the medicines agency has not identified any new risks linked to the vaccine

The Medicines Safety Agency (ANSM) has not identified any new risks linked to the vaccine, as part of the national vaccination campaign for fifth grade students against the papillomavirus which began in the fall, according to an initial assessment Friday. Between September 14 and the end of October, seven cases of adverse events were reported following 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.

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. This is why the ANSM recommended in November that adolescents remain lying or sitting on the ground with their backs against a wall, for a quarter of an hour following the injection. The other people who experienced a serious event have recovered.

“No safety signal”, according to the ANSM

“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. For this campaign, the ANSM has set up a system of “reinforced surveillance” in conjunction with the regional pharmacovigilance centers (CRPV), and will publish monthly reports with a complete summary next spring.