Industry Insights: Maternal vaccine safety, controversial policy changes, and the surprising link between tattoo ink and vaccine response

DISCOVERY AND IMMUNOLOGY

Tattoo ink may alter vaccine-induced immune responses [1]

A mouse study investigated how tattoo ink affected immune responses to vaccines. Tattoo ink rapidly drained to nearby lymph nodes, where it was primarily captured by macrophages. When tattoo ink was present, antibody responses to a mRNA-based SARS-CoV-2 vaccine were reduced, correlating with decreased spike protein expression in macrophages, whereas responses to an inactivated influenza vaccine were enhanced.

CXCL10–IFN-γ signaling may drive myocarditis in mRNA vaccine models [2]

A mechanistic study investigated the mechanism behind rare cases of myocarditis observed after SARS-CoV-2 mRNA vaccination, mostly in young men. By analyzing samples from vaccinated individuals, including some who developed myocarditis, the authors identified CXCL10 and IFN-γ as possible biomarkers for vaccine-induced myocarditis. Neutralizing CXCL10 and IFN-γ during a two-dose vaccination regimen reduced cardiac injury in mice and decreased stress and inflammatory markers in human cardiac cell models.

Reverse vaccinology and AI identify candidate mpox vaccine antigen [3]

A study applied Reverse Vaccinology 2.0 and AI to identify new vaccine and antibody targets against monkeypox virus. Neutralizing monoclonal antibodies were isolated from B cells of individuals with prior MPXV infection or vaccination, and AI-assisted structural modeling and cryo–electron microscopy identified OPG153 as their target. OPG153-directed antibodies neutralized multiple MPXV clades as well as vaccinia virus in vitro, and adjuvanted MPXV OPG153 antigen elicited potent neutralizing antibody responses in mice.

CLINICAL TRIALS

Real-world analysis found no increased pregnancy risks with maternal RSV vaccination after 32 weeks [4]

To address concerns raised in earlier trials, a post-authorization safety analysis evaluated pregnancy outcomes following administration of Pfizer’s RSV prefusion F vaccine, Abrysvo, during late pregnancy. The US study examined 54,011 pregnancies during the first RSV season after approval, with 19% of participants vaccinated between 32 and 36 weeks’ gestation. The analysis found no statistically significant increase in preterm birth, hypertensive disorders of pregnancy, premature rupture of membranes, or preterm premature rupture of membranes among vaccinated individuals.

Canadian study confirms lower maternal and neonatal risks with COVID-19 vaccination during pregnancy [5]

A population-based study examined outcomes among nearly 20,000 pregnant Canadian women who developed COVID-19 and found that vaccinated women were 62% less likely to be hospitalized and 90% less likely to require critical care compared with unvaccinated women. Vaccination was also associated with reduced risk of preterm birth, with a 20% reduction during the Delta wave and a 36% reduction during the Omicron wave. Infants born to vaccinated mothers were less likely to require neonatal intensive care, while rates of stillbirth were similar between groups.

More evidence that shingles vaccination reduces dementia risk – and may slow progression [6,7]

Natural experiments from Canada support previous studies showing that herpes zoster vaccination lowers the risk of developing dementia amongst older adults. Plus, a new analysis of a large cohort in Wales, UK, shows a lower incidence of mild cognitive impairment in vaccinated people without dementia, and fewer deaths from dementia among vaccinated dementia patients.

Interim analyses show moderate effectiveness of the 2025–26 influenza vaccine despite strain mismatch [8]

Two interim analyses from France and China assessed the effectiveness of the 2025–26 seasonal influenza vaccine during early circulation of influenza A(H3N2) subclade K viruses, which were not antigenically matched to the vaccine. A French study analyzing 24,267 patients reported an overall vaccine effectiveness of 36.4% against laboratory-confirmed influenza, with higher protection in children (57.2%) than in adults aged 65 years and older (27.7%). A parallel analysis from Beijing reported similar results.

Reduced-dose yellow fever vaccine less effective than standard dose in infants [9]

The WHO recommends fractional dosing of yellow fever vaccine to address shortages during outbreaks. Fractional dosing has been shown to be effective in adults, but a new double-blind randomized trial conducted in Kenya and Uganda found that a fractional dose (500 IU) of live attenuated yellow fever vaccine was inferior to the standard dose (1300 IU) in infants aged 9–12 months.

