Four Adverse Events "Serious" in People Vaccinated Against Influenza A

As part of its weekly review, the French Agency for the Safety of Health Products (AFSSAPS) announced Friday, November 13th only four adverse events “serious”, including Guillain-Barre have been identified among professionals Health vaccinated against influenza A. Investigations are underway to determine whether these effects are either unrelated to the vaccine. Moreover, a young woman of 27 years, carrying the influenza virus A and without medical history, died Tuesday of heart failure after presenting respiratory

What side effects have been reported among persons vaccinated?
Of about 100,000 health professionals vaccinated between October 21 and November 10, four adverse events “serious” were identified by Afssaps two neurological disorders, allergic reactions and respiratory disorders. It was first reported a possible case of Guillain-Barre to moderate, occurred in a woman 37 years after treatment, has recovered well and was able to return home.

The second case is angioedema, an allergic reaction that can, in some cases, cause a serious risk of suffocation. In this case, it occurred within minutes following vaccination in a 26 year old woman whose condition after treatment, improved “without any sequelae. The third case of neurological disorders (numbness of the upper limbs) seen in a man of 34 years, too, is better. Finally, a 30 year old woman with a history of allergy presented a respiratory (bronchial spasms, shortness of breath). “His condition is improving under appropriate treatment,” says Afssaps.

What is Guillain-Barre?
It is an attack of nerves that results in rapid paralysis, usually starting at the legs, then back up the body. In 85% cases, the patient recovery is complete, but 5% of people die and 10% are affected negatively. In France, there are each year between 1 700 and 1 800 cases of Guillain-Barre. The risk of developing this condition after a flu shot is one or two cases per million persons vaccinated. According to experts, in two thirds of cases, this syndrome is triggered after a viral or bacterial infection. The infectious disease stress is therefore more likely to have Guillain-Barre after the flu after vaccination.

These side effects are they related to the vaccine?
In the case of angioedema, it is quite possible. “It is an uncommon side effect, but can occur after vaccination,” says Carmen Kreft-Jais, head of pharmacovigilance Afssaps. For three other cases, she said that investigations are underway to try to decide on possible vaccine accountability. “It is quite possible that there is no link between vaccination and the onset of the cases of Guillain-Barre. But we can never be certain, “says Professor Odile Launay, head of clinical investigation center of vaccinology Cochin-Pasteur in Paris.

Last Monday, Didier Houssin, director general of health, reminding that every day, normally between three and five people were hospitalized in France for Guillain-Barre. “Inevitably, there will be other cases in the coming weeks. Among these patients, some may have been vaccinated in previous weeks. And it will be very difficult to know whether the syndrome is linked to the vaccine or has another origin, says an expert. For Afssaps, these side effects does “not undermine the risk-benefit balance” of the vaccine.