US ready for fast track to clear future vaccine

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WASHINGTON | The head of the United States Medicines Agency (FDA) announced in an interview published on Sunday by the Financial Times, that it was possible that a future vaccine against the coronavirus would first be authorized under an emergency procedure, before the end of clinical trials supposed to confirm its safety and effectiveness.

• Read also: All the developments of the pandemic

Any authorization request will have to be filed by the vaccine developer, said Stephen Hahn. “If they do it before the end of phase 3, we may see it as appropriate. We might find that inappropriate, we will do an assessment ”.

But he defended himself being pressured by President Donald Trump to authorize a vaccine before the November 3 presidential election, saying: “It will be a decision based on science, medicine, data. It will not be a political decision ”.

Three Western vaccine makers are well advanced and in Phase 3 clinical trials, which will include in fine tens of thousands of participants: AstraZeneca (partner of the British University of Oxford), Moderna (partner of the American Institutes of Health) and the Pfizer / BioNTech alliance.

But, by the very nature of these trials, it is difficult to predict when the first results will appear.

Half of the participants receive the experimental vaccine, and the other half receive a placebo. The normal process is for those responsible for clinical trials to wait, possibly for months, to see if a statistically significant difference in the number of people infected with the virus appears between the two groups.

Conversely, China and Russia announced that they were authorizing two vaccines before the trials were concluded.

According to Stephen Hahn, an emergency authorization could be granted for a particular category of people. “Emergency clearance is not the same as full clearance,” he said.

But the head of the FDA is more and more criticized by the medical and scientific community who suspect him of bending the spine to satisfy the American president, because of two incidents. The FDA authorized emergency hydroxychloroquine to treat COVID-19 patients at the end of March, after the president had touted the drug; but the authorization was withdrawn in June due to significant side effects.

Then, Stephen Hahn admitted he was wrong at a recent press conference with Mr. Trump in announcing the emergency authorization of convalescent plasma for COVID-19 patients; he greatly overestimated its benefits, claiming that the treatment could save 35 out of 100 people, when the more likely figure is around 5 percent.

“To accelerate any process of authorization of a vaccine against the SARS-CoV-2 is scandalous, no matter how subservient Stephen Hahn is to Trump,” Eric Topol, director of the Scripps Research Translational Institute, criticized on Twitter.

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