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July 27, 2020The world's largest human trial for the Covid-19 vaccine, developed by the American company Moderna Inc. with the United States National Institute for Infectious Diseases (Niaid), directed by Anthony Fauci, has started. This was announced by the National Institutes of Health of which Niaid is part. The trial will be done on 89 American sites on about 30,000 healthy volunteers. It is one of 5 vaccines that reached Phase 3 among the 25 now in the human study.

There is still no guarantee that the experimental vaccine will effectively protect people from Covid-19. Several other vaccines produced by China and the University of Oxford in Britain earlier this month began testing in Brazil and other countries hit hard by the pandemic.

The United States has doubled its financial investment, bringing it to around a billion dollars total, to support the development of a Covid-19 vaccine. This is the potential vaccine developed by the American company Moderna which has now entered the last phase of clinical testing. 

The US government has pledged to allocate up to $ 472 million more, which substantially doubles the $ 483 million already announced, Moderna said in a statement. The doubling of the appropriation is motivated by the fact that Moderna has decided to "conduct a much larger Phase 3 clinical trial" than was foreseen.

The test started today on 30 thousand people, half of whom will have inoculated a dose of 100 micrograms, while the rest will take a placebo. The United States is the country most affected by the new coronavirus in the world and in recent months have announced massive investments to secure vaccine doses. The German-American alliance Biontech / Pfizer said Wednesday that Washington will pay nearly $ 2 billion to secure 100 million doses of the vaccine.

If effective, 1 billion doses since 2021
The modern US company ensures that if the covid vaccine, called Mrna-1273, proves to be effective and safe, it will be able to deliver at least 500 million doses per year, but probably up to one billion doses as of 2021. Half of the 30,000 people involved in the Phase 3 trial will receive two injections of the vaccine 28 days apart, the other half two injections of a placebo solution. Both volunteers and researchers won't know who received the vaccine and who didn't.

Fauci: "We urgently need the vaccine"
"Although masks, social distancing and quarantine can help mitigate the spread of the virus, we urgently need a healthy and effective vaccine to control this pandemic," underlines Anthony Fauci. "The results of the early experimental phases indicate that this vaccine is safe and stimulates the immune response. Phase 3 will help to understand if the vaccine can prevent the disease and how long its protection can last." 

Lincei: cautious on results of vaccines
Cautele on the "accelerated evaluation" of candidates for Covid-19 vaccines in human trials, often dictated by haste and urgency, and the need for rigorous safety studies. The invitation to caution comes from the document of the Accademia di Lincei Health Commission and refers both to announcements on preliminary test results and to procedures such as the Human Challenge Trial, which provides for the administration of the virus after that of the vaccine in healthy volunteers .