Reassuring news. The Medicines Safety Agency (ANSM) has not identified new risks related to the human papillomavirus vaccine during the first phase of the national vaccination campaign for 5th grade students, according to a press release published this Monday, 29 of April.
Since the beginning of October 2023, the start of the campaign in all public schools and private voluntary establishments, 46 cases of adverse effects have been reported after a first dose against HPV, the agency stated.
“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 swelling), headaches, feeling of dizziness, gastrointestinal disorders, fever, fatigue , said. saying.
All of these effects can appear quickly after vaccination and last a short time, according to the ANSM.
During the first phase of vaccination in universities, “no new safety signals were identified: this means that there was no new risk suspected of being related to the vaccine,” the drug agency stressed.
Adverse effects occurred mainly in children
The average age of reported adverse reactions is 12.3 years. And these effects occurred mainly in children.
“If vaccination data by sex are not available to date, this may indicate a higher proportion of injections among children during the campaign, unlike the previous period, in which girls were historically vaccinated more than boys,” according to the ANSM.
Following the death of a schoolboy who fell due to post-vaccination discomfort, the Medicines Agency recommended that students lie or sit on the floor after vaccination.
Enhanced surveillance
While the vaccination campaign against the papillomavirus continues with second doses, the ANSM recalled on Monday the importance of post-vaccination surveillance, in particular “to prevent injuries resulting from discomfort.”
At the beginning of February, the Council of State rejected an appeal from the E3M association, which requested a moratorium on the campaign, alleging that vaccines against the human papillomavirus would cause a rare disease, macrophage myofasciitis.
The Council of State 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 greater monitoring of its adverse effects since the beginning of the university campaign, in collaboration 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 secondary schools, including in community medicine, but still needs to be improved, according to data published on Friday by Public Health France.
Source: BFM TV
