The South African Health Products Authority (SAHPRA) has approved the administering of the third dose of the Pfizer COVID-19 vaccine for adults and children with a weak immune system.
This means all adults in South Africa are now eligible for an additional shot six months after the second dose and it may be given at any point after that time.
This comes after SAHPRA received an application for the Pfizer booster shot on 17 November 2021 after it was initially approved for use in March this year.
“Following evaluation of the data submitted, SAHPRA has approved 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,” the drug watchdog said on Wednesday.
In addition, the regulator has given the green light for the third dose to be given to children from the age of 12 who are “severely immunocompromised” after 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.”
Meanwhile, SAHPRA said it was aware of the keen interest in the efficacy and safety of heterologous boosting regimens also known as “mix-and-match” approaches and has since invited submission of supportive data in this regard.
On Wednesday, Pfizer released data that a third dose will protect against severe disease caused by the Omicron strain.
According to the World Health Organisation (WHO), booster doses are administered to a vaccinated population that has completed a primary vaccination series, currently one or two doses of COVID-19 vaccines, depending on the product.
This is done when immunity or clinical protection has fallen below a rate deemed sufficient to restore vaccine effectiveness, the organisation explained.
In October, SAHPRA and Johnson & Johnson (J&J) approved vaccine booster doses for all healthcare workers who received the first shot as part of the Sisonke Study.
According to the Department of Health’s latest data, 202 721 J&J booster shots have been administered to healthcare workers since the rollout started last month.
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