SAHPRA approves Pfizer COVID-19 booster dose in South Africa: Details

Image credit: Flickr/Marco Verch

The South African Health Products Regulatory Authority (SAHPRA) has approved the use of Pfizer’s Comirnaty® COVID-19 vaccine booster dose in South Africa.

SAHPRA announced the approval in a statement on Wednesday (8 December), saying it first approved the Pfizer vaccine in March this year.

Pfizer COVID-19 booster dose in South Africa

“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,” the Authority’s CEO Dr Boitumelo Semete said.

After evaluating the application, SAHPRA said it 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 approval comes as South Africa battles Omicron, a new COVID-10 variant that emerged in late November.

The variant is reportedly driving the current surge in new infections in South Africa. Recent cases crossed the 16,000 mark in a day with positivity rates of around 24 percent. On Tuesday, the reported figure was 13,143 new cases.

Pfizer and Omicron variant

SAHPRA’s announcement also comes amid reports that Pfizer-BioNTech booster doses can provide additional protection against the Omicron variant.

The two vaccine partners announced on Wednesday that the boosters raised antibodies, “giving a similar level of the protective proteins as observed against earlier versions after the standard two shots,” according to a Bloomberg report.

A recent study at the Steve Biko/Tshwane District Hospital Complex in Gauteng suggested that the Omicron variant may be milder compared to previous variants.

However, Dr Fareed Abdullah, the director of the Office of AIDS and TB Research at the South African Medical Research Council and the study’s lead author, urged caution because the study is based on a limited sample of 166 patients.

“The exponential increase in the positivity rate in these patients is a reflection of the rapidly increased case rate for Tshwane but does not appear to be associated with a concomitant increase in the rate of admissions for severe COVID-19 (pneumonia) based on the high proportion of patients not requiring supplemental oxygen,” the study said.

“The relatively low number of COVID-19 pneumonia hospitalisations in the general, high care and ICU wards constitutes a very different picture compared to the beginning of previous waves.”

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