Sinovac starts tests for children’s vaccine

BEIJING, CHINA - SEPTEMBER 24: Syringes and boxes of the potential COVID-19 vaccine CoronaVac are seen on a table at Sinovac Biotech where the company is producing their potential COVID-19 vaccine CoronaVac on September 24, 2020 during a media tour in Beijing, China. Sinovac’s inactivated vaccine candidate, called CoronaVac, is among a number of companies in the global race to control the coronavirus pandemic. The company is running Phase 3 human trials in four countries and ramping up production to 300 million doses per year at a new manufacturing facility south of Beijing. A lack of domestic coronavirus cases in China has meant that companies developing vaccines have shifted their focus overseas to conduct trials to gather the volume of data necessary to win regulatory approvals. When China’s government launched an ‘emergency use’ program in July to vaccinate groups of essential workers, Sinovac’s chief executive says the company supplied tens of thousands of doses, even as trials are still underway. About 90% of Sinovac’s employees have chosen to receive injections of CoronaVac, which is one of eight Chinese vaccine candidates in human trials. The company is also seeking approval to begin clinical trials with teenagers and children as young as age 3.(Photo by Kevin Frayer/Getty Images)

JOHANNESBURG. — In a first for South Africa, Sinovac will start phase three clinical trials of a Covid-19 vaccine for children from today.

Currently, the country has no Covid-19 vaccine approved for children.

According to Numolux, which has the approval to distribute Sinovac in South Africa, the trials will be conducted on 2 000 children aged six months to 17 years. They will be conducted at seven research sites across the country.

The trials will enrol 14 000 children from South Africa, Chile, the Philippines, Malaysia and Kenya.

In a statement on Thursday, Numolux said the study would evaluate the efficacy of two doses of the vaccine against confirmed symptomatic Covid-19 cases in children and adolescents. Efficacy will also be evaluated against hospitalisation and severe Covid-19 cases. They would also investigate the efficacy of the vaccine against hospitalisation.

Participants in the trial will receive two doses of vaccine or placebo 28 days apart. Efficacy assessments to include the surveillance for Covid-19 like symptoms and the laboratory confirmation of infection. An interim analysis will be done when 47 Covid-19 cases have been reported.

A recent paper published in journal The Lancet found that two doses of the vaccine were safe and had generally good reactions in children and teenagers aged three to 17 years old. — News24.com