CARPHA cautions against the use of any adult formulation of the Pfizer vaccine for children aged 5 to 11

The Caribbean Public Health Agency (CARPHA) urges Ministries of Health to continue the rollout of their COVID-19 vaccination campaigns. 

Although CARPHA recognizes that uptake of the vaccine is critical to achieving maximum protection from severe disease and death in the Region, Dr Rian Extavour, Programme Manager, CARPHA Caribbean Regulatory System (CARPHA-CRS) cautions Member States against the use of any adult formulation of the Pfizer-BioNTech COVID-19 vaccine for the vaccination of children aged 5 to 11 years of age.  

Dr Extavour pointed out that there is an absence of information on testing of the phosphate-buffered saline formulation in children 5-11 years. Also of great concern, is the increased possibility of errors in administration with drawing up smaller volumes than 0.3mL which is the adult dose, from the adult formulation.

CARPHA Executive Director, Dr Joy St. John added, “Errors in the administration of fractionated doses can make vaccination of children aged 5-11 years with adult vaccines a risky practice. We are awaiting the WHO Emergency Use Listing before we recommend the use of the U. S. FDA approved vaccine developed specifically for children 5-11 years of age.”

At this time, CARPHA-CRS has not yet recommended the paediatric formulation due to the absence of confirmation of the new formulation by the World Health Organization (WHO) Prequalification team under the relevant Emergency Use Listing (EUL).  

Dr St. John reiterated, “Unless otherwise specified, Member States should continue adherence to recommendations for approved vaccines. This will help to ensure favourable benefits to individuals and communities.”