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Pfizer's Omicron XBB1.5 Covid Vaccine Gets Swiss, UK Approval
Pfizer's New Vaccine Targets Omicron Variant
Swiss and UK Authorities Approve the Vaccine
Pfizer and BioNTech have submitted an application to Swissmedic, the Swiss Agency for Therapeutic Products, for approval of their Omicron XBB1.5-adapted mRNA COVID-19 vaccine.
The European Medicines Agency's (EMA) human medicines committee (CHMP) has recommended authorizing the adapted Comirnaty vaccine for use in the EU.
The companies expect to be ready to ship the Omicron XBB1.5-adapted monovalent COVID-19 vaccine as soon as they receive approval from regulatory authorities.
Broader Age Range for the Vaccine
The vaccine is registered for use in people aged 6 months and older.
Targeting the Omicron Subvariant
The vaccine encodes the spike protein for the Omicron subvariant XBB1.5 of SARS-CoV-2, which is currently circulating in many countries.
Approval Granted by UK's MHRA
The vaccine has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Intended Use of the Vaccine
COMIRNATY Omicron XBB1.5 3 micrograms dose concentrate for dispersion for injection is indicated for:
- Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus, in individuals 6 months of age and older.
- The vaccine is administered as an intramuscular injection.
- The recommended dosage is 3 micrograms for individuals 6 months through 11 years of age and 10 micrograms for individuals 12 years of age and older.
- A booster dose is recommended for individuals 12 years of age and older at least 3 months after completion of the primary vaccination series.
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