The National Medicines Safety Agency has published its report on vaccination against Covid-19 in France. It therefore has the latest highlights and data concerning pharmacovigilance.
The key figures
In its first report dated January 22, the ANSM gathered pharmacovigilance data from the start of vaccination on December 27, until January 15, 2021. As part of monitoring the safety of anti-Covi-19 vaccines, the The agency reports 135 cases of adverse effects for the Comirnaty vaccine developed by Pfizer / BioNtech. Of the mild but unexpected events that have occurred after vaccination, the majority are related to reactogenicity effects such as fever, headache (headache) and nausea. In addition, 31 cases of serious adverse effects (which represents 16% of the 135 cases recorded) were reported and analyzed, including 4 cases of tachycardia or arrhythmia episodes, 2 of anaphylactic reactions (exacerbated allergic reactions) and 2 infection with Covid-19. The four people who presented episodes of cardiac acceleration are the subject of additional investigations. Also, nine patients who received the vaccine died. “These were elderly people residing in EHPAD or in old age residences, most of whom had serious comorbidities. In view of the current knowledge on the Comirnaty vaccine and the information provided on the cases to date, there is no reason to conclude that the deaths reported are linked to the vaccination “, assures the ANSM.
Significant events
The ANSM, in conjunction with the Regional Pharmacovigilance Centers (CRPV), is developing careful and real-time monitoring of vaccinated people, in order to “communicate at any time if a safety signal is identified “. This is how the health organizations in charge of this surveillance detected a potential risk of tachycardia, which is being investigated. On the other hand, investigations are continuing for two cases of aortic dissection (vascular accident), even if the data suggest that the link with the vaccination does not exist. For the moment, no adverse effects have been declared for the vaccine produced by the Moderna laboratory. Note that according to the Ministry of Health, nearly 700,000 people have been vaccinated in France on January 20, 2021.
