No, it is not true that the EMA authorizes the emergency use of the pill against the coronavirus

The European Medicines Agency (EMA) has not endorsed or authorized the emergency use of the antiviral drug ‘Molnupiravir’ in the EU, as claimed by some media outlets, stating that the EMA “endorses the use” or “gives the green light” to ‘Molnupiravir’, that this antiviral “obtains authorization for emergency use” from the EMA , or that they have authorized the first pill against the coronavirus.

These publications arise from the erroneous interpretation of statements by Marco Cavaleri, head of Vaccination Strategy of the EMA, who offered expert advice from the agency to European countries who want to individually issue national emergency use authorizations for this COVID-19 treatment, although the European Agency has not yet finalized the assessment.

In statements to EFE, a spokeswoman for the EMA has clarified that this European regulator has not yet endorsed the use of the antiviral in the EU: “It is incorrect and there seems to have been some misunderstandings on the comments made by Cavaleri “at the press conference where the agency reported on its progress in the analysis of drugs and vaccines for COVID-19.

“As announced on October 25, the EMA is currently evaluating the drug oral antiviral ‘Molnupiravir’ in an ongoing review “which” will continue until there is sufficient evidence available for the company to submit a formal application for marketing authorization, “he explained.

Scientific advice was offered to EU countries

What Cavaleri said at the press conference was: “Although we cannot predict the general timeline for the evaluation of ‘Molnupiravir’, it should take us less time than normal to evaluate an eventual application (for a license to use in the EU) due to the work already done during ongoing ongoing review, “to which he added:” While the marketing authorization process is ongoing, it is also we are ready to advise Member States so that they can make this new antiviral available for emergency use, prior to the “formal authorization of its use at a community level.”

What Cavaleri was referring to with this, says the EMA spokeswoman, is the possibility of advising to European countries that want it, waiting for the license, “as was done previously for other coronavirus treatments, in the context of the so-called Article 5 (3) procedure.”

The process “aims to support national decision-making on the possible use of these medicines before a formal authorization is issued” in the EU. “Nevertheless, this procedure has not yet started“, underlines the spokeswoman, asked if the EMA already” endorses “the emergency use of this drug in the EU.

This procedure was already used during the pandemic. And it is that last March, the EMA reviewed and approved the use of the antibodies monoclonal drugs ‘Bamlanivimab’ and ‘Etesevimab’ as a treatment for patients with coronavirus. As now, that analysis provided “a harmonized (positive) scientific opinion at EU level to support national decision-making on the possible use of antibodies before marketing authorization.”

The Agency also analyzed the use of ‘Bamlanivimab’ alone and concluded that, “despite uncertainties about the benefits of monotherapy, could be considered a treatment optionTo arrive at this recommendation, the EMA initiated the article 5 procedure and reviewed data on the quality, safety and efficacy of the monoclonal antibodies in question, considering their use safe enough for each country to use the treatment if considers it necessary given the context of the health emergency.

The EMA does not issue emergency authorizations

When the EMA receives and study the application for a European license for ‘Molnupiravir’, developed by the American pharmaceutical companies Merck and Ridgeback Biotherapeutic, could announce its conclusions so that the European Commission authorizes or not the use of this treatment in the EU.

Unlike other regulators outside the EU, the EMA does not have an emergency authorization mechanism for the use of drugs in the EU, not even in a pandemic.

When a promising new vaccine or treatment is developed, in this case for COVID-19, the Committee for Human Medicines (CHMP) decides whether there is enough scientific data to open a “rolling review”, which means the real-time analysis of available information about the drug in question. This includes laboratory data and data from ongoing clinical trials.

That assessment continues until such time as the developer and the EMA agree that there are enough data to support quality, safety and efficacy of the vaccine or medicine to apply for a European license.

The CHMP then studies the total data package accompanying that request and issues a scientific opinion, but it is the Commission that has the last word on the issuance or not of an official license valid in a generalized way and at the same time in all EU countries.

In the case of ‘Bamlanivimab’, continuous review started ten days ago, with which it is expected that the authorization, to receive the approval of the EMA, still late to arrive at least a few weeks. European countries can ask the EMA for advice if they consider it to use this treatment, since the pandemic is a health emergency.

The United Kingdom has authorized its use

For the moment, the UK health authorities have approved the use of ‘Molnupiravir’, which may be used in patients who have tested positive in a test and who have at least one risk factor for developing a serious disease.