The European Medicines Agency (EMA) has just given the green light to the use of Pfizer’s pill against covid as an emergency measure. The antiviral Paxlovid would be administered as soon as the disease is diagnosed in adults with COVID who are at risk of developing a severe condition , but who do not require supplemental oxygen. The authorities of each country will have the power to approve its use pending an official license at the European level.
The EMA announcement comes at a time when the omicron variant is spreading across Europe, contagion rates are growing and the number of deaths is rising . “The Agency’s recommendation can be used to support national approvals of the possible use of the medicine before commercial authorization,” the EMA said in a statement.
The European institution has ensured that on the 13th, the so-called “continuous review” of the drug began, which entails reviewing the data of the pill as they become available. The EMA will evaluate more comprehensive data on the quality, safety and efficacy of the drug. Ongoing review will continue until sufficient evidence is available for the company to submit a formal application for marketing authorization.
The pharmaceutical company Pfizer recently announced that its pill against COVID-19 is capable of reducing by almost 90% the risk of hospitalization and death of people belonging to some risk group if it is taken in the first five days after having symptoms. In addition, and as reported by the American company, Paxlovid would act effectively against the omicron variant, more specifically it would be a “powerful inhibitor” of it. The results are based on a study that Pfizer carried out with about 2,250 unvaccinated people who had some risk factor associated with severe covid, such as diabetes, hypertension and obesity.
The most common side effects reported during treatment and up to 34 days after the last dose of Paxlovid were taste disturbances, diarrhea, and vomiting .
Paxlovid is not recommended during pregnancy or in women who could become pregnant. It is also not advised to take while breastfeeding. These recommendations are because laboratory studies in animals suggest that high doses of the drug can affect the growth of the fetus.
