From Texas to India, a patent-free Covid vaccine looks to bridge equity gaps

Millions of doses of a new, cheap coronavirus vaccine will soon be available in India, and they will arrive with a distinction that neither Moderna nor Pfizer can claim: they are patent-free.

Developed in Texas with decades of technology and little support from the US government, the new CORBEVAX vaccine received emergency approval from the Indian Medicines Agency last week.

The researchers behind the vaccine have little to gain financially.

“We don’t own any intellectual property,” said Dr. Peter Hotez, a researcher who helped develop the vaccine.

Efforts to immunize the world go way back fell short of expectations and human rights activists are pushing pharmaceutical companies to transfer new vaccine technologies to accelerate global access to vaccination.

And while CORBEVAX has doubts about its effectiveness against the Omicron variant and a lack of public data, its development outside of the path of typical pharmaceutical development and without the same financial incentives for inventors represents a model for others and could back up their arguments, vaccine Share advocates said.

About 59 percent of the world’s population have received at least one dose of a vaccine, according to Our World in Data, which tracks government reports worldwide. But fewer than 9 percent of residents in low-income countries received a dose.

Call it the “Coronavirus Vaccine in the World” in a press release, Hotez and colleagues say CORBEVAX – which is cheap, stable and relatively easy to scale – will be key to closing global equity gaps.

When Covid-19 began to spread around the world, Hotez and Maria Elena Bottazzi, researchers on Baylor College of Medicine and director of the Texas Children’s Hospital Center for VaccineShe got to work – with a head start.

About a decade ago, the two coronavirus vaccine candidates such as SARS and MERS were developing until funding was depleted. Her other work had focused on neglected poverty-related diseases such as hookworm infections.

“We only know how to make permanent, inexpensive vaccines for global health,” said Hotez.

As the new mRNA vaccine technology advanced, the two pursued the decades-old technology to create a recombinant protein vaccine. Their method, which uses yeast to create a key component of the coronavirus, is similar to what has been used to make hepatitis B vaccines since the 1980s.

“Nobody paid any attention to these conventional technologies,” said Bottazzi.

Hotez and Bottazzi received little government funding, even though government vaccine development, Operation Warp Speed, showered drug companies with cash. But they stuck with it.

“Many of the vaccine manufacturers in low- and middle-income countries have realized that they will be on the outside,” Bottazzi said. “We offered an attractive alternative.”

To date, countries like India have no access to Pfizer-BioNTech and Moderna mRNA vaccines, most of which are bought and sold by wealthy countries. Boosters and even fourth doses are administered in rich countries before access to the first and second dose available worldwide.

“No country can accelerate the way out of the pandemic,” said Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, said in December.

Hotez and Bottazzi hope that CORBEVAX can fill the gap in India and other countries.

Biological E, the company that licenses CORBEVAX and conducted clinical trials there in India, said it will soon be able to manufacture 100 million doses every month, the company said in a statement. The Indian government has already ordered 300 million cans.

CORBEVAX has a number of advantages. Research and development for the vaccine in Texas cost no more than $ 7 million, the majority of which was provided by philanthropists, Hotez and Bottazzi said.

The vaccine is relatively inexpensive to manufacture and easy to store, and it can be made anywhere that hepatitis B vaccines are made.

From Texas to India, a patent-free Covid vaccine looks to bridge equity gaps 1

Since the technology is nearly half a century old, many countries are familiar with it and have perfected their technology, said Jeremy Kamil, an adjunct professor of microbiology and immunology at LSU Health Shreveport who was not involved in the development of CORBEVAX.

“None of this is overly expensive,” Kamil said, adding that protein subunit vaccines are generally stable and much easier to store than mRNA vaccines.

Clinical studies by Biological E have shown the vaccine to be safe and effective. the company said in a statement. The company said the vaccine was more than 90 percent effective against the original strain of Covid-19 and more than 80 percent effective against the Delta variant.

Data from a clinical study with more than 3,000 participants has yet to be published, which makes experts suspicious.

“By the time they show the data, there will be questions about what it really means,” said Kamil.

Hotez said Biological E was working on releasing the data.

Akhal Prabhala, a public health activist and public health researcher based in Bangalore, India, called Biological E a “blue chip” vaccine manufacturer but objected to what he called “science by press release” and said it should Public data are available on how effective CORBEVAX. is is against the omicron variant.

Kamil had concerns about how the vaccine would hold up against the Omicron variant, which has reduced the effectiveness of many vaccines, especially those that rely on technologies other than mRNA.

CORBEVAX is designed to introduce the human immune system into the coronavirus receptor binding domain – part of the spike protein that many vaccines target.

“It’s the fastest changing part of the top. Omicron basically rebuilt the whole thing, ”said Kamil. “I would guess that isn’t very effective against Omicron.”

Kamil said it should be relatively easy to update the vaccine formula to better protect against the variant if necessary, but that it would take time.

Although questions remain about CORBEVAX’s effectiveness in a changing landscape where the omicron variant prevails, experts should say its development should be a model for immunizing the world’s population and reducing vaccine inequality.

“For its practical use, I wish it had appeared months earlier,” said Prabhala, saying it would have been helpful before the Omicron variant appeared. But “its symbolic use is priceless.”

Prabhala, who worked with Human Rights Watch, argues that expanding the production of mRNA vaccines would be the best way to improve access to effective vaccines around the world. Human Rights Watch and other organizations are Put pressure on Moderna and Pfizer to make vaccine formulas and manufacturing technology easier to share with countries that need recordings. (Moderna and Pfizer have shared some technologies, arguing that Localizing vaccine production could take away resources from expanding production capacities within their supply chains).

Prabhala said over 120 facilities around the world, including some in poorer countries, could make mRNA vaccines when the pharmaceutical companies transfer their technology.

The Hotez and Bottazzi approach is an ethic to point out, Prabhala said.

The longer it takes to vaccinate the world, the greater the chance that the coronavirus will mutate when it infects new hosts.

“We know that variants occur more quickly in unvaccinated populations,” said Kamil. “If we don’t deal with vaccine justice, we will always catch up with the latest variant.”

Leave a Comment