The Caribbean Pub­lic Health Agency (CARPHA) says the World Health Or­gan­i­sa­tion (WHO) has not yet giv­en Emer­gency Use List­ing (EUL) sta­tus to the chil­dren’s ver­sion of the Pfiz­er COVID-19 vac­cine, and as such, that lev­el of ap­proval is still pend­ing.

The CARPHA state­ment comes as pae­di­atric cas­es of COVID-19 con­tin­ue to in­crease in the re­gion, and coun­tries weigh the risks and ben­e­fits of vac­ci­nat­ed chil­dren be­tween the ages of five and 11 years against the dis­ease.

The fol­low­ing is the full text of the state­ment is­sued by CARPHA…

Pae­di­atric For­mu­la­tion of the Pfiz­er COVID-19 Vac­cine Pend­ing Ap­proval by WHO Emer­gency Use List­ing Pre­qual­i­fi­ca­tion Team

(CARPHA) — The pae­di­atric for­mu­la­tion of the Pfiz­er COVID-19 vac­cine is not yet list­ed un­der the World Health Or­ga­ni­za­tion’s (WHO) Emer­gency Use List­ing (EUL)

The WHO Strate­gic Group of Ex­perts (SAGE) that ad­vis­es on Im­mu­niza­tion has rec­om­mend­ed the use of the vac­cine in chil­dren 5-11 years of age. How­ev­er, the ap­proval of the prod­uct in full comes from a dif­fer­ent group of ex­perts called 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 giv­en (dis­pensed or ad­min­is­tered)

●   How it is pack­aged, and how it is to be stored

Courtesy CARPHA.

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 rec­og­nizes the WHO EUL pro­ce­dure and col­lab­o­rates with WHO Pre­qual­i­fi­ca­tion team to de­vel­op sum­maries and rec­om­men­da­tions for vac­cines list­ed un­der the EUL.

This is con­sis­tent with pub­lic pre­sen­ta­tions made by Dr Joy St John, the Ex­ec­u­tive Di­rec­tor of CARPHA and Dr. Ri­an Ex­tavour, Pro­gramme Man­ag­er, CARPHA Caribbean Reg­u­la­to­ry Sys­tem (CARPHA-CRS).

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 World Health Or­ga­ni­za­tion (WHO) Pre­qual­i­fi­ca­tion team un­der the rel­e­vant Emer­gency Use List­ing (EUL).