The Medicines Safety Agency (ANSM) has not identified any new risks linked to the human papillomavirus vaccine during the first phase of the national vaccination campaign for 5th grade students, according to a press release published Monday. Since the beginning of October 2023, the start of the campaign in all public colleges and voluntary private establishments, 46 cases of adverse effects have been reported after a first anti-HPV dose, the agency said.
“These are mainly known and non-serious post-vaccination effects of Gardasil 9”, such as reactions at the vaccine injection site (redness, pain and/or inflammation), headaches, feelings of dizziness, gastrointestinal disorders, fever, fatigue, she said. All of these effects can appear quickly after vaccination and last a short time, according to the ANSM.
Adverse effects mainly occurred in boys
During the first phase of vaccination in colleges, “no new safety signal was identified: this means that there was no new risk suspected of being linked to the vaccine”, underlined the drug agency. The average age of reported adverse reactions is 12.3 years. And these effects mainly occurred in boys. “If vaccination data by gender are not available to date, this may nevertheless indicate a greater proportion of injections among boys during the campaign, unlike the previous period when young girls were historically more vaccinated than boys. boys”, according to the ANSM.
After the death of a schoolboy who fell following post-vaccination discomfort, the Medicines Agency recommended that students lie down or sit on the ground after vaccination. While the papillomavirus vaccination campaign continues with second doses, the ANSM recalled on Monday the importance of post-vaccination surveillance, in particular “to prevent injuries following discomfort”.
At the beginning of February, the Council of State rejected an appeal from the E3M association, which called for a moratorium on the campaign on the grounds that vaccines against human papillomavirus would cause a rare disease, macrophage myofasciitis. The State Council highlighted, among other justifications, the “good safety profile” of the vaccine used, Gardasil 9, on the market for fifteen years.
The ANSM has been carrying out increased monitoring of its adverse effects since the start of the college campaign, in conjunction with the regional pharmacovigilance centers. It will publish a second report after the administration of the second doses. Vaccination of adolescents against the papillomavirus has seen a notable increase in France since the start of the campaign in middle schools, including in community medicine, but still needs to be improved, according to data published Friday by Public Health France.