2024 Report: Vaccines in Development and Future Challenges

Vaccines are the most successful public health measure ever, halting the spread of infectious diseases and slowing some of the worst disease ever seen in the vast majority of the world.
As the complex biological mechanisms underlying disease have evolved, so too has the vaccine development process. In this article, we will discuss the recent accelerated vaccine research by cutting-edge US biopharmaceutical research companies for preventive and therapeutic vaccines. All of the vaccines referenced in this report are either in clinical trials or waiting to be reviewed by the U.S Food and Drug Administration.

1. Vaccines in Development
There are currently 286 vaccines in production, according to this report. Even though today’s vaccines are primarily disease preventive, new therapeutic vaccines are likely to help treat diseases. Healing vaccines combat infections and diseases such as cancer by expanding or re-engaging the immune system. Beyond infectious disease, five oral therapeutic vaccines have already been approved for pollen and peanut allergies, and one for prostate cancer—and plenty more are coming.

Vaccines being tested: These are some of the vaccines being investigated:
• Liposomal therapeutic anti-Tau vaccine in Alzheimer’s disease: This vaccine will make the patient’s immune system produce conformational antibodies against the Tau protein. Tau, not just A plaques, loops fibres inside neurons and forms tangles, and is an efficacious Alzheimer’s biomarker. The vaccine reduces Tau aggregates in preclinical models.
• A beta 9-valent E.coli vaccine for ExPEC: ExPEC is a major sepsis (primarily in the elderly) vector, with 10 million cases of ExPEC disease every year worldwide. This vaccine is made of outer layers of bacterial polysaccharides and a protein carrier that stimulates a hostile immune response against ExPEC.
• An mRNA-based respiratory combination vaccine: This vaccine prevents COVID-19 and influenza in adults. mRNA vaccines pass the code to the cells to generate a protein (such as the spike protein found in COVID-19 vaccines), and that protein initiates an immune response in the body. The combo vaccine has already been clinically evaluated for strong anti-flu A and B immunity and SARS-CoV-2, and it could save both respiratory ailments with one injection.
• A multivalent meningococcal conjugate vaccine: It prevents meningococcal disease in 5 serogroups (A, B, C, W, Y). It’s rare but deadly, with serious complications or even death due to invasive meningococcal disease (IMD), the leading cause of meningitis and sepsis. One in 10 people can die without treatment, sometimes in just a day.
• Therapeutic vaccine for advanced melanoma (stage IIb-IV): Melanoma is the most deadly type of skin cancer, with 100,640 new cases and 8,290 deaths estimated by 2024. This customizable treatment vaccine is made from artificial mRNA with up to 34 neoantigens synthesized from the patient’s tumour-specific mutations. When the neoantigens trigger particular T-cell activation on cancer cells expressing those neoantigens, they activate an anti-tumor immune response.
• An mRNA therapeutic vaccine against pancreatic ductal adenocarcinoma (PDAC): PDAC is one of the deadliest cancers, and about 90 percent of patients die within two years of diagnosis. This individualized treatment vaccine is designed for the tumor that the patient has and may include up to 20 patient-specific neoantigens. The targeted administration of the vaccine primes the immune system up to attack specific cancers. This vaccine is also being developed for melanoma and colon cancer.

2. Why Vaccines Are Important
2.1 Vaccines Purging Some of Us of Disease

Some diseases long since caught the cure, but vaccines are the way to purge them.
Vaccines are among the most efficient and affordable preventative, anti-disease and anti-ageing technologies in existence. The childhood vaccine has prevented more than 1 million deaths alone in the U.S. over the last 30 years. The 18 deadliest or most perilous diseases in the U.S. can be vaccinated against.Vaccination avoided over 18 million hospitalizations and nearly 3 million deaths in the first two years of the COVID-19 vaccines being issued.

2.2 Vaccines Prevent Disease and Save on Costly Medical Care
Healthcare for everyone is much less expensive and better through vaccines. Vaccines for children have saved the U.S. healthcare system close to $2.2 trillion over the past 30 years, according to the United States Centers for Disease Control and Prevention (CDC), making them among the least expensive public health tools available. In another study, every $1 spent on child vaccinations translates to $7.50 in savings for healthcare and society. Vaccines even reduce the incidence and severity of vaccine-preventable diseases (VPDs) like influenza, pneumococcal disease, shingles and pertussis that make $27 billion in direct and indirect costs for 50-year-old adults each year.

