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First vaccine against childhood E. coli diarrhea advances toward global use

First vaccine against childhood E. coli diarrhea advances toward global use

New Capabilities
By Newzino Staff |

Phase 2b trial shows ETVAX protects infants from a pathogen that sickens 75 million children annually

February 20th, 2026: Scandinavian Biopharma confirms phase 3 readiness

Overview

Enterotoxigenic Escherichia coli, or ETEC, causes roughly 220 million episodes of diarrhea each year and kills tens of thousands of children under five—mostly in low-income countries where clean water remains scarce. No vaccine against it has ever been licensed. On February 16, 2026, results published in The Lancet Infectious Diseases showed that an oral vaccine called ETVAX cut moderate-to-severe ETEC diarrhea by 48 percent in nearly 5,000 Gambian children, and by 68 percent in infants vaccinated before nine months of age.

In This Story

2 Videos
3 People
Ann-Mari Svennerholm Jahangir Hossain Firdausi Qadri
3 Orgs
Scandinavian Biopharma University of Gothenburg MRC Unit The Gambia at LSHTM
11 Events
5 Key Stats
48%
4 Scenarios
Phase 3 succeeds, ETVAX becomes first licensed ETEC vaccine
3 Context
Rotavirus vaccine introduction (2006-present)

Key Indicators

48%
Reduction in moderate-to-severe ETEC diarrhea
Efficacy across all children when co-infections with common gut pathogens were included
68%
Efficacy in infants under 9 months
Protection was strongest in the youngest age group, which bears the highest disease burden
4,936
Children enrolled in trial
The largest-ever efficacy trial of an ETEC vaccine in a pediatric population
75M
Annual ETEC cases in children under 5
ETEC is among the top five pathogens causing diarrheal death in young children globally
5,800
Infants planned for phase 3 trial
A pivotal phase 3 study in low- and middle-income countries has been approved by the European Medicines Agency

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People Involved

Ann-Mari Svennerholm
Ann-Mari Svennerholm
Lead developer of ETVAX; overseeing phase 3 preparation
 Jahangir Hossain
Jahangir Hossain
Principal investigator at MRC Gambia
 Firdausi Qadri
Firdausi Qadri
Led earlier ETVAX trials in Bangladesh

Organizations Involved

Scandinavian Biopharma
Scandinavian Biopharma
Pharmaceutical Company
Preparing pivotal phase 3 trial

A Stockholm-based pharmaceutical company that develops and manufactures ETVAX in partnership with the University of Gothenburg.
University of Gothenburg
University of Gothenburg
Research University
Originator of ETVAX vaccine technology

The Swedish university where ETVAX was invented, building on a decades-long tradition of oral vaccine research that also produced the world's first licensed oral cholera vaccine.
MRC Unit The Gambia at LSHTM
MRC Unit The Gambia at LSHTM
Research Institute
Conducted the phase 2b field trial

A Medical Research Council unit in Banjul, The Gambia, affiliated with the London School of Hygiene and Tropical Medicine, that served as the implementing organization for the landmark phase 2b trial.

Timeline

  1. Scandinavian Biopharma confirms phase 3 readiness

    Announcement

    Following the Lancet publication, Scandinavian Biopharma announces it is prepared to launch a pivotal phase 3 trial enrolling approximately 5,800 infants aged six to nine months across multiple low- and middle-income countries.

  2. Phase 2b results published in The Lancet Infectious Diseases

    Publication

    The landmark trial shows ETVAX reduced moderate-to-severe ETEC diarrhea by 48 percent across all children and by 68 percent in infants under nine months. The results support advancement to a phase 3 trial enrolling 5,800 infants.

  3. European Medicines Agency approves advancement to phase 3

    Regulatory

    Following formal scientific advice review, the European Medicines Agency concludes that accumulated safety, immunogenicity, and efficacy data support a pivotal phase 3 program.

  4. Safety trial completed in Finnish travelers to West Africa

    Clinical Trial

    A separate placebo-controlled trial tests ETVAX in Finnish adults traveling to Benin, expanding the vaccine's safety and immunogenicity data to a traveler population.

  5. Gambia trial completes enrollment of 4,936 children

    Clinical Trial

    Enrollment closes after nearly 5,000 children are randomized to receive either three doses of ETVAX or placebo, followed by a two-year surveillance period for diarrheal episodes.

  6. Landmark phase 2b trial begins enrolling children in The Gambia

    Clinical Trial

    The MRC Unit The Gambia begins screening and enrolling children aged six to 18 months across four sites in rural Gambia for the largest-ever ETEC vaccine efficacy trial in a pediatric population.

  7. U.S. Army signs development agreement for traveler's diarrhea use

    Partnership

    Scandinavian Biopharma enters into an agreement with the United States Army Medical Research Acquisition Activity to support ETVAX production, reflecting military interest in preventing diarrhea among deployed soldiers.

  8. Phase 1/2 trial demonstrates safety in Bangladeshi children and infants

    Clinical Trial

    Firdausi Qadri's team at icddr,b tests ETVAX in 495 Bangladeshi participants including young children, marking the vaccine's first pediatric trial. Results are published in The Lancet Infectious Diseases.

  9. Phase 1 trial in Bangladeshi adults confirms safety in endemic setting

    Clinical Trial

    The first test of ETVAX in a country where ETEC is common shows the vaccine is well tolerated and immunogenic in Bangladeshi adults, with or without an immune-boosting adjuvant.

  10. ETVAX passes first safety trial in Swedish adults

    Clinical Trial

    A phase 1 study in 95 healthy Swedish volunteers confirms the vaccine is safe and generates immune responses against ETEC antigens.

