Discussions underway for WHO approval for Corbevax COVID-19 vaccine

Houston: Corbevax, a 'recombinant protein sub-unit' vaccine developed by Texas-based vaccine developers, was recently granted emergency approval by the Indian government and will be manufactured by the Hyderabad-based company Biological E, one of the world's largest vaccine manufacturers.

This "old school" coronavirus vaccine has been developed by Prof. Peter Hotez, co-director of Texas Children's Hospitals Center for Vaccine Development and the dean of the National School of Tropical Medicine at Baylor College of Medicine, along with his longtime collaborator Maria Elena Bottazzi.

The scientist duo is already in discussions with the World Health Organization (WHO) for vaccine approvals to vaccinate developing and under-vaccinated world.

"Biological E has started the discussions with the World Health Organization. We have been in some discussions as well. We want to make this as widely available as possible, especially to people who live in poverty," Prof Hotez told ANI in a virtual interview.

Hotez stressed how Corbevax "checks many of the boxes" for global health and is easy to scale, has a great track record of safety, simple refrigeration and more.

"It's really almost ideal target product profile. So we are finding out from the World Health Organization, what they need, either for pre-qualification or emergency use listing. I think those discussions are now underway," the vaccine developer further added.

Corbevax has been given emergency use authorization from the Drugs Controller General of India (DCGI). It's expected to roll out in India and then be made available in other under-vaxxed countries after that.

The Government of India has already ordered 300 million doses of the vaccine. BioE plans to produce 100 million or more doses per month starting in February.

Approximately 150 million doses have already been produced and are ready to roll out. In addition BioE plans to deliver more than one billion additional doses to other countries.

"Corbevax is an old school vaccine and is made through microbial fermentation in yeast, similar to the process used to produce the recombinant hepatitis B vaccine," explains Hotez.

Experts are of the opinion that protein-based COVID-19 vaccines could be game-changing in the coming days.

"I think the advantage of the mRNA technology is you can make a piece of mRNA very quickly. So you can go into populations quickly the disadvantage of mRNA and like any brand new technology, there's not that steep knowledge of how to make it in the billions of doses right away," Hotez adds.

"A balanced portfolio with a vaccine-like ours that takes a little longer to make because it takes longer to make protein than mRNA. But in the end, you'll make it because you can scale it up for the world because it's made locally," says Hotez.

Pegged as a low-cost yet highly effective vaccine, Hotez and his team aims to achieve global vaccine equity and overcome vaccine hesitancy and refusal.

"Delta [variant] rose out of an unvaccinated population in India earlier this year and look at Omicron it arose out of an unvaccinated population out of southern Africa. So Mother Nature is telling us what she has in store for us. As long as we refuse to vaccinate Africa, Asia and Latin America, she will continue to throw variants around the world and it's amazing that people do not seem to understand that they somehow think that if they vaccinate their own populations in Europe and North America that seems to be good enough and, and it's not," Prof Hotez asserted.

Hotez and Bottazzi would not personally get a penny from it and Corbevax is being shared patent-free.

"It's been my dream to use science to help humanity," Hotez exclaimed. "It's it kind of brings things full circle that we have been able to make this contribution where we don't seek to make money we seek to help help the world," Prof Hotez told ANI.

For some vaccine developers the pandemic resulted in billion of dollars in profits apart from receiving huge amounts of public funding to produce the vaccines, developers Hotez and Bottazzi developed CORBEVAX with USD 7 million from mostly private investors and minimal help from the U.S. government.

"The problem was an upstream failure. That there was so much reliance on new technologies what I sometimes call "the shiny new toys," Hotez said.

"The problem was we never got support. I mean, it was no we never got real support from the US government or from the G7 countries. So it was a very dark time for me personally, early on in this pandemic," Hotez told ANI.

When asked about the efficacy of the vaccine and how much impact the vaccine will have Hotez asserted that DCGI approval is a strong sign that the vaccine is safe and effective. "they're (DCGI) not letting any vaccine out the door unless it's both safe and effective. So, I think you'll have a pretty good choice."

In India where only 40 per cent of the country's 1.38 billion people are reported to be fully vaccinated, Hotez says there is an urgent need for everyone to be vaccinated "whatever your physician or healthcare provider recommends get that vaccine."

Corbevax has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well-tolerated and immunogenic according to BioE.

India is slowly turning its focus towards vaccinating children against the coronavirus, having administered over 100 crore doses to adults. Hotez reckoned Corbevax can make a difference.

For now, the vaccine is approved for 18 years and above, but Hotez is confident that going forward Corbevax could be used for pediatric healthcare and even as boosters.