Aadd details and background
JOHANNESBURG, February 7 (Reuters) – South Africa’s health regulator said on Monday it had registered China’s COVID-19 vaccine Sinopharm, paving the way for its use in the country.
South Africa, which is Africa’s worst-hit country in terms of deaths and number of COVID-19 cases, has relied primarily on the Pfizer and J&J vaccine JNJ.N doses as a mainstay of inoculation as the country prepares for a potential fifth wave.
“This authorization is based on acceptable safety, quality and efficacy data submitted by MC Pharma,” the South African Health Products Regulatory Authority (SAHPRA) said in a statement.
MC Pharma is a Beijing-based company that manufactures the Sinopharm vaccine, the regulator said.
The two most used COVID-19 vaccines in China, developed by Sinovac SVA.O and Sinopharm, have been shown to be effective against the Delta variant of the coronavirus, a study based on real data in the country showed in February.
SAHPRA said its authorization for the vaccine, for use on people aged 18 and over, was based on data submitted by the company in the second half of last year.
However, the authorization was subject to several conditions, including that the vaccine supplied and administered in two injections be subject to periodic safety reviews.
The South African government has yet to formally announce an agreement to supply or purchase shipments from Sinopharm.
The country has fully vaccinated only around 28% of the total population of around 60 million.
(Reporting by Promit Mukherjee; Editing by Wendell Roelf and Muralikumar Anantharaman and Sherry Jacob-Phillips)
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