In a new situation update dated January 22, the National Agency for the Safety of Medicines and Health Products (ANSM) reports the number of serious and non-serious adverse reactions occurring following the injection of a vaccine against Covid-19.
In all, 388,730 people vaccinated over the period from 12/27/20 to 01/15/21, the deadline for this situation update. “This report covers data from the national pharmacovigilance database validated until January 15, 2021, i.e. 135 cases of side effects”, Notes the Agency. “In addition, 9 additional cases reported to the ANSM until January 19, 2021 were also the subject of a qualitative analysis.”, She specifies.
The ANSM ensures that the majority of the reported adverse effects correspond to expected or non-serious adverse effects, in particular to effects of reactogenicity, that is to say “expected” reactions and often signs of an excessive immune response, For example fever, headache, and nausea.
“In total, 31 cases of serious side effects were analyzed including 4 cases oftachycardia episodes. These cases will be the subject of further investigation.”, Specifies the ANSM.
The Agency also specifies that cases ofallergy, two of which correspond to possible cases of anaphylaxis, were observed. These two cases “were of very quickly favorable evolution, without complications. None led to a life threatening risk; none corresponded to anaphylactic shock”, Details the public health body.
Nine deaths analyzed, in elderly people with co-morbidities
While a single case of death validated on January 15 was included in the data sent by the ANSM to the reporting Regional Pharmacovigilance Centers (CRPV), 8 additional cases of death were analyzed as part of the assessment of outstanding cases. These cases were received by the ANSM until January 19, the deadline for analysis of the outstanding cases being included in the report.
ANSM has been informed of nine deaths occurred in the days following a vaccination against Covid-19 with the COMINARTY vaccine from Pfizer / BioNTech.
“These were elderly people residing in EHPAD or in old age residences who most 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 evidence that the reported deaths are related to vaccination“, Estimates the ANSM, which adds however that”these cases and the corresponding data will continue to be closely monitored as part of vaccine surveillance.not”.
Note also thatno case of adverse effects with the Moderna vaccine has not been declared to the ANSM. A finding to be considered with caution because this vaccine did not receive the green light from the High Authority for Health until January 8.
According to recent statements by Prime Minister Jean Castex, more than a million people have been vaccinated against the Sars-CoV-2 coronavirus in France since the start of the vaccination campaign.
1 million French people vaccinated. pic.twitter.com/domYssnqcj
– Jean Castex (@JeanCASTEX) January 23, 2021
To find out more about the coronavirus, the editorial staff invites you to discover its more complete and regularly updated articles:
- an article on Covid-19 disease and the evolution of the epidemic
- an article on the different screening tests
- an article on vaccines under development.