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The whole world is waiting for the vaccine

The whole world is closely monitoring the possible evolution of the vaccine issue. With the increase (again) of cases in Europe and the worsening of the trend in many areas of the world, it seems that the only possible solution may be the vaccine.
Meanwhile, Antonio Metastasio, an Italian psychiatrist who lives and works in Cambridge, has received the booster dose of the vaccine that AstraZeneca is developing with the University of Oxford against the coronavirus.
Metastasio is one of the study volunteers. The booster was given to him at Addenbrooke’s hospital in Cambridge.
“I’m fine. I haven’t had any kind of problem – assures Metastasio -. Of course, I can’t know if I received the actual vaccine or a placebo.” The study is carried out in a ‘double blind’ according to which neither the volunteer nor do doctors know the true nature of the injected substance.

Meanwhile, the EU Commission signs a second “insurance” against the coronavirus. Thanks to the agreement signed with Sanofi and GSK, European states will be able to obtain up to 300 million doses of the anti-Covid 19 vaccine that the two pharmaceutical multinationals are developing together. A new step in the fight against the virus, after the 27 August contract with AstraZeneca for 300 million doses with the option to purchase another 100 million.

The EU is betting on different solutions and aims to protect as many people as possible. “Agreements with other companies will soon be concluded – says Ursula von der Leyen, president of the European Commission – and we will create a diversified portfolio of promising vaccines, based on various types of technologies, increasing our chances of finding an effective remedy against the virus”. Among the companies involved are Johnson & Johnson, CureVac, Moderna and BionTech. Member States will be able to donate doses to low- and middle-income countries. Sanofi and Gsk are committed to making a significant portion of their supply available in a short time through collaboration with Covax, the WHO (World Health Organization) structure created to ensure universal access to the vaccine and that the European Union strengthened with 230 million. Funds for the new contract come from the Emergency Support Instrument, the EU’s financial arm for fighting the epidemic. Economic details were not disclosed, while the previous agreement with AstraZeneca is worth 336 million euros according to Reuters news agency.

The French group Sanofi and the British partner GSK collaborate in the production of the vaccine by combining technology based on recombinant proteins (already used for the flu vaccine) and adjuvant technology. These are widely used techniques for vaccines currently on the market. As with so many competitors around the world (around 180), it is difficult to say when the vaccine candidate might make it to the finish line. On September 3, Phase 1/2 trials were announced on 440 healthy adults at 11 test sites in the United States.
The two companies aim to have the first results in December of this year and to start phase 3 at the same time. If sufficient data is collected, the plan foresees the request for regulatory approval in the first half of 2021. For its part, the The Commission together with the Member States and the European Medicines Agency will carry out a flexible but robust regulatory process. The multinationals have already identified the production plants: from plants in Belgium, Germany, France and Italy (to Anagni) it could reach up to one billion doses per year.
The Sanofi-Gsk vaccine differs from the one that the AstraZeneca group is developing together with the University of Oxford: the latter is based on viral vectors. In a phase 3 study in Brazil, South Africa and the United States, the Irbm (Molecular Biology Research Institute) in Pomezia is also collaborating on its implementation. The first doses in Italy were expected by the end of the year, but the race to the finish was interrupted when one of the participants in the clinical trials showed an abnormal reaction. The stop, however, was only temporary: the trials resumed in the United Kingdom after the company received authorization from all the British regulatory bodies. Parallel to the “race” for the vaccine, evaluations are underway on the population groups to be protected first. In Italy, the Minister of Health Roberto Speranza thinks of doctors and the elderly.

By Domenico Greco

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