Detailed vaccine safety update

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

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

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

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

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