Covid-19: SAHPRA approves booster doses

The South African Health Products Regulatory Authority (SAHPRA) announced its approval of Pfizer’s booster shot on December 8.

“SAHPRA initially approved the use of Pfizer’s Comirnaty Covid-19 vaccine in March, in terms of section 21 of the Medicines and Related Substance Act (Act 101 of 1965),” said chief executive officer Dr Boitumelo Semete-Makokotlela.

SAHPRA received an application from Pfizer on November 17, asking to amend the dosing schedule to allow an optional third (booster) dose.

Semete-Makokotlela said following evaluation of the data submitted, SAHPRA approved the following:

• A third dose of the Comirnaty Covid-19 vaccine in individuals aged 18 years and older, to be administered at least six 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 [mix-and-match approach] and invites the submission of supportive data in this regard,” said Semete-Makokotlela.

On Wednesday, Pfizer said that preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech Covid-19 vaccine ‘neutralise the Omicron variant’.

Also read: KZN premier pleads with citizens to get vaccinated

Omicron

The World Health Organisation (WHO) said on Wednesday that the Omicron variant has now been reported in 57 countries and the number is expected to continue growing. However, it said there are signs of hope, as preliminary data indicates that hospitalisations across South Africa remain low.

Data which looked at hospitalisations across South Africa between November 14 and December 4 found that ICU occupancy was only 6.3%. “With Omicron now present in nearly 60 countries globally, travel bans that mainly target African countries are hard to justify,” said Dr Matshidiso Moeti, WHO regional director for Africa.

“Through the diligent surveillance efforts of African scientists, the new variant of concern was first detected on this continent, but it’s unclear if transmission was taking place silently in other regions. We call for science-based public health measures to counter the spread of Covid-19.

“The travel restrictions come at the height of the end-of-year tourist season, ravaging Africa’s economies, with a knock-on impact that is potentially devastating to the health of Africans.”

Also read: #KeepTheFactsGoing Episode 17: Vaccine hesitancy

Latest statistics

As of December 9, the National Institute for Communicable Diseases reported there were 22 391 new Covid-19 cases identified in South Africa, which brings the total number of positive cases to 3 093 452.

With a further 22 Covid-19 related deaths recorded, the total number of deaths was at 90 060.

As of today the cumulative number of #COVID19 cases identified in SA is 3 093 452 with 22 391 new cases reported. Today 22 deaths have been reported bringing the total to 90 060 deaths. The cumulative number of recoveries now stand at 2 870 329 with a recovery rate of 92,8% pic.twitter.com/07iElZZHRZ

— National Department of Health (@HealthZA) December 9, 2021

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