Prudence is a must, as always. But it is useless to hide that around molnupiravir, an oral antiviral that seems to be able to block the replication of the virus, even the most buttoned up virologists and infectious diseases have made it clear that they have more than one hope. The news, which arrived yesterday, is that this pill produced by Merck, would be able to reduce the risk of hospitalization and death in patients with mild or moderate Covid by about 50%.
The American pharmaceutical company requested authorization from the US Food and Drugs Administration for this after data from a Phase III study indicated the effective efficacy of the drug. The trial would have been stopped precisely because, given the results obtained, it was unethical to continue to treat half of the participants with placebo. Let’s try to summarize the main features of this medicine starting with the efficacy data.
How effective is molnupiravir?
Based on the data, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were hospitalized but none died within day 29 of randomization, compared with 14.1% hospitalized or deceased for patients treated with placebo.
Who is this drug intended for?
For Merck’s Phase 3 clinical trial, it enrolled only unvaccinated people considered to be at high risk, that is, the elderly or people with medical conditions. Initially, the drug may only be available to risk categories, but experts expect it to be used on a large scale to treat Covid over time. In the trial, molnupiravir was given to volunteers who had been showing symptoms for no more than five days. According to the researchers, therefore, the drug should be taken immediately as soon as you are sure you have Covid symptoms.
Is molnupiravir or monoclonal antibodies more effective?
With an efficacy against hospitalizations and deaths of up to 85% in theory, monoclonals would be more effective than the drug developed by Merck. But in practice, explains the New York Times, experts expect molnupiravir to have a greater impact against the pandemic. Provided of course that the drug gets the green light from the regulatory bodies.
While effective, monoclonals have several limitations. In addition to the cost, the administration of the antibodies itself is not immediate, and this can make the operations particularly difficult. The infusion of the monoclonal must be done in the hospital, so a covid-positive subject who stays in his home must go to one of the centers that administers the antibodies with all the related difficulties of control, distancing and sanitation. On the contrary, molnupiravir can also be taken at home without particular difficulties.
When will molnupiravir be available
According to the newspapers, the FDA could authorize the drug by the end of this year, if all goes well, but in reality a precise timing is not known, as Anthony Fauci himself, the principal medical adviser of President Biden, admitted. Nor is it known when the medicine might arrive in Europe.
To ensure access to the treatment, even before obtaining the results of the study, the MSD company has started production of molnupiravir and intends to produce 10 million doses by the end of 2021 and more doses will be produced in 2022.
The company has entered into a procurement agreement with the US government (for approximately 1.7 million doses after regulatory green light) and is entering into purchase and supply agreements with other governments worldwide, always subject to the drug’s green light. The intention is to adopt a differentiated pricing policy, capable of reflecting the differing ability of individual states to finance the healthcare response to the pandemic. Another move is voluntary non-exclusive licensing agreements with generic drug manufacturers to accelerate the availability of molnupiravir in more than 100 low- or middle-income countries.
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