Serum Institute of India (SII) is likely to begin clinical trials of Novavax’s Covid-19 vaccine candidate on children in July, sources at the Pune-based vaccine manufacturer said.
The recombinant nanoparticle protein-based vaccine — NVX-CoV2373 — developed by the American biotechnology firm has been branded Covovax in India. SII, which is partnering with Novavax, expects to launch Covovax in India by September.
Earlier this week, Novavax announced excellent results from its PREVENT-19 phase 3 trials at 119 sites in the United States and Mexico, reporting an overall efficacy of 90.4 per cent — on a par with Pfizer-BioNTech’s and Moderna’s mRNA shots, and better than both Oxford-AstraZeneca (Covishield) and Johnson & Johnson’s one-dose vaccine.
A day after Novavax announced its trial data, Dr V K Paul, head of India’s Covid-19 Task Force, had urged SII to begin clinical trials in the paediatric population without delay, given the impressive safety profile demonstrated by the vaccine candidate.
“There is an important, interesting, and positive development with regard to the Novavax results which are very promising. What we are learning from the data that is available is that this vaccine is highly effective,” Dr Paul said on Tuesday.
“But what makes this vaccine relevant for today, is the fact that this vaccine will be produced in India. The preparatory work is already accomplished by Serum Institute… In fact, the bridging trial is an advanced stage of completion…and I am also hoping that they would start, in good time, trials in children; now because we have the safety data, it is time, without delay, for us now to start bridging trials in the paediatric population, which as you know is of special interest for us,” he said.
As and when SII is allowed by the Indian drug regulator to conduct clinical trials on children, Covovax will become the third vaccine candidate to be tested in the country’s paediatric population.
Bharat Biotech is conducting phase 2-3 trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy volunteers between the ages of 2 and 18 years at six sites in the country; Zydus Cadila’s ZyCov-D Covid-19 vaccine candidate is being tested in volunteers above the age of 12 years.
The Covovax trials are important because of two reasons.
One, the government expects approximately 20 crore doses of the vaccine to be made available between August and December for the country’s immunisation programme. Covovax can be stored at temperatures between 2° and 8° Celsius and is, therefore, suitable for India’s cold chain requirements.
Two, the Novavax vaccine, uses a tried and tested recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. Similar technology has been used to develop vaccines for Human papillomavirus (HPV), hepatitis, and influenza.
The US has cleared Pfizer’s vaccine for young people of ages 12 years and older. Dr Paul had said earlier this month that the decision on vaccinating children in India was being “continuously examined”. He had emphasised that once the vaccination of children was allowed, all of them above the specified age would be covered at the same time.
Asked whether the government was considering procuring Pfizer’s vaccine, Dr Paul had said India would require 25-26 crore doses to vaccinate all its children.
“On the issue of which vaccine to be used for children, please remember that the child cohort is not a small cohort. My rough analysis is that if it is between 12 and 18 years, it itself is around 13-14 crore. This means we need 25-26 crore doses. We cannot have some children getting and others not getting it,” he had said.