Are the number of deaths in the unvaccinated population currently matching those deaths in the vaccinated population when we look at the AZ vaccine?
If they are not currently matching each other then AZ can’t be deemed safe until further testing /analysis is done, as is done with any new drug on the market.
Either way you look at it, if there is any chance that another vaccine protects life better(weather that be from covid and/or clots) than the one you are allocated to receive, the majority of people will want the vaccine they perceive to be the one which gives the best chance.
If there’s choice, I would prefer to be given that choice. If that means I go to the back of the queue then that’s a consequence of my choice I’ll have to live, or not live with.
That’s a false choice though. We await a more detailed breakdown of the risk/benefit analysis per age group (and gender too although this may be less relevant) but even at the most pessimistic modelling you are many times more likely to die from coronavirus if unvaccinated than from bloodclots if vaccinated (even those in the most at risk category from these particular type of clotting disorders).
The AstraZeneca vaccine saves lives, that is clear. What it may not do is prevent people dying from CVST and/or thrombocytopenia. There is a possibility, that it might even slightly increase the risk of fatality from these reactions (although not currently established). Pfizer, however, may prevent people dying from CVST and, to a lesser degree, thrombocytopenia, as well as also preventing people dying from covid-19 just as effectively as AstraZeneca.
Again the total risk of fatality associated with AstraZeneca is almost identical to that associated with Pfizer. Reactions from CVST (and to a lesser extent thrombocytopenia) are one of the few areas where there is a marked difference between the two vaccines and this may be because Pfizer is preventing these reactions rather than AstraZeneca causing them.
Statement from the EMA:
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
News 07/04/2021
EMA confirms overall benefit-risk remains positive
EMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.
EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.
People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets (see below).
The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.
The Committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.1 The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine.
COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.
EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and vaccine availability in the individual Member State.
One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT). The PRAC has requested new studies and amendments to ongoing ones to provide more information and will take any further actions necessary.
The PRAC stresses the importance of prompt specialist medical treatment. By recognising the signs of bloods clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications.
Patients should seek medical assistance immediately if they have the following symptoms
- shortness of breath
- chest pain
- swelling in your leg
- persistent abdominal (belly) pain
- neurological symptoms, including severe and persistent headaches or blurred vision
- tiny blood spots under the skin beyond the site of injection
Vaxzevria is one of four vaccines authorised in the EU for protecting against COVID-19. Studies show that it is effective at preventing the disease. It also reduces the risk of hospitalisation and deaths from COVID-19.
As for all vaccines, EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.
Information for the general public
- Cases of unusual blood clots with low platelets have occurred in people who received Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
- The chance of having this occur is very low, but you should still be aware of symptoms so you can get prompt medical treatment to help recovery and avoid complications.
- You must seek urgent medical attention immediately if you have any of the following symptoms in the weeks after your injection:
- shortness of breath
- chest pain
- leg swelling
- persistent abdominal (belly) pain
- neurological symptoms, such as severe and persistent headaches or blurred vision
- tiny blood spots under the skin beyond the site of the injection.
- Speak to your healthcare professional or contact your relevant national health authorities if you have any questions about the roll out of the vaccine in your country.
Information for healthcare professionals
-
EMA has reviewed cases of thrombosis in combination with thrombocytopenia, and in some cases bleeding, in people who received Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
-
These very rare types of thrombosis (with thrombocytopenia) included venous thrombosis in unusual sites such as cerebral venous sinus thrombosis and splanchnic vein thrombosis as well as arterial thrombosis. Most of the cases reported so far have occurred in women under the age of 60 years. Most cases occurred within 2 weeks of the person receiving their first dose. There is limited experience with the second dose.
-
As for the mechanism, it is thought that the vaccine may trigger an immune response leading to an atypical heparin-induced-thrombocytopenia like disorder. At this time, it is not possible to identify specific risk factors.
-
Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia so that they can promptly treat people affected in line with available guidelines.
-
Healthcare professionals should tell people receiving the vaccine that they must seek medical attention if they develop:
- symptoms of blood clots such as shortness of breath, chest pain, leg swelling, persistent abdominal pain
- neurological symptoms such as severe and persistent headaches and blurred vision
- petechiae beyond the site of vaccination after a few days.
-
The benefits of the vaccine continue to outweigh the risks for people who receive it. The vaccine is effective at preventing COVID-19 and reducing hospitalisations and deaths.
-
National authorities may provide additional guidance on the roll out of the vaccine based on the situation in your country.
Healthcare professionals involved in giving the vaccine in the EU will receive a direct healthcare professional communication (DHPC). The DHPC will also be available.
More about the medicine
Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus. COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. The vaccine does not contain the virus itself and cannot cause COVID-19.
The most common side effects are usually mild or moderate and improve within a few days after vaccination.
More about the procedure
This review was carried out in the context of a safety signal, under an accelerated timetable. A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine such as a vaccine and that warrants further investigation.
The review was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. EMA’s human medicine committee, CHMP, will now rapidly assess any necessary changes to the product information.
EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. EMA’s recommendations are the foundation upon which individual EU Member States will design and implement their own national vaccination campaigns. These may differ from country to country depending on their national needs and circumstances, such as infection rates, priority populations, vaccine availability and hospitalisation rates.
