New Delhi: Sources at the Pune-based vaccine manufacturer, Serum Institute of India (SII), announced that SII is expected to start clinical trials of Novavax’s Covid-19 vaccine candidate on children in July. The recombinant nanoparticle protein-based vaccine, NVX-CoV2373, produced by the American biotechnology firm has been marked as Covovax in India. SII, which is partnering with Novavax, assumes to launch Covovax in India by September.
Novavax, earlier in the week, announced that excellent results from its PREVENT-19 phase 3 trials at 119 sites in the United States and Mexico, describing an overall efficacy of 90.4 percent — on par with Pfizer-BioNTech’s and Moderna’s mRNA shots, and better than both Oxford-AstraZeneca (Covishield) and Johnson & Johnson’s one-dose vaccine. Soon after Novavax had 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 pediatric population without delay, given the remarkable safety profile demonstrated by the vaccine candidate.
Dr. Paul said on Tuesday, ‘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. 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 pediatric population, which as you know is of special interest for us.’
SII, as and when, is approved by the Indian drug regulator to conduct clinical trials on children, Covovax will be the third vaccine candidate to have experimented in the country’s pediatric population.
Bharat Biotech is handling phase 2-3 trials to assess 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 experimented on volunteers above the age of 12 years.
There are two reasons to consider the Covovax trials as important. Firstly, the government assumes approximately 20 crore doses of the vaccine to be made available between August and December for the country’s immunization program. Covovax can be stored at temperatures between 2° and 8° Celsius and is, therefore, proper for India’s cold chain requirements. Secondly, the Novavax vaccine uses a tried and tested recombinant nanoparticle technology to produce antigens obtained from the coronavirus spike protein. Similar technology has been adopted to produce vaccines for Human papillomavirus (HPV), hepatitis, and influenza.
The US has made Pfizer’s vaccine for young people of ages 12 years and older. Dr. Paul had said earlier this month that the resolution on vaccinating children in India was being ‘continuously examined’. He had emphasized that once the vaccination of children was granted, all of them above the stipulated age would be covered at the same time.
When asked if the government is preparing to buy Pfizer’s vaccine, Dr.Paul had said that India would need 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.
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