The South African Health Products Authority (Sahpra) has approved a booster shot of the Pfizer Covid-19 vaccines for individuals over 18 years of age.
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 then received an application from Pfizer to amend the dosing schedule for the Comirnaty® Covid-19 vaccine, allowing an optional third (booster) dose, said Sahpra in a statement on Wednesday.
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 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 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.
Pfizer has already started working on a version of its Covid-19 vaccine specifically targeting the new Omicron variant in case the current inoculation is not effective against the latest strain, the US drugmaker‘s CEO Albert Bourla said last week.
Bourla told CNBC that his company began testing the current vaccine against the Omicron variant, which was first reported in South Africa and has reignited fears of a global wave of Covid-19 infections.
“I don’t think the result will be the vaccines don’t protect,” Bourla said.
But the testing could show that existing shots “protect less,” which would mean “that we need to create a new vaccine,” Bourla said.
“Friday we made our first DNA template, which is the first possible inflection of the development process of a new vaccine,” he said.
Additional reporting by AFP