Posted in: 01/10/2020 – 01:00
Washington (AFP)
The American company “Moderna” announced that clinical tests on its experimental vaccine against Covid-19, which are among the most advanced, will not show results before November 25, thus ruling out any commercial marketing of this vaccine before the US presidential elections scheduled for November 3. Nov.
“We will have enough safety data on November 25 to be able to submit an emergency request to the Food and Drug Administration, provided that the safety data are good, that is, the vaccine is considered good,” Moderna General Manager Stephan Bancel said during a conference organized by the Financial Times. Safe. ”
Moderna, in addition to Pfizer and Johnson & Johnson, is conducting the third phase of clinical trials on experimental vaccines for the virus, during which tens of thousands of volunteers are injected with the vaccine and a similar number with a placebo vaccine, to verify the vaccine’s effectiveness and safety.
There is a fourth vaccine in the United States, which reached this third stage, but clinical trials on it were temporarily suspended. It is a vaccine developed by the “AstraZeneca” company in cooperation with the University of Oxford.
US President Donald Trump has expressed several times his hope that a vaccine will be found before the November 3 elections, which has raised fears among public health experts of putting political pressure on the regulatory process for adopting vaccines.
Only Pfizer expects to achieve results by the end of October, days before the polling date, allowing the company to immediately file a license application from the Food and Drug Administration. The testing protocol provides for a relatively fast data analysis.
But scientists and statisticians in the field of biology and experts in clinical tests have warned of the risks of granting accelerated approval, and preferred to test the vaccine for an additional few months to ensure its effectiveness and possible side effects.
Ass / H / bomb
© 2020 AFP
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