2.3 Vaccines Support Healthy Aging
The world over is getting older. More than a third of us will be 60 or older by 2030—that’s 1.4 billion people. By 2050, there will be more elderly people than adolescents and young people aged 10-24. Longer life means you can be a better person, create more jobs, and do more for the world. Healthy aging is also one of the biggest engines of labor force participation, productivity, socioeconomic stability, and GDP growth.
We lose immune function as we get older, so anyone over 50 will be more susceptible to infectious diseases like COVID-19, shingles, influenza, pneumococcal disease, pertussis, and respiratory syncytial virus and their sequelae. VPDs put those aged 50-64 at risk of other diseases that early vaccination could have eliminated. So-called acute infections, like the flu and shingles, have been associated with increased cardiovascular and neurovascular diseases such as heart attack and stroke within months of infection. Medications and vaccines will sustain the elderly well into old age, provided they exercise, eat well, go to the doctor and use mental health resources.

2.4 Vaccines Enhance Herd Immunity
Vaccines teach the body which pathogens are harmful (e.g., bacteria, viruses, parasites) and help it target them accordingly. When one part of a population is immunized, disease is less likely to spread, and medical expenses are reduced. Herd immunity slows the spread of infectious diseases like measles, polio, and smallpox. However, measles outbreaks have occurred where vaccines are disappearing and herd immunity is vanishing.

2.5 Vaccines Reduce AMR with Antimicrobial Resistance (AMR)
AMR emerges when microbes—bacteria, viruses, fungi, and parasites—develop resistance to antimicrobials. AMR bacteria infections are a global epidemic. In 2019, 1.95 million people died from AMR. Over the past 30 years, we’ve seen new antibiotics struggling to keep up as AMR increases. AMR is expected to kill 10 million people per year by 2050. It is infection prevention that combats AMR, so vaccines are critical in the fight against AMR. Vaccines place us at the mercy of epidemics or outbreaks caused by threats like AMR.

3. The Future of Vaccine Development
New vaccine studies are carried out by the U.S. biopharmaceutical industry, and more than half of all global biopharmaceutical R&D spending, vaccines included, is undertaken in the US biopharmaceutical industry. The great majority of the world’s vaccines approved in the past 20 years were invented in the U.S. As science becomes the foundation of next-generation preventive and therapeutic vaccines, the biopharmaceutical sector is breaking special scientific and clinical barriers. What is happening now with research also inoculates the U.S. and the rest of the world for outbreaks in the future.

Incentivizing investment in the slow, expensive and involved vaccine development process with strong intellectual property protection is essential. As with any pharmaceutical intervention, vaccines are rigorously formulated and run through huge clinical trials in which thousands of volunteers are tested for safety and effectiveness.

Years of research and development into new vaccines involve advanced large-scale clinical trials. Biopharmaceutical companies invest in the machines, supplies, materials, and human resources needed for vaccine research, development, and manufacturing. They also collaborate with government agencies on new vaccines and help public health institutions deliver vaccines to the people who need them. These interventions—and vast amounts of private sector money to correct the first technical hurdles faced by mRNA vaccine research—have saved millions from lethal COVID-19 and death, and billions in medical costs.

Vaccines that are in development are under the vigilance of U.S. biopharma companies. Manufacturers undergo strict safety monitoring and reporting during clinical trials and post-approval

Scientific Challenges
• Determining which virus types to attack and test for vaccines (a long process especially with new viruses).
• Complexity of many infectious disease pathogens and immune system responses to them as a whole (in rare or epidemic diseases).
• Developing validated preclinical models that are closer to the human immune system so that we can better model human immune responses.
Clinical Trial Challenges
• A reduction in recruiting negatively affects vaccine research because vaccines are preventative and must be administered to healthy subjects, it’s hard to find enough volunteers for clinical trials.
• There aren’t many volunteers available for a new infectious disease, particularly for an outbreak or sporadic disease because we never know when or where the disease will appear or spread.
• Multiple-dose vaccination schedules for protection are not compliant in trial participants.
Manufacturing and Distribution Challenges
• Vaccines are biological molecules, made through a complex series of steps, to create the most important vaccine components.
• Making over 10,000 units a year is hard and time-consuming.
• Once developed, vaccines have to be sealed, stored and transmitted. Delivery must be done under the right circumstances, some even requiring refrigeration.
Despite all these challenges, biopharma research companies and their ecosystem partners are deciphering pathogens and developing vaccines to meet the demands of modern health. In the future, we will need to fund critical R&D to fuel vaccine biopharmaceutical innovation.

Creative Biolabs specializes in vaccine development, offering a wide range of services and products. Below is a table listing some of our key services and products.

These entries provide a glimpse into the vast array of specialized offerings provided by Creative Biolabs in the field of vaccine development.