Sars-CoV-2 / Covid-19
Comirnaty - Pfizer
AIC: 049269
Mechanism of action: The nucleoside-modified messenger RNA present in Comirnaty is formulated into lipid nanoparticles to enable delivery of non-replicating RNA into host cells and direct transient expression of SARS-CoV-2 S antigen. The mRNA encodes a full-length protein S anchored to the membrane, with two point mutations at the level of the central strand.
The mutation of these two amino acids into proline stabilizes the protein S in the prefusion conformation, which is antigenically preferential. The vaccine induces both a neutralizing antibody response and a cell-mediated immune response to the spike (S) protein antigen, which may help protect against COVID-19.
AIFA Data Bank - RCP / Illustrative leaflet
Comirnaty Original/Omicron BA.4-5 - Pfizer
AIC: 050306
Mechanism of action: The nucleoside-modified messenger RNA present in Comirnaty is formulated into lipid nanoparticles to enable delivery of non-replicating RNA into host cells and direct transient expression of SARS-CoV-2 S antigen. The mRNA encodes a full-length protein S anchored to the membrane, with two point mutations at the level of the central strand.
The mutation of these two amino acids into proline stabilizes the protein S in the prefusion conformation, which is antigenically preferential. The vaccine induces both a neutralizing antibody response and a cell-mediated immune response to the spike (S) protein antigen, which may help protect against COVID-19.
AIFA Data Bank - RCP / Illustrative leaflet
Spikevax - Modern vaccine mRNA-1273 - Modern
AIC: 049283
Mechanism of action: Spikevax (elasomeran) contains mRNA embedded in lipid nanoparticles. The mRNA encodes the full spike protein of SARS-CoV-2 modified by 2 proline substitutions within the seven-peptide repeat domain (S-2P) to stabilize it in the pre-fusion conformation. Following intramuscular injection, the cells in the injection site and the draining lymph nodes absorb the lipid nanoparticles managing to release the mRNA sequence inside them for translation into viral protein. The conveyed mRNA does not enter the cell nucleus or interact with the genome; it is not replicating and its expression is transient, mainly by dendritic cells and macrophages of the subcapsular sinuses. The expressed and membrane-bound spike protein of SARS-CoV-2 is then recognized by immune cells as a foreign antigen. This induces both a T-cell and B-cell response that generate neutralizing antibodies, which may help protect against COVID-19.
AIFA Data Bank - RCP / Illustrative leaflet
Vaxzevria (formerly Covid-19 Vaccine Astrazeneca) - Astrazeneca
AIC: 049314
Mechanism of action: Vaxzevria is a monovalent vaccine composed of a single recombinant vector of replication-deficient chimpanzee adenovirus (ChAdOx1) encoding the S-glycoprotein of SARS-CoV-2. The SARS-CoV-2 S immunogen in the vaccine is expressed in the trimeric prefusion conformation; the coding sequence was not modified to stabilize the protein S expressed in the prefusion conformation. Upon administration, SARS-CoV-2 S-glycoprotein is locally expressed stimulating neutralizing antibodies and cellular immune responses, which may contribute to protection against COVID-19
AIFA Data Bank - RCP / Illustrative leaflet
JCOVDEN (ex Janssen Covid-19 vaccine) - Janssen
AIC: 049395
Mechanism of action: JCOVDEN is a monovalent vaccine composed of a recombinant replication-incompetent human adenovirus type 26-based vector, encoding the complete spike (S) glycoprotein sequence of SARS-CoV-2 in a stabilized conformation. Following administration, SARS-CoV-2 S-glycoprotein is transiently expressed, stimulating both neutralizing anti-S and other functional anti-S-specific antibodies, as well as cellular immune responses directed against the S antigen, which may contribute to protect against COVID-19.
AIFA Data Bank - RCP / Illustrative leaflet
Nuvaxovid - novavax
AIC: 049811
Mechanism of action: Nuvaxovid is composed of recombinant SARS-CoV-2 spike (S) protein purified to full length and stabilized in the pre-fusion conformation. The addition of the saponin-based Matrix-M adjuvant facilitates the activation of cells of the innate immune system, enhancing the degree of the specific immune response against protein S. The two components of the vaccine induce the immune responses of B lymphocytes and T lymphocytes against S protein, including neutralizing antibodies, which may help protect against COVID-19.
AIFA Data Bank - RCP / Illustrative leaflet
VidPrevtyn Beta - Sanofi Pasteur and GlaxoSmithKline
AIC: 050402
Mechanism of action: VidPrevtyn Beta is an adjuvanted vaccine composed of the recombinant spike (S) soluble trimeric protein of SARS-CoV-2 (strain B.1.351) stabilized in the pre-fusion conformation and stripped of its transmembrane and intracellular domains. The combination of antigen and adjuvant enhances the extent of the immune response, which may contribute to protection against COVID-19.
AIFA Data Bank - RCP / Illustrative leaflet
COVID-19 (INACTIVATED, ADJUVATED) Valneva - Valneva
AIC: 050168
Mechanism of action: The COVID-19 vaccine (inactivated, adjuvanted) Valneva (VLA2001) is a purified, inactivated and adjuvanted vaccine with whole virus SARS-CoV-2 (Wuhan hCoV-19/Italy/INMI1-isl/2020 strain) grown on Vero cells. The vaccine manufacturing process renders the virus unable to replicate and delivers intact spike proteins on the surface of the virus. Adjuvants are added to increase the magnitude of vaccine-mediated immune responses.
Following administration, the VLA2001 vaccine stimulates SARS-CoV-2 neutralizing antibodies and cellular (Th1) immune responses directed against the spike and other surface proteins, which may contribute to protection against COVID-19. Using this vaccine, the cellular immune response is therefore not limited to protein S, but is also directed against other surface antigens of SARS-CoV-2. There are no human data on the stimulation of humoral immune responses directed against SARS-CoV-2 antigens other than protein S.