CARPHA: Pfizer 5-11 formula not yet listed for emergency use

The Caribbean Public Health Agency (CARPHA) said the paediatric formulation of the Pfizer covid19 vaccine has not yet been granted emergency use listing by the World Health Organization (WHO). It said its Caribbean Regulatory System (CARPHA-CRS) had not yet recommended the paediatric formulation for use in the Caribbean for this reason.

In a release, the agency said even though the WHO’s strategic group of experts (SAGE), which advises on immunisation, had recommended the use of the vaccine, in children 5-11 years of age, approval for the product in full comes from the WHO EUL prequalification team.

“This prequalification team looks at all aspects of the vaccine including the composition, how it is made and where, how it is dispensed or administered, how it is packaged, and how it is to be stored. This full product assessment is critical as it helps countries to be assured of the final vaccine product that may be registered in the country and used in children.”

CARPHA said it recognises the WHO EUL procedure and collaborates with the WHO prequalification team to develop summaries and recommendations for vaccines listed under the EUL, as stated in public presentations made by CARPHA executive director Dr Joy St John, and CARPHA-CRS programme manager Dr. Rian Extavour.

“In that regard, at this time, CARPHA-CRS has not yet recommended the paediatric formulation due to the absence of confirmation of the new formulation by the WHO prequalification team under the relevant emergency use listing (EUL).”