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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

Denmark considers moving outpatient nurses to night shifts to ease shortage

Danish hospitals could ask nurses that usually work in outpatient services to cover night and weekend shifts in an effort to ease a lack of staff cover.

Denmark considers moving outpatient nurses to night shifts to ease shortage

The Danish Regions, the elected bodies which operate hospitals in Denmark’s five regions, are considering a plan to require nurses who work at outpatient clinics to fill night and weekend shifts in hospitals, newspaper Jyllands-Posten reports.

The policy would aim to prevent hospital nurses — particularly those working in intensive care, surgery, and emergency departments — from leaving the public system for more favourable working conditions at private clinics. 

Nurses in departments with shift rotas bear the brunt of a nurse labour shortage, meaning many must take on an untenable number of night and weekend shifts as many of their colleagues leave, according to the report.

“The lack of staff is currently the biggest challenge for the health service and a more transparent and fair rota, in which staff have an input on their schedules, is one of the most important keys to becoming a more attractive place of work and retaining personnel,” Stephanie Lose, chair of the Southern Denmark regional council and vice-president of the Danish Regions, told Jyllands-Posten.

“We have to share the heavy on-call load on to more shoulders, and our clear message is that all hospitals must work with this systematically in all areas, otherwise we will not achieve our goal,” she said.

The Danish Regions want to base the plan on a model already used in the South Denmark region, according to Jyllands-Posten.

This would mean staff having rotas with at least eight weeks’ notice, and weekend shifts no more often than every third week.

The Regions also propose that nurses employed in outpatient clinics spend a third of their working time on the schedule in an inpatient ward.

The leader of Danish trade union for nurses DSR, Grete Christensen, did not dismiss the prospect in comments to Jyllands-Posten.

Christensen warned against forcing all hospitals and departments to comply with a defined model, however.

She said that the essence of the problem is a lack of nurses in the public health system.

READ ALSO: Denmark takes ‘far too long’ to approve qualifications of foreign medics, nurses 

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