ROME, January 11. / Corr. TASS Vera Shcherbakova /. Italy may register its own vaccine against the new type of coronavirus by summer. As the head of the group of immunologists of the developer company Reither, Stephanie Capone, told on Monday in an interview with TASS, in February it is planned to start conducting the second and third stages of clinical trials, and by the summer to collect the data necessary for registration of the drug.
"Our vaccine is based on adenovirus technology, like Sputnik V, the AstraZeneca vaccine being developed by Oxford, and Johnson & Johnson. The difference is the adenovirus used. We use the adenovirus isolated from the gorilla. This is a new adenovirus, AstraZenec uses material from chimpanzees." and your "Sputnik" and Johnson are of human origin, "the specialist explained. She reported that the adenovirus was isolated at the end of 2019.
“After successful animal trials in the summer, we started the first phase of human trials in Rome and Verona. The results are encouraging. Clinical trials are being carried out in collaboration with a leading medical institution, the National Institute of Infectious Diseases named after Lazzaro Spallanzani. We are working to start in February, studies of the second and third stages at once. According to our calculations, the data that must be provided for registration of the drug, we should receive by the end of spring, early summer, "- said the agency's interlocutor.
She also clarified that, according to the available data from the first phase, one dose of the vaccine is sufficient. And its cost on the market will be 6-8.
Pioneers with a long history
Biotechnology company Reither is one of the leading in the field of work with adenoviruses. “We are pioneers in monkey-derived adenoviruses, we have been developing this technology for more than 15 years. Previously, the company collaborated on various developments with the University of Oxford, and was also involved in the development of vaccines against Ebola, against malaria, as well as against respiratory syncytial virus. dangerous for newborns.
Reither began to work on a vaccine against the coronavirus independently, having received support from the regional authorities of the metropolitan area of Lazio and the Italian Ministry of Health. In case of successful completion of all stages, this will become the first product under the brand name of the company. Not only does Reither have extensive laboratory capabilities, but also its own manufacturing capacity, Capone said, which could produce up to 100 million doses of vaccine per year.
“We have not received orders yet, but WHO calls for continuing to develop vaccines, because many effective drugs based on different principles of action will be needed. We do not know how many doses will be needed, because any statement about the duration of immunity is just a guess, no one can yet know this. It is possible that additional injections will be needed, "said the expert. The company hopes primarily to offer the vaccine to Italy. “We do not mind cooperation and are ready to sell abroad,” she added.
Virus mutations
Capone considers it unlikely that vaccines will be completely inactive against new variations of the coronavirus. In her opinion, in any case, the developers have the technology to quickly respond to mutations.
“Like any respiratory virus, the coronavirus is prone to constant mutation, and this was quite expected. What variants may appear is unknown, but so far only small parts of the spike protein are modified, and vaccines act on the entire protein in the complex. In addition, the vaccine provokes the production of many antibodies in the body that counteract various elements of the spike protein, "the immunologist explained." Perhaps, with the appearance of special modifications, the vaccine may lose its power a little, "the expert continued," but even in an extreme case, which to me seems almost impossible, we already have at our disposal effective technologies that will allow us to modify the vaccine against the new spike protein in the shortest possible time."