Sahpra approves Sinopharm vaccine

The South African Health Products Regulatory Authority (Sahpra) has registered Covid-19 vaccine MC Pharma, known as Sinopharm, manufactured by the China National Pharmaceutical Group.

The regulatory body said Sinopharm was registered on 31 January, along with Pfizer’s Corminaty vaccine.

Sinopharm was authorised based on safety, quality and efficacy data submitted last year to Sahpra by the manufacturer.

“The authorisation is, however, subject to a number of conditions which includes that the vaccine is supplied and administered in accordance with the national Covid-19 vaccination programme.

“Further conditions relate to the reporting of the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates,” Sahpra said in a statement on Monday.

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Sahpra received Sinopharm documentation for evaluation in June last year.

At the time, only the Pfizer and J&J vaccines had been approved for inoculation.

In June last year, the Economic Freedom Fighters took to the streets demanding more vaccines for the population.

They marched to the Sahpra head office in Pretoria, demanding that Russian Sputnik V and Sinovac, another Chinese jab be registered and used by government in its vaccination program.

Sahpra approved Sinovac a month after the march.

For Sinopharm, clinical evidence submitted showed mild or moderate side effects which cleared within a few days of vaccination.

The most common were pain at the injection site, headache, tiredness, muscle pain and nausea, said Sahpra CEO Boitumelo Semete-Makokotlela.

“The registration of these vaccines is a vast stride in vaccine registration as Sahpra plays its role in the fight against Covid-19.

“Sahpra will continue to play its part in ensuring the quality, safety and efficacy of all health products, including all vaccines to ensure that the South African public is protected at all times.”

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