Spikevax (previously COVID-19 Vaccine Moderna)

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About Spikevax (previously COVID-19 Vaccine Moderna)

Spikevax works by preparing the body to defend itself against COVID-19.

What it is used for

This information is not provided in the source facts.

How it is used

The originally authorised Spikevax is given in people from the age of 6 months as two injections, usually into the muscle of the upper arm, or the thigh in infants and young children, 28 days apart. A booster dose may be given to adults and children from the age of 6 years, at least 3 months after primary vaccination with Spikevax, or another mRNA vaccine or an adenoviral vector vaccine. Spikevax bivalent Original/Omicron BA.1 may be given as a single injection to adults and children from the age of 6 years, at least 3 months after primary vaccination or a booster dose with a COVID-19 vaccine. Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5, Spikevax JN.1 and Spikevax LP.8.1 are given as a single injection to adults and children aged 5 years and older, irrespective of their previous COVID-19 vaccination history. In children from 6 months to 4 years of age, they are given as a single injection in those who have completed a primary vaccination course or have had COVID-19 before, or as two injections 28 days apart in those who have not previously been vaccinated against COVID-19 or had COVID-19. An additional dose of Spikevax, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5, Spikevax JN.1 or Spikevax LP.8.1 may be given to adults and children aged 6 months and older with a severely weakened immune system. The vaccines should be used according to official recommendations, issued at national level, by public health bodies.

How it works

Spikevax contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of SARS-CoV-2 which the virus needs to enter the body’s cells and which can differ between variants of the virus. When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it. If, later on, the person comes into contact with SARS-CoV-2, their immune system will recognise it and be ready to defend the body against it. After vaccination, the mRNA from the vaccine is broken down and removed from the body. Adapted vaccines work in the same way as the original vaccine and are expected to maintain protection against the virus as they contain mRNA more closely matching circulating variants of the virus.

Active substance: single-stranded

Source: EMA EPAR