Unpatented Shot Dubbed 'The World's Covid-19 Vaccine' Wins Emergency Approval in India

An unpatented Covid-19 vaccine developed by the Texas Children's Hospital, Baylor College of Medicine, and the pharmaceutical firm Biological E. Limited received emergency-use authorization from Indian regulators on Tuesday--news that the jab's creators hailed as a potential turning point in the push to broaden global vaccine access.

"Our Texas Children's Center does not plan to make money on this, it's a gift to the world."

"This announcement is an important first step in vaccinating the world and halting the pandemic," Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children's Hospital Center for Vaccine Development, said in a statement.

Formally known as Corbevax, the protein-based vaccine has been nicknamed "The World's Covid-19 Vaccine" because it is not patented, meaning that manufacturers across the globe can produce the shot without fear of legal retribution from governments or private companies.

"This vaccine can be made locally all over the world, and we've now technology-transferred our Texas Children's vaccine to producers in India, Indonesia, Bangladesh, [and] Botswana," Hotez wrote on Twitter. "Our Texas Children's Center does not plan to make money on this, it's a gift to the world."

The approach Corbevax's developers have opted to pursue stands in stark contrast to that of Pfizer and Moderna, U.S.-based pharmaceutical giants that are fiercely guarding their vaccine recipes--and reaping massive profits--as billions of people in low-income countries remain without access to the lifesaving shots nearly two years into the deadly pandemic.

According to new figures from the healthcare data firm Airfinity, poor countries have received fewer than 2% of all coronavirus vaccine doses distributed worldwide.

Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children's Hospital Center for Vaccine Development, said Tuesday that "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 and that today are still not able to be quickly scaled for global production."

In a press release issued Tuesday, the Hyderabad, India-based company Biological E. Limited (BE) said Corbevax was "found to be safe, well-tolerated, and immunogenic" in two Phase III clinical trials involving more than 3,000 subjects between the ages of 18 and 80 at dozens of study sites across India.

Specifically, the company said Corbevax demonstrated a superior immune response compared to the Oxford/AstraZeneca vaccine--also known as Covishield--against both the original coronavirus strain and the still-pervasive Delta variant.

BE announced Tuesday that it intends to produce more than 100 million Corbevax doses per month starting in February 2022 and pledged to distribute over a billion doses globally in the coming months as nations grapple with surging cases.

"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," Mahima Datla, BE's managing director, said in a statement. "It has now become a reality."

The makers of Corbevax didn't specifically say whether the shot is effective against the heavily mutated Omicron strain, which is quickly becoming dominant in countries across the globe. But Hotez argued that "widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants."

"Our scientists at Texas Children's Hospital and Baylor College of Medicine are thrilled to help in the development of this vaccine, possibly the first Covid vaccine specifically designed for global health," said Hotez.