MANY Covid-19 vaccines are now distributed globally, and countries have their ways of authorising medicine.
Here’s what the process looks like in Mzansi.
Any medicine or health product must first be approved by the South African Health Products Regulatory Authority. The independent entity reports to the Department of Health. It monitors, evaluates, inspects and registers health products.
In November 2020, the regulator released a document detailing the process that manufacturers would have to undergo to get a vaccine registered in the country.
It declared that the document intended to offer guidance to applicants wishing to submit the application for registration of Covid-19 vaccines was a “living document” that would be updated regularly.
In response to the Covid-19 crisis, it decided that all vaccine applications would undergo a prioritised or expedited review that would be done without compromising the quality or standard of the reviews.
The pre-submission meeting:
Before any submission is made, applicants schedule a pre-submission meeting with the regulator, where guidance related to the application concerned will be offered.
At the meeting, the applicant will then make a presentation detailing information about the health product in question, technology used, data available, specific transport and/or storage and labelling information.
Applicants must also share information on whether the vaccine has been or intends to be submitted to the World Health Organisation or any other regulators for approval, and the time frame for those submissions.
Recently, the regulator held a pre-submission meeting with the Gamaleya Institute from Russia – the developers of the Sputnik V vaccine. The regulator described it as a “work in progress” in a press statement.
The rolling review:
The reguator allows manufacturers to file submissions for a rolling review to speed up the process for candidate Covid-19 vaccines.
This allows it to review the information submitted from early development while later-stage clinical trials are taking place.
Applicants must have a certain level of evidence on the safety, quality and efficacy of their vaccine before filing for a rolling review.
For example, the Johnson & Johnson vaccine, which is being administered to healthcare workers across the country and is part of an implementation study, is currently undergoing the rolling review.
According to the information and guidance on application for registration of candidate Covid-19 vaccine document, submissions of information on the efficacy (a vaccine must at least meets the 50% target threshold) and safety evidence of clinical or no-clinical phase 2 trials must be made.
The applicant is also expected to submit proof that phase 3 trials have started and that there are enough participants enrolled in the trials (a clinical trial has at least 3 000 subjects) to provide evidence of safety and efficacy within a specified period of time.
Since Covid-19 vaccines are a top priority, the regulator will, on a risk-based analysis, grant a vaccine authorisation on the basis that outstanding information be submitted within a specified period of time.
The quality, efficacy and safety of the vaccine will inform the regulator on whether the data warrants a conditional registration.
Covid-19 conversations is brought to you by the African Alliance in partnership with the South African Medical Research Council, the Department of Science and
Innovation and Vaccine Advocacy Resource Group. Questions? firstname.lastname@example.org. Twitter @Afri_Alliance