safe Oxford Covid jab, says government adviser
EXCLUSIVE
Professor Jeremy Brown, of the joint committee on vaccines and immunisation (JCVI), said European governments had ignored facts and science
By Tom Bawden
March 16, 2021 12:42 pm
A government adviser has warned the public will need fresh reassurance on the safety of vaccines following the controversy over the Oxford-AstraZeneca jab.
Professor Jeremy Brown, of the joint committee on vaccines and immunisation (JCVI), said European governments had ignored facts and science when they decided to halt the rollout of the AstraZeneca vaccine against Covid.
But the impact, he warned, would be to unjustifiably erode public faith in the vaccination programme in the UK and across Europe
“Obviously it doesn’t help us in this country having others questioning the safety of the vaccine that we’re using, even if that questioning is not based on much fact,” he told i.
“Hopefully it won’t put people off in the UK because they might be sensible and see that Europe has been throwing up AstraZeneca issues left, right and centre throughout the past few months, which have been dispersed, or got rid of, shortly after. But it is a potential issue,” said the University College London Professor, who sits on the Covid vaccine sub-committee.
“I guess it basically means that there will probably be a lot more communication about safety. We’ll likely have to counter the safety question more than we have done before, it just creates more work for us, convincing the public about safety. It’s things like going on the radio to say ‘there’s no safety issue that we see’. We’ll have to do more of that,” he said.
Prof Brown’s comments came after Sweden and Latvia became the latest countries to halt their roll-outs of the Covid AstraZeneca jab.
Ireland, Denmark, Norway, France, Germany, and Spain are also among the countries who have stopped using the vaccines because of concerns over reports of blood clots after receiving a dose.
However, in the UK, medical experts have defended the use of the vaccine while Prime Minister Boris Johnson said there was “no reason at all” to stop its roll-out.
According to AstraZeneca, about 17 million people in the EU and the UK have received a dose of the vaccine, with fewer than 40 cases of blood clots reported to date
As we speak the Lareb -side effects lab that does the testing for the Netherlands just declared that they can not find any evidence that the cloth problems are connected to Astra Zeneca’s vaccine.
I expect that the vaccination with Astra Zeneca resumes soon.
Important context on these declining mortality stats - this is happening despite strong evidence the UK variant is in fact more deadly.
https://twitter.com/_nickdavies/status/1371441682089132032?s=20
If I’m AstraZeneca right now I’d be absolutely fuming. Meanwhile…
EMA accepts that there are similar reported numbers of these incidents in Pfizer and Moderna from studies in the US and elsewhere.
Drones?? To see whether the beach crosses the threshold from ‘super packed’ to ‘super-duper packed’? 
AZ shares have been taking a bit of a hammering for months now, the minor ups and downs of share price have been happening long before this week or even this year and as such they are back up today.
EMA’s position is that member states should continue using AZ at the moment. They are going to keep looking at the data and will make a further announcement Thursday afternoon.
The regulation of drugs and medicinal products in the EU (inc UK) has become quite complicated, but on a high level view the situation has been created that many of the member states play little role in what products are authorized for use there. This is especially true for vaccines where ordinarily this is driven centrally by the EMA, meaning that individual member states don’t have too much experience in making skin in the game decisions like they have been found they’ve had to make with these Corona vaccines (as the Emergency Use Authorizations have been granted by the individual states, not the EMA). Would be interested in ISMF’s opinion on this, but I wonder whether part of what seems like an over reaction has been due to this lack of experience, something that probably leads to a greater tendency towards second guessing yourself, especially as the EMA, where all the vaccine regulation expertise exists, have been fairly straight on this throughout.
EMA say that the number of thrombolic events following vaccination is far lower than otherwise in the general population. Focusing on rare CVST events is much harder because the numbers themselves are so low in any event (single figures across 10s of millions of people vaccinated).
EMA says 30 cases as at 10 March 2021 have been reported across the EU of thromboembolic events following vaccination, presumably including CVST. More reports have come in since (seen this described as “notoriety bias”). These are not numbers of deaths, but numbers of reactions.
Here’s a journalist picking up on this…
