(News Bulletin 247) – Pfizer and BioNTech announced today that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization to provide a single booster dose of the bivalent COVID-19 vaccine suitable for Omicron BA.4/BA.5- from Pfizer and BioNTech in children aged 6 months to 4 years and older.

The vaccine is also licensed in this age group as the third dose in a primary series of three; for these children, a booster (fourth) dose is not allowed at this stage.

According to data from Pfizer, a booster dose of the adapted bivalent Omicron vaccine elicits better Omicron neutralizing antibody responses compared to participants who received three doses of the company’s original vaccine.

Pfizer and BioNTech have also submitted an application to the European Medicines Agency (EMA) to extend the marketing authorization for this vaccine to include use in children aged 6 months to 4 years at time.

The companies plan to submit applications to other regulatory authorities worldwide for the use of their bivalent Omicron BA.4/BA.5 vaccine in children under 5 years of age.

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