The EMA endorses the antiviral against COVID-19 from the pharmaceutical company Merck for its “emergency use”

They ask people to get vaccinated. They encourage you not to lower your guard. They remember that there are areas of Europe where the situation is once again “worrying”. They affirm that, in a few weeks, the results of the evaluation will be known to authorize vaccination for people over five years of age, perhaps in December. And, in addition, experts from the European Medicines Agency (EMA) have given this Thursday “a more positive note.”

Indeed, if last week the EMA announced the continued review of Merck’s oral antiviral Molnupiravir for the treatment of COVID-19 in adults, this week it has gone one step further. “The decision to initiate an ongoing review was based on preliminary results from laboratory and clinical studies, and these studies suggest that medicine may reduce the ability of the virus that causes COVID-19 to multiply in the body, thus preventing hospitalization or death in patients with coronavirus disease, “Dr. Marco Cavaleri said at a press conference this Thursday.

And he added: “Although we cannot predict the timing of the review, it should take less time than normal to evaluate an eventual application due to the work already done in the context of ongoing review. Although the marketing authorization process is ongoing. , we can advise Member States that they can make this new oral antiviral available for emergency use before authorization. ”

In other words, national regulators can enable the use of a medicine licensed for “emergency use” while obtaining marketing authorization from the European regulator. And, while the evaluation is promising, the European regulator encourages the use of Molnupiravir.

“As we are already in the fourth wave of this pandemic,” say the EMA experts, “we are analyzing whether a scientific opinion from the EMA can support the authorization of emergency use in each Member State. We do not have a framework for authorization for emergency use at the central level at the EMA, but as we have done similarly with the other monoclonal antibodies with antiviral activity, we are considering whether this approach could also be done here to quickly provide an EMA position that could help Member States to use this product. ”

Regarding the epidemiological situation in Europe, Dr. Fergus Sweeney has recognized that “it is very worrying now that winter is approaching, with increases in infection rates, hospitalizations and we can also see the increase in deaths. It is very important that everyone get vaccinated or complete their vaccination dose if they have already received a first dose. It is very important that we are all vaccinated because not everyone is protected until everyone is protected. We must follow all precautions very carefully. ”

Cavaleri has also recognized that “expanding booster doses to a more general population could be envisioned as a likely step, and the agency’s recommendations provide the flexibility required by national public health authorities to allow rapid decision-making to in Member States to protect citizens. At the moment, there are no concerns about the use of booster doses after the full guidelines. ”

Regarding vaccines for children aged five and over, the EMA announces that “the current schedule for evaluation foresees a possible conclusion in December, unless additional analysis or data is deemed necessary. This is a reduced schedule compared to similar types of procedures and reviews outside of a pandemic. Pfizer BioNTech has collected and preliminarily submitted more data from the ongoing pediatric trial to expand the available safety database. The EMA is committed to making every effort to complete the assessment as soon as possible, while ensuring a careful and robust evaluation of all the efficacy and safety data available in this very young age group. ”


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