Biological E develops next gen XBB1.5 variant Covid vax, awaits clearance
Hyderabad-based vaccine maker Biological E (BE) is awaiting the drug regulator’s clearance to begin clinical trials of its XBB1.5 variant Sars-CoV-2 virus, a senior company official said.
The move comes at a time when Omicron and its sub-variants have remained the dominant variants in circulation now for close to two years, and most vaccines available and administered in India are based on the original Wuhan strain of the virus. As of now, Gennova Biopharmaceuticals has launched a vaccine Gemcovac-OM which is based on the Omicron variant.
Vikram Paradkar, Executive Vice President, Vaccine Division, Biological E. Ltd told Business Standard that the company has developed a ‘next-generation’ Covid-19 vaccine based on the XBB1.5 variant of the Sars-CoV-2 virus according to the World Health Organisation (WHO) recommendations.
Paradkar said, “BE’s candidate vaccine has finished all required pre-clinical animal studies, which suggests that it will provide adequate protection against the currently circulating variants. The COVID-19 Subject Expert Committee of CDSCO has approved BE’s Clinical Trial application and we are awaiting final CDSCO clearance to begin the clinical trials of the XBB variant vaccine in India.”
He added that they also have the manufacturing infrastructure for producing variant vaccines to initiate supply at short notice.
XBB 1.5 is a sub-variant of Omicron, and a sub-lineage of XBB variant. It is a recombinant of the two BA.2 sub-lineages, and carries a mutation of the spike protein (F486P) which increases infectivity due to increased binding affinity to the ACE2 receptor.
Recently, Pune-based Serum Institute of India (SII), the world’s largest vaccine maker by volume, said that they are also working on an XBB 1.5 variant vaccine which would be effective against the current variant of interest JN.1.
The JN.1 sub-variant is a descendant of BA.2.86 (also known as Pirola), which itself is a sub-variant of the widely circulating Omicron.
Meanwhile, Paradkar said that BE also has a significant stockpile of Corbevax, their protein-sub-unit vaccine which was administered in children earlier apart from being approved as a mix-and-match booster shot after two doses of Covaxin and Covishield.
The company has a stockpile of various components necessary to manufacture the variant vaccine (protein antigen and adjuvants) that can be formulated at large scale quickly for the supply of large quantities.
An article published on the Gavi, the vaccine alliance website written by science journalist Linda Geddes said that “Human studies have also assessed the immune response induced by the BA.4/5 vaccine against XBB.1 (which XBB.1.5 descended from) and several descendants of the BA.2 and BA.4–BA.5 sub-variants. One of these studies, published in The New England Journal of Medicine, suggested that older individuals who received a fourth dose (second booster) of the BA.4/5 vaccine experienced a greater increase in antibodies against XBB.1 and descendants of the BA.2 and BA.4–BA.5 sub-variants that were circulating in mid-late 2022, compared to people who received a fourth dose of the original vaccine.”
First Published: Dec 27 2023 | 8:02 PM IST