India’s hope may lie in locally developed vaccine
As the COVID-19 pandemic raged ever further out of control in India, it was easy to miss last week’s shred of good news: Biological E Ltd., one of that country’s largest vaccine manufacturers, had successfully completed Phase I and II safety trials of a vaccine developed in Houston, and will soon begin large-scale testing in India and other countries.
“If all the stars align, it might be released for emergency use later this summer,” said Peter Hotez, who co-directs the Texas Children’s Hospital lab that developed the vaccine.
Even assuming the best, that means the vaccine won’t be available in time to ease the COVID wave now crushing India, where the official death toll has passed 208,000. Crematoriums and hospitals are overwhelmed. On Friday, India reported 386,452 new infections: an alarming global record suggesting that far
more deaths will follow in coming weeks.
The hope is that the Houstondeveloped vaccine will help prevent other such waves. The vaccine is low-cost, easily produced in enormous quantities, and easy to distribute. If the testing proves it effective, it could play an important role in the global fight against COVID — particularly in low- and middle-income countries.
Biological E is preparing to make more than 1 billion doses of the vaccine, at least some of which would be deployed in India. At present, only 9 percent of Indians have received a first dose of the India-created Covaxin vaccine; Covishield (the Indian version of AstraZeneca); or Sputnik V. Two percent of Indians are fully vaccinated.
The vaccines currently available can’t be manufactured fast enough to meet that demand, Hotez noted: “Most people don’t understand the scale and magnitude of India. Think what it means for a country to have more than a billion people. To interrupt transmission, you need to vaccinate 80 percent of people. That means 800 million people. And since most vaccines require two doses, we could be talking about 1.6 billion doses.”
If anything, Hotez’s off-thecuff estimate is an understatement: India’s population is roughly 1.4 billion.
The global demand for vaccine is even higher, noted Andrew Natsios, director of Texas A&M’s Scowcroft Institute of International Affairs and a former administrator of the U.S. Agency for International Development. “The only way to stop these mutations is to get herd immunity for the whole world,” he said. “COVID-19 doesn’t stop at national borders.”
Unlike the vaccines currently in use in the U.S., which are based on new technologies, the Texas Children’s Hospital/Biological E vaccine calls for traditional techniques and manufacturing processes. Like the widely used hepatitis B vaccine, it uses yeast to produce proteins that the virus contains. Once injected, those proteins train the human immune system to recognize the target virus and swing into action.
“Vaccines have been made this way for 50 years or more,” said Maria Elena Bottazzi, who co-directs the Houston vaccine lab. That, she explains, means that both manufacturers and distribution sites already have the experience and equipment needed: “It’s exactly the same way that they make and store the vaccine for hepatitis B.”
The Houston lab’s vaccine is one of a dozen that’s received support from CEPI, the Coalition for Epidemic Preparedness Innovations, a global foundation that finances vaccine research.
“That it only requires regular refrigeration is huge,” said Natsios. “Not many places can handle -70 degrees.”
The vaccine’s projected cost — around $1.50 per dose, meaning $3 for both a first shot and a booster — is significantly cheaper than the prices that other vaccines currently command. ( Moderna, for instance, has said it will charge between $27 and $37 per dose.)
The vaccine requires a second dose, administered roughly 28 days after the first. “It would be better if it didn’t require the second dose,” said Natsios.
The vaccine could have been developed more quickly, Hotez noted. The first missed opportunity came in 2016. The Texas Children’s Hospital lab was ready to begin human testing on a vaccine for SARS-1, a coronavirus closely related to the one that causes COVID-19. But that was 10 years after the SARS-1 outbreak in China, and by then, neither federal funders nor investors were willing to support the testing needed to prepare the vaccine. So untested, that vaccine went into a freezer.
Had that vaccine been ready to go when this coronavirus hit, Hotez says, it might have provided cross-protection — and would have given researchers a leg up on the new threat.
The second delay came at the beginning of the COVID-19 pandemic. Federal funding went mainly to newer vaccine technologies, which promised to move through testing and begin manufacturing more quickly.
But those newer technologies came with new problems. Few of the world’s vaccine factories could make the newer vaccines, and existing distribution systems often can’t handle new requirements such as super-cold storage.
“They never thought we’d need so many doses,” Hotez said. “Once the virus was out of control, those newer technologies couldn’t scale up.”
Without much federal funding, the lab’s work was delayed. Hotez dedicated much of his time during the pandemic’s early months to raising money. Texas donors — including Tito’s Vodka and the Kleburg Foundation — made the research possible.
“Texas does science in a different way,” Hotez said. “We support science locally. That’s why we moved our lab here: We’re supported by Texas Children’s Hospital, Baylor and philanthropists. If we’d had to rely on the National Institute of Health for everything, it would have been hard.”