UK vaccinations
First dose, 25,735,472
Second dose, 1,879,054
Based on about 11 million doses of each vaccine, AZ and Pfizer
AstraZeneca
[ Ссылка ]
19 thrombotic events
DVT, 15
Non specific
Embolism, 1
Thrombosis, 3
Haemorrhage, 23
Thrombocytopenia, 43 (1 death)
Cerebral sinus vein thrombosis, (CSVT), 0
Pfizer- BioNTech
[ Ссылка ]
18 thrombotic events
DVT, 9
Non specific
Embolism, 0
Thrombosis, 13
Haemorrhage, 25 (1 death)
Thrombocytopenia, 24 (1 death)
Cerebral sinus vein thrombosis, (CSVT), 0
UK, HMRA, 18th March
[ Ссылка ]
Government response
UK regulator confirms that people should continue to receive the COVID-19 vaccine AstraZeneca
Following a rigorous scientific review of all the available data
VTE, DVT, PE
Available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by
COVID-19 Vaccine AstraZeneca
Confirmed by the Government’s independent advisory group, the Commission on Human Medicines
Cerebral sinus vein thrombosis
Five UK reports of CSVT (1 death)
Occurring together with lowered platelets (thrombocytopenia)
Reported in less than 1 in 2 million people vaccinated so far in the UK
Can occur naturally
A causal association with the vaccine has not been established
MHRA’s advice, vaccine continues to outweigh any risks
Dr June Raine, MHRA Chief Executive
Our thorough and careful review,
alongside the critical assessment of leading, independent scientists,
shows that there is no evidence that that blood clots in veins is occurring more than would be expected in the absence of vaccination, for either vaccine.
Risk of dying from covid, x 1000 for most people
CSVT
After 11 million doses of AZ
1 case in 2.2 million
1 fatality in 11 million
UK, all men
a link to the vaccine is unproven
the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects.
anyone with a headache that lasts for more than 4 days after vaccination,
or bruising beyond the site of vaccination after a few days, to seek medical attention
mild flu-like symptoms remain one of the most common side effects of any COVID-19 vaccine,
including headache, chills and fever
These generally appear within a few hours and resolve within a day or two, but not everyone gets them
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines
Re. 5 cases
Further work with expert haematologists is under way
to further understand the nature of these cases
and whether there is a causal association with any of the vaccines.
AstraZeneca COVID vaccine, 80% reduction in hospitalisation and death
HMRA and EMU working closely
EMA, 18th March
Pharmacovigilance Risk Assessment Committee
COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
[ Ссылка ]
The benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects
The vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events)
(Lower than in unvaccinated groups)
There is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites
However, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).
20 million people in the UK and EEA had received AZ (March 16)
DIC, 7 cases
CVST, 18 cases
A causal link with the vaccine is not proven, but is possible and deserves further analysis.
DIC and CVST
Reported from Member States,
9 resulted in death (DIC and CVST combined)
Mostly under 55s, mostly women
DIC, Based on pre-COVID figures, younger people
Expected, less than 1 case, among people under 50 within 14 days of receiving the vaccine
Actual, 5 cases
CVST, younger people
Expected, 1.35 cases
Actual, 12 cases
A similar imbalance was not visible in the older population given the vaccine.
Results
Never stopped
UK
Belgium
Czech
Poland
Reversals, now using AZ again from tomorrow
Italy
France
Ireland
Spain
Germany
Latvia
Lithuania
Cyprus
No reversal
Sweden, next week
