Vaccine Efficacy Studies

🚀 breaking review on The Lancet affirms that currently approved mRNA vaccines are safe and highly effective and suggests that mRNA vaccine technologies have potential as new options for treating a variety of diseases. 👉 The authors use clear schematics to map the real in vivo timeline of mRNA-LNP vaccines — from injection, biodistribution, and protein expression to eventual clearance. It further summarizes the safety evidence for mRNA vaccines across preclinical toxicology studies, Phase III clinical trials, global pharmacovigilance systems, and special-population cohorts. Several important topics were discussed in detail: 1. The risk of myocarditis and pericarditis associated with mRNA vaccines; 2. Clarification of the major mechanisms underlying allergic reactions, while also highlighting that individuals with prior severe allergic reactions can still be safely revaccinated under appropriate management; 3. The critical importance of manufacturing process, product quality, and residual DNA fragments in determining vaccine safety. ☝ This review represents a strong endorsement of the current state of mRNA platform technologies. However, next-generation mRNA vaccines still need further improvements in reactogenicity, durability of immune responses, mucosal protection, global accessibility, and public trust. The Lancet Group 6/30/2026 Review link: https://lnkd.in/gQzfjgUj

A few years ago, I was working on a project that prompted me to do a deep dive on safety and efficacy of mRNA vaccines and I found myself wishing I had a central resource to provide data-driven evidence for many of the questions being raised: How do we know that mRNA doesn't integrate into the genome? How long does the mRNA actually stick around in the muscle/lymph nodes/blood? How effective were the mRNA COVID vaccines in different populations (elderly, pregnant or immunocompromised)? How does the risk of myocarditis for the mRNA COVID vaccines compare to a COVID infection? And importantly, how do we improve our communication around this platform? No such resource existed, so Dr. Manish Sadarangani and I teamed up with a group of world-leading experts on these topics, including Dr. Karina Top, Ben Cowling, Heidi Larson and Robin Shattock to compile a review, which is out today in The Lancet Group: https://lnkd.in/gbNReNQC Big thanks to all the contributors (including Chia Hao Ho for the figures and tables)- we hope it's a useful resource!

A phase 3 #clinicaltrial has shown that #ButantanDV, a tetravalent #denguevaccine developed by the Instituto Butantan in São Paulo, Brazil, demonstrated 80.5% effectiveness against severe #denguefever cases with warning signs over five years. ▫️ The results, published in Nature Medicine, were based on a large multicenter study conducted across 16 research centers in Brazil, involving 16,235 participants aged 2–59 years, where vaccinated individuals showed no hospitalizations compared to eight in the placebo group and an overall 65% protection against symptomatic #dengue. ▫️The vaccine was approved on November 26, 2025, by the Brazilian Health Regulatory Agency ANVISA for individuals aged 12–59, and doses have since been distributed through Brazil’s National Immunization Program and the Sistema Único de Saúde. A pilot #immunization program launched by the Ministry of Health of Brazil in Nova Lima, Maranguape, and Botucatu aims to vaccinate 90% of the target population, starting with #primarycare health professionals. ▫️Butantan-DV is a live attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4) and uses technology originally developed by The National Institutes of Health of Health. According to Dr Fernanda Boulos, medical director of clinical trials at the Butantan Institute, the vaccine represents an important tool for reducing dengue transmission and strengthening protection against the disease in Brazil. 🗃️ See comments for reference.

Our new study, published in The Lancet Infectious Diseases, provides the first real-world evidence on the effectiveness of the TAK-003 dengue vaccine (Qdenga). During the largest dengue outbreak in Brazil’s history (São Paulo, 2024), we observed: 50% effectiveness after the first dose against symptomatic dengue, and 62% after the second dose. The first dose offered 67% protection against hospitalizations, with protection beginning around 8 days after vaccination. Protection against symptomatic disease declined after 90 days, reinforcing the importance of completing the two-dose schedule. These results highlight the critical role of dengue vaccines as a public health measure in high-transmission settings and during outbreak responses. I would like to thank the São Paulo State Secretary of Health for their partnership in data integration and campaign implementation, and Otavio Ranzani Thiago S. Tatiana Lang D'Agostini Regiane Cardoso de Paula  for the excellent collaboration in leading this project. 👉 Full article available here: Lancet Infectious Diseases – https://lnkd.in/drZRG2GR

