The evaluation of the CoronaVac COVID-19 vaccine, produced by Chinese pharmaceutical company Sinovac Biotech, is at “very advanced stages”.
This is according to the South African Health Products Regulatory Authority (SAHPRA), as the country races against the clock to get more lifesaving COVID-19 jabs.
“Furthermore, reports recently made available by the World Health Organisation (WHO) that articulate the basis for the Emergency Use Listing is being considered,” said SAHRPA on Monday.
Last month, the WHO approved China’s Sinovac COVID-19 vaccine for emergency use and recommended the use on people with comorbidities such as obesity, cardiovascular disease, and respiratory disease.
According to the WHO, a trial in Brazil showed that two doses, administered at an interval of 14 days, had an efficacy of 51% against symptomatic SARS-CoV-2 infection, 100% against severe COVID-19, and 100% against hospitalisation starting 14 days after receiving the second dose.
Meanwhile, Russia’s Sputnik V application is a rolling review, “thus as data becomes available to the applicant it is submitted to SAHPRA”.
SAHPRA is an independent health products regulatory authority focusing on quality, safety, and efficacy.
“These core elements of its mandate also apply to COVID-19 vaccines as well.”
The drug watchdog said clinical trial data for safety and efficacy from phase one to three should be provided together with manufacturing information of the product quality.
“The assessment is then conducted considering all information provided.”
However, to respond to the pandemic, SAHPRA introduced another mechanism to facilitate the review of COVID-19 applications, which is the rolling review process.
“The rolling review is a mechanism that facilitates the submission of data as it becomes available. Whilst reviews can commence earlier with a rolling submission, it is important to note that some very important efficacy, quality, and safety information is sometimes outstanding and would require review for consideration of such products for public use.”
Therefore, SAHPRA said pharmaceutical companies could submit applications indicating a plan of when they will be submitting their data, that is, outline when the next rolling submission sequence is available for review.
“When an applicant submits their respective dossiers, SAHPRA works closely with the applicant in evaluating the data.”
The team of technical, subject matter experts within SAHPRA and external members, appointed by the Chief Executive Officer (CEO), evaluate these applications.
“SAHPRA also works closely with other regulators across the world as well as with the WHO in assessing the quality, safety and efficacy of health products, and in this case, COVID-19 vaccines.”
Meanwhile, the watchdog said it cannot approve any product if an application has not been submitted to the authority.
Sinopharm and Moderna vaccines
“Thus, there is no SAHPRA decision on Sinopharm and Moderna vaccines, which have a WHO Emergency Use Listing, as there have not been any applications for these vaccines in South Africa.”
So far, SAHPRA has approved the Pfizer and the Johnson & Johnson vaccines.
Meanwhile, the regulator said it has to take into account the prevalence of variants of concern such as the Beta variant in South Africa.
“This requires that SAHPRA ensures efficacy against such variants and hence information on studies supporting efficacy would be expected to be provided by the applicant.”
SAHPRA’s CEO, Dr Boitumelo Semete-Makokotlela, reiterated the commitment to prioritise all COVID-19- related health products, including vaccines, as the world and South Africa grapple with ending the scourge of a pandemic of “mammoth” proportions.
“SAHPRA will not be pressured to allow the public access to any product that has not met the necessary regulatory requirements,” she added.–SAnews