If seven adverse events linked to the papillomavirus vaccine have occurred since the start of the national campaign among fifth grade students, no new risk has been reported, assures the ANSM.
- Since October 2023, free and non-compulsory vaccination against papillomaviruses has been generalized for all 5th grade students.
- Seven cases of adverse events were recorded by the ANSM between September 14 and the end of October.
- Continuous analysis of reported adverse events does not identify a safety signal.
Two months after the launch of the national vaccination campaign for fifth grade students against the papillomavirus, the National Agency for the Safety of Medicines and Health Products (ANSM) draws an initial assessment. No new risks linked to the vaccine have been identified.
Papillomavirus: 3 serious cases after vaccination
The institution specifies in its HPV vaccine monitoring point that seven cases of adverse events were declared after vaccination with Gardasil 9 between September 14 and the end of October. Four cases of them are linked has “a vaccination carried out as part of the campaign, for more than 20,000 injections in colleges by the end of October 2023,” indicates a communicated.
“Among these seven cases, three serious cases were reported (discomfort or allergic reaction), including the death of an adolescent after head trauma following discomfort with loss of consciousness.”, continues the press release.
However, these events remain in the minority. As recalled by Ministry of Healththis vaccine “prevents up to 90% of HPV infections, often non-symptomatic, but causing precancerous lesions and/or cancers of the cervix, vulva, vagina and anus.”
For its part, the medicines agency emphasizes in its first report that it has not recorded any new risks linked to the vaccine. “HAS To date, continuous analysis of reported adverse events does not identify a safety signal“, assures the ANSM in its press release.
Discomfort after an HPV vaccine: steps taken to avoid injury
Although no new type of reported adverse event has been identified, the death of the adolescent vaccinated against papillomavirus last October led to the issuance of post-vaccination monitoring instructions to avoid injuries.
“If the risk of feeling unwell after vaccination is known, measures should be put in place to avoid any injury that could occur after a fall”reminds himANSM in its press release.
Vaccinated adolescents must remain lying or sitting on the floor, leaning against a wall for fifteen minutes following the injection of the product. The organization explains: “these discomforts (or even brief loss of consciousness), infrequent and quickly resolved, may correspond to a psychogenic reaction to the injection. They may be accompanied by tremors or stiffness.” It is therefore very important to keep young patients safe.
A “reinforced surveillance” system has been put in place by the authority. Monthly reports and a complete summary, planned for next spring, should be published.