mRNA vaccines utilize messenger RNA to trigger an immune response. The vaccine introduces antigen-encoding mRNA into cells, instructing them to produce a foreign protein, mimicking a pathogen or cancer cell. This protein stimulates an adaptive immune response, enabling the body to recognize and eliminate the corresponding threat. Lipid nanoparticles encapsulate and protect the mRNA, facilitating its entry into cells. This technology offers a rapid and adaptable approach to vaccine development compared to traditional methods.
In 1989, the first successful transfection of designed mRNA packaged within a liposomal nanoparticle into a cell was published, marking an important step in mRNA technology.
In 1993, it was shown that liposome-encapsulated mRNA encoding a viral antigen stimulated T cells in mice, demonstrating the potential of mRNA to elicit an immune response.
In 2001, the first human clinical trial using ex vivo dendritic cells transfected with mRNA encoding tumor antigens (therapeutic cancer mRNA vaccine) was started, marking an early step in the development of mRNA-based cancer therapies.
In 2008, BioNTech was founded to develop mRNA biotechnologies, playing a key role in the advancement of mRNA technology.
In 2008, clinical trial results of an mRNA vaccine directly injected into the body against cancer cells were reported, contributing to the growing body of research on mRNA vaccines for cancer treatment.
In 2010, Moderna was founded with the goal of developing mRNA biotechnologies, marking a significant step in the growth of the mRNA field.
In 2013, the first human clinical trials using an mRNA vaccine against an infectious agent (rabies) began, marking a significant milestone in the development of mRNA vaccines for infectious diseases.
In 2018, the FDA approved the use of lipid nanoparticles as a drug delivery system with the approval of Onpattro, the first siRNA drug. This was a critical breakthrough for producing viable mRNA vaccines.
In November 2020, Nature reported on the thermostability differences between the Pfizer–BioNTech's BNT162b2 and Moderna's mRNA-1273 vaccines, suggesting they might have similar storage requirements despite initial claims.
In December 2020, Pfizer–BioNTech and Moderna received authorization for their mRNA-based COVID-19 vaccines, marking a significant milestone in the use of mRNA technology to combat the COVID-19 pandemic.
In 2020, the COVID-19 pandemic led to debate about the type of initial authorization mRNA vaccines should receive, including emergency use authorization or expanded access authorization, due to the need for faster production and potential risks.
In 2020, the companies manufacturing lipids for lipid nanoparticles faced the challenge of scaling up production to meet the demand for mRNA vaccines, highlighting a bottleneck in the large-scale use of this delivery method.
In December 2020, BioNTech and Moderna obtained approval for their mRNA-based COVID-19 vaccines. The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the Pfizer–BioNTech's BNT162b2 COVID-19 vaccine first, followed by the US FDA giving emergency use authorization for the Pfizer–BioNTech COVID-19 vaccine and subsequently the Moderna COVID-19 vaccine. This marked a major turning point for mRNA vaccine technology.
In June 2021, the US FDA added a warning about the possibility of increased risk of myocarditis and pericarditis for some people after receiving mRNA COVID-19 vaccines, highlighting potential side effects.
In 2021, GSK and Gritstone bio initiated Phase 1 trials of saRNA COVID-19 vaccines, showcasing the ongoing efforts to develop more advanced vaccine technologies.
In June 2022, Gemcovac became the first saRNA COVID vaccine authorized, marking a milestone in vaccine development in India.
In November 2023, a version of ARCT-154, developed by Arcturus Therapeutics and manufactured by Meiji Seika Pharma, was authorized in Japan, signifying further advancements in saRNA vaccine technology.
In 2023, Katalin Karikó and Drew Weissman were awarded the Nobel Prize in Physiology or Medicine for their discoveries concerning modified nucleosides. Their work enabled the development of effective mRNA vaccines against COVID-19, marking a significant achievement in the field.
In 2023, interim results of Gritstone bio's Phase 1 trial of an saRNA COVID-19 vaccine, used as a booster vaccine, were published, contributing to the understanding of saRNA vaccine potential.
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