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‘Possible link’ between AstraZeneca vaccine and rare blood clots, EMA concludes

The European Medicines Agency has come to the conclusion that the unusual blood clots suffered by numerous people around Europe should be considered as rare side effects of AstraZeneca's Covid-19 vaccine, but that overall the benefits of the jab outweigh the risk.

'Possible link' between AstraZeneca vaccine and rare blood clots, EMA concludes
Photo by Tiziana FABI / AFP

A statement published online read: “The EMA’s safety committee has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of the COVID-19 AstraZeneca vaccine.”

The EMA added however that the benefits of the vaccine outweigh the risks.

While millions of doses of the vaccine developed with Oxford University have been administered, small numbers of people have developed deadly blood clots, which prompted countries including the European Union’s three largest nations – Germany, France and Italy – to temporarily suspend injections pending the EMA investigation.

In March the EMA said the vaccine was “safe and effective” in protecting people against Covid-19 but that it couldn’t rule out a link to blood clots, and that more investigations were needed.

On Wednesday the EMA said the AstraZeneca vaccine should continue to be used for all age groups but that people should be told of the possible rare side effects. The announcement came as the UK’s own drugs regulator said the AZ vaccine should now only be given to over 30s.

The EMA said it was “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 two weeks of vaccination.”

One plausible explanation for the combination of blood clots and low blood platelets is an immune response, the EMA said but that it had not identified any clear risk factors for causing the clots including age or gender.

So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination. 

The EMA advised that 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.

Symptoms include shortness of breath, chest pain, swelling in legs, abdominal pain, severe headaches, blurred vision and tiny blood spots under the skin at the sight of the injection.

The EMA 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 agency concluded: “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.”

Germany, France and Italy have all restarted AstraZeneca vaccines, but in the case of France and Germany with extra guidelines on the age of patients it should be used for. France is currently not administering the AstraZeneca vaccine to under 55s or over 75s.

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COVID-19

When should I get my next dose of Covid-19 vaccine in Sweden?

Covid-19 has not been classified as a "critical threat to society" in Sweden since April. But the Swedish Public Health Agency still recommends that everyone aged 12 and above get vaccinated. So when should you get your next dose?

When should I get my next dose of Covid-19 vaccine in Sweden?

As winter approaches, it’s a good time to check that you’re up to date on your booster shots.

If you’re aged 12 or older, the agency recommends that you should at least have completed your primary dose of the vaccine, which comprises two shots. Because vaccine efficacy wanes over time, if you are aged 18 and above, you should have already had your third dose.

The booster dose, called a påfyllnadsdos, can be administered a minimum of four months after the primary dose or the most recent booster. A booster shot is recommended even if you have tested positive for Covid-19 since your most recent vaccination, because the protection offered by a vaccine is more reliable than that offered by an infection.

The agency has also warned that the Omicron BA.5 variant spreads more easily than previous Covid-19 mutations.

Deliveries of two of the new vaccines targeting the new variant, Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron BA.1, have arrived in Sweden but have not yet reached all health regions, meaning it is not certain that if you will currently receive the updated vaccine. 

A third vaccine, an adapted version of the mRNA Covid-19 vaccine Comirnaty (Pfizer/BioNTech), is expected to arrive in Sweden in October. 

READ ALSO: When will the new Covid-19 vaccines be available in Sweden?

The höstdosen, or “autumn vaccine”

On September 1, the agency issued new guidelines for a höstdosen, or autumn vaccine dose.

During the campaign, all adults aged 18 and over who belong to an at-risk group are recommended to get a booster dose, as are seniors aged 65 and above. 

Risk categories include people who are pregnant, have a weakened immune system, have heart and lung diseases, or have Down syndrome.

You can get the autumn booster regardless of how many vaccine doses you may have received, which means it might be a fourth shot for some people, and a fifth for others.

The autumn vaccine is also available for those aged 18-64 who do not fall into any of the at-risk categories but would like a fourth dose. The Swedish Public Health Agency has said that regional health providers must make booster doses available to those who want them.

Chart showing recommended vaccination schedules. Chart: Folkhälsomyndigheten

Chart showing recommended vaccination schedules. Chart: Swedish Public Health Agency

How do I get an appointment for the autumn dose? 

Region Stockholm has been offering appointments for an autumn vaccination to everyone over 18 since September 12th. You can book a dose through the Alltid Öppet app

In Region Skåne, the region responsible for healthcare in Malmö and Lund, appointments for an autumn vaccine have been available since August 22nd. Appointments are available for vaccinations in Region Stockholm, as are drop-in times at locations listed on 1177.se.

In Region Västergötland, the region responsible for healthcare in Gothenburg, health centres, or vårdcentraler, are prioritising people aged 80 and older.

Those in other categories, including at-risk adults 18 and older and seniors over 65, are requested to make their vaccination appointments with other providers through 1177.se

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