Protection against Covid-19: Ema recommends approval of adapted Moderna vaccine

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Moderna's Covid-19 vaccine

Photo: Hannah Beier / REUTERS

Spikevax XBB.1.5 is intended to protect adults and children from the age of 6 months from severe Covid-19 disease and, to some extent, from infection with the coronavirus. The European Medicines Agency (EMA) on Thursday gave the green light for the approval of Moderna's adapted vaccine. Now the EU Commission still has to agree.

The new vaccine targets the Omicron subvariant XBB.1.5. Adults and children aged five and over who need to be vaccinated are to receive one dose, regardless of how they were previously vaccinated against Covid-19. Younger children can be given one or two doses, depending on their infection and vaccination history. The Standing Committee on Vaccination (Stiko) in Germany recommends annual booster vaccinations for people aged 60 and over and with an increased risk of infection, preferably in autumn.

Adapted vaccines work in the same way as the original. In the case of mRNA vaccines, only the template for the production of the spike protein of the virus is exchanged. The body uses the exchanged mRNA in the new vaccine to produce the spike protein of the XBB.1.5 variant. The immune system reacts to the protein and produces antibodies and T cells against it.

If an infection with the coronavirus occurs later, the immune system recognizes the pathogen and can fight it more effectively than without vaccination or without variant vaccination. Roughly speaking, the more precisely the immune system is shaped by the vaccination for a variant, the more precisely it can take action against it. When the body comes into contact with different variant vaccines, the immune response broadens.

Price still unclear

The approval of the new vaccine was preceded, among other things, by a study in which adults had received Spikevax XBB.1.5 as a booster vaccination. The participants then produced antibodies against XBB.1.5. "The vaccine also generated an immune response against a number of other strains of the Covid-19 virus, including the currently circulating Omicron XBB.1.16 subvariant," the EMA writes. In addition, tests in the laboratory have shown that Spikevax triggers a sufficient immune response against the XBB.1.5 variant.

For the safety of the adapted vaccines, the EMA relies on the data of the already approved drugs against Covid-19. "Since the first approval of Spikevax, the authorities have gained comprehensive knowledge about the safety of the vaccine," the agency said. Spikevax was first approved in the EU in January 2021. Further approvals for adapted versions targeting the Omicron BA.1 and BA.4-5 subvariants were granted by EMA in September 2022 and October 2022 respectively.

The side effects of the corona vaccines are usually mild and short-lived, according to the authority. She mentions redness, pain and swelling at the injection site, fatigue, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting. More serious side effects could occur rarely.

The new Moderna vaccine should be available in Germany as soon as possible, but the responsible authorities are currently still negotiating the price with Moderna.

BioNTech's corona vaccine, which has been adapted to XBB.1.5, is to be vaccinated in doctors' offices in Germany in a few days. The European Medicines Agency (EMA) had recommended approval at the end of August.

JME