The European Medicine Agency (EMA) opens the door to the use of emergency of antiviral molnupiravir against COVID-19.
This has been announced at the Framework Cavaleri press conference, responsible for biological products and vaccine strategy of EMA.
The European Agency is reviewing the data of this MSD drug which, according to the data provided by the pharmaceutical company, is capable of halving the risk of death and hospitalization by Covid.
While the experts in charge of the review reach a conclusion on the drug, EMA has decided to streamline access to treatment by giving free to the EU Member States to authorize their use under the emergency route.
It will be the Spanish Agency of the Medicine (AEMPS), therefore, who makes a decision about it.
EMA “is prepared to advise Member States so that they can make this treatment available for emergency use, before it receives their commercial authorization,” said Cavaleri, who explained that the decision to favor emergency use.
Del drug should be interpreted in the context of the new increase in cases that many European countries are experiencing.
In Spain, however, the incidence has been stuck and, at the moment, the increase that is appreciated in Germany, Denmark or Greece is not occurring among other countries.
“The epidemiological situation of the Covid in Europe is worrisome,” said Cavaleri.
In this regard, the person responsible for vaccine strategy encouraged to streamline and expand vaccine coverage, as well as to carry out precautionary measures.
EMA’s decision on antiviral MOLNUPIRAVIR coincides with the authorization of the drug by the British regulatory authorities.
United Kingdom is, at the moment, the only country that has approved the use of antiviral.
MOLNUPIRAVIR is an antiviral drug that in a phase 3 clinical study (in 775 patients) performed by MSD has been shown to halve the risk of hospitalization and death in adult patients at risk of developing severe Covid.
In his speech, Cavaleri has also indicated that EMA expects to arrive in December to a conclusion on the approval of the Pfizer / Biontech vaccine against Covid in children between 5 and 11 years old.
Last Tuesday, the FDA, the US regulatory agency, gave green light to the use of the drug in this age range.
Cavaleri stressed that one of the aspects that EMA is reviewing especially is the relationship between benefits and risks of the drug in children.
The Agency is also reviewing the data on the reinforcement doses.
After the inoculation of the third dose to vulnerable people, the expansion of reinforcement to the general population “could be the next step,” said Cavaleri.
Responsible for EMA noted that at least three new pharmacological tools against COVID-19 receive approval before the end of the year.
One of them could be the Novavax vaccine, whose review is in the last stages.
