EMA recommends approval of adapted Covid-19 vaccine targeting Omicron XBB.1.5

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant, the EMA said.

The vaccine – known as Comirnaty Omicron XBB.1.5 – is to be used for preventing Covid-19 in adults and children from six months of age.

In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control (ECDC), adults and children from five years of age who require vaccination should have a single dose, irrespective of their Covid-19 vaccination history, the EMA said.

Children from six months to four years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had Covid-19.

In its decision to recommend the authorisation, the human medicines committee considered all the available data on Comirnaty and its other adapted vaccines, including data on safety, efficacy and immunogenicity (how well they trigger immune responses).

In addition, the committee assessed new laboratory data showing a strong response of the adapted vaccine against XBB.1.5 and related strains of the virus that causes Covid-19, the EMA said.

Bulgaria’s Health Ministry said on August 31 that the country will receive 1.3 million doses of the vaccine after it is approved for use by the European Commission.

The first delivery of 80 640 doses is planned for the third week of September.

The vaccines the ministry expects to arrive then are indicated for use in adults and people 12 years of age and older.

Delivery of paediatric vaccines intended for the immunisation of children from six months to 11 years of age is also planned for the last week of September.

Vaccines will continue to be administered free of charge to Bulgarian citizens and permanent residents who request it from their general practitioner, at immunisation offices of the regional health inspectorates and at designated medical facilities.

(Photo: Bulgaria’s Health Ministry)

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