Registered South Africa · SAHPRA

COMIRNATY OMICRON XBB ADULT VACCINE

RAXTOZINAMERAN

59/30.2/0764

What it does

Raxtozinameran is a medication used to help the body fight off infections and diseases by strengthening the immune response.

Commonly used for: prevention of viral infections, supporting the immune system

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
59/30.2/0764
Registration date
2026/09/01
Expiry date
-
Status
Registered
Active ingredient
RAXTOZINAMERAN
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-09-20 04:02:20 · updated 2026-09-30 04:12:33

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Raxtozinameran is a medication used to help the body fight off infections and diseases by strengthening the immune response.

What it treats

  • prevention of viral infections
  • supporting the immune system

How it works

It works by boosting the body's immune response, helping to protect against certain viruses.

Who it's for

It is suitable for individuals looking to enhance their immune defenses, particularly those at risk of viral infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: raxtozinameran

Raxtozinameran is an investigational mRNA-based vaccine designed to elicit an immune response against specific viral proteins, potentially providing protection against viral infections. It operates by utilizing lipid nanoparticles to deliver messenger RNA into host cells, which then translate the mRNA into viral antigens, triggering an immune response. This novel approach to vaccination aims to enhance the body's ability to recognize and combat pathogens.

Indications

  • Prevention of viral infections
  • Immunization against specific viral pathogens

Dosage

Children: Refer to clinical guidelines for specific dosing information. Pediatric dosing may vary based on age, weight, and specific health considerations.

Adults: Refer to clinical guidelines for specific dosing information. Typically, vaccines are administered in a series, with the first dose followed by a booster dose after a set interval.

Mechanism of action

Raxtozinameran functions by delivering a synthetic mRNA encoding for a viral antigen into host cells via lipid nanoparticles. Once inside the cells, the mRNA is translated into the target protein, which is then presented on the cell surface. This process stimulates the immune system, leading to the production of antibodies and activation of T-cells specific to the virus, thereby providing adaptive immunity.

Pharmacodynamics

The pharmacodynamics of raxtozinameran involve the stimulation of both humoral and cellular immune responses. Upon administration, the vaccine induces the generation of specific antibodies against the viral antigens, as well as the activation of CD4+ and CD8+ T lymphocytes. This dual action contributes to both neutralization of the virus and the development of immunological memory, which is crucial for long-term protection against reinfection.

Pharmacokinetics

The pharmacokinetics of raxtozinameran involve rapid uptake of the lipid nanoparticle-mRNA complex by cells following intramuscular injection. The mRNA is translated within the cytoplasm of the host cells, and the resulting protein is expressed on the cell surface. The half-life of the mRNA is relatively short, as it is subject to degradation by cellular mechanisms, while the immune response typically peaks several weeks after vaccination. The exact pharmacokinetic parameters are still under investigation.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether raxtozinameran is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store in a refrigerator at 2 to 8 degrees Celsius. Do not freeze. Protect from light.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.