The South African Health Products Regulatory Authority (SAHPRA) on Thursday said they have approved the use of Johnson & Johnson COVID-19 vaccine with certain conditions.
“This registration signals a significant step in the fight against the COVID-19 pandemic. This authorization is based on acceptable safety, quality and efficacy data submitted by JANSSEN PHARMACEUTICA (PTY) LTD to SAHPRA as a rolling submission over the period 11 December 2020 to 17 March 2021,” said SAHPRA CEO Boitumelo Semete-Makokotlela.
She stated that the vaccine is administered as a single dose by intramuscular injection to individuals over 18 years, adding that the vaccine could cause mild or moderate side-effects such as pain at the injection site, headache, tiredness, muscle pain and nausea which will clear within a few days after vaccination.
Semete-Makokotlela said the vaccine has to be supplied and administered in accordance with the department of health COVID-19 vaccination plan and applicable guidelines.
“Further conditions relate to the reporting of the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates,” she added.