In short
Comirnaty LP.8.1 is an updated mRNA vaccine against COVID-19, authorised in the EU and studied in a completed Phase 3 trial with 4,000 participants. The trial compared immune responses after vaccination with different COVID-19 vaccine products, including Comirnaty LP.8.1, against the prevailing virus variant.
Key points
- Phase 3 trial completed with 4,000 participants enrolled.
- Studied in COVID-19 infection to evaluate immune responses after vaccination.
- Given as a dispersion for injection by intramuscular injection.
- Primary outcome measured antibody levels at 6 months after two doses.
- Authorised in the EU under record EU/1/20/1528/045.
- Compared with other COVID-19 vaccines including Spikevax and Nuvaxovid.
What is Comirnaty LP.8.1?
Comirnaty LP.8.1 is an updated mRNA vaccine against COVID-19. Its full registered name is 5'-capped mRNA encoding SARS-CoV-2, variant LP.8.1, spike protein, pre-fusion stabilised (K981P and V982P). The product name is Comirnaty LP.8.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine. It is authorised as a medicine in the European Union, with authorisation record EU/1/20/1528/045, held by BioNTech Manufacturing GmbH. The substance is part of a fixed combination in one product record.
How does Comirnaty LP.8.1 work?
Comirnaty LP.8.1 is an mRNA vaccine. It contains messenger RNA that encodes the spike protein of the SARS-CoV-2 virus, specifically the LP.8.1 variant, in a pre-fusion stabilised form. After injection, the body's cells read this mRNA and produce the spike protein, which trains the immune system to recognise and respond to the virus. The stabilising changes K981P and V982P help keep the spike protein in the shape the virus uses before entering cells.
Which conditions is it used or studied for?
- COVID-19 infection — the disease caused by the SARS-CoV-2 virus, which can lead to respiratory illness and other complications.
How is Comirnaty LP.8.1 given?
Comirnaty LP.8.1 is given as a dispersion for injection by intramuscular injection. In the trial, the dose used was 30 micrograms in 0.3 millilitres.
What do the clinical trials show?
One completed Phase 3 trial evaluated Comirnaty LP.8.1 in COVID-19 infection. The trial enrolled 4,000 participants and compared immune responses after vaccination with different COVID-19 vaccine products. The primary outcome was the proportion of seropositive subjects with an antibody level above the target level in groups of vaccine recipients receiving different vaccine products at 6 months after two doses against the prevailing virus variant. Other vaccines used as comparators included Spikevax bivalent Original/Omicron BA.1, Comirnaty 30 micrograms/dose, Spikevax 50 micrograms, Comirnaty JN.1, Nuvaxovid, a non-replicating viral vector COVID-19 vaccine, Comirnaty Original/Omicron BA.4-5, and Comirnaty Omicron XBB.1.5.
What side effects are known?
No side effect information was provided in the available sources for this specific page.