In 2021, two landmark vaccines—Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax—were introduced to the market. Not only did these two vaccines make headlines for being the first FDA-approved COVID-19 vaccines, but they were also the first messenger RNA (mRNA) vaccines to receive FDA approval for human use. Unlike traditional vaccines, which rely on weakened or inactivated forms of a virus, mRNA vaccines utilize synthetic mRNA to instruct cells in the body to encode proteins found on the surface of the virus, thereby generating an immune response.
These two vaccines were highly effective in immunizing against the virus, significantly advancing global public health efforts during the COVID-19 pandemic. The success validated mRNA technology, leading to increased funding for mRNA vaccine research and development.
Sharing the Facts
The widespread dissemination of mRNA vaccines generated considerable public interest but also led to the spread of misinformation. As a trusted source for healthcare information, it’s critical that clinicians play an active role in vaccination decisions. We provide common facts about mRNA vaccines to help clinicians address hesitancy and instill confidence in patients.
Fact 1: mRNA Vaccines Are Safe
Similar to other vaccines, mRNA vaccines may cause mild side effects, but severe side effects are exceedingly rare. The ingredients in COVID-19 vaccines are commonly found in food, and do not include preservatives, tissues, antibiotics, latex, or metals.
Fact 2: mRNA Vaccines Are Thoroughly Researched and Tested
While the COVID-19 vaccines were developed in record breaking time, thorough research and testing was not compromised in the process. Both clinical projects received immense funding and were backed by 50 years of existing mRNA research.
Fact 3: mRNA Vaccines Don’t Alter DNA
mRNA functions by delivering instructions in the form of genetic material to your cell’s ribosomes. The mRNA never enters the cell nucleus, where our DNA is kept, and therefore, the vaccine does not alter an individual’s DNA.
Advantages of mRNA Vaccines
Advancements in biotechnology have enabled scientists to rapidly synthesize mRNA molecules that specify any desired protein, making the mRNA vaccine development process significantly faster than traditional methods. This accelerated development is particularly beneficial for rapidly mutating or highly transmissible viruses, allowing quicker public access to effective vaccines. Moreover, the "plug-and-play" nature of mRNA technology facilitates swift and scalable vaccine production. Lastly, as demonstrated by both clinical trials and real-world studies, mRNA vaccines have proven to be highly effective in preventing illness.
Looking Ahead: The mRNA Pipeline
mRNA vaccines have demonstrated promising potential and evolved into a hotspot in vaccinology research. Below are some of the most anticipated mRNA vaccine trials and studies:
Seasonal Influenza (Flu)
Several clinical trials are underway for mRNA-based flu vaccines. Most notable are the Phase 1 trial of an experimental universal flu vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), Moderna’s flu and COVID-19 combination vaccine that has recently met Phase 3 trial goals, and Pfizer’s successful Phase 3 flu vaccine trial. These mRNA flu vaccines could potentially offer greater efficacy than current flu vaccines due to their faster production times, allowing for more accurate targeting of circulating flu strains.
H5N1 (Bird Flu)
In July 2024, the US Department of Health and Human Services announced $176 million in funding for Moderna to develop a mRNA-based pandemic influenza vaccine aimed at addressing the rise in bird flu cases. The vaccine can be quickly redirected to target other influenza strains if a more significant threat emerges. The vaccine is in early-stage testing.
Cancer
mRNA vaccines are also being explored to treat various forms of cancer. The technology allows for the personalization of vaccines using a patient’s tumor cells, enabling targeted cancer treatment, while also maintaining quick commercialization capabilities. An ongoing Phase 1 pediatric clinical trial at the University of Florida is testing an mRNA vaccine for brain cancer, following promising results in generating immune responses against the aggressive brain cancer, glioblastoma.
Immunology is entering an exciting new era with groundbreaking research pushing the boundaries of mRNA vaccine technology. We look forward to seeing the progress our industry makes, and as new mRNA vaccines enter the market, we’re committed to advancing vaccine procurement and distribution across all care settings.