# PfSPZ Vaccine for Malaria: Towards a Successful Biologics License Application and Commercialization

> **NIH NIH SB1** · SANARIA, INC. · 2022 · $974,007

## Abstract

ABSTRACT
The WHO estimates that in 2017, malaria caused 219M clinical episodes and 435,000 deaths worldwide.
Despite annual investments >$3 billion for intensive control measures, 2017 was the third consecutive year in
which there was no decrease in malaria, indicating existing tools are inadequate to make further progress.
There is an urgent unmet medical need for a vaccine that prevents malaria in individuals, and which can be
deployed in mass vaccination programs (MVPs) to support malaria elimination campaigns. Sanaria’s whole
Plasmodium falciparum sporozoite (PfSPZ) vaccines, composed of aseptic, purified, cryopreserved PfSPZ are
being assessed in clinical trials globally. Sanaria’s lead PfSPZ product, PfSPZ Vaccine, is attenuated by
radiation and has been safe and well tolerated in >1,570 infants, children and adults in 19 clinical trials in 9
countries, 6 in Africa. It has induced >90% vaccine efficacy (VE) against homologous controlled human malaria
infection (CHMI) at 3-11 weeks after immunization in the US, Germany, Mali and Tanzania; 80% and 54% VE
against heterologous CHMI at 2.5 and 8 months; and VE durable for at least 6 months against intense naturally
transmitted Pf malaria in 3 field trials in Africa. Based on this success, funded by partners in the US, Europe,
and Africa, including for the first time from African governments and US energy companies, PfSPZ Vaccine is
being manufactured to meet Phase 3 and commercialization compliance. Clinical trials with Phase 3-compliant
PfSPZ Vaccine are planned for 2020 in Africa and the US, filing of a Biologics License Application (BLA) is
anticipated in late 2021 and commercialization launch in 2022. As we pursue this ambitious development
program, the funds needed to support the quality systems, manufacturing (CMC), regulatory, and clinical
(especially database) requirements for preparation and successful submission of a BLA to the FDA and
commercialization, are enormous. An award under this Commercialization Readiness Pilot (CRP) Program will
provide the foundation for the quality systems, manufacturing (CMC), regulatory, and clinical teams to have the
professional packages that will withstand FDA audits, and investor due diligence as we move to
commercialization. Our specific aims focus on 1) quality programs for commercialization readiness, 2) GMP
manufacturing of clinical trial supplies supporting BLA submission for PfSPZ Vaccine, 3) Achievement of the
level of regulatory compliance required by Federal Code to submit a successful BLA, and 4) Clinical quality,
data, and reporting prepared to the proper standards for successful FDA meetings and submissions, product
launch, and commercialization. Success in this CRP project will significantly shorten the time until product
licensure and launch, which will lead to sales and income significantly earlier than without this project, and
save many lives.

## Key facts

- **NIH application ID:** 10445035
- **Project number:** 5SB1AI058375-14
- **Recipient organization:** SANARIA, INC.
- **Principal Investigator:** STEPHEN Lev HOFFMAN
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $974,007
- **Award type:** 5
- **Project period:** 2004-02-15 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10445035

## Citation

> US National Institutes of Health, RePORTER application 10445035, PfSPZ Vaccine for Malaria: Towards a Successful Biologics License Application and Commercialization (5SB1AI058375-14). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10445035. Licensed CC0.

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