Biological E is developing next generation XBB1.5 variant Covid vax, awaiting approval
Hyderabad-based vaccine maker Biological E (BE) is awaiting approval from the drug regulator 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 for almost two years, and most of the 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 recommendations of the World Health Organization (WHO).
Paradkar said: “BE's vaccine candidate has completed all required pre-clinical animal studies, indicating that it will provide adequate protection against the currently circulating variants. CDSCO's COVID-19 Subject Expert Committee has approved BE's clinical trial application and we are awaiting final CDSCO approval to initiate clinical trials of the XBB variant vaccine in India.”
He added that they also have the manufacturing infrastructure for variant vaccine production so that delivery can start at short notice.
XBB 1.5 is a sub-variant of Omicron and a sub-line of the XBB variant. It is a recombinant of the two BA.2 sublines and carries a mutation of the spike protein (F486P) that increases infectivity due to its increased binding affinity for the ACE2 receptor.
Recently, Pune-based Serum Institute of India (SII), the world's largest vaccine maker by volume, said they are also working on an XBB 1.5 variant vaccine that would be effective against the current variant of concern JN.1.
The JN.1 subvariant is a descendant of BA.2.86 (also known as Pirola), which is itself a subvariant of the widespread Omicron.
Meanwhile, Paradkar said BE also has a significant stock of Corbevax, their protein sub-unit vaccine that was previously administered to children, apart from being approved as a mix-and-match booster shot after two doses of Covaxin and Covishield.
The company has a stock of various components required for the manufacture of the variant vaccine (protein antigen and adjuvants) that can be quickly formulated on a large scale for the supply of large quantities.
An article published on the vaccine alliance website Gavi, 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 (of which XBB. 1.5) and several descendants of the subvariants BA.2 and BA.4 – BA.5. 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 had a greater increase in antibodies against experienced BA vaccine. .2 and BA.4-BA.5 subvariants circulating in mid-late 2022, compared to people who received a fourth dose of the original vaccine.”
First print: December 27, 2023 | 8:02 PM IST