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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

Madrid confirms seven monkeypox infections as suspected cases rise in Spain and Portugal

Spain and Portugal have detected over 40 suspected cases of monkeypox, a viral infection rarely seen in Europe, with both outbreaks concentrated in the Madrid and Lisbon areas, officials said Wednesday.

Madrid confirms seven monkeypox infections as suspected cases rise in Spain and Portugal

Seven out of the eight suspected monkeypox cases announced on Tuesday were confirmed as positive by Madrid’s health department on Wednesday.  

In a statement, health authorities in the Madrid region said they had now detected another “22 possible cases of monkeypox”, indicating all of them were believed to have been transmitted through sexual activity.

“In general, its transmission is via respiratory drops but the characteristics of the 22 suspected infections point to it being passed on through bodily fluids during sex relations,” the statement said, without giving further details.

“All of them are young adult males and most of them are men who have sexual relations with other men, but not all of them,” Elena Andradas, head of public health in the Madrid region, told Cadena Ser radio.

The announcement came just days after the British health authorities said they had detected seven cases so far this month, with the World Health Organisation working with the government to investigate the outbreak.

Health officials have noted some of these infections may be through sexual contact — in this instance among gay or bisexual men — which would be a new development in understanding how the virus is transmitted.

Another 20 suspected cases of monkeypox — endemic in parts of Central and Western Africa — have been detected in the Lisbon region, Portugal’s health ministry said in a statement.

“The cases were all among males, the majority of them young, who had ulcerated lesions,” it said.

Symptoms of monkeypox in humans include a rash which often starts on the face then moves to other parts of the body, fever, muscle ache and chills. Most people recover from the illness within several weeks.

Handout showing the rashes that develop on the skin when there is a monkeypox infection. Photo: UKHSA

Transmission is usually via close contact with infected animals such as rodents and monkeys, and is limited between people. It has only been fatal in rare cases.

The UK Health Security Agency (UKHSA), a public health protection body, on Monday said it had detected four new cases after registering three cases earlier in May.

All four of the additional cases were men who have sex with men or self-identify as gay or bisexual, it said.

None have known connections with the three earlier confirmed cases, the first of which was linked to travel from Nigeria, raising fears of community spread of the virus.

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