Unpatented COVID-19 Vaccine Corbevax Gets Emergency Use Authorisation in India
Moneylife Digital Team 29 December 2021
Corbevax, an unpatented vaccine for COVID-19 developed by Texas Children’s Hospital and Baylor College of Medicine, has received emergency use authorisation (EUA) approval from the Drugs Controller General of India (DCGI) to launch it in the country, with other underserved countries to follow suit.
 
In a release, Texas Children’s Hospital says that Corbevax, dubbed ‘The World’s COVID-19 Vaccine’,  uses a traditional recombinant protein-based technology to enable its production at large scales, making it widely accessible to inoculate the global population. 
 
The initial construct and production process of the vaccine antigen was developed at Texas Children’s Hospital Center for Vaccine Development (CVD), led by co-directors Dr Maria Elena Bottazzi and Dr Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialisation team, to Hyderabad-based vaccine and pharmaceutical company Biological E Ltd (BE).
 
According to Dr Bottazzi, protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world. 
 
“Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies that today are still not able to be quickly scaled up for global production,” says Dr Bottazzi, who is professor and associate dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Center for vaccine development.
 
The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world’s fight against the COVID-19 pandemic. Without widespread vaccination of populations in the global south, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the US and other Western countries.
 
“This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability that the low- and middle-income countries face against the delta variant,” says Dr Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Center for vaccine development.
 
“Widespread and global vaccination with our Texas Children’s-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow,” he added.
 
Mahima Datla, managing director, Biological E Ltd, says, “Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality.”
 
After completing two phase-III clinical trials involving more than 3,000 subjects, Corbevax was found to be safe, well-tolerated and immunogenic, the release says. 
 
It says, “Corbevax demonstrated superior immune response in comparison with Covishield vaccine when assessed for neutralising antibody (nAb) geometric mean titers (GMT) against the ancestral-Wuhan strain and the globally dominant Delta variant. Corbevax vaccination also generated significant T helper type 1 (Th1) skewed cellular immune response.” Th1 cells are a lineage of CD4+ (white blood cells) effector T cells that promote cell-mediated immune responses and are required for host defence against intracellular viral and bacterial pathogens.
 
“In the continuous monitoring of phase II studies, Corbevax showed high persistence of immune response as indicated by less than 30% drop in nAb GMT till six months from the second dose as compared to greater than 80% drop observed with majority of the vaccines,” Texas Children’s Hospital says.
 
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