SAHPRA APPROVAL OF BOOSTER DOSING WITH THE PFIZER (COMIRNATY®) COVID-19 VACCINE

08 December 2021

The South African Health Products Authority (SAHPRA) initially approved the use of Pfizer’s Comirnaty® COVID-19 vaccine on 16 March 2021, in terms of section 21 of the Medicines and Related Substance Act (Act 101 of 1965).

On 17 November 2021, SAHPRA received an application from Pfizer to amend the dosing schedule for the Comirnaty® COVID-19 vaccine, allowing an optional third (booster) 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.

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 the submission of supportive data in this regard.

Issued by SAHPRA, 8 December 2021