Being able to vaccinate those who have not yet been able to do so because they live in countries where the resources to immunize the population are lacking and where the distribution of the – insufficient – doses provided by rich countries encounters major logistical difficulties: this is the goal of an Italian-Honduran scientist , Maria Elena Bottazzi, a lecturer at Baylor College of Medicine in Houston.
“I was born in Genoa, to an Italian mother and a father born in Honduras but of Italian origin, since his father was Italian and a diplomat in Honduras – explains the microbiologist -. At 9 I left Genoa for Honduras and I studied there before move to the United States “.
The Covid vaccine developed by the immunologist was approved in India in late 2021. It is inexpensive to produce on a large scale, because it does not require cutting-edge technologies, and is more than 80% effective against the Delta variant. . And above all, it is not protected by any patents, because Bottazzi wanted its production cost to be as low as possible, so as to facilitate its distribution in the poorest countries of Africa and South America.
Professor Bottazzi, how was your Covid vaccine born?
“At Baylor College of Medicine we started working on a program to develop coronavirus vaccines in 2011. We started working on Sars and then MERS vaccines. So we had the prototypes and preclinical data to understand how these vaccines behaved for induce immunity safely. Since Sars-CoV-2 is similar to Sars virus, with a similar sequence for the Spike protein, we have developed the vaccine for Sars-CoV-2. As antigen we do not use the complete Spike protein, but only the The little bit of the Spike that the virus uses to make contact with cells. We make these synthetic proteins by introducing the Spike protein genes into a yeast cell. Then, with fermentation, the yeast produces the proteins. It’s a similar system to making the protein. beer, except that in that case with fermentation the yeast produces alcohol, while in our case it produces the proteins useful for vaccinating “.
How did you organize yourself to produce Corbevax?
“Corbevax is the name given to the vaccine by our Indian partner, Biological E. We gave them these yeast cells with the code to produce the synthetic protein and co-developed the manufacturing processes with stability and quality control tests with them. We conducted preclinical studies with them for the effectiveness of the vaccine. And the company took care of the production: they carried out all the clinical studies to receive approval in India – obtained in December – today they are able to produce 100 million doses per month. Now we are also working with other producers to whom we transfer our cells and our know-how: for example the company BioPharma in Indonesia, and Incepta in Bangladesh and then ImmunityBio, based in the United States but with plants in the African countries, such as Botswana. Now after the announcement of the authorization given by India to Corbevax, we are also talking with other producers. It is all very open: we have no exclusivity with ness one and we have not registered patents for this technology. Our studies are all published and allow any manufacturer to replicate these manufacturing processes. “
Corbevax, the ‘low-cost’ vaccine created by an Italian scientist
by Valeria Pini
Why did you decide not to patent the vaccine?
“We needed a quick response to the pandemic and the patents would have lengthened the time. But our position precedes Covid: our center was originally created to develop vaccines for tropical diseases, or drugs that pharmaceutical companies have little interest in producing. . To encourage the possibility of collaborations with producers, the ideal is to use production systems that are open and easy to implement, systems for which producers already have the necessary know-how. The most important aspect is to fill the gap. the gap that exists between poor countries and rich countries regarding the production and distribution of vaccines, and our collaborative and patent-free model goes precisely in this direction “.
What is the benefit of using yeast to make the vaccine?
“The yeasts used for this type of vaccine are of the species Pichia pastoris. But other yeasts can also be used with the fermentation process. We chose yeasts instead of mammalian cells because they cost more. Yeast is one of the least expensive models and is the easiest for very large scale productions, even billions of doses. And there are already so many manufacturers who know how to use them, so you don’t need to build new factories, or buy new machinery, or hire more people to produce the vaccine. Because pharmaceutical companies already have all the necessary production ecosystem. Economies of scale and the fact that there is no need to spend on research and development mean that this vaccine costs less than three dollars per dose, as do hepatitis B and whooping cough vaccines, which are very cheap. On the other hand, mRNA vaccines can cost $ 20-30 per dose. “
Are there any other benefits?
“Normal refrigeration is sufficient to store them. Then this type of vaccine remains stable for a long time: it can be refrigerated for years. And this is very important for distribution. The safety profile of these protein-based vaccines is also superior. to other vaccines: Biological E in its trial in India saw a 50% reduction compared to the side effects of the vaccine distributed in India by AstraZeneca. The vaccine contains purified synthetic protein, with an alum-based adjuvant that has already been used for 40-50 years in most pediatric vaccines and is therefore very safe. The efficacy of our vaccine against the Delta variant exceeds 80%, while data on efficacy against Omicron are not yet available. “
What can an Italian producer do if he wants to collaborate with you?
“You can call us. We already have all these cells and we can transfer them, along with our processes, our reports, our quality control tests. We use non-exclusive licenses to be able to contribute materials or training made by our scientists. But in fact, manufacturers can even read our vaccine publications without even calling us. Obviously, if they want to get involved, we are very happy to lend ourselves. “
How do you see the evolution of this pandemic?
“The most important thing is that the vaccines get where they need to go, especially in the areas most deprived of resources: that’s where we need to put more immune barriers, for the virus to stop mutating. It is also important that a universal vaccine is developed, which does not it has to be updated continuously to keep up with the virus, and that it offers long enough protection to be able to prevent other variants that do not yet exist. And we are working towards this, based on the hitherto known genealogy of the virus, we have a program called ‘Pan Coronavirus‘ to arrive at a universal vaccine “.
How can a universal coronavirus vaccine be made?
“There are two strategies: either to create a multivalent vaccine, where different types of antigens are mixed so as to be able to neutralize as many variants as possible, or to isolate a sequence that appears in all variants, so as to use a protein as antigen synthetic that does not exist in reality but which is sufficiently similar to that present in all the manifestations of the virus, so that our body can produce an adequate immunological response “.
Vaccines: Big Pharma has already grossed 90 billion. To exit Covid, patents must be suspended
by Daniela Minerva