Phase 1 trial reports safety and immunogenicity of a novel Nipah virus vaccine [10]

A Phase 1 randomized, placebo-controlled clinical trial evaluated the safety and immunogenicity of an investigational Nipah virus vaccine in 192 healthy adults aged 18–49 years. Two doses of the vaccine were well tolerated and induced robust immune responses, with antibodies detected within 1 month after the second dose.

Multistage malaria vaccine shows promising results in controlled human infection study [11]

A Phase 2 randomized controlled trial evaluated the multistage malaria vaccine ProC6C-AlOH/Matrix-M in Malian 34 adults with lifelong exposure to Plasmodium falciparum. Participants received either three doses of the malaria vaccine or a rabies vaccine control, followed by controlled human malaria infection 94 days after the final dose. Among participants completing the challenge, there was an estimated vaccine efficacy of 54% and vaccination delayed time to detectable parasitemia by a median of 2 days.

Cohort study reports no increase in mortality 4 years after COVID-19 mRNA vaccination [12]

A national cohort study using French National Health Data System records examined 4-year all-cause mortality in 22.8 million adults who received a COVID-19 mRNA vaccine versus 5.9 million unvaccinated participants. After controlling for sociodemographic factors and comorbidities, vaccinated individuals showed no increased risk of all-cause mortality and a 74% lower risk of death from severe COVID-19. All-cause mortality was also lower among vaccinated individuals.

MARKET TRENDS

CEPI commits up to $54 million to take Moderna’s H5 avian influenza mRNA vaccine into Phase 3 trials [13]

Moderna announced it secured up to $54.3 million in funding from CEPI to advance its H5 avian influenza messenger RNA (mRNA) vaccine candidate, mRNA-1018, into Phase 3 clinical testing. The agreement supports late-stage development after prior US government funding for the program was discontinued earlier in 2025. Under the terms, Moderna will allocate 20% of its production capacity to low- and middle-income countries at affordable pricing in the event of a pandemic, subject to regulatory approval. The Phase 3 trial is expected to begin in early 2026 in the US and UK, building on earlier-stage safety and immunogenicity data in healthy adults.

NIH-funded program advances fungal vaccine VXV-01 toward Phase 1 trials [14]

The Lundquist Institute and its start-up company Vitalex Biosciences announced that its second-generation fungal vaccine candidate VXV-01 is nearing a Phase 1 clinical trial under a NIH/NIAID contract valued at up to $40 million. VXV-01 is a dual-antigen vaccine designed to target invasive Candida infections, with reported broader cross-kingdom protection potential against Gram-negative healthcare-associated pathogens.

Sanofi to acquire Dynavax [15]

Sanofi has entered into an agreement to acquire vaccine biotech Dynavax. Dynavax has a marketed hepatitis B vaccine and a shingles vaccine in clinical trials. Sanofi’s EVP for Vaccines, Thomas Triomphe, stated: “Dynavax enhances Sanofi’s adult immunization presence by adding differentiated vaccines that complement Sanofi’s expertise.”

REGULATION AND POLICY

Moderna files global regulatory submissions for seasonal influenza vaccine mRNA-1010 [16]

Moderna has submitted marketing authorization applications for its investigational seasonal influenza mRNA vaccine, mRNA-1010, to regulators in the US, EU, Canada, and Australia for use in adults aged 50 years and older. The company stated that mRNA-1010 demonstrated a relative vaccine efficacy of 26.6% versus licensed comparators, with consistent results across age and risk subgroups, as well as superior immunogenicity across all included influenza strains.

Controversial hepatitis B newborn vaccine study in Guinea-Bissau halted over ethical concerns [17]

A US-funded study evaluating hepatitis B vaccination strategies in newborns in Guinea-Bissau was halted by Africa CDC following concerns about its ethical design. The $1.6 million study, supported under the US Department of Health and Human Services, drew criticism for potentially withholding a proven hepatitis B vaccine from a control group in a country with a high disease burden. Africa CDC officials stated the trial was cancelled due to ethical issues and would only proceed if redesigned to meet international research standards.

