The Committee of New Molecules of the Federal Commission for the Protection against Sanitary Risks (Cofepris) unanimously issued its favorable opinion for the authorization of the emergency use of the Vero Cell Inactivated vaccine from the Sinopharm laboratory.
In addition, experts from the auxiliary body of the health regulator also gave their favorable opinion for the health registration of the drug with active ingredient remdesivir for the treatment of people with COVID-19.
“Both opinions of the committee represent the previous step for any type of authorization, which are issued by the Federal Commission for the Protection against Sanitary Risks,” said the sanitary regulator in a statement.
He explained that the authorization for emergency use of the vaccine against COVID-19 Sinopharm, prequalified by the World Health Organization (WHO) on May 7, was requested by the Birmex laboratory for its application in people over 18 years of age.
Regarding the drug remdesivir, Cofepris reported that the pharmaceutical company Gilead submitted the application for health registration for the drug, whose authorization for emergency use was reported on March 12.
The drug received the opinion of the experts with the therapeutic indication for adult and pediatric patients (from 12 years with a minimum weight of 40 kilos), who have less than seven days of COVID-19 symptoms and require hospitalization.
The next step for both cases consists of the submission of files by each pharmacist, which will be ruled by expert personnel from the regulator’s Sanitary Authorization Commission.
