Italians in the vaccine ring: ReiThera vaccine against gorilla adenovirus – € 5 each

Started at the end of the last century, the small Italian pharmaceutical company Okairos, together with the University of Oxford, developed a vaccine against malaria, developed vaccines against hepatitis C and collaborated with pharmaceutical giants in the production of vaccines against Ebola. Italians became famous in the pharmaceutical market after discharging the feces of these monkeys from a European zoo without obtaining permission to work directly with gorillas and extract a powerful adenovirus from them.

The company’s developers are leading Italian virologists. The exploration and production activities take place near Rome, but ReiTher is financially controlled by Swiss capital, so its official headquarters are in Basel. The company has a total of 110 specialists, mostly women. Currently, 70 employees are engaged in the development and production of coronavirus vaccines.

ReiThera is the smallest company compared to the pharmaceutical giants developing the coronavirus vaccine, but with big ambitions. After serious uncertainties about the effectiveness of the Astra Zeneca vaccine for various age groups and its final approval dates, interest in ReiThera grows every day in both Italy and Europe. We discussed the prospects for the Italian vaccine with Antonella Folgori, President of the ReiThera Group, and Stefano Colloca, Director of Technological Processes.

“We have successfully completed the first phase of vaccine testing. During it, volunteers of two age groups were vaccinated. The first group consisted of men and women under 55 years of age, and the second group consisted of 65 to 85 years. So far, all I can say is that the results of this phase are positive. We will soon begin the second phase of testing, during which healthy test subjects will receive the vaccine we have developed and we will monitor their health. If successful, we will start the last and third phase of testing this spring, and present the results of the experiments to the European Medicines Agency EMA in early summer, ”says Antonella Folgori, President of the ReiThera Group.

– What is the real capacity of your company? When will Grad-Cov2 testing end and vaccination begin?

S. Colloca: – We will not wait for the decision of the EMA, we will begin mass production of the vaccine already in March. If all phases of the trial are successful, we will be ready to market a certain number of doses. Our capacity is 10 million doses per month or around 100 million doses per year. We hope that the approval process will not be delayed, we are optimistic, we imagine that early this summer people will be able to receive the ReiThera vaccine.

– Tell me how your vaccine works.

A. Folgori: – We have a lot of experience in the development of genetic vaccines. Our goal is a vaccine for an adenovirus vector extracted from non-human primates. The technology is somewhat similar to that of pharmaceutical companies such as Astra Zeneca or Johnson & Johnson.

Of course there are differences. Let’s say Astra Zeneca used a vector isolated from a chimpanzee and Johnson & Johnson used a human. We were able to isolate a sufficiently effective group C adenovirus vector from a gorilla. We use it as a miniature rocket, a carrier that carries a tiny portion of the virus to the human body. It is modeled in such a way that its reproduction on the body would be absolutely impossible. On the other hand, it will be used to activate the patient’s immune response in case of COVID-19 infection.

– There is a lot of competition in the vaccine market. How special is your vaccine compared to other drug companies?

S. Colloca: – We are developing a single dose immunization vaccine. It is not an easy task, but the results obtained so far are truly gratifying. The single dose vaccine will probably be the most important feature of ReiThera.

A. Folgori: – This vaccine stimulates the reaction of a certain group of lymphocytes, stopping the penetration of the virus into cells. In this way, our body uses a powerful weapon to fight infection. The experiments showed that all of the vaccinated volunteers were able to elicit a powerful lymphocytic response to COVID-19.

– What will be the logistics of the medicines? Will extremely low temperatures be required to transport and store your vaccine?

S. Colloca: – No. For the final record, we are committed to providing a product that can be stored and transported in a simple household refrigerator at a temperature of 2 to 8 degrees.

– And what about the various mutations of the coronavirus: the English, South African variants? Will your vaccine protect against these mutations? Are you, the vaccine developer, concerned about this problem?

S. Colloca: – So far we know that our vaccine protects effectively against the English variant. Until now, we have not had a chance to test the effectiveness of your immune response to the South African variant. Without a doubt, COVID-19 mutations are a complex topic for all vaccine developers.

– Will the vaccines you develop be only for Italy? Can other countries buy them?

S. Colloca: – We will first discuss the distribution with the Italian government. But our approach is this: ReiThera Grad-Cov2 is for everyone. As I mentioned, the company’s annual production capacity is around 100 million doses, but the capacity can be increased if there is interest in our product. Therefore, we are already awaiting cooperation proposals. We are open to everyone.

– When will the second phase of the test begin, how many volunteers will participate in it?

A. Folgori: – We plan to start the second trial phase in February, we will use 900 volunteers. We will not only investigate the overall efficacy of the vaccine, but we will also evaluate the effect of single-dose immunization. We will run two-dose immunization tests in parallel. Several thousand volunteers will participate in the final third stage.

– Has the Italian government financed the development of your vaccine?

Mr. Folgori: – Yes, the Regional Government of Lazio, the Italian Ministry of Universities and Research have already transferred 8 million euros to us, which we have used for the initial clinical trials of the vaccine.

– The prevailing view is that vaccines are developing too quickly during this pandemic, so this urgency will affect their reliability and quality in one way or another. What can answer this question for vaccine users?

A.Folgori: – If we evaluate the safety protocol for the development of the vaccine, I can guarantee that there were no irregularities or artificial accelerations in our case. It should simply be understood that the fight against the COVID-19 virus has focused on exceptional capabilities, not only in terms of technology, but also in terms of funding opportunities. The usual vaccine development and production practice so far has been different: each stage of the experiment has had to look for separate funding opportunities, so the whole process obviously took a long time. This time we had exceptional financial opportunities not only to conduct clinical research at the same time, but also to coordinate and optimize production in parallel.

– What will the final price of Grad-Cov2 be?

S. Colloca: – We plan that the price of a dose will be around the level of Astra Zeneca vaccines. It will not exceed 5 euros.