  11. Gothenburg team's oral cholera vaccine Dukoral licensed

    Foundation

    Jan Holmgren's group at the University of Gothenburg achieves the first internationally licensed oral cholera vaccine, establishing the scientific foundation for oral enteric vaccines including ETVAX.

Scenarios

1

Phase 3 succeeds, ETVAX becomes first licensed ETEC vaccine

Discussed by: The Lancet Infectious Diseases editorial board, Scandinavian Biopharma, and the European Medicines Agency (which has already provided scientific advice supporting phase 3 advancement)

The pivotal phase 3 trial in 5,800 infants confirms the efficacy signal seen in infants under nine months, meeting its primary endpoint. ETVAX receives regulatory approval and enters routine immunization programs in high-burden countries, potentially preventing millions of diarrheal episodes annually. This is the scenario the developers are actively preparing for, with EDCTP funding secured and EMA alignment in place.

2

Phase 3 shows modest efficacy, narrower approval follows

Discussed by: Vaccine researchers who note the phase 2b primary endpoint was not met and that efficacy varied significantly by age group and co-infection status

The phase 3 trial replicates the pattern seen in The Gambia: strong protection in the youngest infants but weaker overall efficacy when older children and those with parasitic co-infections are included. Regulators approve ETVAX for a narrower age window of six to nine months, limiting but not eliminating its public health impact. This mirrors the experience of rotavirus vaccines, which showed lower but still meaningful efficacy in low-income settings.

3

Phase 3 fails to meet primary endpoint, ETVAX development stalls

Discussed by: Skeptics in the vaccine research community who note that the phase 2b trial did not meet its own primary endpoint and that environmental enteropathy and parasite co-infections may fundamentally limit oral vaccine performance in the populations that need it most

The phase 3 trial, conducted in a broader set of low- and middle-income countries with varying pathogen exposures, fails to demonstrate statistically significant protection. ETVAX joins a long list of promising enteric vaccine candidates that could not clear the final efficacy hurdle in the field. Development continues with reformulated versions or alternative delivery strategies, but licensure is delayed by years.

4

Competing ETEC vaccine candidates advance, reshaping the field

Discussed by: Researchers tracking ACE527 (a live attenuated ETEC vaccine) and newer subunit approaches targeting ETEC adhesins and enterotoxins

Regardless of ETVAX's phase 3 outcome, other ETEC vaccine candidates advance into late-stage trials. ACE527, a live attenuated vaccine mixture, or newer subunit approaches could offer higher efficacy or simpler dosing. The field matures from a single frontrunner into a competitive landscape, similar to how multiple rotavirus vaccines eventually reached the market.

Historical Context

Rotavirus vaccine introduction (2006-present)

2006-present

What Happened

In 2006, two rotavirus vaccines were licensed after decades of development. Rotavirus caused roughly 500,000 child deaths annually before vaccination. Nicaragua became the first low-income country to introduce the vaccine the same year as the United States.

Outcome

Short Term

Countries that adopted the vaccine saw rotavirus hospitalizations drop by a median of 59 percent within years of introduction.

Long Term

By 2019, rotavirus vaccines had saved an estimated 140,000 children's lives. More than 120 countries now include them in routine immunization programs, though efficacy is lower in low-income settings where the disease burden is highest.

Why It's Relevant Today

ETVAX faces the same challenge rotavirus vaccines encountered: demonstrating sufficient efficacy in the low-income, high-burden populations where the vaccine is most needed, where gut infections and malnutrition can blunt immune responses to oral vaccines.

Dukoral oral cholera vaccine (1991)

1991

What Happened

Jan Holmgren at the University of Gothenburg developed Dukoral, the first internationally licensed oral cholera vaccine. The vaccine used inactivated cholera bacteria combined with a cholera toxin B subunit and showed 85 to 90 percent efficacy in the first six months after vaccination in trials across Bangladesh, Peru, and Mozambique.

Outcome

Short Term

Dukoral was licensed first in Scandinavia, then internationally, providing three years of immune protection against cholera.

Long Term

Through technology transfer, Dukoral's approach spawned lower-cost oral cholera vaccines like Shanchol, which became the backbone of the World Health Organization's global cholera vaccine stockpile. The same Gothenburg mucosal immunology group that created Dukoral went on to develop ETVAX.

Why It's Relevant Today

ETVAX is a direct scientific descendant of Dukoral, built on the same University of Gothenburg platform for oral mucosal vaccination. Its development demonstrates how foundational research in one enteric disease can enable vaccines for related pathogens decades later.

Oral polio vaccine global rollout (1960s-2020s)

1960s-present

What Happened

Albert Sabin's oral polio vaccine, licensed in the early 1960s, became the primary tool for global polio eradication. Its oral delivery made mass vaccination campaigns feasible in low-resource settings where injectable vaccines were logistically impractical.

Outcome

Short Term

Wild polio cases dropped from an estimated 350,000 annually in 1988 to fewer than 100 per year by the 2020s.

Long Term

The oral polio vaccine demonstrated that oral immunization could achieve population-level disease control in the developing world, though lower efficacy in tropical settings required more doses and supplementary campaigns.

Why It's Relevant Today

ETVAX's oral delivery strategy reflects lessons learned from oral polio vaccination: oral vaccines are far easier to deploy in low-resource settings, but their performance in tropical, high-pathogen environments is consistently lower than in temperate climates, a challenge ETVAX must also overcome.

Sources

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The Lancet Infectious Diseases Scientific American Scandinavian Biopharma University of Gothenburg Human Progress London School of Hygiene and Tropical Medicine The Lancet Infectious Diseases Medindia ReachMD