No-rule war between the US, Russia and China worries scientists



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Controversy in the medical-scientific community for the words of Stephen Hahn, commissioner of the Food and Drug Administration (FDA) American who in an interview with the English newspaper Financial times hypothesized a go-ahead for Vaccine for COVID-19 even before the conclusion of phase III, the last step in the rigorous clinical trial that new pharmaceutical products must undergo.

Although Hahn has assured that “this will not be a political decision” but “a scientific, medical decision, based on data”, the fear expressed by many is that the announcement has weighed on the pressure of the president. U.S Donald Trump, before the next US elections.

For Walter Ricciardi, advisor to Health Minister Roberto Speranza, this is a “wrong and dangerous decision.” “For vaccines – warns Ricciardi in a tweet – safety must be demonstrated even before efficacy. It is not possible to repeal the appropriate methods and times”.

Sergio Abrignani, an immunologist and Senior Lecturer in General Pathology at Milan State University, had voiced his criticism of the similarly hasty procedures used for the Russian vaccine in an interview with Corriere Salute on August 11. “The Russians will have won the race, but without following the scientific rules because it is not possible to know if the vaccination works and especially if there are side effects since phase 3 usually takes a year and a half.“.

In fact, the Kremlin aims to begin mass vaccination of high-risk groups against Covid-19 from November-December this year. As reported by local press agencies, the Minister of Health Mikhail murashko He explained how Russia became the first country to grant regulatory approval for a new coronavirus vaccine after less than two months of human testing. A fact that has led international experts to question its safety and efficacy.

“The first vaccines will begin to arrive in small quantities from September,” explains Mikhail Murashko quoted by the news agency. Sputnik – while a more massive vaccination is scheduled for November-December. The vaccine will be administered first to health professionals and teachers. “

If the trial phase of the tricolor vaccine has started in Italy, the China has registered 4 of the 7 vaccines that have been admitted in Phase 3 of the trials in the world and the chances that the current tender between the large pharmaceutical multinationals will be won by Sinopharm, the national pharmaceutical group of Beijing, are very high. Sinovac is also in the running, for the first time he was able to publish the results of his animal experiments in May in the journal Science and begin testing on a sample of 600 volunteers. Today it has signed an agreement with Brazil where phase 3 began at the end of July with 9,000 volunteers. In exchange for this collaboration, Brazil will receive 120 million doses as soon as possible.

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Meanwhile, the case of a 9-year-old Italian boy isolated from April to early August is being discussed because the hyssop was always positive. He had only experienced a little cough and a few fever lines for a single day, but could he really infect other people? That of viral load It will be an important issue to explore given the impact on the definition of the necessary quarantine times also in view of the reopening of schools.

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