New Delhi: With the inclusion of Covovax in India’s Covid vaccination programme, children aged 12 years and above now have an additional vaccine option to choose from. Other Covid vaccines available for this age group are Covaxin and Corbevax.
Covovax, developed by US company Novavax and manufactured in India by the Serum Institute of India (SII), is a protein-based vaccine developed from the original SARS-CoV-2 strain. It achieves full efficacy against the virus after administration of two doses through the intramuscular route. This is the second vaccine from the SII stable, after Covishield, to be included in the national vaccination programme.
On Tuesday, SII lowered the price of the vaccine from the initial Rs 900 per dose, to Rs 225 plus GST and taxes.
However, like Sputnik V, which was never procured by the government, but has been available in private vaccination centres, Covovax, too, will only be available in private centres.
According to health officials, there are currently enough vaccine stocks available with states — 19,01,68,140 doses according to a Press Information Bureau (PIB) update Tuesday — and it is unnecessary to add more vaccines to the government’s procurement list at present.
Covovax is the SII’s version of Novavax’s NVX-CoV2373 Covid vaccine, according to a statement issued last year by the Pune-based vaccine manufacturer. It was created using Novavax’ recombinant nanoparticle technology, to generate antigen derived from the coronavirus spike protein, and is formulated with the vaccine’s patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies.
The vaccine was approved by the Drugs Controller General of India in March for use in adolescent age groups. The second dose of Covovax is administered three weeks after the first dose.
92.6% efficacy against variants of concern
While announcing the vaccine’s emergency-use authorisation in March, Novavax and SII had said that “a phase 2/3, observer-blinded, randomised, controlled study in a total of 460 Indian adolescents aged ≥12 to <18 years was conducted to evaluate the safety and immunogenicity of Covovax”.
“The study demonstrated that Covovax was well-tolerated with a reassuring safety profile. Furthermore, the data indicated that Covovax is immunogenic in adolescents aged ≥12 to <18 years. The authorisation in India also references the ongoing PREVENT-19 pivotal Phase 3 pediatric expansion trial of NVX-CoV2373 in adolescents in the US aged ≥12 to <18…”
That trial, according to the Novavax statement, found that the vaccine was well tolerated, safe and immunogenic in 12-17-year-olds, and showed an 82 per cent clinical efficacy against Delta variant.
The results of the NVX-CoV2373 trial in adults — showing 92.6 per cent efficacy against variants of concern — were published in the New England Journal of Medicine in February.
According to the Covovax package insert, pain (among 36.4 per cent recipients) and tenderness (11.3 per cent) were the most frequent local adverse events. Fever (in 22.5 per cent recipients), headache (18.8 per cent), fatigue (14.2 per cent), and malaise (9.2 per cent) were the most commonly reported adverse events.
Covovax is contraindicated in people who have hypersensitivity to the active substance or to any of the constituents of the vaccine.
The SII factsheet on the vaccine added, “Currently, limited amount of data are available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. People with weakened immune systems due to other illnesses or medications might be at increased risk for severe Covid-19. They may receive Covovax.”
It said, however, that “people with weakened immune systems should also be aware of the potential for reduced immune responses to Covovax, as well as the need to continue following all current guidance to protect themselves against Covid-19”.
Covovax had received emergency-use listing from the World Health Organisation last December, just a few days before the vaccine received a nod from the Drug Controller General of India, for use in adults.
(Edited by Poulomi Banerjee)