Next-gen platform in mRNA vaccines? Albumin-recruiting LNPs boost safety and efficacy A just-released study in Nature Materials introduces an albumin-recruiting LNP system that could boost mRNA vaccine delivery. By leveraging Evans blue-modified lipids (EB-LNPs), this platform enhances lymphatic drainage, eliminates liver accumulation, and delivers superior antitumour and antiviral outcomes, setting a new standard for vaccine safety and efficacy. Some key highlights: 1) Innovative design: EB-LNPs replace traditional PEG-lipids with albumin-binding lipids, utilizing albumin’s natural lymphatic transport to drive efficient delivery to lymph nodes (LNs) while avoiding hepatic uptake, thus reducing hepatotoxicity risks. 2) Enhanced efficacy: In mouse models (B16-OVA and HPV-associated tumours), EB-LNP-based vaccines (EB-Vax) activated cytotoxic T lymphocytes (CTLs), achieving robust tumour suppression at lower doses than PEG-LNPs. For infectious diseases, EB-Vax induced high neutralizing antibody titres against H1N1 and SARS-CoV-2 (Omicron BA.5), with minimal lung damage and prolonged survival. 3) Superior safety?: Unlike PEG-LNPs, which caused liver enzyme elevations and lipid accumulation in mice, EB-LNPs showed no liver toxicity, minimal inflammation, and low immunogenicity, avoiding adverse reactions like anaphylaxis. 4) Ah, the beauty of the mechanism: Albumin-mediated transport was reported to enhance dendritic cell (DC) internalization via receptors like gp60, ensuring efficient antigen presentation. EB-LNPs exhibited high stability (over 30 days) and optimal particle sizes (95-110 nm), with strong albumin binding driving lymphatic preference over blood vessel penetration. Overall, really interesting platform. Still, it will be interesting if the authors can do some fine-tuning EB-LNP formulations to target specific LN subsets or immune cell types for tailored therapeutic applications. Regarding issues, scalability is an important one -optimizing large-scale production of EB-LNPs to ensure consistent quality and cost-effectiveness for clinical translation is a hassle. Learn more about it here: https://lnkd.in/e6hMNsNY #Nanotechnology #mRNAVaccines #LipidNanoparticles #CancerTherapy #VaccineInnovation #PrecisionMedicine

Our research published in Elsevier Virology journal , exploring new strategies to enhance vaccine efficacy and breadth against evolving viral threats. As SARS-CoV-2 continues to mutate, the scientific community faces two persistent challenges: the limited cross-reactivity of monovalent vaccines and the potential for adverse effects associated with high-dose formulations. Our study investigated whether "𝐥𝐨𝐰-𝐝𝐨𝐬𝐞 𝐦𝐮𝐥𝐭𝐢𝐯𝐚𝐥𝐞𝐧𝐜𝐲"could be the key to a more robust immune response. 𝐅𝐢𝐧𝐝𝐢𝐧𝐠𝐬: We found that a low-dose trivalent mRNA vaccine elicited broader cross-reactive IgG antibodies and stronger neutralizing activity against multiple variants compared to a standard high-dose monovalent vaccine. Combining low-dose trivalent mRNA with spike proteins from various variants further amplified the immune response, which can be a potent path for next-generation boosters. Co-administering low-dose SARS-CoV-2 mRNA with inactivated influenza vaccines significantly boosted the immunogenicity and efficacy against the flu, hinting at more effective seasonal "combo" shots. By diversifying the vaccine targets and optimizing dosages, we can achieve superior protection with a potentially improved safety profile. Read: https://lnkd.in/eSKfU-K7 Follow ⚜️ Surya Sekhar Pal ⚜️ for more! #vaccine #research #mRNA #immunology #publichealth #SARSCoV2 #infectious #disease #sciencecommunication #global #MSL #KOLs

A new phase 3 study just published in #NEJM offers encouraging evidence that mRNA technology can finally move the needle on influenza vaccination. The quadrivalent modified mRNA flu vaccine demonstrated 34.5% superior relative efficacy compared to a standard licensed vaccine in adults 18–64, driven by stronger protection against the A/H3N2 and A/H1N1 strains that dominated the 2022–23 season. Immunologically, the signal is even more striking: the mRNA platform generated higher antibody titers for A strains and markedly stronger CD4⁺ and CD8⁺ T-cell responses, with cellular immunity persisting to 6 months. Reactogenicity was higher but predictable, short-lived, and without myocarditis or pericarditis. This study doesn’t solve influenza, and it tells us little about B-strain protection in a season where B barely circulated. But it does show that mRNA flu vaccines are feasible, immunologically potent, and capable of outperforming our current egg-based tools.  #mRNA #vaccines https://lnkd.in/eh7Jrz9r

I'm proud to share new data published by The Lancet Infectious Diseases that underscores the critical role of vaccination in helping to protect older adults against pneumococcal pneumonia. A U.S. retrospective cohort study observed that Medicare-enrolled adults aged 65 and older who received a 20-valent pneumococcal pneumonia vaccine were associated with reductions in the risk of invasive pneumococcal disease (IPD), pneumococcal pneumonia (PP), all-cause pneumonia (ACP), and lower respiratory tract infections (LRTIs) compared to unvaccinated individuals in the study. These findings highlight the vaccine’s ability to help protect individuals from 20 pneumococcal serotypes contained in the vaccine. This study serves as a vital reminder of how #vaccination can help reduce the burden of preventable diseases.   Explore the full publication here: https://lnkd.in/eQppVBRm   #PfizerProud #Vaccines #PneumococcalPneumonia