Sinovac launched Covid-19 clinical trials for children aged from 6-months to 17 years old on Friday.Two South African teenagers aged 17 were the first to receive their doses.Participants will receive two doses of the vaccines, or a placebo, 28 days apart.The first South African children who are part of Sinovac Covid-19 vaccine trials received their first jabs at the Sefako Makgatho University in GaRankuwa on Friday.
A 17-year-old boy and girl were the first to receive their dose. Their identities are being kept secret to protect their privacy.
Sinovac, through Numolox, which has the local licence for the vaccine, is conducting the first paediatric phase three Covid-19 trials in the country.
Sinovac’s medical director for clinical research, Gang Zeng, said the vaccine has already been administered to about 40 million children aged between three and 17 in China.
READ | Covid-19 vaccine: Sinovac to start South African trials on children
The South African Medical Research Council’s (SAMRC) Professor Glenda Gray said this was the first step in getting a Covid-19 vaccine for children.
The trials will enrol 14 000 children in five countries to investigate the efficacy of the Covid-19 vaccine. Locally, 2 000 children will be enrolled in seven sites.
These are the first steps of getting a vaccine for children in South Africa.
Dr Sanet Aspinall, principal coordinator for the trials, said:
Sinovac is a safe vaccine. It has been tested and there’s been no safety issues for the vulnerable population.
The trials will be conducted at sites in Brits in the North West, Germiston, Newtown, Sandton and Sefako Makgatho University in Gauteng, as well as in Bellville and Paarl in the Western Cape.
Aspinall said as they were working with a vulnerable group, they would be giving the SA Health Products Regulatory Authority (Sahpra) safety data every two weeks.
The team is also starting the trials with the 12 to 17 age group, before moving to younger children.
Participants will receive two doses of the vaccines or a placebo 28 days apart. Efficacy assessments will include surveillance for Covid-19-like symptoms and laboratory confirmation of infections. An interim analysis will be done when 47 cases of the virus are reported.
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