Italy on Monday began human testing of its vaccine against covid-19, created and produced in the country. The first experimental dose of the compound was injected into a 50-year-old woman, having passed preclinical tests both in vitro and in animals with a strong immune response and a good safety profile, according to the researchers. The formula has been devised by the biotechnology company RaiThera and the trials will be carried out at the Lazzaro Spallanzani National Institute of Infectious Diseases in Rome, the reference center on the matter.
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The woman, who remains anonymous, has been the first of the 90 volunteers who will receive the vaccine from this Monday and has said that she is "excited and proud" to participate in the experiment. "I believe in Italian science, I hope that this gesture will save lives and I hope that people are more responsible not to put themselves or others at risk," said the Italian before starting, as explained by the director hospital health worker, Francesco Vaia.
Like her, the rest of the volunteers will have to remain under observation for four hours after the injection and in the next 24 weeks they will undergo a total of eight reviews to control that they do not present serious side effects. The 90 patients who will test the drug have been selected from the more than 5,000 people who volunteered to participate in the experiment, many of whom are doctors and health personnel. Half of them are between the ages of 18 and 55 and the other half are over 65. Each will be given a different dose of the vaccine. If those who receive the injection these first weeks do not have dangerous reactions, it is expected that the September volunteers will receive increasing doses of the compound.
The project is in the first phase of experimentation, the main tasks of which are to evaluate the safety of the candidate vaccine and later determine if it is capable of activating the production of antibodies. One of the laboratory's research managers, Stefano Còlloca, told La Repubblica newspaper that technicians are optimistic about the compound's ability to elicit an immune response in the human body, although that is not enough to guarantee its effectiveness. "The biggest question is how long this response will last," he said.
If the results of this stage are positive, phase 2 could begin in about seven months, with a greater number of volunteers, also outside the transalpine country, in places where there are a greater number of infected, as Francesco Vaia has pointed out, who has Latin America was mentioned as a possible test bed for the successive stages. "If all goes well, we are counting on being able to have a formula to market next spring," he added. The laboratory, with more than two decades of experience, is preparing in advance to expand its offices and its production capacity, in order to be able to manufacture, if necessary, millions of doses.
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The Italian experimental vaccine follows the method of the one developed by the University of Oxford, one of the most advanced, and is made from a weakened version of an adenovirus of the common gorilla cold that is genetically modified to prevent its multiplication when inoculated in the human being. The laboratory, based on the periphery of the Italian capital, does not have gorillas in its facilities, but they have carried out tests on feces of these primates sent from a zoo in Germany. The researchers added genes to the DNA of the simian virus with instructions to make only the spike proteins of the coronavirus, the key that allows the pathogen to enter human cells.
The frenzied race for a coronavirus vaccine is taking place not just in the pharmaceutical industries but also in politics. The ReiThera group started working with its own funds in January and invested some five million euros in the preclinical phase. With the first effective results came public funding: five million from the Lazio region, whose capital is Rome and another three from the Ministry of Health. “The Italian vaccine will be public and will be available to all who need it. We believe in the vaccine as a common good ”, said the president of Lazio, Nicola Zingaretti. The Minister of Health, Roberto Speranza, has specified that Italian intelligence and investigation "are at the service of the global challenge to defeat COVID-19".
The director of the Spallanzani, Giuseppe Ippolito, has stressed that guaranteeing the independence of the transalpine country in the fight against the pandemic is another of the strengths of the project. "Italy enters the war fully to get the vaccine, but not to arrive first but to arrive better. Having an Italian vaccine will allow us not to be slaves of other countries that will say I go first ”.
Vaccines, first for risk groups
The World Health Organization (WHO) has warned this Monday in Geneva (Switzerland) that a race between countries to get the largest possible number of vaccines would end up worsening the effects and duration of the coronavirus pandemic. This has been stated by the general director of the organization, Tedros Adhanom Ghebreyesus, who has defended "the worldwide coordinated deployment" that the COVAX platform entails, reports Oriol Güell . Right now there are 30 experimental vaccines in human trials.
This initiative has been created by the WHO itself, Gavi (the Global Alliance for Vaccines and Immunization), and the Coalition for Epidemic Preparedness Innovations. Its objective is that all countries have access to vaccines in an equitable way according to their population and needs. This approach has run into large agreements signed with pharmaceutical companies by countries like the United States and blocs like the European Union to get hold of hundreds of millions of doses.
“It is a pleasure for me to announce that as of today 172 countries are collaborating with the global COVAX vaccine mechanism,” Ghebreyesus celebrated. The WHO has insisted that the platform "has the largest portfolio of vaccines, at the moment we have nine" and that there are another nine under study.
The system foresees that each country can initially vaccinate 20% of its population with the vaccines received, which includes practically all risk groups. In a second round, new doses would be distributed according to the vulnerability and situation of each country. This, and the global dialogue with the collaborating pharmaceutical companies, will allow "not only to group risk, but also to keep prices as low as possible", concluded the director general of the WHO.
For its part, Spain is "absolutely committed to the establishment of a global approach to access to the vaccine that protects the population," according to a spokesman for the Ministry of Health told EL PAÍS. "It is a matter of Public Health so we should not leave anyone behind," the same sources point out. They also detail that there are currently conversations between COVAX and the EU and its member states to determine how participation in COVAX and the European Strategy are made compatible (Spain is part of the agreement for the advance purchase of vaccines against COVID-19 ). In Europe, 75% of vaccines are produced worldwide; Through the agreements with the companies, their production capacity is increased to allow deployment not only in Europe but also in third countries.
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