New data confirms that the papillomavirus vaccine is safe

It is an unambiguous message. After more than 15 years of use and 300 million doses administered worldwide, vaccines against human papillomaviruses are “safe and effective”, according to the National Medicines Safety Agency (ANSM). The health authority has just published a report on the adverse effects reported during the college vaccination campaign, launched in September 2023. “This analysis, carried out with the French network of regional pharmacovigilance centers, shows that no signal of Safety has not been detected with this vaccine. The cases reported are mainly known and non-serious post-vaccination effects of Gardasil 9,” reports the ANSM.

In October 2023, 5th grade students in all public middle schools and voluntary private establishments were invited to receive a first dose of human papillomavirus (HPV) vaccine. As a reminder, infections with one of these viruses can develop into cancers, the most common of which is cervical cancer. In France, 6,400 cancers are linked to these viruses each year, including nearly 3,000 new cases of cervical cancer. Furthermore, a quarter of cancers caused by papillomaviruses concern men (ENT, anal and penile cancers). However, when carried out before the start of sexual life, the effectiveness of the vaccination is close to 100%.

In total, 46 cases of adverse effects were reported as part of the vaccination campaign in colleges, most often in boys. “Analysis of the cases shows that these are mainly known and non-serious post-vaccination effects of Gardasil 9,” indicates the ANSM. These include, for example, reactions at the vaccine injection site (redness, pain and/or inflammation), headaches, feelings of dizziness, gastrointestinal disturbances, fever or fatigue. “All these effects can appear quickly after vaccination and last a short time,” specifies the medicines agency.

In 2020, a large Australian study, which followed the fate of 9 million doses of vaccines over 11 years, concluded that there were no more complications in the vaccinated group than in the unvaccinated. Other data point in the same direction.

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 end of October 2023, the death of a schoolboy who suffered a fall after post-vaccination discomfort led the Medicines Agency to refine its recommendations. Adolescents must therefore be supervised for 15 minutes following the injection and they must preferably remain lying or sitting on the ground, leaning against a wall.

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 is continuing its reinforced surveillance and 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.