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SAHPRA approval of second/booster dose of the COVID-19 vaccine Janssen

23 December 2021

Embargo: Immediate release

The South African Health Products Regulatory Authority (SAHPRA) initially registered the COVID-19 Vaccine Janssen, with conditions on 30 March 2021, in terms of section 15 of the Medicines and Related Substance Act (Act 101 of 1965).

On 10 December 2021, SAHPRA received an application from Janssen to amend the dosing schedule for the  COVID-19 Vaccine Janssen (Ad26.COV2.S), allowing for 2nd dose at least 2 months after primary vaccination and the use of Ad26.COV2.S for heterologous booster immunisation following completion of primary vaccination with an approved mRNA COVID- 19 vaccine. SAHPRA reviewed the safety and efficacy data provided and has subsequently approved the COVID-19 Vaccines Janssen 2nd dose/booster dose as follows:

  1. A second dose of 0.5 mL of COVID-19 Vaccine Janssen may be administered intramuscularly at least 2 months after the primary vaccination in individuals 18 years of age and older
  2. A booster dose of the COVID-19 Vaccine Janssen (0.5 mL) may be administered as a heterologous booster dose following completion of primary vaccination with an approved mRNA COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination.

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