NATIONAL NEWS - The South African Health Products Authority (Sahpra) announced in a media statement today, Thursday 23 December, that a booster dose of the Covid-19 Johnson & Johnson (Janssen) vaccine for all residents over 18 years of age has been approved.
The Janssen vaccine was also approved for heterologous use after primary or full vaccination with an mRNA vaccine.
The approval was as follows:
• The Janssen vaccine 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.
• The vaccine may also be used as a second dose to any mRNA Covid-19 vaccine at least two months after primary vaccination in individuals 18 years of age and older.
The single-dose Janssen vaccine was initially registered with conditions on 30 March this year for use in the Sisonke programme to vaccinate South Africa's healthcare workers, and later also for vaccination of the public.
According to Sahpra, the approval follows after it has reviewed safety and efficacy data after Johnson & Johnson on 10 December applied for an amendment to the dosing schedule for the vaccine.
Sahpra on 8 December approved a third booster dose of the Pfizer mRNA vaccine in people 18 years and older, administered at least six months after the second dose.
A third dose of the vaccine was also approved in individuals aged 12 years and older who are severely immunocompromised, at least 28 days after the second dose.
