Governing off-label vaccine use: An environmental scan of the Global National Immunization Technical Advisory Group Network.

Background: National Regulatory Authorities approve the indications for vaccine use in the product information. Occasionally, National Immunization Technical Advisory Groups (NITAGs) make off-label recommendations for use in different age groups, populations, and dosing schedules from the product information. We sought to determine the rationale, policies and procedures for NITAG off-label recommendations.
Methods: We conducted an environmental scan of Global NITAG Network members, immunization program managers and regulators in 38 high-, middle- and low-income countries. Participants completed an online survey regarding policies, procedures, and legislation governing development of off-label recommendations. A sub-sample of respondents met for a focus group and interviews which were analyzed qualitatively.
Results: Thirty-four people responded from 26/38 (68%) countries surveyed; 76% of respondents were NITAG members or immunization program managers. Recommendations for off-label vaccine use were made in 14/26 (54%) countries; the NITAG made those recommendations in 8/14 (57%) countries. Reasons for off-label vaccine recommendations included response to disease outbreaks or vaccine shortages. Only one country had standard operating procedures for developing off-label recommendations while 6/14 (43%) countries had policies for implementing off-label recommendations. Nine respondents from 8 countries agreed to participate in a focus group (n = 6) or individual interviews (n = 3). Barriers to off-label recommendations included legal concerns, lack of standard definition for off-label use, and manufacturer reluctance to update product information. Facilitators included confidence in the decision-making process, and transparency of open communication among stakeholders.
Conclusions: Best practice guidelines are needed that define off-label use and outline a transparent, evidence-based approach to develop off-label recommendations.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [KAT has received grants from GSK and consultancy fees from Pfizer outside the submitted work. All other authors report no conflicts of interest].
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