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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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TRAVEL NEWS

Paxlovid, tests and isolation: Covid care for tourists in France

With travel opening up, many people are planning trips to France over the next few months, but the Covid pandemic has not gone away. Here are your questions answered on testing, isolation and medical treatment if you do fall sick while on holiday.

Paxlovid, tests and isolation: Covid care for tourists in France

Travel rules

Covid-related travel rules have mostly been relaxed now but you will still need to show proof of being fully vaccinated at the French border. If you are not vaccinated you will need to show a negative Covid test – find the full breakdown of the rules HERE.

Testing

Once in France if you develop symptoms or you have been in contact with someone who has tested positive you will need to get a Covid test.

The good news is that testing is widely available in France, both for residents and tourists.

The easiest way to get a test is head to a pharmacy, most of which offer the rapid-result antigen test on a walk-in basis Tests are available to everyone who wants one, there is no need to fulfill any set criteria.

For full details on how to get a test, and some handy French vocab, click HERE.

The difference for tourists is that you will have to pay for your test, while residents get their costs reimbursed by the French state health system.

In the pharmacy you may be asked for your carte vitale – this is the health card that residents use to claim refunds. As a tourist you won’t have the card – you can still get the test, you will just need to pay for it. Costs vary between pharmacies but are capped at €22 for an antigen test or €54 for a PCR test.

Isolation

If your test is positive you are legally required to isolate, but how long your isolation period is depends on the your vaccination stats – full details HERE.

Treatment

For most fully-vaccinated people without underlying health conditions the symptoms of Covid are fairly mild, but if you do become ill, here’s how to access medical help while in France.

Pharmacy – one of the first things you will notice about France is that pharmacies are everywhere, just look out for the green cross. As well as selling over-the-counter medication, pharmacies all have at least one fully-qualified pharmacist on the staff who can offer medical advice. 

Take advantage of pharmacists – they train for at least six years so they’re very knowledgeable and they’re easy to access by simply walking into the shop. In tourist areas it’s likely that they will speak English. Pharmacists can also signpost you to a nearby doctor if you need extra help.

Doctors – if you need to see a doctor, look out for a médecin généraliste (a GP or family doctor). There is no need to be registered with a doctor, simply call up and ask for an appointment if you need one. If you have a smartphone you can use the medical app Doctolib to find a généraliste in your area who speaks English. You will need to pay for your consultation – €25 is the standard charge and you pay the doctor directly using either cash or a debit card.

You may be able to claim back the cost later on your own health/travel insurance depending on the policy.

Ambulance – if you are very sick or have difficulty breathing you should call an ambulance – the number is 15. All non-residents are entitled to emergency treatment in France, whether or not you have insurance, but if you are admitted or have treatment you may need to pay later.

READ ALSO Emergency in France: Who to call and what to say

Paxlovid – several readers have asked whether the Covid treatment drug Paxlovid is available in France. It was licenced for use in February 2022 and is available on prescription from pharmacies, mainly for people with underlying health conditions or an impaired immune system. You can get a prescription from a medical practitioner.

The drug is reimbursed for French residents, but as a tourist you will have to pay.

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