Third dose of COVID-19 vaccine approved for immunocompromised over 12

pharmafile | October 6, 2021 | News story | Research and Development  

The EMA have authorised the third dose of the Moderna COVID-19 vaccine (Spikevax), to be administered on immunocompromised individuals aged 12 and older.

As people from this group do not mount a full response to vaccination, they are less protected than the rest of the population, according to Public Health England. Numerous studies have shown the benefit of a third vaccination dose on immunocompromised subjects, in particular a recent double-blind, randomised, controlled trial of 120 individuals who had undergone solid organ transplant procedures. These patients demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo. In the study, the third dose was generally well tolerated.

There are still some safety concerns surrounding the Spikevax vaccine, and adverse reactions have been reported following administration during mass vaccination outside of clinical trials. These include severe allergic reactions, myocarditis and pericarditis, and syncope (fainting). Additional adverse reactions, some of which could be severe, may become more apparent with more widespread administration.

Despite this, immunocompromised persons, including individuals receiving immunosuppressive therapy, may actually have a diminished response to Spikevax.

Spikevax 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.

“We recognise the need to protect immunocompromised individuals who are at the highest risk of severe COVID-19 disease. It is promising to see recent trials demonstrating that a third dose of the Moderna COVID-19 vaccine may enhance immune response in this important population,” commented Stéphane Bancel, Chief Executive Officer of Moderna.

“We remain committed to helping to end the COVID-19 pandemic with our mRNA vaccine.”

Spikevax has been granted conditional marketing authorisation in the EU, by the European Commission, for active immunisation against COVID-19.

Lina Adams

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