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SAHPRA approves Pfizer Covid-19 booster shot for Over 18s

SAHPRA approves Pfizer booster shots. File picture: Henk Kruger/African News Agency (ANA)

SAHPRA approves Pfizer booster shots. File picture: Henk Kruger/African News Agency (ANA)

Published Dec 8, 2021

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CAPE TOWN – The South African Health Products Authority (SAHPRA) on Wednesday has announced the approval of Pfizer Covid-19 booster shots to those 18 years and older.

It said on November 17, it received an application from Pfizer to amend the dosing schedule for the Comirnaty Covid-19 vaccine that allows for an optional third (booster) dose.

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In a statement released, SAHPRA has said it has approved the following options: a third dose can be administered to individuals aged 18 years and older at least six months after the second dose.

Individuals aged 12 years and older who are severely immunocompromised can be administered the booster dose at least 28 days after their 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,” it said.

SAHPRA initially approved the use of Pfizer’s Covid-19 vaccine on March 21, 2021 in terms of section 21 of the Medicals and Related Substances Act.

This announcement from SAHPRA comes on the same day as Pfizer Inc and BioNTech SE announced an initial study from its laboratory demonstrated that serum antibodies induced by the Pfizer vaccine neutralises the SARS-CoV-2 omicron variant after three doses.

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It said that sera obtained from vaccines one month after receiving the booster vaccination, neutralised the omicron variant levels comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses.

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