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Not enough data available to ascertain COVID-19 vaccine safety for infants: NISEC

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Chairperson of the National Immunisation Safety Expert Committee (NISEC) Professor Hannelie Meyer says while vaccines have in the past proven effective in preventing diseases in babies, there is not enough data available to ascertain if the COVID-19 vaccine is safe for infants and children.

South Africa is currently participating in a global paediatric trial to test Chinese company Sinovac Biotech’s two-dose Coronavac vaccine. The phase 3 study will evaluate the efficacy, safety and immune response of CoronaVac in children between the ages of six months and 17 years.

Chile, Philippines, Malaysia and Kenya are other participants in the study.

Meyer says until more research is released, it is advisable for parents to vaccinate and limit transmission to their children.

“If we look in general at the safety and efficacy of vaccines in young children, there is ample evidence over many, many years that vaccines are safe and effective in children and babies. It’s saving millions of lives each and every year. When it comes to the COVID-19 vaccine, we don’t have enough safety data for babies.”

Sinovac trial

Two thousand South African children between the ages of six months and 17 years have been enrolled in the trial which involves 14 000 children in five countries.

Participants will receive two doses of the Sinovac vaccine.

The Health Department’s Acting Director-General, Nicholas Crisp, says they followed a strict selection process.

He says, “Usually in all trials, they would need to be healthy, no other contraindications and they go through very small numbers and then a slightly larger number for a second phase and then a larger number before they go for a full trial in the community. These are normal international protocols that are followed and they are very strictly regulated, especially by our regulator.”

Procuring of Sinovac

In July, the South African Health Products Regulatory Authority (SAHPRA) outlined the processes to be taken by government and health authorities in procuring Sinovac’s COVID-19 vaccine.

SAHPRA authorised Sinovac’s CoronaVac vaccine for use with conditions under Section 21.

The double-dose shot, developed by a Chinese pharmaceutical group, is approved for people between the ages of 18 to 59.

SA’s vaccine drive progress

Although South Africa has made significant progress in its COVID-19 vaccine drive, many unvaccinated people remain vulnerable to infection.

Part 1: Rehad Desai, Spokesperson for the People’s Vaccine Campaign shares more:

Part 2:

Scientific research has shown that vaccines are currently the most potent weapon we have to fight this pandemic, yet vaccine hesitancy and misinformation continue to hinder the public health work being done.

The National Institute for Communicable Diseases has recorded a total of 3 699 new COVID-19 cases in the past 24 hours, with a further 300 COVID-19 related deaths being reported, bringing total fatalities to 85 302 to date.

Latest COVID-19 stats:

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