The world needs more vaccines. But the Italian project to bridge the gap faces new obstacles.

Nothing stands in the way of ReiThera except for the confusing logistics of turning science into medicine, and some of the drawbacks of this process have already surfaced in the uneven and slower-than-expected global vaccine rollout. Even in places like Europe that secured on paper multiple doses per person, the lack of production – and questions about AstraZeneca’s effectiveness for the elderly – caused a panicked realization that the first wave of the supposed solutions might not be enough. To bridge the gap, the path is at least as difficult as it was for the first comers. Like its predecessors, ReiThera faces the challenge of rapidly increasing production. But it also faces a series of new obstacles, related to this particular point in the epidemic, when major pharmaceutical companies claim that they have significant supplies and the existence of effective vaccines raises ethical questions about testing new vaccines. Politicians talk about hoping to have a homemade vaccine by September, ReiThera admits it’s still trying to navigate long waiting lists for many of its essential ingredients. “There is competition between the producers for the important substances,” said Stefano Coluca, the company’s chief technology officer. The obstacles are large enough that some Italian scientists say it makes more sense to expand production of already proven vaccines rather than investing resources to develop new vaccines. The idea got a big boost last month when French pharmaceutical company Sanofi, which has struggled with its vaccine bid, said it would instead produce 100 million doses of the vaccine made by its rival, Pfizer. In the long run it makes more sense to have many vaccinations rather than many fewer doses. They say diversity is crucial, because it remains unclear which vaccines will respond well to the new variants and which might provide longer protection or prevent transmission. Some vaccines may better protect certain populations. “It’s an actual painting.” Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh, said, “You have to think of it as a painting of an artist to draw this image, and this image stops the virus.” That’s why we need backup copies of the backups. Pfizer and Moderna, the first vaccines approved in Europe, use a new technology called mRNA that has proven surprisingly effective. But this technology makes it more expensive – and more difficult to store – than the alleged vector vaccines, which include AstraZeneca, Johnson & Johnson and ReiThera. ReiThera executives say that if their vaccine falls short of expectations, they would theoretically be able to produce an AstraZeneca vaccine. But they call that “Plan B.” “We still think our plan could be better,” Colloca said. , The company has a long list of issues to resolve first.It says it needs to hire and train 40 additional people – a 35 percent increase in its workforce.In November, it bought a 500-gallon container known as the bioreactor, which enables the chemical process. Ecological to make the vaccine. But Coluka said there is now a long waiting period for disposable bags, which contain a starter kit of liquid pollen, that are inserted into the container. “We have some stock,” Coluka said. “But it is not enough.” Even ReiThera is worried about getting glass vials. Fearing shortages, the company looked for alternatives and was considering using a medical pouch similar to an IV, and then there is the issue of increased production – and the possibility that manufacturing hiccups could cause shortages and delays in delivery, as happened with AstraZeneca. Kuluka said companies like him can learn from other people’s struggles “only to some extent”. “It’s not like AstraZeneca said,“ Here were our problems, ”Colloca said.“ I can imagine. But I don’t know. They were not ready to rise. Most of the challenge is to scale it up. The Italian government recently threw its support behind the ReiThera project, injecting 81 million euros into the company. Domenico Arcuri, the commissioner leading the coronavirus response in Italy and executive director of the Italian government’s investment arm, described ReiThera as “an integral part of the Italian vaccination strategy and campaign.” In a written statement to the Washington Post, Arcuri said he hoped the doses could be available publicly “by summer.” In addition to supplying Italy – which is now getting doses from Pfizer, Moderna and AstraZeneca – ReiThera says it has also received inquiries from countries in South America and Eastern Europe. In those regions, a European-made vaccine may represent an alternative to options from Russia and China, which have targeted poor countries, in part as a way to gain influence and goodwill. If there is enough interest from outside, ReiThera says, he plans to collaborate with a Belgium-based commercial facility, Univercells, to expand production. The candidate Rethira vaccine is one of 63 worldwide in the midst of clinical trials, according to the World Health Organization. Before the pandemic, ReiThera was what Colloca called a “strong little business”. It was only a few years old, but top scientists had years of experience creating vaccines against emerging diseases, using modified adenoviruses from great apes, and the company said the results of the first phase of its trial, which was completed this month, were encouraging: The vaccine seemed safe for young and old. Both, the antibodies were stimulated in more than 90 percent of the volunteers, however, scientists warn that there are many types of antibodies, some of which may fight aggressively with the Corona virus and others may not, and the Phase 1 experiment does not provide enough information. . In normal situations, the company will eventually subject its candidate to a large-scale trial in which some volunteers receive the vaccine while others receive a placebo. But many medical experts say it has become a mystery whether the company can ethically inject people, especially the elderly, with no more than saline when effective vaccines are already available. There is no doubt that placebo trials are the best way to test a vaccine but she is unsure if ReiThera will be able to perform one, said Antonella Folgore, CEO of ReiThera. She says she has been anxiously joining webinars, talking to others in the field, and looking for clues about what governments are thinking. So far, the medical staff in Europe has not provided any rules, there are alternatives that can be imagined, including the possibility of giving the ReiThera vaccine to all volunteers, and then comparing their antibody response to responses from other vaccines already proven. But this comparison cannot be made on the basis of the current level of scientific knowledge. More research needs to be done to determine the type of immune response associated with protection. This could be at least several months, Folgori said, describing it as a “resilient situation.” “There is still a chance that it will not work out as we hope,” Coluka said. But he said, “You cannot start this project if you are not optimistic.”