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Covid-19: Sahpra registers J&J vaccine with conditions

Covid-19: Sahpra registers J&J vaccine with conditions
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Regulatory authority grants approval for Pfizer vaccine

The South African Health Products Regulatory Authority (Sahpra) has approved the Covid-19 vaccine developed by Pfizer and BioNTech for use in South Africa. The approval is dependent on the guarantee of more safety and efficacy surveillance of the vaccine in South Africa. This will include how it fares against the variant 501Y.V2. Pfizer and BioNTech applied for their vaccine to be approved through Section 21 of the Medicines and Related Substance Act, Act 101 of 1965. This allows for unregistered products to be sold in South Africa. The person who sells the medicine has to provide regular safety updates and progress reports on the use of the medicine to Sahpra.

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