Cape Town - CoronaVac has been registered with the South African Health Regulatory Authority (SAHPRA).
The Covid-19 vaccine is manufactured by Sinovac Biotech in China and is distributed by the country’s South African partner, the Numolux Group.
The announcement was made earlier this month.
But many may ask what CoronaVac is.
In a statement sent to Weekend Argus, Numolux and Sinovac explained it was an inactivated vaccine against Covid-19 which helps to stimulate the immune system without the risk of disease.
They explained: “CoronaVac is an inactivated vaccine against Covid-19, which stimulates the body’s immune system without the risk of causing disease.
“Once the inactivated vaccine gets presented to the body’s immune system, the production of antibodies is stimulated, which makes the body ready to respond to an infection with live SARS-CoV-2.
“Inactivated viral vaccines, such as these, have been successfully used in immunisation programmes for decades. Since they do not contain replicating viruses, they are often a preferred product class for special populations and public members.
“Over the years, many childhood vaccines administered to South Africans have been based on this inactivated vaccine technology.”
Deputy responsible pharmacist at Numolux Curanto Pharma, Wilma Cerff, said she was satisfied that CoronaVac had undergone the requisite SAHPRA evaluation and assessments to meet the regulatory requirements before being made available to the public.
“CoronaVac has gone through the same rigorous evaluation processes (as other products and vaccines) from submission to emergency use approval and finally full registration.”
COO of the Numolux Group, Anton Arendse, agreed that the full registration of CoronaVac was a victory for Covid-19 vaccine choice in South Africa and that millions had already used the vaccine across the world. “There has always been a narrative that there are two thought streams in South Africa, as far as Covid is concerned.
“Those who are pro-vax and those who are anti-vax.
“There is, however, another group of South Africans, those who want to be vaccinated against Covid-19, but who prefer an inactivated vaccine which uses the more classical, inactivated technology of vaccines known to them – as opposed to a vaccine using the mRNA (messenger RNA) technology.
Since CoronaVac received emergency use approval last year, we have received an influx of requests from those who want access to the inactivated Covid-19 vaccine.
“The National Department of Health (NDOH) is the sole purchaser of vaccines for distribution to provincial governments and the private sector.
“We are hopeful that CoronaVac can now be procured for those who prefer the inactivated virus vaccine. CoronaVac has already been administered to over 2.8 billion people worldwide (nearly a third of the global population).
“We believe South Africans should have the access to this vaccine as soon as possible.”
They added in its collective bid to combat the Covid-19 pandemic, BRICS countries launched the BRICS Vaccines Research and Development Centre on 22 March. This initiative was driven by China and South Africa.
Various South African government departments, the Medical Research Council of South Africa and the Numolux Group (from the SA private sector) were part of the panel that presented at this inaugural event.
At the launch, South Africa’s Minister of Higher Education, Science and Innovation, Dr Blade Nzimande, reiterated South Africa’s support for initiatives like these, which deepen BRICS partnership, solidarity and friendship.
Further in their statement the company said world leaders had met at the 14th BRICS Leaders Summit.
“Last week, President Cyril Ramaphosa met with the leaders of China, Brazil, Russia and India at the 14th BRICS Leaders’ Summit.
“In his opening statement, the president said: ‘The BRICS response to the Covid-19 pandemic demonstrated what can be achieved when we work together in the spirit of friendship, solidarity and responsibility’.
“The launch of the BRICS Vaccine Research and Development Centre (in March this year) will strengthen international health and science co-operation to prepare for future crises.
“It is a cause for great concern that the rest of global community hasn’t sustained the principles of solidarity and co-operation when it comes to equitable access to vaccines.”
Arendse added their vaccine was ready for any new variant: “We simply do not know what Covid-19 variants may come to the fore in the future. (We) firmly believe that South Africans should have a choice of the type of Covid-19 vaccine they are injected with, as protection against severe illness, hospitalisation and death.”
They added that the registration of CoronaVac was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. The authorisation is based on acceptable safety, quality and efficacy data submitted and is subject to a number of conditions.
These include that the vaccine is supplied and administered in accordance with the NDoH Covid-19 vaccination plan and applicable guidelines.
They explained: “The side-effects of Corona Vac, as outlined in the clinical trial evidence submitted, were usually mild or moderate and cleared within a few days after vaccination. The most common side effects reported were pain at the injection site, headache, tiredness, muscle pain and nausea.”
Weekend Argus