India is likely to proceed with the rollout of Novavax soon with Serum Institute as manufacturing partner on the basis of strong interim data. Overall, the efficacy of the vaccine was 90.4 per cent — that is, it showed the ability to bring down symptomatic Covid-19 cases by more than 90 per cent compared with those who had not received a vaccine.
According to a report by Times of India, 20 crore Novavax shots (five crore a month) can be available during September-December and the number may rise.
Novavax, named Covavax in India, is in advanced stages of Phase 2/3 “observer-blinded, randomised, active-controlled” bridging trials with SII enrolling 1,600 participants over 18 years across 15 centres. SII has also indicated an interest in conducting trials in children.
It may well vaccine be possible that India becomes the first country for the launch of the vaccine.
Trials found it effective against the Alpha variant first found in Kent, though at a less efficacy of 86 per cent. It reported a much lower 49 per cent efficacy against the variant first found in South Africa. The shots were found to have milder after-effects.
The official said that the government is looking at an August-September timeline for the first lot of supplies of Covavax, if the regulatory processes advance smoothly.
Niti Aayog Member (Health) and Chair of the National Expert Group on Vaccine Administration (NEGVAC) Dr VK Paul last month 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.
“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 last 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.
SII CEO, Adar Poonawalla had announced 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).
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.