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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

EXPLAINED: What is monkeypox and what is Switzerland doing about it?

Switzerland has reported its first monkeypox patient on Saturday, but with over 80 cases across the world to date, Swiss officials are preparing to handle the eventual increase in the number of infections.

EXPLAINED: What is monkeypox and what is Switzerland doing about it?

The first case so far was detected in Bern in a person who was “exposed to the virus abroad”, according to the statement by cantonal officials, who did not specify in which country the patient could have been infected.

The traveller is receiving outpatient treatment and self-isolating. Close contacts have been informed through contact tracing.

READ MORE: Switzerland confirms first monkeypox case

While Swiss health officials currently assess the risk of contracting monkeypox as low outside rural areas of Central and West Africa, “the epidemiological data is still limited”, said Céline Gardiol, head of the vaccination section at the Federal Office of Public Health (FOPH).

“However, it can be assumed that more infections can also occur here, as is the case in other countries”, she added.

What measures are Swiss health authorities taking?

For the time being, “the epidemiological situation is being monitored in cooperation with international health authorities and experts, according to FOPH’s vice-president Linda Nartey.

FOPH is also recommending that the cantons carry out contact tracing in proven cases and isolate those who test positive — all of which has an eerie sense of déjà-vu.

“The cantonal systems are in place and ready to be deployed. Quarantines are not currently planned”.

There is no specific vaccine against monkeypox, tough first- and second-generation smallpox vaccines provided effective protection. But they were discontinued in 1972 when the World Health Organisation declared that the disease was successfully eradicated.

There is now also a third-generation smallpox vaccine that is approved for adults in Europe but not yet in Switzerland, as the drug regulatory body, Swissmedic, has not received any approval request from the manufacturers.

However, Narty said Switzerland is examining the possibility of buying these vaccines.

What is monkeypox?

Monkeypox, Affenpocken in German, vaiolo delle scimmie in Italian and variole du singe in French is a zoonotic virus (a virus spread from animals to humans) that most often occurs in areas of tropical rainforest in Central and West Africa.

However, it is occasionally found in other regions, and cases have recently been discovered in Europe, North America, and Australia.

The name monkeypox originates from the initial discovery of the virus in monkeys in a Danish laboratory in 1958, according to WHO. The first human case was identified in a child in the Democratic Republic of the Congo in 1970.

Monkeypox virus is transmitted from one person to another by close contact with lesions, body fluids, respiratory droplets and contaminated materials such as bedding. The incubation period of monkeypox is usually from 6 to 13 days but can range from 5 to 21 days.

People can also be infected through contact with the lesions of the skin, blood, tissues, or excretions of infected animals (mainly rodents) and by handling the meat of sick animals.

The disease is not known to be sexually transmitted. Still, close contact between people during sex can make the transmission of the virus easier.

How contagious and dangerous is monkeypox ?

According to FOPH, immunocompromised people, as well as children and young adults who have become infected seem to have a higher risk of a severe course of the disease, whose symptoms include fever, headache, muscle aches, fatigue, and chickenpox-like skin rash.

Most people affected by the disease recover within a few weeks.

It takes a close, direct contact with the infected person, for instance by touching skin lesions, to become contaminated. Infectious disease specialist Jan Fehr confirmed that monkeypox virus is not transmitted through air, like coronavirus.

Many of the cases presented are in men who have sexual relations with other men and health authorities have asked for extra care and are studying current cases.

And this brings is to the question that is likely on everyone’s mind right now.

Is monkeypox as contagious as Covid and will there be another pandemic?

“Based on what is known about the virus, one can assume that it is less transmissible than the coronavirus”, Nartey pointed out.

She added that at the moment there is no indication of another pandemic emerging in Switzerland or elsewhere.

However, the evolution of the disease must be closely observed, she said.

“We have to watch the outbreaks and in each case carry out contact tracing immediately to quickly interrupt any transmission chains”.

Tracing became widespread during the Covid pandemic to identify, and quarantine, people who were in contact with an infected person.

READ MORE: Q&A: How will Switzerland’s coronavirus tracing app work?

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