The reason why we have this situation now with Omicron... is we allowed large unvaccinated populations in low- and middle-income countries to remain unvaccinated. Delta arose out of an unvaccinated population in India in early 2021, and Omicron out of a large unvaccinated population on the African continent later in the same year. So, these two variants of concern represent failures, failures by global leaders to work with sub-Saharan Africa, Southeast Asia and Latin America to vaccinate the Southern Hemisphere, vaccinate the Global South.... myself...Dr. Bottazzi... and our team of 20 scientists... make vaccines for diseases that the pharma companies won’t make... the only thing we know how to do is make low-cost, straightforward vaccines for use in resource-poor settings... it was very difficult to get funding. We got no support from Operation Warp Speed, no support really from the G7 countries... now we’ve licensed our prototype vaccine, and help in the co-development, to India, Indonesia, Bangladesh and now Botswana.... it’s really exciting to show that, you know, you don’t need to be a multinational pharmaceutical company and just make brand-new technologies that will only be suitable for the Northern Hemisphere. We can really make a vaccine for the world.

One reason... to move our scientists to Houston was to take advantage of being located within the [TMC]... comprising more than 50 biomedical institutions and 100,000 employees, occupying a building space that exceeds that of downtown Los Angeles. A second reason... generous support from Texas Children's Hospital (the world's largest...) which also housed the Sabin Vaccine Institute PDP... Our goal for moving and becoming linked to the TMC was to increase the number of new vaccines we are creating for the poorest people in less developed countries, [and] to accelerate the pace at which they are produced. ...[T]oday we have two vaccines in clinical trials—with others in various stages of development.

We invite scientists from all over the world to come into our vaccine labs to learn how to make vaccines under a quality umbrella, whereas you cannot walk into Merck or GSK or Pfizer or Moderna and say, “Show me how to make a vaccine.” With our group, we can.... the biggest frustration was never really getting that support from the G7 countries... I going on cable news networks... trying to raise meager funds just to get started... fortunately, we were able to get some funding through Texas- and New York-based philanthropies, and...we raised about...$7 million...with that, we were able to pay our scientists to actually do this, transfer the technology, no patent, no strings attached, to India, now, as I said, Indonesia, Bangladesh and Botswana... we’ve been getting calls for help all over the world from ministries of science and ministries of health, and we do what we can. We could do a lot — I mean, if we had even a fraction of the support that, say, Moderna or the other pharma companies had gotten, who knows? We might have been able to have the whole world vaccinated by now.... It’s even a vegan vaccine... So, now our partners in Indonesia... are trying to do this as a halal vaccine for Muslim-majority countries, which is pretty exciting, as well.

Baylor's National School of Tropical Medicine... includes as its research arm a... product development partnership (PDP). There are 16 PDPs worldwide... international nonprofit organizations that develop and manufacture s—drugs, diagnostics, and vaccines—for NTDs, as well as for HIV/AIDS, tuberculosis (TB), and malaria. Together, the NTDs, Tb, and malaria are sometimes broadly defined as "neglected diseases." PDPs develop and test new products for neglected diseases that the major pharmaceutical companies may not have an interest in because they are poverty-related afflictions that will therefor not generate significant sales income. The National School of Tropical Medicine's PDP is known as the PDP, and it is specifically focused on developing NTD vaccines.

[O]ne of the things that we're not hearing a lot about is the unique potential safety problem of Coronavirus vaccines. ...This was first found in the early 1960s with the respiratory syncytial virus [RSV] vaccines, and it was done here in Washington with the NIH and Children's National Medical Center... [S]ome of those kids that got the vaccine actually did worse, and I believe that there were two deaths in the consequence of that study. ...[W]hat happens with certain types of respiratory virus vaccines, you get immunized, and then when you get actually exposed to the virus you get this kind of paradoxical immune enhancement phenomenon. ...[I]t's a real problem for certain respiratory virus vaccines. That killed the RSV program for decades. Now the Gates Foundation is taking it up again, but when we started developing Coronavirus vaccines (and our colleagues) we noticed in laboratory animals, that they started to show some of the same immune pathology that resembled what had happened 50 years earlier.

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But we collaborated with a unique group that figured out how to solve the problem. That if you narrow it down to the smallest subunit, the piece that... [is] called the receptor binding domain, that docs with the receptor, you get protection, and you don't get that immune enhancement phenomenon. ...We proposed this to the . They funded it and we wound up actually making and manufacturing, in collaboration with , a first generation SARS vaccine. So SARS was the one that emerged in 2003... and then this new one... we call the SARS 2 Coronavirus. We had it manufactured, but then we could never get the investment to take it beyond that. ...We had the vaccine ready to go, but we couldn't move it into the clinic, because of lack of funding, because by then nobody was interested in Coronavirus vaccines.

Today, the NTDs represent the most common afflictions of people who live in extreme poverty. These ailments include diseases such as hookworm, , , and —or... the most important diseases you've never heard of. Virtually every impoverished individual is infected with at least one NTD.

The big pharma companies are still not going in. Some of the biotechs are starting to, because they're trying to really accelerate their technology... and hopefully to flip it around for something else that will make money. We need a new system in place.

[W]e also took on, a decade ago, the interesting problem of making Coronavirus vaccines because we recognized these as enormous public health threats, and yet we have not seen the big pharma guys and the biotech's rushing into this space. So we... partnered with a group at the and the to take on the big scientific challenge of Coronavirus vaccines...

In 2006, I became founding editor in chief of PLOS Neglected Tropical Diseases, a then new journal for a growing community of scientists and public health officials committed to studying the (NTDs). ...I became deeply impressed with the number of papers reporting on disease findings in middle-income countries, and even in some high-income countries. This... combined with my personal experiences after moving to Texas and seeing first-hand the endemic tropical diseases, inspired me to look more deeply into the health disparities of the poor who live in the midst of wealth. ...Many of the findings in this book are based on data and information published in [the journal].

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When the Chinese started putting up the data on Bioarchive in January-February, we saw a very close homology between the two, and realized that we may be sitting on a very attractive Coronavirus vaccine. Now, we're working... again with NIH, and we're working with BARDA and others to get the funding, but now we'll have that lag. ...[T]hese clinical trials are not going to go that quickly because of that immune enhancement. It's going to take time. ...[U]nfortunsately, some of my colleagues in the biotech industry are making these inflated claims. ...[Y]ou've seen this... in the newspapers, "We're going to have this vaccine in weeks..." What they're really seeing is that they can move a vaccine into clinical trials, but this will not go quickly because as we start vaccinating human volunteers, especially in areas where we have community transmission, we're going to have to proceed very slowly, very cautiously. The FDA is on top of that. They have a great team in place at the . They're aware of the problem, but it's not going to go quickly. We are going to have to follow this very slowly, cautiously, to make certain that we're not seeing that immune enhancement. So now we're hearing projections, a year, 18 months, who knows...

In 2011, together with a team of 15 scientists, I relocated to Houston, Texas, to launch a new school devoted to poverty-related diseases. The National School of Tropical Medicine at is a joint venture among three biomedical institutions—Baylor, , and the —with a mission devoted to research on and training in the treatment of neglected tropical diseases, or NTDs...