Pfizer Covid-19 vaccine in final stages of full approval in SA
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The Pfizer Covid-19 vaccine has reached the final stages of full approval in the country according to the South African Health Products Regulatory Authority (Sahpra).
Earlier this week, the US Food and Drug Administration (FDA) granted full approval of Pfizer-BioNTech's vaccine, making it the first coronavirus vaccine to move beyond emergency-use status.
Sahpra spokesperson Yuven Gounden, said the health regulator was aware of the FDA’s full approval and that rolling reviews were continuing.
“Sahpra will use reliance on work done by other regulatory authorities it aligns with such as USFDA, provided their reports are shared with Sahpra. The Pfizer rolling review has already reached final stages and is awaiting input from Pfizer which will determine the outcome of registration in South Africa,” he told IOL News.
In the US, the Johnson & Johnson, Pfizer, and Moderna were distributed under emergency use authorizations, but now the FDA has approved use of the Pfizer vaccine for people 16 years and older.
The Pfizer vaccine has been available in the US under emergency use since December 2020.
In South Africa, Sahpra approved Pfizer’s Section 21 application (for exemption in terms of the Medicines and Related Substances Control Act) in March, and began administering the vaccines in May.
Chairman and chief executive officer at Pfizer, Albert Bourla, said the decision by the FDA affirms the efficacy and safety profile of the vaccine.
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the US since December 2020, and we look forward to continuing to work with the US government to reach more Americans now that we have FDA approval,” he said.