Limited availability of the vaccine Gardasil 9: recommendations for prescribers

Due to a worldwide increase in demand for the vaccine Gardasil 9, used for the prevention of Human Papillomavirus (HPV), stocks of this vaccine are currently limited in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) issues recommendations for prescribers.

The vaccine Gardasil 9, administered to protect against diseases caused by the Human Papillomavirus (HPV), has been available in Belgium in limited supply since December 2019. This situation is expected to last until April 2020. In order to find a short-term solution, a Task Force of experts met within the FAMHP's Unavailability working group.

The Task Force formulates recommendations for prescribers.

  • Reserve the available vaccines for the vaccination of patients aged between 9 and 14 years old
  • For the vaccination of the population aged between 9 and 14 years old
  • Follow the two-dose schedule, except for immunosuppressed people (three doses).
  • Depending on organizational feasibility, delay the second vaccination dose in a two-dose schedule (up to 13 months between doses).
  • For vaccination of the population aged 15 to 26 years
  • Delay primary vaccination or offer the Cervarix alternative if the subject's vaccination is urgent.
  • For subjects who have already received a first dose of Gardasil 9, delay the second and third dose of vaccination (all three doses to be administered within 1 year).

Recommendations for patients who have received a first dose of Gardasil 9
The FAMHP recommends completing the vaccination schedule with Gardasil 9 when the first dose of Gardasil 9 has already been administered to the patient. No safety, immunogenicity or efficacy data are available regarding the interchangeability of Gardasil 9 with bivalent or quadrivalent HPV vaccines.

The FAMHP is closely monitoring the situation and continues to look for complementary solutions, in collaboration with the National Institute for Health and Disability Insurance (NIHDI), the communities, the marketing authorisation holder for Gardasil 9 and the Strategic Unit of the Minister responsible for public health.

Last updated on
09/03/2020