Covid-19: SA Regulator Gives Pfizer Booster Dose Nod

The South African Health Products Regulatory Authority (SAHPRA) on Wednesday announced that it has approved a booster dose with the Pfizer (Comirnaty®) Covid-19 vaccine.

SAHPRA said the move comes after it evaluated data submitted.  

In a terse statement attributed to CEO Dr. Boitumelo Semete said: “SAHPRA has approved 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”.

Dr. Semete said SAHPRA has also approved “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”.

Dr. Semete said 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).

The SAHPRA announcement coincided with Pfizer saying late on Wednesday that a three-shot course of their Covid-19 vaccine was able to neutralise the new Omicron variant in a laboratory test.

“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 Dr. Semete.

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. 

The new variant – Omicron – detected in South Africa last month is thought to be more transmissible and vaccinations are considered the best protection.

South Africa is entering the fourth wave and health authorities are urging more people to get the jab.

More than 25 million people in South Africa, in a population of about 60 million, have been vaccinated against Covid-19.

In its latest update, the National Institute for Communicable Diseases said 52 890 tests were conducted in the last 24hrs, with 13 147 new cases detected, which represents a 24.9% positivity rate.

A further 27 Covid-19 related deaths have been reported.

MADE IN CAPE TOWN: The MD SARS-nCoV-2 Antigen Device

In another development, SAHPRA approved an affordable, locally developed Covid-19 antigen test.

The MD SARS-nCoV-2 Antigen Device was developed by Medical Diagnostech, a local developer and manufacturer of high-quality rapid diagnostic test kits.

Commenting on the development, Founder and CEO of Medical Diagnostech Ashley Uys said: “Medical Diagnostech has already produced initial commercial batches, and has a production capacity of 20 million units per annum, but is also in the process of scaling up”.

Uys said all test kits were produced in Cape Town.