Investigational vaccines remain subject to regulatory authorization or approval
Since the COVID-19 pandemic began, the scientific community has come together to work on potential treatments and vaccines. As a part of this effort, newer technologies are being explored, including one based on messenger RNA, also known as mRNA. Right now, this technology is being used to research a new type of vaccine, an mRNA vaccine, to determine whether it may be able to help combat COVID-19.
mRNA vaccines are not made up of the actual pathogen, meaning that they don't contain weakened, dead, or noninfectious parts of a virus or bacterium. They contain genetic information about the pathogen.1
Scientists have identified a coronavirus protein, the spike protein, that the virus uses to attack our cells.2 If one could “train” the body to identify and block the virus spike protein interaction or to recognize a virus-infected cell, it may be possible to help protect an individual from infection or disease.3
mRNA vaccines are being designed to instruct the body’s cells to make a spike protein, which could potentially train the immune system to recognize and destroy the virus by summoning its defenses, like antibodies and T-cells.4,5
When the real virus comes along, scientists believe that the immune system could recognize the virus’ spike and prepare to defend against infection and illness. Because a vaccinated person may not encounter the virus for some time after vaccination, the goal is to train memory cells so that they can quickly respond to a potential invasion.4,5 Clinical trials are being run to confirm whether this process works to help provide protection.
Dr. Alejandra Gurtman, vice president of Vaccine Clinical Research and Development at Pfizer explained, “You don’t need the actual virus or bacterium to create an mRNA vaccine, instead you only need a small part of its genetic code.”1
“It is also believed, and will continue to be studied, that mRNA vaccines may be given multiple times, and that these ‘boosts’ to the immune system may help to increase immunity should it decrease in the future,”5 Gurtman noted.
Scientists have been working closely with clinicians and regulators to evaluate the possible risks and benefits of this type of vaccine candidate. And they continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of all vaccine studies.6 This includes extensive clinical research, such as robust studies designed through feedback from regulatory bodies, independent safety monitors, and subject-matter experts, enrolling tens of thousands of participants.6
Research is under way to determine the safety and efficacy of mRNA vaccine candidates. It is our hope that mRNA vaccines become one of the tools in the fight against COVID-19.
- Maruggi G, Zhang C, Li J, Ulmer J, Yu D. mRNA as a Transformative Technology for Vaccine Development to Control Infectious Diseases. Molecular Therapy. 2019;27(4):757-772. doi:10.1016/j.ymthe.2019.01.020
- Mayo Clinic. Get the facts about a COVID-19 (coronavirus) vaccine. Accessed August 18, 2020. https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-vaccine/art-20484859.
- PHG Foundation. RNA vaccines: an introduction. Accessed August 18, 2020. https://www.phgfoundation.org/briefing/rna-vaccines.
- WHO. Q&A on vaccines. Published August 2019. Accessed August 18, 2020. https://www.who.int/news-room/q-a-detail/q-a-on-vaccines.
- Pardi N, Hogan M, Porter F, Weissman D. mRNA vaccines — a new era in vaccinology. Nature Reviews Drug Discovery. 2018;17(4):261-279. doi:10.1038/nrd.2017.243
- Pfizer. Our progress in developing a potential COVID-19 vaccine. Updated October 2020. Accessed October 2020. https://www.pfizer.com/science/coronavirus/vaccine