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HEALTH

‘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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HEALTH

WHO says European festivals should go ahead despite monkeypox risk

Most new cases of monkeypox are currently detected in Western Europe. The World Health Organisation says this is no reason to cancel more than 800 festivals scheduled to take place on the continent this summer.

WHO says European festivals should go ahead despite monkeypox risk

The World Health Organization said Friday that European summer festivals should not be cancelled due to the monkeypox outbreak but should instead manage the risk of amplifying the virus.

A surge of monkeypox cases has been detected since May outside of the West and Central African countries where the disease has long been endemic.

Most of the new cases have been in Western Europe.

More than 3,200 confirmed cases and one death have now been reported to the WHO from 48 countries in total this year.

“We have all the summer festivals, concerts and many other events just starting in the northern hemisphere,” Amaia Artazcoz, the WHO’s mass gatherings technical officer, told a webinar entitled “Monkeypox outbreak and mass gatherings: Protecting yourself at festivals and parties”.

The events “may represent a conducive environment for transmission”, she said.

“These gatherings have really close proximity and usually for a prolonged period of time, and also a lot of frequent interactions among people,” Artazcoz explained.

“Nevertheless… we are not recommending postponing or cancelling any of the events in the areas where monkeypox cases have been identified.”

Sarah Tyler, the senior communications consultant on health emergencies at WHO Europe, said there were going to be more than 800 festivals in the region, bringing together hundreds of thousands of people from different countries.

“Most attendees are highly mobile and sexually active and a number of them will have intimate skin-to-skin contact at or around these events,” she said.

“Some may also have multiple sexual contacts, including new or anonymous partners. Without action, we risk seeing a surge in monkeypox cases in Europe this summer.”

Risk awareness

The UN health agency recommends that countries identify events most likely to be associated with the risk of monkeypox transmission.

The WHO urged festival organisers to raise awareness through effective communication, detect cases early, stop transmission and protect people at risk.

The outbreak in newly-affected countries is primarily among men who have sex with men, and who have reported recent sex with new or multiple partners, according to the WHO.

People with symptoms are advised to avoid attending gatherings, while people in communities among whom monkeypox has been found to occur more frequently than in the general population should exercise particular caution, it says.

The normal initial symptoms of monkeypox include a high fever, swollen lymph nodes and a blistery chickenpox-like rash.

Meg Doherty, from the global HIV, hepatitis and sexually-transmitted infection programmes at WHO, said: “We are not calling this a sexually-transmitted infection.

“Stigmatising never helps in a disease outbreak,” she added.

“This is not a gay disease. However, we want people to be aware of what the risks are.”

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