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SAHPRA approves booster dose with the Pfizer vaccine

The SA Health Products Regulator (SAHPRA) has approved a third or booster shot of Pfizer's COVID-19 vaccine for adults and children over the age of 12 years, reports MedicalBrief. SAHPRA also said that in response to the “keen interest” in so-called “mix-and-match” regimens, it was inviting further submissions of data in this regard.

SAHPRA said in a statement that on 17 November 2021, it had 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 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.

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