Houston COVID vaccine gets approval for use in India

The Texas Children's Hospital (TCH) and Baylor College of Medicine (BCM) announced on Tuesday that Corbevax, a protein subunit Covid vaccine, has received approval from the Drugs Controller General of India (DCGI) to launch it in India.

The initial construct and production process of the vaccine antigen was developed at TCH's Centre for Vaccine Development, led by co-directors Maria Elena Bottazzi and Peter Hotez.

"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 the low- and middle-income countries face against the delta variant," said Dr Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Centre for Vaccine Development.

TCH said the vaccine has been through phase three clinical trials with more than 3,000 subjects and was found to be safe and well-tolerated. The trials suggested a better immune response to the Ancestral-Wuhan strain of the virus as well as the delta variant compared to Covishield, developed by Oxford-AstraZeneca.

None of the subjects showed severe adverse reactions to the vaccine; and adverse effects in the study were half of those from Covishield.

"TCH does not plan to make money on this, it is a gift to the world. The vaccine uses a traditional recombinant protein yeast fermentation technology, similar to that used for the recombinant hepatitis B vaccine, which has been around for 40 years. It was authorized based on superiority studies to another well- established Covid vaccine. This can be made locally all over the world, and we have now technology transferred our Texas Children’s vaccine to producers in India, Indonesia, Bangladesh, Botswana,” Dr Hotez said.

The vaccine relationship will also bring the two countries closer, according to Hotez.

"We have strong ties with the India community here in Houston and I spoke at the Indo American Chamber of Commerce of Greater Houston (IACCGH) gala recently, where I met Ambassador Taranjit Singh Sandhu, Indian ambassador to the United States. I am very excited about the stronger US-India ties through this vaccine diplomacy. India is also very committed to developing vaccines for the world even beyond ours, we have known about India for many years,” Hotez said.

Tweeting about the announcement, he mentioned that BioE has 150 million doses ready and will be making 100 million per month.

"We technology transferred our vaccine and helped in its co-development with no patent and no strings attached. As a result, it should be the least expensive Covid vaccine available yet," Hotez said.

The vaccine uses an older recombinant protein yeast fermentation technology similar to that used for the recombinant hepatitis B vaccine which has been around for 40 years. It was authorised based on superiority studies to another well- established Covid vaccine.

"This can be made locally all over the world, and we have now technology transferred our Texas Children’s vaccine to producers in India, Indonesia, Bangladesh, Botswana. TCH does not plan to make money on this, it is a gift to the world," Hotez said.

For nearly two years, Hotez has offered insights and interpretations regarding COVID-19.

The two doctors were well-suited for development of this particular vaccine, having spent a decade studying coronavirus vaccine prototypes.

Bottazzi said Corbevax will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production.

Hotez recently described how the southern hemisphere is complicating efforts to combat the pandemic, referring to a disconnect regarding the scale of necessary vaccination.

"The Biden administration just announced that we've donated 300 million doses," he said.

"To me that's kind of tone deaf. We need nine billion doses on the African continent. We need a better understanding there," he added.

"Global vaccination could hinder subsequent new variants from emerging and spreading. Now is our chance to prevent a new global wave," Hotez said.

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