- Who
- Tozinameran
- What
- first first
- Where
- Germany ()
- When
The first mRNA vaccine to be approved for use by a national regulatory body is the Tozinameran COVID-19 vaccine, developed by BioNTech (DEU) with funding, manufacturing and testing support from Pfizer (USA) and Fosun (CHN). Tozinameran was approved by the British Medicines and Healthcare Products Regulatory Agency (MHRA) on 2 December, with approvals from the medical regulatory bodies of Bahrain, Canada, Saudi Arabia, the United States, Mexico, Kuwait and Singapore coming over the following two weeks.
Most vaccines work by injecting a dead or weakened form of the targeted pathogen into the body, usually along with an ingredient called an adjuvant which helps stimulate a strong immune response. This foreign, but harmless material is targeted by the immune system and destroyed, with the immune system learning to recognize it as a threat as a result.
With mRNA vaccines, instead of injecting a weakened version of the virus, a the vaccine introduces a package of genetic material called messnger RNA. This can be best understood as a set of instructions for producing some specific characteristic of the targeted virus (in the case of Tozinameran, it's SARS-Cov-2's distinctive spike protein). This mRNA enters a few cells in the body and causes them to produce the protein encoded in the instructions. The immune system then attacks this protein, learning the profile of SARS-Cov-2 in the process.
This approach mimics how viruses work in the wild (injecting their own code into the body's cells), but carries no risk of real infection because only a fragment of the virus is involved. The cells that are compromised do not transmit their modification to subsequent generations.
Because the production process of an mRNA vaccine is completely synthetic (with no need to culture and grow the virus), such vaccines can be manufactured at scale relatively easily. They can also be developed much more quickly. It takes at least six months to develop the conventional vaccine for each year's new strains of influenza, and many more complex vaccine projects take years, even decades. Tozinameran, by contrast, was ready for Phase I/II trials within four months of the SARS-Cov-2 genome being published.
The downside of mRNA-based vaccines is the inherent fragility of mRNA. It has to be keep at supercool temperatures (typically around -70°C) to prevent it from degrading and breaking apart. This means that distributing and storing mRNA vaccines is extremely difficult.
