Regulator to start reviewing Covid-19 vaccine applications
It was previously announced that there were four candidate vaccines that had been trialled by South Africa, which were produced by AstraZeneca, Novavax, Johnson & Johnson and Pfizer-BioNTech.
Picture: Graeme Robertson/various sources/AFP
The South African Health Products Regulatory Authority (SAHPRA) has announced that it will commence a review of the Covid-19 vaccine applications for registration amid a second wave of virus infections in the country.
This is after President Cyril Ramaphosa revealed that South Africa had concluded all necessary processes to ensure participation in the World Health Organisation’s (WHO’s) Covax programme, which will ensures equitable access to vaccines for all developing countries.
South Africa is expected to receive its initial order of vaccines early next year, and this will be enough to cover 10% of the population.
SAHPRA confirmed it would prioritise Covid-19 applications and will apply an expedited approach to health products, including vaccines.
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For vaccines registration, the expedited process will include using approaches such as:
- Performing rolling reviews of submissions, that is reviewing data that is available and accepting ongoing data in batches for review
- Reliance on regulatory work done by other regulators that SAHPRA aligns with
- A collaborative approach through the WHO
The regulator further said it may issue terms and conditions requiring the applicant to provide additional data, thus, confirming the elements of safety, quality and efficacy.
“SAHPRA will review the safety and efficacy of each vaccine on a case-by-case basis and will only grant approval for public use once it has met acceptable standards of quality, safety and efficacy,” SAHPRA chief executive officer (CEO), Boitumelo Semete-Makokotlela said in a statement.
Meanwhile, Semete-Makokotlela noted that Covid-19 vaccine could potentially also have adverse effects in some individuals and urged the public to immediately alert their doctors if they experienced any adverse effects once the vaccine was rolled out.
It was previously announced that there were four candidate vaccines that had been trialled by South Africa, which were produced by AstraZeneca, Novavax, Johnson & Johnson and Pfizer-BioNTech.
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