AstraZeneca jab re-approved in France but only for over 55s
National health authority has said the age cap is temporary until there is more data on possible links between the vaccine and rare blood clotting disorders
Update March 20. This article originally stated: Europe-wide, 25 cases of blood clotting disorders have been identified in patients who have had the AstraZeneca vaccine out of a total of around seven million vaccinations. This was an error and it has now been amended to "EU-wide".
The Haute Autorité de Santé (HAS) has re-recommended the use of the AstraZeneca Covid-19 vaccine in France - but only for the over 55s - after it was suspended on March 15 due to a small number of vaccinated people suffering blood clotting disorders.
Vaccinations using it are set to begin again this afternoon (March 19), with Prime Minister Jean Castex, 55, among those being vaccinated.
The health body stated that the vaccine should only be used on patients over 55 years old as serious and the rare blood clotting issues that motivated its suspension were only reported in people aged younger than this.
Before this decision, the AstraZeneca vaccine was being rolled out to people aged 50 to 74 with certain existing medical issues and everyone over the age of 75.
Suite à l'avis de l'EMA, la @HAS_sante donne son feu vert à la reprise de la vaccination avec AstraZeneca pour les personnes âgées de 55 ans et plus. Merci à tous nos médecins, pharmaciens qui dès aujourd'hui vont tous se mobiliser pour continuer la campagne vaccinale.— Olivier Véran (@olivierveran) March 19, 2021
In France, one case of disseminated intravascular coagulation was observed in a 26-year-old woman, and two cases of thrombocytopenia - a blood platelet deficiency disorder - were reported in a 51-year-old man and a 24-year-old woman.
This is out of a total of 1.4 million people who have received the vaccine in France.
EU-wide, 25 cases of blood clotting disorders have been identified in patients who have had the AstraZeneca vaccine out of a total of around seven million vaccinations, leading to nine deaths.
The HAS’s recommendation deviates from the opinion of the European Medicines Agency (EMA), which yesterday declared AstraZeneca’s Covid-19 vaccine safe for all adults following a review by its risk assessment committee PRAC.
“The committee has come to a clear scientific conclusion. This is a safe and effective vaccine,” Emer Cooke, the executive director of EMA, said during a press conference on Thursday (March 18).
“Its benefits of protecting people from Covid-19...outweigh the possible risks.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots,” she said.
Ms Cooke stated that during the review process a small number of cases of rare and unusual but very serious clotting disorders were identified.
She said that based on available evidence, EMA still cannot rule out “definitively” a link between these cases and the vaccine.
The committee has recommended including this information on the product information and has stressed the importance of closely monitoring all reported side effects noticed after vaccination.
“We are also launching additional investigations to understand more about these rare cases and we are conducting targeted observation studies,” she said.
“I would like to highlight that the situation like the one we have just seen here is not unexpected. When you vaccinate millions of people it is inevitable that rare or serious instances of illnesses will occur in the time immediately following vaccination.”
The HAS has recommended patients aged under 55 be vaccinated with the two other vaccine types currently being used in France, those of Pfizer-BioNTech and Moderna, while it awaits additional data relating to the AstraZeneca vaccine.
When the HAS initially approved the AstraZeneca vaccine in France it recommended only using it on patients aged 50 to 64 as there was not enough data available on its effects on people aged over 65.