Pfizer and BioNTech Receive Regulatory Approval for Updated Covid-19 Vaccine Targeting Omicron Variant

Pfizer and BioNTech have received important regulatory approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for their updated version of the Comirnaty Covid-19 vaccine. This updated vaccine specifically targets the highly contagious sublineage of the virus known as Omicron.

According to the recommendation, the Omicron XBB.1.5-adapted monovalent Covid-19 vaccine should be administered as a single dose to individuals aged 5 and up, regardless of their prior vaccination history. Additionally, the updated vaccine is recommended for children aged 6 months through 4 years as part or all of the primary three-dose vaccination series, depending on their vaccination history or as a single dose for those who have already completed a Covid-19 primary vaccination course or have a prior infection.

The European Commission, which typically follows the advice of the CHMP, will now review this recommendation. A final decision is expected soon.

Pfizer and BioNTech have been proactive in manufacturing the updated vaccine and have it ready to ship upon approval. They anticipate increased demand during the upcoming fall and winter season.

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