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In an interview published today by the Financial Times, the director of the Food and Drug Administration (FDA), the federal agency that oversees the marketing of drugs in the United States, said that any request for authorization must be made by those who are developing the vaccine.
“If they do this before the end of phase 3, we may consider it appropriate, we may find it inappropriate, we will do an assessment,” said Stephen Hahn.
Still, Hahn defended himself against pressure from US President Donald Trump to authorize a vaccine before the November 3 presidential election, saying it will be a “decision based on science, medicine and data, not a decision”. politics”.
Three Western vaccine manufacturers are well advanced and in phase 3 clinical trials, which will include tens of thousands of participants: AstraZeneca (partner, British University of Oxford), Moderna (partner, American Institutes of Health) and the Pfizer / BioNTech alliance.
However, due to the very nature of these tests, it is difficult to predict when the first results will appear.
Half of the participants receive the experimental vaccine and the other half a placebo. The normal process is for clinical evaluators to wait, possibly months, to see if there is a statistically significant difference in the number of people infected with the virus between the two groups.
On the other hand, China and Russia announced that they authorized two vaccines before the completion of all phases of the tests.
According to Stephen Hahn, an emergency clearance can be granted for a specific category of people.
“An emergency clearance is not the same as a full clearance,” he said.
The FDA chief is increasingly criticized by the medical and scientific community, who suspect that he has stepped down to satisfy the US president for two incidents.
In late March, the FDA authorized hydroxychloroquine as an emergency to treat COVID-19 patients after the president launched the drug, but the authorization was withdrawn in June due to negative side effects.
Later, Hahn acknowledged that he had been wrong again during a press conference with Trump, announcing the urgent authorization of convalescent plasma for patients with COVID-19, after overestimating the benefits of it, claiming that the treatment could save 35 of every 100 people. , although the most likely figure is around 5%.
“Speeding up any process to authorize a SARS-CoV-2 vaccine is outrageous, no matter how cunning Trump is,” Eric Topol, director of the Scripps Translational Research Institute, criticized on Twitter.
The United States is the country with the most deaths (182,785) and also with the most confirmed cases of infection (more than 5.9 million).
The covid-19 pandemic has already claimed at least 843,000 deaths and infected more than 25 million people in 196 countries and territories, according to a report by the French agency AFP.
The disease is transmitted by a new coronavirus detected in late December in Wuhan, a city in central China.
