COVID-19 is the disease caused by a new coronavirus called SARS-CoV-2. This disease was officially named as ‘coronavirus disease (COVID-19)’ by the WHO.
Naming the coronavirus disease (COVID-19) and the virus that causes it
Coronavirus disease (COVID-19), WHO
Messenger ribonucleic acid (mRNA) vaccines are a novel technology that stimulate the body’s own immune response. These vaccines contain information from messenger RNA, including the “blueprint” or code of a specific virus trait (virus antigen). The information enables the body to produce this antigen on its own: mRNA transfers the information for the production of the antigen to our cell machinery that makes proteins. Cells in our body then present the antigen on their surface and thus trigger the desired specific immune response. When the body comes into contact with the virus, the immune system recognizes the specific antigen and can fight the virus and thus the infection quickly and in a targeted manner.
How do mRNA COVID-19 vaccines work?
With COVID-19, the entry of the coronavirus into the host cell in humans is mediated by the coronavirus spike protein that is located on the surface of the virus. mRNA vaccines against COVID-19 are designed to provide our bodies with the code to solely produce the non-infectious virus spike protein to instruct the cell’s machinery to help stimulate a natural immune response. This response is achieved primarily through T-cells and the production of neutralizing antibodies by B-cells, which aim to prevent SARS-CoV-2 infection (and its associated disease, COVID-19). If a vaccinated person later comes into contact with the actual SARS-CoV-2, the immune system will recognize the surface structure and will be able to combat the virus and eliminate it.
Neutralizing antibodies targeted at SARS-CoV-2 are circulating in your body and will immediately bind to the virus, “neutralize” it and prevent it from entering the cell, thus protecting you from getting sick. T cells help the immune system to fight intracellular infections and can also kill the infected cells directly.
COVID19 mRNA vaccine consists of a short segment of genetic material, called messenger RNA, that provides instructions for a human cell to make a harmless version of a target protein or antigen, which activates the body’s immune response against SARS-CoV-2. mRNA can be produced at a large scale in a short manufacturing cycle, which allows for a scale-up of manufacturing aimed at a worldwide supply
To manufacture mRNA at a large scale, we use biochemical reactions, similar to those occurring in every cell of the human body. This reaction can be replicated with a bioreactor in a so-called in-vitro transcription (IVT). This enzyme-based process “translates” a DNA template into mRNA. Due to the highly specific and effective enzyme RNA polymerase, more than 500 mRNA copies can be produced with one DNA molecule
Following the mRNA production in the bioreactor, the mRNA is purified by a separating process and product-related impurities, including the DNA templates, are removed by using a proprietary purification process. After purification, the mRNA solution is concentrated. In a final step, the drug substance is filtered to remove any potential microbial contamination.
The mRNA in the drug substance needs to be appropriately formulated to ensure the delivery of the RNA to the particular target cells and is critical to protect the encapsulated mRNA from degradation after injection into the human body. Therefore, the mRNA is combined with a mixture of lipids to form lipid nanoparticles (LNP). The lipids in the BNT162b2 mRNA formulation are selected to deliver the drug substance to lymphatic cells to induce the immune response against the SARS-CoV-2 protein. The LNPs in the solution give the vaccine a slightly turbid appearance.
The final manufacturing step is a sterile filtration and filling of the vaccine into vials. The vials are labelled and undergo a strict quality control before packaging. About 200 multi-dose vials fit in one carton and can then be shipped to the sites where individuals will be vaccinated. On-site, the mRNA-LNP formulation will be diluted with saline to adjust the concentration prior to the intramuscular injection.
Safety and immunogenicity of the SARS-CoV-2BNT162b1 mRNA vaccine in younger and olderChinese adults: a randomized,placebo-controlled,double-blind phase 1 study