European Medicines Agency approves urgency use of Merck’s emergency

Europe has become the epicenter of the Pandemic of Covid-19. One year after the autumn epidemic earthquake 2020, the old continent is the victim of a powerful replica.

Le Monde with AFP

At the edge of a new wave of coronavirus contamination, while the sanitary pass is generalized across Europe, the European Medicines Agency (AEM) approved, Friday, November 19, the use, In case of emergency, before its formal authorization within the European Union, the pill against Merck’s VVID-19, and begun a review of that of Pfizer.

The two treatments of American pharmaceutical giants are very expected, and studies indicate that they reduce the risk of hospitalization and death in risky patients.

The AEM said that the Merck tablet has not yet been approved, it had “issued recommendations” so that the countries of the European Union can individually decide to use it in case of peak. infections. Member States can now use it “to treat adults with CVIV-19 that do not need additional oxygen and have an increased risk of developing a severe” disease, has announced the proceeding. In a Communiqué .

“The AEM has issued this notice to support the national authorities who may decide on a possible anticipated use of the drug before the marketing authorization, for example in emergency situations,” observing ” Increasing rate of infection and death from COVID-19 in the EU, “said the European regulator in a statement.

The Merck pill should not be used by pregnant women or women who do not take contraception and could fall pregnant, said the AEM. “These recommendations are given because laboratory studies on animals have shown that high doses of [Merck’s pill] can have an impact on growth and development of the fetus,” he added. The regulator, based in Amsterdam, says hope to pronounce on the formal authorization of the Merck pill, also known as Molnupiravir, by the end of the year.

The AEM separately announced having launched a review for emergency authorization of the Pfizer’s Anti-Covid Pill. “EMA examines the data currently available on the use of PaxLovid, an oral treatment for COVID-19 developed by Pfizer,” said Authority in a communiqué . A “continuous” examination of the pfizer pill, more complete, should begin next week, but the European regulator wanted to be able to support the authorities “as soon as possible”

The pandemic due to the new coronavirus has made at least 5,122,675 people in the world since the end of 2019, according to a balance sheet established by the France-Presse agency from official sources Thursday at noon. More than 254,952,650 cases of infection have been officially diagnosed since the beginning of the epidemic. The World Health Organization estimates, taking into account the overmortality directly and indirectly related to CIVID-19, that the overall pandemic assessment could be two to three times higher than that calculated from official figures.

/Media reports.