For some vaccine developers, the coronavirus pandemic has had a silver lining in billions of dollars in profits. But a new vaccine rolling out soon in India is taking the opposite approach: Its developers are getting zilch.
On Tuesday, the Indian government granted emergency approval to a vaccine manufactured by the Hyderabad-based company Biological E. This “second generation” coronavirus vaccine was developed by Hotez and his longtime collaborator Maria Elena Bottazzi. It was then licensed to Biological E. through a commercialization team at Baylor College of Medicine in Houston, where both developers also work.
Biological E. has ambitious plans to produce more than 1 billion doses of the vaccine in 2022. Hotez and Bottazzi won’t personally get a penny from it, but their employer Baylor College will get a fee.
Unlike the vaccines of big-name manufacturers such as Pfizer-BioNTech and Moderna, the Texas Children’s Hospital vaccine, which is called Corbevax, is being shared patent-free. The Texas Children’s Hospital team is also working with manufacturers like Biological E. to ensure they have the know-how to make doses.
The ambition is to create a low-cost, open-source alternative to expensive and limited-supply mRNA vaccines for developing and under-vaccinated countries. And it won’t stop at India: Hotez and Bottazzi are talking to other manufacturers around the world and have consulted with the World Health Organization to see how they can share the vaccine globally.
If everything goes to plan, manufacturers all around the world could produce their own versions of the Texas Children’s Hospital vaccine, which uses older recombinant protein technology that many manufacturers already have experience with, rather than newer and potentially more complicated technology. Some advocates hope it could be a model for how vaccines should be developed and shared globally during a pandemic.
“Texas Children’s Hospital’s commitment to sharing technology is a challenge to the pharma giants and the false narrative that vaccine production and medical innovation thrive through secrecy and exclusivity,” said Peter Maybarduk, director of the advocacy group Public Citizen. “If Texas Children’s Hospital can do it, why can’t Pfizer and Moderna?”
Hotez and Bottazzi developed their vaccine with minimal help from the U.S. government, even though Operation Warp Speed invested $4.1 billion in Moderna alone. Instead, the Texas Children’s Hospital vaccine was developed with $7 million from mostly private investors. One of the big early investors was Austin-based Tito’s Vodka, which donated $1 million in May 2020.
“If we had even a fraction of the support that Moderna had, who knows, maybe the world would be vaccinated by now. We wouldn’t be having a discussion about omicron,” Hotez said.
How much impact the vaccine will have is not yet clear. Scaling up production for any vaccine, even one that uses older technology, can be difficult. The very limited clinical data about the effectiveness of the Texas Children’s Hospital vaccine — there is a complete lack of data for the omicron variant — has led some vaccine experts to take a skeptical view of the project.
Biological E. has said it has completed two Phase 3 clinical trials involving more than 3,000 people across India, with one finding that Corbevax is more than 80 percent effective against symptomatic disease, but the company has not publicly released the underlying data.
Joseph Osmundson, a virologist at New York University, criticized the high hopes for Corbevax, given the lack of public data from Phase 3 clinical trials. “It’s health care for lower- and middle-income countries that we would never accept here,” Osmundson said.
James Krellenstein, co-founder of the health-equity organization PrEP4All, noted that unlike Texas Children’s Hospital, Biological E. has a financial interest in the vaccine. “Maybe this vaccine will be great. Maybe it won’t,” he said. “But science, especially when it involves public health, is based on objective analysis of open data, not trusting the word of a vaccine manufacturer with a vested interest in the underlying product.”
Hotez said he understood the criticism about the lack of public clinical data but said that Biological E. did not have the scale that other vaccine manufacturers have. “They’ve assured us they’re working on getting that out as fast as possible. Remember, it’s a smaller company. They’re not one of the big multinationals,” he said.
Biological E. has 150 million doses ready to go, according to Hotez, and the Indian government has placed a large preorder of 300 million doses. The aim is to quickly scale up to manufacturing over 100 million doses a month — a potentially significant amount even in India, where only 40 percent of the country’s 1.38 billion people are reported to be fully vaccinated.
While a company representative declined to discuss the price per dose, Indian media has reported that it may be as low as $2.50 — which would make Corbevax not only the cheapest coronavirus vaccine in India but one of the cheapest in the world. Doses from Pfizer and Moderna sometimes cost almost 10 times that amount, according to publicly available contracts.
Hotez and Bottazzi hope that India is just the start. There are advanced talks to manufacture versions of the Texas Children’s Hospital vaccine in Indonesia, Bangladesh and Botswana. And while other vaccine developers have fiercely guarded their intellectual property during the pandemic, Hotez and Bottazzi are in talks to share the license for the vaccine with the WHO’s covid-19 technology access pool.
James Love, director of the advocacy group Knowledge Ecology International, said he was hopeful Corbevax would work both as an initial immunization and a booster. Love, who has consulted with Hotez and Bottazzi on how to share their vaccine globally, noted that because it relies on familiar technology, it may appeal to those concerned about the novelty of mRNA vaccines.
A “simple back-of-the-envelope calculation” showed the need for more inexpensive vaccine doses, Hotez said. In terms of unvaccinated people, he continued, “you’ve got a billion people in sub-Saharan Africa, almost a billion in Latin America and the Caribbean, another billion in the smaller, low-income countries of Southeast Asia. That’s 3 billion people.”
“You’re going to need 6 to 9 billion doses of vaccine. So you know, when the president stands up a couple of weeks ago and says the U.S. government is the largest donor of vaccines, 275 million doses,” Hotez said, “I’m looking at that and saying: That’s not something to boast about.”