EUU, Alm.del - 2020-21 - Bilag 431: Orienteringsbrev vedr. Covid-19-vaccinen fra AstraZeneca

Europaudvalget 2020-21
EUU Alm.del Bilag 431
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7.4.2021

AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets | Europe…

An official EU website

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.

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.

https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

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EUU, Alm.del - 2020-21 - Bilag 431: Orienteringsbrev vedr. Covid-19-vaccinen fra AstraZeneca

7.4.2021

AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets | Europe…

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.

https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

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EUU, Alm.del - 2020-21 - Bilag 431: Orienteringsbrev vedr. Covid-19-vaccinen fra AstraZeneca

7.4.2021

AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets | Europe…

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.

https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

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EUU, Alm.del - 2020-21 - Bilag 431: Orienteringsbrev vedr. Covid-19-vaccinen fra AstraZeneca

7.4.2021

AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets | Europe…

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.

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.