{"id":927637,"date":"2026-01-15T10:05:30","date_gmt":"2026-01-15T15:05:30","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/vaxart-publishes-positive-data-for-its-oral-bivalent-norovirus-candidate-in-lactating-women-and-their-infants\/"},"modified":"2026-01-15T10:05:30","modified_gmt":"2026-01-15T15:05:30","slug":"vaxart-publishes-positive-data-for-its-oral-bivalent-norovirus-candidate-in-lactating-women-and-their-infants","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/vaxart-publishes-positive-data-for-its-oral-bivalent-norovirus-candidate-in-lactating-women-and-their-infants\/","title":{"rendered":"Vaxart Publishes Positive Data for its Oral Bivalent Norovirus Candidate in Lactating Women and Their Infants"},"content":{"rendered":"
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\n Vaccine was safe and well-tolerated and led to a significant increase in norovirus-specific antibodies in serum and breast milk<\/em>\n <\/p>\n

\n Norovirus-specific IgA in infant stool correlated with breast milk IgA, suggesting passive transfer of immunity to breastfed infants and the potential for a new approach to confer mucosal anti-norovirus immunity to a vulnerable population<\/em>\n <\/p>\n

SOUTH SAN FRANCISCO, Calif., Jan. 15, 2026 (GLOBE NEWSWIRE) — Vaxart, Inc. (OTCQX: VXRT) (\u201cVaxart\u201d or the \u201cCompany\u201d), a clinical-stage biotechnology company developing a range of oral vaccines based on its proprietary delivery platform, today announced the publication in npj Vaccines<\/em><\/a> of data from a double-blind, placebo-controlled Phase 1 trial evaluating a single-dose, oral bivalent vaccine candidate in post-partum, breastfeeding women (NCT07254728<\/a>). Topline safety and immunogenicity results in lactating women were initially reported in April 2024<\/a>; the newly published study additionally shows vaccine-induced functional norovirus-specific antibodies in breastmilk and serum from vaccinated women, and norovirus-specific IgA in the stool of their breastfed infants. A positive correlation between levels of breast milk IgA and infant stool IgA was observed.<\/p>\n

\u201cThese findings demonstrate that oral vaccination of lactating women led to passive transfer of norovirus-specific antibodies\u00a0to their infants via breastmilk consumption,\u201d said Sean N. Tucker, Vaxart\u2019s Chief Scientific Officer. \u201cThis promising finding could be especially important given that children under the age of five years can experience severe disease from norovirus infection, particularly in under-resourced areas. The passive immunity generated by our oral norovirus vaccine candidate has the potential to protect this highly vulnerable population from infection and illness at a time when their immune systems are still developing.\u201d<\/p>\n

There is no approved vaccine against norovirus, which sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work \u2013 approximately 2.2 days on average \u2013 to care for their children. The annual disease burden from norovirus is $10.6 billion in the United States alone. Globally, norovirus has become the leading cause of pediatric gastroenteritis in health care settings in countries that have adopted a rotavirus vaccine program.1<\/sup> Pediatric deaths in the United States due to norovirus are rare, but they are more common in the developing world.<\/p>\n

\n About the Trial<\/strong>
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The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study was designed to evaluate the safety, tolerability, and immunogenicity of an orally administered bivalent GI.1\/GII.4 norovirus vaccine in healthy lactating women. The primary outcomes of the study were safety and reactogenicity, and breast milk and serum norovirus-specific IgA; passive transfer of IgA to infants was an exploratory outcome. The Bill & Melinda Gates Foundation provided partial funding for the study.<\/p>\n

The study enrolled 76 women 18-43 years of age at five sites in South Africa. Participants were randomized into high- or medium-dose vaccine (n=30 per group) or placebo (n=16). As previously reported, the vaccine was safe and well tolerated, and reports of mild or moderate adverse events (AEs) were similar between the placebo group and each of the vaccine groups; no AEs beyond grade 2 were reported. Results for serum and breastmilk IgA at Day 29 post vaccination were consistent with the prior report. Serum norovirus-specific IgA rose an average of 5.6-fold in response to GI.1 and 4.7 fold in response to GII.4 in the high dose group. Breastmilk norovirus-specific IgA rose on average 4.0 fold in response to G1.1 and 6.0 fold in response to GII.4 in the high dose group (p=0.018 and p=0.004, respectively).<\/p>\n

Newly reported data show:<\/p>\n