The South African Health Products Authority (Sahpra) has approved a third booster dose for South Africans following the outbreak of the Omicron Covid-19 variant.

This follows concerns at early evidence suggesting that the Omicron has a higher re-infection risk.

In a statement Sahpra CEO Dr Boitumelo Semete said the approval follows the application SAHPRA received on 17 November 2021 from Pfizer to amend the dosing schedule for the Comirnaty Covid-19 vaccine, allowing an optional third dose, or booster.

Initially the use of Pfizer’s Comirnaty Covid-19 vaccine was approved on March 16, 2021, in terms of Section 21 of the Medicines and Related Substance Act (No 101 of 1965).

In a statement, Sahpra says following evaluation of the data submitted, it has approved a third dose of the Comirnaty Covid-19 vaccine for individuals aged 18 years and older, to be administered at least 6 months after the second dose.

Secondly, a third dose of the Comirnaty Covid-19 vaccine may be given to individuals aged 12 years and older who are severely immunocompromised, to be administered at least 28 days after the second dose.

“The data provided only dealt with the situation of homologous boosting, where the third dose is of the same vaccine as the initial course (in this case, two doses). Sahpra is aware of the keen interest in the efficacy and safety of heterologous boosting regimens (so-called “mix-and-match” approaches), and invites submission of supportive data in this regard,” said Semete.