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Spikevax (COVID-19 Vaccine Moderna)

The European Commission authorized the marketing of Spikevax’s vaccine developed by Moderna (previously COVID-19 Vaccine Moderna) on the 6th of January 2021. Spikevax is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

  • Spikevax contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19.
  • The recommended interval for two doses of the Spikevax’s vaccine is four weeks. A maximum protection is achieved two weeks after the second dose.
  • To vaccinate 6-11 year-old children, half (50 µg) of the dose meant for the age group 12+ is used. NB! Spikevax can be used to vaccinated 6-11-year-olds only if parents ask for it, but the current data shows that mild or moderate side effects are more common than with the Pfizer/BioNTech vaccine.
  • Spikevax is safe to use in pregnant women (previous consultation with a doctor is needed).
  • Spikevax’s vaccine doesn’t have a virus in it, and it’s not capable of generating COVID-19.
  • Spikevax (Former COVID-19 Vaccine Moderna) was given a conditional marketing permit on the 6th of January 2021.

Additional information

  • The information about Spikevax vaccine (SPC) in Estonian can be found HERE
  • More information about Spikevax on the website of the European Medical Agency 

How it works?

Spikevax works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.

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 virus, their immune system will recognise it and be ready to defend the body against it.

The mRNA from the vaccine does not stay in the body, but is broken down shortly after vaccination.

What's the efficacy?

A very large clinical trial showed that Spikevax, given as a two-dose regimen, was effective at preventing COVID‑19 in people from 18 years of age. The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection.

This means that the vaccine demonstrated a 94.1% efficacy in the trial. The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes, or HIV infection.

Possible side effects

The most common side effects with Spikevax in the trials were usually mild or moderate and got better within a few days after vaccination.

The most common side effects are pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea (feeling sick) and vomiting. They may affect more than 1 in 10 people.

Redness, hives, and rash at the injection site, sometimes occurring more than a week after injection, rash, and diarrhoea may affect less than 1 in 10 people. Itching at the injection site and dizziness may affect less than 1 in 100 people. Swelling of the face, which may affect people who had facial cosmetic injections in the past, weakness in muscles on one side of the face (acute peripheral facial paralysis or palsy) and hyperaesthesia (reduced sensation to touch, pain and temperature) may affect less than 1 in 1,000 people.

A very small number of cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) have occurred with Spikevax. Allergic reactions have also occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis). As for all vaccines, Spikevax should be given under close supervision with appropriate medical treatment available.

The ingredients of Spikevax

This is a multi-dose vial that contains 10 doses of 0.5 ml.

One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid

Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription
from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

Other ingredients:

Lipid SM-102 (heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino}octanoate)
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000 DMG)
Trometamol hydrochloride
Acetic acid
Sodium acetate trihydrate
Water for injections

Everything you should know about the COVID-19 vaccination

Vaccination is free of charge for all people living in Estonia, even without the national health insurance.
  • Vaccination is voluntary.
  • Vaccination is open to all people who are at least 5 years old.
  • Compared to COVID-19 illness, vaccination is safe, and generally, the side effects pass quickly.
  • Booster doses are available only for adults, and the time for a booster jab is 2 months after finishing the vaccination course with the Janssen vaccine, and 3 months after finishing the vaccination course with AstraZeneca, Pfizer/BioNTech and Moderna vaccines.
  • Booster doses for people, who are recovered from COVID-19 are recommended 5 months after their recovery or their last vaccination. 
  • After getting a booster dose, you need to create a new vaccination certificate in 
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