Vaccine safety update

EMA

possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination

86 European cases

plausible explanation for these rare side effects is an immune response to the vaccine

18 deaths

Benefits of the vaccine outweighed the risk

25 million doses

(One case per 290,697 doses)

(One death per 1,388,888)

Could not list specific risk factors such as age or gender, but most blood clot cases were women under 60

Emer Cooke

No available evidence of specific risk factors such as age, gender, or previous medical history of clotting disorders

This vaccine has proven to be highly effective - it prevents severe disease and hospitalisation, and it is saving lives.

Belgium

Restrict AstraZeneca to those aged 56 and above

Italy

Over 60s

No evidence to stop people having a second dose of AstraZeneca

Spain

Restricting AstraZeneca to those between 60 and 64

France

Given only to those aged 0ver 55

Germany

Over 60s, plus high-priority groups

Under-60s who have received an AstraZeneca first dose should get a different vaccine for their second

Norway and Denmark

Full suspension

Germany also says its

World Health Organization's advisory vaccine safety panel

Blood clot link was plausible

not confirmed

very rare among 200 million people vaccinated with AstraZeneca globally

Statement from the Joint Committee on Vaccination and Immunisation (JCVI) on the use of the AstraZeneca COVID-19 vaccine

Acting on a precautionary basis, if these persons (under 30) are still unvaccinated, it is preferable for them to be offered an alternative COVID-19 vaccine, if available.

MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots

Slides from press conference

Medicines and Healthcare products Regulatory Agency (MHRA)

Possible risk of extremely rare and unlikely to occur specific types of blood clots

MHRA has undertaken a thorough review into UK reports

Very rare and unlikely to occur, cerebral venous sinus thrombosis (CVST)

Occurring together with low levels of platelets (thrombocytopenia)

It is also considering other blood clotting cases (thromboembolic events) alongside low platelet levels

Most presenting within 14 days of first dose

Analysed by

Commission on Human Medicines (CHM)

COVID-19 Vaccines Benefit Risk Expert Working Group

Up to and including 31 March 2021

20.2 million doses of AstraZeneca had given in the UK

Overall risk of these blood clots is approximately 4 people in a million

(One in 255,696)

MHRA had received 79 UK reports of blood clotting cases alongside low levels of platelets

44 of the 79 cases were of CVST with thrombocytopenia

35 of the 79 cases were of thrombosis in other major veins with thrombocytopenia

79 cases occurred in 51 women and 28 men, aged from 18 to 79 years

19 deaths

(One in 1,063,157)

19 people have died out of the 79 cases, 13 females and 6 males

11 out of the 19 people who died were under the age of 50

3 of whom were under 30

14 of these 19 cases were of CVST with thrombocytopenia

5 of the 19 were thrombosis with thrombocytopenia

All 79 cases occurred after a first dose of the vaccine

UK CoViD deaths

8th April, + 53 = 126,980

or 149,968

Level of risk

31 March numbers, slightly higher than 24 March

Anyone who did not have these side effects should have second dose

Pregnancy predisposes to thrombosis, discuss with their healthcare professional

Precautionary measure, seek prompt medical advice

Shortness of breath, chest or persistent abdominal pain, leg swelling

Blurred vision, confusion or seizures

Pin-prick rash or bruising beyond the injection site

New onset of severe or persistent headache that does not respond to simple painkillers starting four days or more after vaccination should speak to their doctor.

Dr June Raine, MHRA Chief Executive

Use Yellow Card Website

It is still vitally important that people come forward for their vaccination when invited to do so

Advice for health care professionals

Following administration, the S glycoprotein of SARS CoV 2 is expressed locally stimulating neutralising antibody and cellular immune responses.