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Inactivated CoronaVac vaccine receives full registration by SAHPRA and brings Covid vaccine choice to South Africans

A health worker shows a vial of the Sinovac's CoronaVac coronavirus disease (Covid-19) vaccine. Picture: Rodolfo Buhrer/Reuters

A health worker shows a vial of the Sinovac's CoronaVac coronavirus disease (Covid-19) vaccine. Picture: Rodolfo Buhrer/Reuters

Published Jun 27, 2022

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The CoronaVac Covid-19 vaccine has been approved for use access by the South African Health Products Regulatory Authority (Sahpra).

The inactivated vaccine – which has already been administered to more than 2.8 billion people worldwide – was approved for use in the age group 18-59.

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Manufactured by the biopharmaceutical company based in China, Sinovac Biotech, it will be distributed by their in-country South African partner, the Numolux Group.

In early July 2021, Sahpra authorised emergency use access of the vaccine with conditions.

COO of the Numolux Group, Anton Arendse, says the full registration of CoronaVac is a victory for vaccine choice in South Africa.

Vaccines currently available in the country include Pfizer’s mRNA vaccine, Johnson and Johnson’s viral vector vaccine, and CoronaVac’s inactivated vaccine.

CoronaVac works by stimulating the body’s immune system without the risk of causing disease. Once the vaccine enters the body, the production of antibodies is stimulated, which makes the body ready to respond to a Covid-19 infection.

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Inactivated viral vaccines have been successfully used in immunisation programmes for decades and many childhood vaccines administered to South Africans, have been based on this technology.

It is for this reason that Arendse says many people would prefer the protection offered by CoronaVac, which uses a more classical vaccine technology.

“We simply do not know what Covid-19 variants may come to the fore in the future, and firmly believe that South Africans should have a choice of the type of vaccine they are injected with, as protection against severe illness, hospitalisation and death,” he said.

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Based on the clinical trial evidence submitted by Sinovac Biotech, most of the side effects following administration were mild or moderate, and cleared within a couple of days.

The frequently-reported adverse reactions included pain at the injection site, headache, fatigue, muscle pain, diarrhoea and nausea.

Deputy Responsible Pharmacist at Numolux Curanto Pharma, Wilma Cerff, says she is satisfied that CoronaVac has undergone the requisite Sahpra evaluation and assessments to meet the regulatory requirements, before being made available to the public.

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“Coronavac has gone through the same rigorous evaluation processes (as other products and vaccines) from submission to emergency use approval and finally full registration,” she said.

The National Department of Health is the sole purchaser of vaccines for distribution to provincial governments and the private sector.

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