Pharma 5: Game-Changing Vaccine Developments in the Pipeline

Vaccine hesitancy, conflicting information, changing regulations and the ever-evolving nature of pathogens pose a formidable challenge to getting the right protection to people who need it.

But research continues to push forward, exploring new applications for vaccine technology. From preventing fungal infections to teaching the body to tolerate itself, exciting vaccine developments may soon change the way doctors treat, and even cure, serious disease.

Fungal Vaccine

“We can’t just keep swinging away and trying to make new drugs to fight fungal infections because we’re going to lose. These organisms are always adapting to resist new drugs,” explained Karen Norris, CEO and founder of NXT Biologics, the company behind the University of Georgia’s NXT-2, a pan-fungal vaccine candidate aimed at preventing fungal infections before they happen.¹

NXT-2 is a recombinant protein designed as a consensus peptide based on the conserved amino acid sequence of the KEX1 regions of Candida albicans, Aspergillus fumigatus, Pneumocystis jirovecii and Cryptococcus neoformans.²

The vaccine is still in development, but findings published in June 2025 are promising: It was highly immunogenic against vulvovaginal candidiasis in mouse models.²

Researchers hope that, once approved, NXT-2 will both prevent fungal infections and reduce the clinical need for antifungal medications.

HIV Vaccine

A new vaccine — Gilead Science’s Yeztugo (lenacapavir), which received approval from the United States Food and Drug Administration in June 2025 — may fundamentally change the strategy in the fight against human immunodeficiency virus (HIV).

More than 400,000 people in the United States use pills to prevent HIV, but in a survey of more than 500 pre-exposure prophylaxis users, 95 percent indicated they would prefer a long-lasting injection rather than a daily pill.

“We know it’s challenging to take a daily pill for prevention, and we see an incredible opportunity here,” said Johanna Mercier, Gilead’s chief commercial officer. In clinical trials, Yeztugo was tested in a study comprised of women and girls; the participants who received the vaccine did not contract HIV. Yeztugo was found to be effective when given twice per year, and the change could fundamentally change HIV prevention.³

“Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, chairman and chief executive officer of Gilead Sciences.⁴

Though challenges remain, the company is working with government agencies and health groups in low-income countries to make the product known and available.³

Personalized Cancer Vaccine

Personalized cancer vaccines train the immune system to recognize neoantigens (tiny cancer mutations) and target them, making each patient’s treatment personal, precise and robust. The result? A tailored therapy unique to each patient that could ultimately cure patients.

While still early in development, personalized cancer vaccines show promise. Researchers at the Icahn School of Medicine at Mount Sinai have tested a new type of personalized multi-peptide neoantigen cancer vaccine (PGV001) in an early Phase I trial that can be customized to fit each patient’s unique cancer. It uses neoantigens (small changes in cancer cells) that are not found in healthy cells, then teaches the immune system to target the changes. This approach makes the treatment personal, precise — and seemingly effective. Researchers say it may even help keep the cancer from coming back. Additional trials of PGV001 are on the horizon.⁵

Inverse Vaccines

Research shows inverse vaccines work; biotech startups are feverishly developing them; and big pharma is banking on the game-changing approach. Inverse vaccines could be a reality within the next five to 10 years.

Inverse vaccines teach the immune system to recognize its own cells as safe, therefore preventing it from attacking its own body’s cells. They keep the immune system from reacting, and the method could revolutionize treatment of autoimmune disease as we know it.

Inverse vaccines use certain synthetic nanoparticles attached to disease-related antigens as messengers to retrain the immune system. The particles mimic dying human cells that are part of the body’s ongoing, natural process. The immune system then learns to ignore both the nanoparticles and the attached proteins and stops attacking the body.⁶

The method has been successful in early trials in multiple sclerosis and celiac disease, and researchers believe the model could apply to a wide variety of other autoimmune diseases — and may even extend to food allergies.⁷

Universal Flu Vaccines

The dream of a one-and-done flu vaccine may soon become a reality — research and testing are well underway. By November 2024, there were at least 218 separate universal flu vaccines in development, with 166 separate developers and 40 vaccines in clinical testing.⁸

Further, in May 2025, the U.S. Department of Health and Human Services and the National Institutes of Health (NIH) announced federally funded work on a new universal flu vaccine platform — Generation Gold Standard — using a beta-propiolactone (BPL)-inactivated, whole-virus platform.⁹

The initiative aims to prepare for all influenza viral threats, not just those that are currently circulating. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today’s, but tomorrow’s as well – using traditional vaccine technology brought into the 21st century,” said NIH director Dr. Jay Bhattacharya.

In addition to influenza and coronavirus, the BPL platform is adaptable for future use against respiratory syncytial virus (RSV), metapneumovirus, and parainfluenza. It also offers the unprecedented capability to protect against avian influenza without inducing antigenic drift—a major step forward in proactive pandemic prevention.

Clinical trials are scheduled to start in 2026, with the aim of approval in 2029.