The South African government has received a request from the US drug company Pfizer seeking approval for its booster drug to be used in the country, the South African Health Products Regulatory Authority (SAHPRA) said on Tuesday.
According to the local drug watchdog, it would start with the assessment of data for the safety and efficacy of the third dose meant for those adults who have completed their dosage soon.
“Pfizer’s latest request says results from a Phase 3 clinical trial, with more than 10,000 participants, found that the third dose was safe and effective,” the health regulatory agency said.
“Booster doses are administered to a vaccinated population that has completed a primary vaccination series, currently one or two doses of Covid-19 vaccine, depending on the product,” the UN World Health Organisation said.
“This is done when immunity/clinical protection has fallen below a rate deemed sufficient, with the aim of restoring vaccine effectiveness,” the organisation explained.
Last month SAHPRA and Johnson & Johnson approved vaccine booster doses for all healthcare workers who had received the first shot.
According to the Ministry of Health’s latest data, some 81,840 Johnson & Johnson booster shots have been administered to healthcare workers since the rollout started this month in the country.
NM/as/APA