The Caribbean Public Health Agency (CARPHA) urges Ministries of Health to continue the rollout of their COVID-19 vaccination campaigns but warns against using adult vaccines for children.
In a statement, CARPHA said it recognizes that the “uptake of the vaccine is critical to achieving maximum protection from severe disease and death in the region.” However, its Programme Manager for its Caribbean Regulatory System, Dr. Rian Extavour, “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.”
Pfizer, while feverishly promoting its new vaccine, has submitted requests for approval by the US Center for Disease Control (CDC), but the regulatory body on Friday delayed “approval” until April 2022 at the earliest. “Approval” for a vaccine is a statement by the regulator that the vaccine is safe and effective for its designed use. While some vaccines may not have “approval”, they may be “authorized”, meaning that the benefits of using the vaccines outweigh the known risks, and therefore permissible for use in the case of an emergency, like the Covid-19 pandemic. With children aged 5-11 being in a very low-risk category, “approval of a new Pfizer vaccine for that group would need at a minimum “approval”.
Dr. Extavour points out that insofar as vaccination of children is concerned, “There is an absence of information on testing of the phosphate-buffered saline formulation in children 5-11 years.” Of concern to CARPHA, she adds, 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, also spoke on the issue, saying: “Errors in administration of fractionated doses can make vaccination of children aged 5-11 years with adult vaccines a risky practice.”
Dr. St John says CARPHA is “awaiting the WHO Emergency Use Listing before we recommend use of the US FDA-approved vaccines developed specifically for children 5-11 years of age.”
The statement concluded: “At this time, CARPHA has not yet recommended the pediatric 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).”
As with unauthorized and unapproved drugs like Ivermectin, CARPHA only recommends COVID-19 drugs authorized and approved by the WHO.