1 As of 4 April 2021, a total of 169 cases of CVST and 53 cases of splanchnic vein thrombosis were reported to EudraVigilance. Around 34 million people had been vaccinated in the EEA and UK by this date. The more recent data do not change the PRAC’s recommendations.
AZ does save lives and if it were the only option then that is what you take or you get nothing. But it’s not the only option and there are question marks over it. Until that question is fully answered there is a certain group in the population who should not be given it. They should be given a vaccine which for now seems less of a risk of this particular and sometimes fatal side effect.
If right now someone was handed 2 vaccines, AZ and Pfizer, and told to choose, I would call bullshit on anyone who says they would pick AZ over Pfizer.
Depends how old they are. It seems to be generally accepted that the older someone is the less likely they are to have a serious reaction to AstraZeneca compared with Pfizer.
With all the information at hand, you should be given the choice.
I took this from the EMA statement above
“COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.”
You see the bolded bit all the time but this is of no comfort to those who may die from this side effect within 2 weeks of receiving a vaccine, unless of course they knew in those 2 weeks they were naturally gonna die from clots or covid and there was no alternative vaccine which could have prevented this from happening.
The MHRA on the other hand…
JCVI are now reporting that in the UK there have been 19 fatalities from rare blood clots following vaccination (I presume nearly all of these are AstraZeneca) and that all of the people who died were aged between 18 and 79. 2/3rds of them were women. Although it’s worth noting that women have been vaccinated in greater numbers than men.
I am glad that there is at least guidance now for the general population on what to look out for - pain in the abdomen, blurred vision, severe and persistent headache.
We’ve just heard from the EMA that the blood clotting events occurred predominately in younger women, but they did occur in elderly. I would like to see the age brackets and I hope we can see some better analysis on the causes of this so we can mitigate that risk.
VERY interested in what has resulted in the UK choosing non-AZ vaccines for under 30s. Do they see a trend there? MHRA speaking now so hopefully an answer soon.
MHRA identified 79 cases of extremely rare clots among 20m vaccinated. 19 of these people died
Cases aged 18 to 79. 51 of the 79 cases were women
I know a lot of people have had AZ vaccine in the UK but when I seen the number of deaths I was genuinely shocked.
One of the issues here is how much choice do you have in reality when there are supply issues? If we were in a situation where every person who needed a shot had the choice of which one to have, and enabling that choice didn’t slow down the vaccination drive, then the consideration is absolutely one that should be factored in. But that isn’t reality, and we are in many ways in a race to get populations vaccinated. When the difference in absolute risk is so small and possibly not even real it cost-benefit analysis of exercising your “choice” to forgo an AZ shot in favour of waiting for a different one to be available is incredibly difficult to justify.
Admittedly said from the privileged position of having been able to get the vaccine that I’d probably have chosen if I had the choice to pick (Pfizer).
OK so 3 of the 19 deaths are of under 30’s. I guess the MHRA has decided that the risk-benefit for under 30’s makes alternatives to AZ the safer choice given the low risk of severe disease and death in this age group.
As of last week roughly 25% of vaccinations in Ireland were with AZ.
Have they said how many of the 19 fatalities were women?
51 out of 79 is 64.6%. That is very slightly higher than the gender breakdown for that cohort as a whole where out of 79 you’d expect 43 to be women if split proportionately, suggesting that being a woman would give you approximately a 40% elevated risk of this reaction than for a man. But that’s the overall cohort. The proportion of women being vaccinated compared to men is much greater for the under 50s (61% of whom are women) than those older so we still need a breakdown of the age of those who had reactions (and also those who died).
This is a good graph for demonstrating risk. I imagine it would be a bit different using the Germany data who have inoculated many more younger people with AZ.
This is what the EMA needed to do in their press conference though as they are the ones facing widespread vaccine skepticism. Well played Mr. Van-Tam.
Simply and categorically not true. Ignore-ance is clearly bliss.
The UK has vaccinated more people with AstraZeneca under the age of 50 (and more just to women under the age of 55) than any of Germany, Italy or France has in total to both men and women of all ages.
But according to you there cannot be any deaths associated with AstraZeneca for those under the age of 55 because, according to you, as of last week, the UK hadn’t started vaccinating the under 55s…
Notwithstanding the NHS called forward those under the age of 55 more than two weeks earlier…
https://www.england.nhs.uk/2021/03/nhs-england-invites-everyone-aged-50-and-over-to-be-jabbed-as-nhs-vaccination-programme-marks-100th-day/
And as at 28 March 2021, four days before you were saying the UK hadn’t even begun (or perhaps only just started) vaccinating those under the age of 55, had actually administered vaccines to more than 10 million people under 55, majority women, the majority of whom received AstraZeneca.
But then…
Compared to the number of people who got the jab, it’s a rate of 0,00000395%. If these numbers are accurate, the risk of getting a blood clot is really very near to nil. The dead rate is even less than that: 0,00000095%.
The difficulty is in not knowing the precise age or gender breakdown as to who these 70 cases (and 19 deaths) affected.
We know that approximately 2/3rds were in women and all under the age of 79. But what if those 51 women were all aged under 50 and that all of the deaths were women also under the age of 50?
That would mean that the incident rate for cases for women under the age of 50 was approximately 1 in 80,000 (0.00125%) and the death rate just under 1 in 210,000 (0.000476%).
Still very very small but the risk for any particular demographic is likely to vary such that some will be at higher risk than others.