Abstract
The world seemed to sigh in relief in early November 2020, when it was announced that the Covid-19 vaccine developed by Pfizer and BioNTech showed itself to be 90 per cent effective in early data analysis. This announcement was followed by one from Moderna Inc that its vaccine in development was showing to be almost 95 per cent effective. Soon after, numerous other companies announced the efficacy of their respective vaccines and roll-out plans and policies were made and even implemented.However, this sigh of relief was perhaps premature. Although these announcements were good news on the face of it, they also brought to light some concerns. The fast pace at which the vaccines were developed and made available for human use raises various ethical and legal issues as well as questions related to the safety and efficacy thereof. The correct dosage and timing of vaccination is still not fixed, vaccine expiration periods and the discovery of new variants of the Covid-19 virus has further added to these concerns. In addition, uncertainty exists regarding the approval process that should be followed for these vaccines. This last concern forms the focus of this note.
Highlights
The world seemed to sigh in relief in early November 2020, when it was announced that the Covid-19 vaccine developed by Pfizer and BioNTech showed itself to be 90 per cent effective in early data analysis
South African Health Products Regulatory Authority (SAHPRA) is a National Department of Health entity, which assumes the roles of the Medicines Control Council (MCC) and the Directorate of Radiation Control (DRC)
research ethics committees (RECs) are responsible for ensuring that ethical norms and standards are met, and for the safeguarding of the rights of the human participants and ensuring that a clinical trial is scientifically relevant in South Africa
Summary
The world seemed to sigh in relief in early November 2020, when it was announced that the Covid-19 vaccine developed by Pfizer and BioNTech showed itself to be 90 per cent effective in early data analysis. In early February 2021, Minister of Health Dr Zweli Mkhize announced that South Africa would halt the roll-out of the Oxford/AstraZeneca vaccine, which had arrived in the country only a week before This was due to the publication by the lead investigator in the trial describing the results as “disappointing” as shown against the South African N501Y variant of the virus. As variants of the virus become more prevalent, scientists are being pushed to develop vaccines targeting multiple versions of the relevant pathogens; as a result, Pfizer, Moderna, Johnson & Johnson and AstraZeneca have started development on booster shots to accompany their vaccines (BusinessTech http://www.businesstech.co.za/news/ government/467932/expiring-vaccines-doomed-south-africas-rollout-plansfrom-the-start-report/). We might still need to hold our breath, behind a mask, a little longer, the author feels somewhat assured knowing that South Africa has a well-established procedure for the approval of new medications, it is not exactly swift.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
