Conclusions & Recommendations

While drug supplies remain low, TEC encourages consideration of targeting children only following community-wide MDA in areas conducting more frequent than annual treatments.

Confidential: TEC recommends that ITI explore with Pfizer the opportunity to increase the bottle size for POS to 90mL.

TEC is committed to managing the Zithromax® shortage applying the principles of equity, transparency, and data-driven defensibility. The current allocation approach (80% of Approved; 100% of Surgery; and 95% of Research) will be kept the same for now. Pfizer is actively working to address the supply challenges; however, in the short term, a shortfall will remain resulting in the need for additional reductions to demand and/or delayed shipments. The TEC and ITI are committed to communicating additional information as it becomes available, which may lead to a need to call an extraordinary meeting between TEC, Pfizer, and key partners and donors to address these challenges together.

TEC noted with concern the current global shortage of Zithromax and appreciated Pfizer’s engagement and transparency in describing the associated challenges at TEC 28. The TEC encourages frequent ongoing conversations between Pfizer and ITI regarding the shortage and evolving plans to address it, which will facilitate ITI in providing clear, transparent guidance to national trachoma programs and implementing partners.

After weighing and discussing the pros and cons of several options to distribute the reduced Zithromax supply to national programs in a way that is fair, recognizes the need for flexibility in decisions by national trachoma programs, and maintains progress towards elimination of blinding trachoma, the TEC recommends that ITI:
- reduce Zithromax shipments to 80% of the amount requested by all countries (but not yet shipped), effective immediately
- prioritize requests initially scheduled for shipment in 2022, but do not ship a second dose to those districts in 2023 unless drug becomes available in late 2023
- ship 95% of all operational research allocations and for trichiasis surgeries

The TEC suggested several options for national trachoma programs to consider as they decide how best to manage their reduced allocations (in no particular order):
- Consider prioritizing high prevalence districts (TF1-9 ≥30%)
- Consider prioritizing districts with persistent or recrudescent trachoma
- Consider early trachoma impact surveys for any district currently in the last round of MDA (i.e., 3/3; 5/5; 7/7)
- Consider delaying or skipping treatment in districts with TF1-9 5-9%

TEC also suggests national trachoma programs consider collecting data on alternative indicators (e.g., infection and/or serology) during impact surveys to guide prioritization and decision making.

The TEC asked that ITI expeditiously convene teleconferences to communicate these decisions and options with national programs and implementing partners, in collaboration with TEC and WHO.

TEC appreciates the work that has already been done to develop electronic data systems to collect and manage data related to mass drug administration and looks forward to following future developments to optimize the quality of data on drug coverage to improve and refine programs.

TEC appreciated the inclusion of national program managers at TEC 28, whose presence provided additional richness and insights into discussions.

TEC was excited to see the co-administration and pharmacokinetics and pharmacodynamics (PK/PD) trial results demonstrating the safety of delivering azithromycin with ivermectin, albendazole, or diethylcarbamazine. TEC recommends to ITI management to support the WHO Guidelines Review Committee process.

TEC notes with enthusiasm the ongoing research on the use of azithromycin for child survival and looks forward to future discussions and presentations of data.

The TEC appreciated the analysis and presentation of examples on how the algorithm developed by the TEC Refugee/IDP Request Guidelines Subcommittee has been used for allocating Zithromax® to refugees, displaced persons, and migratory populations. Application of this algorithm in practice aspires to TEC’s values of equity and inclusion.