PharmaJet Announces Implementation Study Results: Increased Coverage, Cost Savings, and Preference for Routine Polio Immunization with Tropis® ID Needle-free Delivery

• Vaccination coverage with the second dose of inactivated polio vaccine (IPV2) was 11.2% higher among those vaccinated intradermally with Tropis compared to the standard of care (full dose needle and syringe intramuscular delivery).
• Up to 47% total immunization cost savings can be realized using Tropis needle-free for fractional inactivated poliovirus vaccine (fIPV) administration compared to the standard of care.
• A significant majority of routine immunization healthcare workers were in favor of implementing needle-free as the standard method for IPV administration with 95% preference.

GOLDEN, Colo. — October 24, 2024 — PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free technology, today announced the results of an implementation study in Nigeria that evaluated the impact on coverage, costs, and acceptability of intradermal fractional inactivated poliovirus vaccine (fIPV) administration using their Tropis® ID Needle-free System, compared to the standard of care (full-dose, IPV intramuscular delivery with needle and syringe). The study results were presented at an event attended by experts from the Nigeria Federal Ministry of Health (FMOH), WHO, UNICEF, and the United States Agency for International Development (USAID). The study principal investigators from the Nigeria National Primary Health Care Development Agency (NPHCDA), Jhpiego, PATH, and Sydani Group reported increased coverage, decreased program costs, and a strong preference for routine immunization using Tropis among healthcare workers¹:

• Increased coverage: Among those vaccinated with Tropis, IPV2 coverage was 11.2% higher compared to the standard of care. On a relative basis, the odds of receiving 2 doses of IPV are doubled when Tropis is used.
• Decreased cost: Incremental cost savings with Tropis ranged from $0.07 to $1.00 per dose administered across the evaluated scenarios, with up to 47% total immunization costs savings for IPV delivered with Tropis compared to IPV delivered by needle and syringe in a full-scale scenario. Switching to Tropis-delivered fIPV could save the Nigeria immunization program ~US$50 million over a 5-year period.
• Feasibility/scalability: Acceptability was high among caregivers whose children were vaccinated with Tropis. More than 96% said they would be more likely to return for future vaccinations if Tropis was used. Additionally, 95% of healthcare workers preferred needle-free over the standard of care. They noted that Tropis is easy to operate, a safer alternative to needles, and associated with less discomfort by recipients during vaccine administration. Tropis reduced administration time compared to standard of care.

The study, funded by a multi-year $1.5 million grant from the USAID Development Innovation Ventures Program in collaboration with NPHCDA, Jhpiego, PATH, and the Sydani Group, was launched in September 2022, and included a six month implementation period.² The introduction of a second dose of inactivated polio vaccine (IPV2) is critical to addressing immunity gaps for poliovirus and to build and sustain resilience to eradicate all forms of poliovirus.³ The current coverage rate for a first dose of IPV (IPV1) for the Africa Region is 78% while the IPV2 coverage rate is only 19%.⁴ “Through USAID investments in this study, we sought to generate in-country evidence on the acceptability, feasibility, and cost effectiveness of deploying this device,” said Gertrude Odezugo, Health Population and Nutrition Office, USAID/Nigeria. “The intervention has allowed us to explore innovative strategies in vaccine delivery whilst addressing persistent challenges. It marks a significant step towards ensuring equitable and sustainable polio immunization coverage for Nigerian children.” “It is very important that this study has happened,” said Dr. Emmanuel Odu, Senior Special Advisor to Minister of Health, FMOH. “This is one of the first times where a strategy is being implemented through research on the basis of evidence that is generated locally in our country, not research or evidence generated from some other country and exported into our country. There is evidence that this will improve coverage of the target population and cost savings. Millions of dollars will be saved in a period of time.” “This study provides solid evidence that Tropis needle-free is a tool that works very well within the routine immunization program in areas that are at high risk for polio transmission. The effectiveness of Tropis has already been demonstrated in several countries including Cuba, The Gambia, Pakistan, and Somalia. In addition, these new data build on recent published evidence from Nigeria that demonstrated Tropis’ ability to enable house-to-house campaigns,” noted Paul LaBarre, Vice President of Global Business Development, PharmaJet. “On this World Polio Day 2024, we have enormous gratitude for our partners on this important study, and we reconfirm our commitment to the Global Polio Eradication Initiative.” The results from this study will also be presented at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting held in the New Orleans Ernest N. Morial Convention Center, New Orleans, Louisiana from November 13-17, 2024. For more information about PharmaJet visit https://pharmajet.com.

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¹ Data on file ² Biya, O et al, Notes from the Field: House-to-House Campaign Administration of Inactivated Poliovirus Vaccine — Sokoto State, Nigeria, November 2022, CDC Morbidity and Mortality Weekly report, November 24, 2023 / 72(47);1290–1291 ³ World Health Organization, Highlights from the meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; 23-26 September 2024 ⁴ World Health Organization, Africa Regional Polio Eradication Plan, 2024 – 2025 plan, Objective 3b – Immunization System Strengthening, p. 34

This press release and the related study are made possible by the support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of PharmaJet and the Project Partners and do not necessarily reflect the views of USAID or the United States Government.

About PharmaJet The PharmaJet mission is to improve the performance and outcomes of injectables with our enabling technology that better activates the immune system. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ can improve vaccine effectiveness, and promote a preferred patient and caregiver experience while being safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. They are both commercially available for global immunization programs. For more information or if you are interested in partnering with PharmaJet to improve the impact of your novel development program, visit https://pharmajet.com or Contact | PharmaJet. Follow us on LinkedIn. About Tropis ID The PharmaJet Tropis® ID Precision Delivery System&8482; was developed with support from the World Health Organization, US CDC, and the Bill & Melinda Gates Foundation and has CE Mark and is WHO Prequalified for intradermal injections. It has been used for millions of injections in multiple immunization campaigns worldwide. Data have repeatedly shown improved immunogenicity for nucleic acid vaccines and therapeutics administered with Tropis compared to needle and syringe and electroporation delivery. In addition, Tropis is the exclusive intradermal delivery system for two authorized novel Covid-19 vaccines: ZyCoV-D by Zydus Lifesciences, and GEMCOVAC-OM by Gennova Biopharmaceuticals.