SA children to join Sinovac vaccine trial
International study will also include Chile, Philippines, Malaysia and Kenya
Scientists are poised to launch a phase 3 paediatric clinical trial of Chinese manufacturer Sinovac Biotech’s coronavirus vaccine in SA, as part of an international study that aims to evaluate the efficacy of two doses of the Coronavac shot. The research is an important step towards obtaining approval for paediatric use of the vaccine.
Scientists are poised to launch a phase 3 paediatric clinical trial of Chinese manufacturer Sinovac Biotech’s coronavirus vaccine in SA, as part of an international study that aims to evaluate the efficacy of two doses of the Coronavac shot. The research is an important step towards obtaining regulatory approval for paediatric use of the vaccine.
The SA Health Products Regulatory Authority has so far only granted Coronavac emergencyuse authorisation for adults aged between 18 and 59 years.
The jab is, however, authorised in China for children as young as three years.
“China has, to date, administered about 60-million doses to 40-million children, and has found it to be very safe,” said the trial’s principal co-ordinator for SA Sanet Aspinall, chief virologist at Sinovac’s local representative Numolox.
Sinovac’s vaccine uses inactivated Sars-CoV-2 to prompt
the body’s immune system to make antibodies to the virus, an approach that is used in several childhood vaccines, including polio and hepatitis A.
The study aims to enrol 14,000 children aged between six months and 17 years in SA, Chile, Philippines, Malaysia and Kenya. The SA arm of the trial will include 2,000 children at seven different sites, with the first participant due to be vaccinated on Friday at the MeCRU Clinical Research Unit at the Sefako Makgatho Health Sciences University.
Trial participants will receive two doses of Coronavac or a placebo, 28 days apart.
The trial aims to assess Coronavac’s safety and efficacy at preventing symptomatic Covid-19 cases, hospitalisation and severe disease. It will also measure vaccine recipients’ immune response to the jab, and the extent to which their antibody levels wane over time, said Aspinall. An interim analysis will be conducted once 47 Covid-19 cases occur among trial participants, who will be followed for a year to monitor possible longterm side effects.
Only HIV-negative children have been recruited for the trial, but a smaller study may be undertaken at a later stage among HIV-positive children, she said.
“Evaluating this vaccine in children is very exciting. It is a good move because the more you protect adults, the more we will see infections in unvaccinated children. Even though children are mostly left unscathed by Covid-19, they are susceptible to post-inflammatory illnesses, which can be debilitating,” said Medical Research Council president Glenda Gray, who is not directly involved in the trial.
“At this stage, SA has its work cut out to make sure everyone over 18 years is vaccinated. But hopefully SA will move to vaccinating children over 12 next year,” she said.
A growing number of countries are offering coronavirus vaccines to children. Earlier this week, Cuba began immunising toddlers as young as two years old with its locally developed vaccines Soberana and Abdala, while Chilean regulators approved Sinovac’s shot for children as young as six years.
The US recently began offering Covid-19 jabs to children aged 12 years and above, following in the footsteps of Israel, Singapore, Hungary, France and Denmark, which began inoculating children from the age of 12 years several months ago.