CDC to revise US childhood immunization schedule [18,19]

Acting CDC Director Jim O’Neill signed a decision memorandum directing the CDC to make changes to the recommended childhood vaccination schedule. The US Department of Health and Human Services stated this was in response to an assessment comparing US recommendations with those of 20 other nations. Under the revised framework, the number of vaccines recommended for all children will drop from 17 to 11, with vaccines for flu, COVID-19, rotavirus, hepatitis A & B, dengue and meningitis now recommended only for specific high-risk populations or based on shared clinical decision-making. The changes have been called ‘dangerous and unnecessary’ by the American Academy of Pediatrics.

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References

1. Capucetti A, Falivene J, Pizzichetti C, et al. Tattoo ink induces inflammation in the draining lymph node and alters the immune response to vaccination. Proc. Natl Acad. Sci. USA 2025; 122, e2510392122. Link

2. Cao X, Manhas A, Chen Y-I , et al. Inhibition of CXCL10 and IFN-γ ameliorates myocarditis in preclinical models of SARS-CoV-2 mRNA vaccination. Sci. Transl. Med. 2025; 17, eadq0143. Link

3. Paciello I, Rundlet EJ, Zhou L, et al. Antigen-agnostic identification of poxvirus broadly neutralizing antibodies targeting OPG153. Sci. Transl. Med. 2025; 17. Link

4. Michnick AI, MacDonald SC, Cosgrove A, et al. Interim safety of RSVpreF vaccination during pregnancy. JAMA 2026; published online Jan 8. Link 

5. McClymont E, Blitz S, Forward L, et al. The role of vaccination in maternal and perinatal outcomes associated with COVID-19 in pregnancy. JAMA 2026; 335, 154–162. Link

6. Pomirchy M, Chung S, Bommer C, Strobel S, Geldsetzer P. Herpes zoster vaccination and incident dementia in Canada: an analysis of natural experiments. Lancet Neurol. 2026; 25, 170–180.

7. Xie M, Eyting M, Bommer C, Ahmed H, Geldsetzer P. The effect of shingles vaccination at different stages of the dementia disease course. Cell 2025; published online Dec 11. Link 

8. De Clercq A, Blanquart F, Vieillefond V, et al., on behalf of the RELAB study group. Interim vaccine effectiveness against influenza virus among outpatients, France, October 2025 to January 2026. Euro. Surveill. 2026; 31, pii=2500992. Link

9. Kimathi D, Juan-Giner A, Bob NS, et al. Low-dose yellow fever vaccination in infants: a randomised, double-blind, non-inferiority trial. Lancet 2026; published online Jan 13. Link 

10. Frenck RW, Naficy A, Feser J, et al. Safety and immunogenicity of a Nipah virus vaccine (HeV-sG-V) in adults: a single-centre, randomised, observer-blind, placebo-controlled, phase 1 study. Lancet 2025; 406, 2792–2803. Link

11. Kone MK, Plieskatt J, Thienta M, et al. Efficacy of ProC6C-AlOH/Matrix-M against Plasmodium falciparum infection and mosquito transmission: a phase 2, randomised, controlled human malaria infection study. Lancet Infect. Dis. 2025; published online Dec 16. Link

12. Semenzato L, Le Vu S, Botton J, et al. COVID-19 mRNA Vaccination and 4-Year All-Cause Mortality Among Adults Aged 18 to 59 Years in France. JAMA Netw. Open 2025; 8, e2546822. Link

13. Moderna. Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine. Jan 5, 2026.

14. The Lundquist Institute. The Lundquist Institute and its start-up company Vitalex Biosciences announces strategic advancement of second-generation fungal vaccine VXV-01 through Phase 1 trials under $40 million competitive contract from NIH/NIAID. Dec 15, 2025.

15. Sanofi. Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline. Dec 24, 2025.

16. Moderna. Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine. Jan 5, 2026.

17. Schreiber M. Controversial US study on hepatitis B vaccines in Africa ‘cancelled.’ The Guardian 2026; Jan 16.

18. US Department of Health and Human Services. CDC acts on Presidential memorandum to update childhood immunization schedule. Jan 5, 2026.

19. Jenco M, Schering S, Stangland S. AAP: CDC plan to remove universal childhood vaccine recommendations ‘dangerous and unnecessary.’ AAP News; Jan 5, 2026.