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Tuesday 5 January 2021 17:01

Italy a step closer to "vaccine independence"

Italy took a step closer to “vaccine independence" on Tuesday when Rome-based biotech company ReiThera presented the results of Phase One testing of its GRAd-CoV2 vaccine. The new vaccine was pronounced safe by Giuseppe Ippolito, scientific director at the Spallanzani, Italy's premier infectious disease hospital. A total of 100 volunteers were enrolled in the first […]

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Italy took a step closer to “vaccine independence" on Tuesday when Rome-based biotech company ReiThera presented the results of Phase One testing of its GRAd-CoV2 vaccine. The new vaccine was pronounced safe by Giuseppe Ippolito, scientific director at the Spallanzani, Italy's premier infectious disease hospital.

A total of 100 volunteers were enrolled in the first phase of testing, and 45 individuals aged between 18 and 55 were vaccinated with varying doses. None showed serious adverse effects in the 28 days after the vaccination, a better result than the Moderna and Pfizer vaccines which had “undesired effects”, Ippolito claimed. The new vaccine developed antibodies in 92.5% of those tested and is stable at a temperature of between two and eight degrees Celsius, making it easier to distribute than the Moderna and Pfizer/BioNTech vaccines. "The peak of production of antibodies remains constant at four weeks and the vaccine is single dose."

ReiThera is working with Germany’s Leukocare and Belgium’s Univercells and began talks with the European Union in September to supply the bloc. Italy's Covid-19 tzar Domenico Arcuri announced that the Italian government is planning to invest in the company to support Phases 2 and 3 and “allow Italy to depend as little as possible on other countries”. ReiThera hopes to complete Phase 3 by the summer and submit an application for registration of the vaccine in early summer. Eventually, the company is aiming to produce 100 million doses a year.

Meanwhile, Italy is relying entirely on a European Union joint procurement initiative. There is growing criticism of the slow pace of Europe’s regulatory process. With Pfizer/BioNTech so far the only vaccine approved, demand from EU countries is outstripping supply. Ugur Sahin, BioNTech’s chief executive, told Der Spiegel: “At the moment it doesn’t look good – a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own.”

Italy has administered 180,000 Covid jabs, Higher Health Council (CSS) chief Franco Locatelli announced Tuesday, one of the highest rates in Europe. By the weekend France had only managed to vaccinate 516 people, despite having 500,000 doses. The Netherlands is not even beginning its vaccination programme until later this week.

A single dose, easily distributed Italian vaccine would be a game-changer for the country, but with regulatory approval at best six months away, and large-scale manufacturing yet to begin, “vaccine independence” is still far off. Meanwhile, Italians, like all Europeans, must hope that regulatory delays, supply chain issues and manufacturing bottlenecks don’t continue to slow the administration of the vaccines that already exist.

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