France issues statement on AstraZeneca and batch ABV5300

There have not been any deaths or severe reactions in France to the latest batch of the Oxford/AstraZeneca vaccine - the batch that Austria has temporarily suspended use of, the country’s medical safety agency reports.

The Agence nationale de sécurité du médicament (ANSM) published its latest figures on Covid-19 vaccination side-effects yesterday.

It said that 316,800 doses of the latest AstraZeneca batch (number ABV5300) had been delivered to France since February 9, 2021. Of these, half have been administered, and there have not been any deaths or “exceptional reactions” reported.

In a statement, the ANSM said that there have not been any reports of deaths, life-threatening side-effects, or any cases of thrombosis or blood thickening in connection with the latest ABV5300 batch in France.

The agency added that the European Medicines Agency continues to recommend the use of the AstraZeneca vaccine in Europe, which the agency supports, but that this position could change if the data changes.

It said: “At this stage, nothing indicates that there is a specific problem with the ABV5300 batch, nor that the vaccination causes the effects, which do not appear on the list of side-effects of this vaccine.”

Overall, ANSM figures show that up to March 4, 454,545 AstraZeneca injections have been delivered in France, with reports of undesirable side-effects after 3,013 injections. This equates to less than 1% (0.66%).

This is slightly higher than reported figures for other vaccines. Pfizer/BioNTech has seen reported side-effects after 0.19% of injections, and Moderna 0.12%.

Two-thirds of reported side-effects for the AstraZeneca vaccine are considered “non-serious”, including pain at the site of injection and some fever. In rarer cases, around 10% of the reported side effects mentioned nausea or vomiting, headaches, and dizziness.

The World Health Organisation said again this week that “there is no reason not to use” the AstraZeneca vaccine.

France’s Health Minister Olivier Véran has said that there is no need to fear the vaccine, and said that in France, the ANSM has noted “one case of thrombosis” out of the 454,545 AstraZeneca doses administered so far, which was not connected to the latest AstraZeneca batch.

This is lower than the national risk of thrombosis without the vaccine, which is currently at one in 300,000 people.

Doctors in France have today published an open letter in le Journal du Dimanche, calling on the public to not be afraid of getting a vaccine, including the AstraZeneca jab.

They wrote: “Today, there is far more risk of getting a severe form of Covid-19 if you do not get the vaccine, than there is of getting a blood clot [because of the vaccine].”

Austria suspends vaccine batch

Controversy around the vaccine’s side-effects continues across Europe.

Austria has suspended administration of the latest AstraZeneca batch (the same as the one delivered and used in France), after two reports of severe blood clotting, and one death amongst those receiving the vaccine although no link between the events has been established.

Italy has also suspended the use of its latest batch (ABV2856) in response to the reports, but no doses from this batch have been delivered to France.

Denmark, Iceland, Norway and Bulgaria have temporarily suspended administration of the vaccine pending investigations into reports of blood clotting issues in some people after vaccination. No links between the cases and the vaccine have yet been established.

Thailand has delayed starting its vaccination programme using the AstraZeneca jab due to the reports.

Norway has also reported cases of skin haemorrhages in relatively young people after they received the vaccine, although no link has yet been confirmed.

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