The country's oldest Indian private vaccine manufacturer, Biological E is to be the beneficiary of a Rs 1,500 crore advance payment made by the central government to reserve 30 crore doses of its recombinant protein subunit vaccine Corbevax.
A statement from the Union health ministry added that the vaccine doses will be manufactured and stockpiled by the company between August and December 2021. “The proposal of Biological E was examined and recommended for approval after due diligence by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC),” read the MoHFW's statement.
This, it is worth noting, is the first time that the central government has made an 'at risk' investment into an unapproved vaccine. While the Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech received advance payments from the government of Rs 1,500 crore and Rs 750 crore, respectively, these sums were doled out only after Covishield and COVAXIN had received regulatory approval.
Such an investment, while not irregular – the US and UK had invested into Pfizer's and Moderna's vaccine candidates while they were still in development – represents a significant deviation from the Centre's vaccine policy.
Biological E has a strong reputation in the global vaccine industry and currently manufactures eight World Health Organisation pre-qualified vaccines for measles and rubella, tetanus, pentavalent vaccines and snake anti-venom.
In August 2020, the company licensed a recombinant protein COVID-19 vaccine candidate originally developed by Houston-based Baylor College of Medicine. The technology was transferred from the university with a view to scale up manufacturing and further develop the vaccine candidate.
The recombinant protein platform that Corbevax – as it has now come to be called – uses is not in use by any other vaccine currently being distributed in the country. Like other vaccines, it targets the spike protein on the virus particle's surface, but instead of instructing cells to replicate them, instead injects a small volume of cloned spike proteins grown in a lab.
The immune system recognises these proteins as a threat and develops a response accordingly, ultimately, reducing the ability of the live virus to infect cells and cause serious disease.
Biological E started Phase I and Phase II trials of Corbevax in the second week of November 2020. The trials were conducted in around 360 healthy adults between the ages of 18 and 65 years, with two doses administered to each participant intramuscularly with an interval of 28 days.
The promising results of the trials led the company to progress to Phase III clinical trials in late April, to be conducted across 15 sites in India. The trial, reportedly, includes 1,268 healthy subjects between the ages of 18 and 80 years. The India Phase III trial is set to be a part of a larger global Phase III study.
If the vaccine is found to be effective, it would become the second indigenously-developed vaccine after Bharat Biotech's COVAXIN and, crucially, will also likely be the most affordable.
When the vaccine manufacturer initially struck a deal with the Houston university, Mahima Datla, managing director of Biological E stated, “The deal is for the development of an affordable vaccine, especially for India and other low and middle-income nations.”
Narender Dev Mantena, director of BioE Holdings Inc and head of Biological E's novel vaccine programme added that, if the candidate is proven to be a success, “we expect to make several hundred million doses of the vaccine available annually.”