AstraZeneca France: Vaccine pause ‘catastrophic’ say doctors
Leading doctors in France say the decision is political and could stoke distrust, even as health authorities say there is ‘no reason to be alarmed’ by the jab
The suspension of the AstraZeneca vaccine in France is a “catastrophic” decision, leading doctors have said, as one case of thrombosis is reported in France.
France paused its use of the Anglo-Swedish AstraZeneca vaccine yesterday (March 15), pending investigations into its side-effects by the European Medicines Agency (EMA). An announcement on this is due on Thursday (March 18). Several other EU nations have also suspended their use of the vaccine, including Germany, Ireland, Italy, Spain and the Netherlands.
The jab is suspected of causing blood clot issues in small numbers of recipients, but no link has been formally found.
The EMA is expected to meet today (March 16), and issue new advice on the use of the vaccine on Thursday, President Emmanuel Macron said yesterday.
Dr Jean-Paul Ortiz, president of medical union group la Confédération des syndicats médicaux français (CSMF), told news service FranceInfo: “This decision is catastrophic when it comes to the Covid-19 epidemic.
“It is a very political decision and very clearly a tough blow to vaccination. All the side-effects of this vaccine are simply flu-like symptoms that last 24 to 48 hours. I also note that the UK has vaccinated 20 million people with no problems.”
Dr Ortiz said that the decision to suspend the vaccine would increase mistrust of the vaccine “whatever the decision” of the EMA today.
He said: “I fear that sadly, even with a positive decision, this decision will have an extremely negative effect. I confess I am very worried about what is going to happen over the next few days.”
Philippe Besset, president of pharmaceutical union la Fédération des syndicats pharmaceutiques de France (FSPF), said: “I trust this vaccine. I share the view that these rare unwanted side-effects have never been seen among the millions of vaccinations that have been done in the UK.”
He said: “I find this decision [to suspend the vaccine in France] surprising” and added that he was “impatiently waiting for the decision of the [national safety group] pharmacovigilance committee” mid-week.
Mr Besset said that France could have waited for that decision before choosing to suspend the vaccine.
He said: “There are 300 deaths from Covid per day in France, that is not benign. Only vaccination can get us out of this.”
He called on the public to trust health agencies and said that “there has been no scientific advice [saying to suspend the vaccine]. There have been political decisions to interrupt the vaccination.”
He added that he believed health authority decisions this week will “confirm what they have already said, which is that it is reasonable to continue to use this vaccine”.
Professor Jean-Louis Montastruc, pharmacologist and member of national medicine authority l’Académie nationale de médecine, said: “So far, there has been no link established between the development of thrombosis - blood clots - in certain people vaccinated with the AstraZeneca vaccine.
“Unwanted side-effects come very quickly after injection. If patients do not see anything in the days after, there is no reason to be alarmed.”
Suspension ‘legitimate’ but ‘no problems in France’
It comes as the president of the country’s pharmacovigilance centre network, le réseau français des centres régionaux de pharmacovigilance (CRPV), said that “only one case of thrombosis” has been detected in France.
This is in addition to the arrhythmia reported in the south of the country, and the thrombosis reported in Denmark.
Dr Annie-Pierre Jonville-Béra told FranceInfo that the suspension of the vaccine in France “does not call into question the continuation of the vaccination campaign”.
Yet, Dr Jonville-Béra said that the suspension of the vaccine was “completely legitimate”. She said: “It’s the principle of precaution. Although, in France, we have not had problems with this vaccine.
“We have no reason to say that the problems reported are directly linked to this vaccine.”
She added: “By March 4, more than 12,000 side-effect cases had been reported. In 80% of cases, these are expected side-effects, that we knew about when the vaccine went on the market, and are listed on the box, such as fever or muscle aches.
“On the other hand, we have some unexpected side-effects, which are not listed on the box, and which we will study very closely and evaluate the link with the vaccine. There were some blood pressure spikes, but they were very temporary.
“This does not call into question the continuation of the vaccination campaign. We can allow a suspension of 24-48 hours, awaiting the response of the EMA. If the response is clear, we will restart vaccination, no problem.”
Call for ‘perspective’ on side-effects
Professor Jean-François Timsit, head of intensive care at the Bichat hospital in Paris, has also said that the reported side-effects should be “put into perspective”. He said: “Only a small number of young patients will feel fever and maybe stay in bed for a few hours after their vaccine.”
He said that possible side-effects should be seen in the context of the lives that the vaccine would save, and the “life-poisoning” effects of “long Covid”.
He said: “People need to know that if you vaccinate 100,000 people aged 50 or over today instead of tomorrow, we will have 15 fewer deaths.”
He said that there is no “comparing” the impact of suspending the AstraZeneca vaccine in Iceland or Norway versus in France, as those countries have “three to seven deaths per day” compared to the “major and fatal risk” that the virus is continuing to pose in France.
The latest figures from Santé publique France show that there were 333 new deaths in France in the past 24 hours.
Campaign ‘restart as soon as possible’
It comes as Health Minister Olivier Véran said today: “I ardently want us to restart the vaccination campaign with AstraZeneca as quickly and soon as possible.”
Further medical advice on the safety of the vaccine is expected this week following evaluations by the World Health Organisation (WHO) and the EMA.
Director general of the WHO, Tedros Adhanom Ghebreyesus, has so far said that its research group that has “examined the data” is in “close contact” with the EMA, and that the groups are set to meet today to discuss new advice for the vaccine.
What if you have already had the AstraZeneca vaccine?
France has received 316,800 doses of the vaccine batch causing concern. Half the doses have so far been given, and there have been no deaths or blood clot issues reported.
If you have received one or two doses of the vaccine, doctors have said that there is no reason to worry. So far, the decision taken by President Macron is a simple “pause” in the campaign, and not a ban.
Dr Jérôme Marty, a GP from Fronton, told newspaper La Dépêche that the suspension would “last a few days or a week” at the most. As he vaccinates people at his surgery “on Thursdays”, he said that he would simply miss a week, until new advice has been issued by the EMA.
Dr Martin Blachier, epidemiologist and public health doctor, said: ”If we look at the number of people with blood clot issues compared to those vaccinated, we cannot say that it is alarming.”
Professor Montastruc has echoed the health minister’s comments, saying that the “risk-benefit ratio” of the vaccine compared to the epidemic, which is killing hundreds of people per day, is still in favour of the vaccine.
He said: “The advantages of the AstraZeneca vaccine are higher than the risks.”
Health Minister Olivier Véran also said last week that “the benefits brought by the vaccination are greater than the risk”.
If you have had a vaccine in France (or any kind of medical treatment), you can report any side-effects online on the health ministry website here.
New advice from the WHO and EMA is expected this week.