Limited availability of Gardasil 9 vaccine: updated recommendations for prescribers

Due to a worldwide increase in demand for the Gardasil 9 vaccine, used to prevent Human Papillomavirus (HPV), stocks of this vaccine are currently limited in Belgium. This limited availability has been extended and should continue until September 2020. The Federal Agency for Medicines and Health Products (FAMHP) has updated the recommendations for prescribers.

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

The Task Force makes recommendations for prescribers.

  • Keep the available vaccines for vaccination of patients between 9 and 14 years old
  • For vaccination of the population between 9 and 14 years old
    • Follow the two-dose schedule, except for immunocompromised people (three doses).
    • Depending on the organisational feasibility, delay the second dose of vaccination during a two-dose schedule (preferably up to thirteen months between two doses).
  • For vaccination of the population from 15 to 26 years old
    • Delay the 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 dose and third dose of vaccination (the three doses should preferably be administered in less than a year).

If, due to unavailability, it is not possible to carry out booster vaccinations within one year and the vaccination schedule is interrupted, any vaccines already received will not have to be repeated (there is no maximum interval).

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

The FAMHP is monitoring the situation closely and continues to seek additional solutions, in collaboration with the National Institute for Health and Disability Insurance (INAMI), the communities, the company holding the marketing authorisation for Gardasil 9 and the Minister of Public Health’s Strategic Cell.

 

Last updated on
01/07/2020