Probe into Covid-19 booster jabs for SA babies and toddlers
This is the latest statement from Pfizer in the wake of what it says are favourable results of its clinical trials pertaining to children under 12.
"[We are seeing] a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from seven days after the second dose," the statement read.
The sentiment coincided with the kickoff of the vaccine roll-out for children aged 5 to 12 in Bolivia last week. Spain expects to begin inoculating children aged 5 to 11 this coming Wednesday, December 15.
Australia announced that its children aged 5 to 11 will start to receive the Pfizer Covid-19 vaccine from January 10. This after it cleared the final regulatory step and was recommended for use in this age group by the Australian Technical Advisory Group on Immunisation (ATAGI).
SA awaits outcome
South African parents, in the meantime, have their ears to the ground as they await approval from The South African Health Products Regulatory Authority (Sahpra) on if and when the Covid-19 vaccine is set to kick off in tiered stages: first for its children aged 5 to 11, and then their babies and toddlers.
Whether a booster jab will be in the offing for all children is a question that remains to be answered.
"The results from the pivotal Phase 2/3 trial in the 5 to <12 years cohort are promising. They show a favorable safety profile and robust immune responses," the Pfizer statement said.
"Efficacy data collected through this trial was during the time that the Delta variant was prevalent. These data were published in New England Journal of Medicine (NEJM) on November 9 2021."
Clinical trial details
In March this year, Pfizer and BioNTech began a global Phase 1/2/3 continuous study to learn if their vaccine could produce an immune response against Covid-19, and if it was safe in children aged 6 months to <12 years. Participants in the study are split among three age cohorts: 6 months to <2 years, 2 to <5 years and 5 to <12 years.
In June this year the study transitioned to the Phase 2/3 portion of the ongoing trial, and enrollment was expanded, recruiting up to 4,500 participants from countries such as US, Finland, Poland and Spain at more than 90 clinical trial sites.
Children aged 5 to < 12 years old receive Cominarty 10µg x 2 doses, given 21 days apart.
"At this point, it is unknown whether or not children will need a booster of the vaccine," a Pfizer spokesperson said.
Sahpra has, in the meantime, approved a booster vaccine for SA's immunocompromised children between the ages of 12 and 17.
