Pfizer submitted an application to the South African Health Products Regulatory Authority (Sahpra) on 17 November 2021 for testing of the Covid-19 booster shot.
Pfizer booster shots
Sahpra said it would now “commence with the assessment of data for the safety and efficacy of the third vaccine dose”, also known as the Pfizer Comirnaty Booster shot.
Sahpra is committed to ensuring medicines meet all required standards to ensure safety, efficacy and quality, and CEO Boitumelo Semete-Makokotlela says the outcome of the assessment will be communicated in due course.
Initial data from the Phase 3 clinical trial – conducted with more than 10,000 participants – found that the third dose was safe and effective.
Why are booster shots needed?
The World Health Organization (WHO) said booster shots are needed when immunity or clinical protection has fallen below a rate deemed sufficient.
The aim of a booster shot is to restore vaccine effectiveness. WHO’s Dr Katherine O’Brien explains:
“Over time, the immunity that you received and achieved as a result of being vaccinated starts to wane, it starts to deteriorate or go down over time.”
She said there is “some evidence that there’s a small proportion of people don’t respond to the vaccine in the same way as a person without an immunocompromised condition”.
J&J third dose
Last month, 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.
This was after the FDA recommended a second dose of the J&J vaccine for all Americans 18 years and older who received a single dose.
Early this year, the South African Medical Research Council (SAMRC), working with the National Department of Health (NDoH), Desmond Tutu Health Foundation, CAPRISA, and the pharmaceutical company came together to provide early access to J&J.
Earlier this month, Sahpra pharmacovigilance manager, Mafora Matlala, discussed the issue of mitigating Covid-19 vaccine hesitancy in South Africa.
Matlala said the evidence is clear when one weighs the risk of being vaccinated to the risk of contracting the coronavirus:
Covid-19 is riskier; it’s safer to take the vaccine.
She said monitoring the safety of Covid-19 vaccines – and additional booster shot data – is a critical priority for Sahpra.
Additional reporting on J&J booster shots by SA News