Between September 14 and the end of October, seven cases of adverse events were reported after vaccination with Gardasil 9, the agency said.
Four cases were linked to a vaccination carried out as part of the campaign in colleges which represented more than 20,000 injections. The others concerned vaccinations carried out in town.
The most frequently observed adverse reactions with Gardasil 9 vaccines are not serious in the vast majority of cases.
Among these seven cases, three serious cases were reported (discomfort or allergic reaction), including the death of an adolescent following head trauma following discomfort with loss of consciousness. The other people who experienced a serious event have recovered.
“The most frequently observed adverse effects with Gardasil 9 vaccines are not serious in the vast majority of cases and disappear spontaneously within a few days, even if they can be annoying”, the drug agency clarified in September, citing pain at the site of the injection or headaches. In rare cases, as with other vaccines, the patient may experience discomfort or a serious allergic reaction.
“To date, continuous analysis of reported adverse events does not identify a safety signal”underlines the medicines agency on Friday. “The data is reassuring because it is consistent with the safety profile of the vaccine”Mehdi Benkebil, head of the ANSM surveillance department, told AFP.
No “dysfunction in the organization of the vaccination campaign”
Unlike Covid, we already had “around fifteen years of hindsight on this vaccine”also recalled Céline Mounier, assistant to the deputy general director in charge of operations.
The administrative investigation opened after the death of the schoolboy at the end of October did not reveal any “dysfunction in the organization of the vaccination campaign”according to the Regional Health Agency (ARS). = In mid-November, the ANSM recommended that in the quarter of an hour following the injection, adolescents remain lying or sitting on the ground leaning against a wall.
For this campaign, the ANSM has set up an “enhanced surveillance” system in conjunction with the regional pharmacovigilance centers (CRPV), and will publish monthly reports with a complete summary next spring. If a new risk was identified, she could “communicate at any time” and put in place “adapted measures”, she assured.