Niti Aayog Member (Health) and Chair of the National Expert Group on Vaccine Administration (NEGVAC) Dr VK Paul on Thursday said Serum Institute of India (SII) intends to begin clinical trial of the Novavax vaccine on children and Bharat Biotech has received permission for pediatric trial.
“Covaxin has received permission, they will start pediatric trial, I think they’re going all the way to 2 years of age in a systematic way. I’ve been told SII wants to begin pediatric trial of Novavax,” he told ANI.
The statement came after Paul in a statement on ‘myths’ regarding the national vaccination programme said trials on children will begin soon in India.
“As of now, no country in the world is giving vaccines to children,” he said adding that the World Health Organisation has no recommendation on vaccinating children. “There have been studies about safety of vaccines in children, which have been encouraging. Trials in children in India are also going to begin soon,” he said.
However, Paul noted that vaccinating children should not be decided on the basis of panic in Whatsapp groups and because some politicians want to play politics. “It has to be a decision taken by our scientists after adequate data is available based on trials,” he pointed out.
Earlier this month, US biotech firm Novavax said it had started clinical trials of its proposed Covid-19 vaccine on children, in a program that will involve up to 3,000 adolescents aged 12-17. Novavax said the trials would test “the efficacy (and) safety” of the vaccine, with participants receiving either the vaccine candidate or placebo in two doses, 21 days apart. Participants will be monitored for up to two years after their injections.
The Novavax vaccine has not yet been authorized in any country, including for adults, but the company plans to file for emergency authorization in Britain “in the second quarter of 2021”, followed by in the United States.
SII CEO, Adar Poonawalla had announced that the company’s plans to launch its Novavax version, named Covovax, in India by September 2021. However, according to an Economic Times report, Novavax said that its worldwide launch of the COVID-19 shot will get pushed beyond Q3 2021 (July to September). SII CEO, Adar Poonawalla had announced that the company’s plans to launch Covovax in India by September 2021.
Poonawalla had complained that the manufacturing of the Novavax vaccine was getting delayed in India due to a shortage of raw materials caused by the US export ban. However the situation was sorted out after the United States lifted its export ban on raw materials last month.