The Medicines Safety Agency (ANSM) assures that it has not identified new risks related to the vaccine, within the framework of the national vaccination campaign for fifth grade students against the papillomavirus that began in autumn, a report initially published this Friday December 1st.
Between Sept. 14 and the end of October, seven cases of adverse events following vaccination with Gardasil 9 were reported, the agency said.
Four cases were related to a vaccination carried out within the framework of the campaign at universities, which represented more than 20,000 injections. The others referred to vaccinations carried out in the city.
Three serious cases declared
Among these seven cases, three serious cases (malaise or allergic reaction) were reported, including the death of a teenager following head trauma following malaise 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 in a few days, although they can be annoying,” the drug agency clarified in September, causing pain at the injection site. the injection. itching or headaches.
In rare cases, as with other vaccines, the patient may experience discomfort or a severe allergic reaction.
“There is no security sign”
“To date, ongoing analysis of reported adverse events does not identify any safety signals,” the drug agency stressed this Friday.
“The data are reassuring because they correspond to the safety profile of the vaccine,” Mehdi Benkebil, head of the ANSM surveillance department, told AFP.
Unlike Covid, we have already had “about fifteen years of hindsight on this vaccine,” also recalled Céline Mounier, assistant to the deputy director general responsible for operations.
“Reinforced surveillance” as a precautionary measure
The administrative investigation opened after the death of the schoolboy at the end of October did not identify any “malfunction 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 should remain lying or sitting on the floor with their backs against a wall.
For this campaign, the ANSM has created an “enhanced surveillance” system in collaboration with the regional pharmacovigilance centers (CRPV) and will publish monthly reports with a complete summary next spring.
If a new risk were identified, it could “communicate it at any time” and apply “adapted measures,” he said.
Source: BFM TV
