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South Africa

SA's first application for #Covid19 vaccine

───   15:45 Tue, 15 Dec 2020

SA's first application for #Covid19 vaccine  | News Article
Image: Jacaranda/iStock

The South African Health Products Regulatory Authority (Sahpra) has confirmed that pharmaceutical giant Johnson & Johnson has become the first company to apply for a Covid-19 vaccine registration in South Africa.


The National Press Club on Monday hosted the body that approves and regulates medical products for an online update on Covid-19 vaccine registration.

SAHPRA CEO Boitumelo Semete-Makokotlela says an application was received on Thursday.

“As of today, we have received one application this was received on Thursday evening from J&J and we have started the review process.

“Every application will be reviewed based on its scientific merit so we will look at it as a case-by-case basis, but also what we have done to ensure that we enable is that we have engaged with pharmaceutical companies, we’ve had pre-submissions discussions with them where we advised them on what is the data that we will require as the regulator.

“So, we really hope that this process that we have outlined and published on our website gives the industry sufficient information in terms of what is expected.”

She encouraged the public to report any side effects as it is Sahpra’s mandate to monitor adverse effects and ensure that they are recorded and managed properly.

“Our intention is to ensure that any product that is used is a safe product so we encourage the public to report.”

Meanwhile, Sahpra board chairperson Professor Helen Rees says a vaccine will be rolled out on priority basis.

“We are going to get a vaccine coming to us in small quantities to begin with, but we are going to see a lot of more results coming from clinical trials but we are going to have limited quantities, we are going to then think of who does this vaccine work for and to whom is going to be targeted and MAC (ministerial advisory committee) is looking into that as well.”

Jacaranda

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