Originally published by our sister publication Infectious Disease Special Edition
The FDA has expanded the regimen options for Sanofi’s Imovax Rabies vaccine for pre-exposure prophylaxis (PrEP) to include a two-dose primary series. Previously, the vaccine was approved as PrEP in a three-dose regimen.
For the new two-dose schedule, shots are administered at days 0 and 7, while the three-dose schedule has shots at days 0, 7, and either 21 or 28.
The vaccine is approved for use in all age groups, including children; however, there is not safety data for pregnant or lactating people. Imovax Rabies also is approved for post-exposure prophylaxis and is administered differently depending on the person’s prior vaccination status.
This update follows positive results from two studies (ClinicalTrials.gov Identifiers: NCT03700242, NCT04127786) that showed the vaccine’s safety in two-dose and three-dose regimens. The most common solicited adverse events (AEs) were pain at injection site (≥18 years, 35.4%; 2-17 years, 25.7%), headache (≥18 years, 21.3%; 2-17 years, 13.9%), malaise (≥18 years, 26%) and myalgia (≥18 years, 22.8%). Grade 3 AEs, although only experienced by a small proportion of patients, included malaise (≥18 years, 0.8%) and fever (≥18 years, 0.8%; 2-17 years, 2%). In the two study participants who were between 1 and 2 years of age, the only reported systemic AEs were experienced by one of the participants: vomiting and abnormal crying.
The vaccine as PrEP is contraindicated in patients who may have a hypersensitivity reaction to ingredients in the vaccine. Discontinuation of the vaccine due to allergic reactions or AEs must be weighed against the risk for developing rabies, especially in people who have been exposed to rabies and need post-exposure prophylaxis. For more information, refer to the package insert.
The CDC recommends rabies PrEP for certain individuals who could be exposed to rabies in their profession, including lab workers who study rabies, veterinarians and those who have frequent contact with bats. It also recommends rabies vaccination for those who are traveling to a place where rabies is more common in dogs or other animals and medical care is limited.
