The South African Health Products Regulatory Authority has approved third-dose booster shots of the Pfizer vaccine, opening the way for the department of health to embark on a booster vaccination programme.
Booster shots will strengthen immunity in the face of the fourth wave of the new coronavirus variant, Omicron, which is spreading at a rapid rate throughout the country, particularly in Gauteng. The Pfizer-BioNTech vaccine now marketed as Comirnaty was initially approved by Sahpra in March. The company applied for an amendment of the dosing schedule for its use as a third-dose booster on November 17 and Sahpra conducted an assessment of the data to establish the safety and efficacy of a third dose.
“Following evaluation of the data submitted, Sahpra has approved the following options: a third dose of the Comirnaty Covid-19 vaccine in individuals aged 18 years and older, to be administered at least 6 months after the second dose; a third dose of the Comirnaty Covid-19 vaccine in individuals aged 12 years and older who are severely immunocompromised, to be administered at least 28 days after the second dose,” Sahpra CEO Boitumelo Semete said in a statement.
“The data provided only dealt with the situation of homologous boosting, where the third dose is of the same vaccine as the initial course . Sahpra is aware of the keen interest in the efficacy and safety of heterologous boosting regimens , and invites submission of supportive data in this regard,” he said.
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