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On 4 November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that it had approved molnupiravir (▼Lagevrio) as the first oral antiviral drug authorised for COVID-19.1 In its press release, the MHRA chief executive was quoted as saying, “Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously.” Shortly before 11am on the same day, the Secretary for State for Health and Social Care posted a video on social media extolling the benefits of molnupiravir, suggesting “in clinical trials this treatment has been shown to reduce the risk of hospitalisation or death for COVID-19 patients who are most at risk by 50%.”2
Molnupiravir is indicated for treatment of mild to moderate COVID-19 disease in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.3 The MOVe-OUT study, on which the MHRA’s licensing decision was based, assessed the efficacy of molnupiravir in preventing death or hospitalisation in the 29 days after use in people with mild or moderate COVID-19.4 The study involved symptomatic subjects not vaccinated against SARS-CoV-2 and who had laboratory-confirmed infection and symptom onset within 5 days of enrolment.3 Participants also had to have at least one risk factor, such as age ≥60 years, diabetes mellitus, obesity, COPD or active cancer. Originally designed to include 1550 participants, trial recruitment was terminated on 5th August following assessment of interim efficacy and safety results from 775 people of whom 386 received molnupiravir. The interim findings that hospitalisation or death occurred in 7.3% of those in the molnupiravir group compared with 14.1% of those in the placebo group (p=0.0012) were announced in a press release on 1st October.5 While the headline results seem compelling, it is important to understand that those taking part in the study had not been vaccinated against SARS-CoV-2. Given that over 80% of the UK population aged ≥12 years has received two doses of COVID-19 vaccine and we have no idea of molnupiravir’s efficacy in such a population, it’s unclear how best to target its use for greatest effect. Furthermore, molnupiravir has not been tested in children, nor in pregnancy and those opposed to the vaccine due to concerns over the action of vaccine on host DNA may baulk at a drug that has been shown to display host mutational activity in an animal cell culture assay.6 At a global level, there is a danger that only wealthy countries and healthcare systems will have the resources to procure, test and supply treatment within the 5-day window. Demand for testing could rise significantly as patients become concerned not to miss out on a possible treatment and supplying the drug could create significant bottlenecks.
COVID-19 has highlighted the need for rapid and pragmatic clinical trials and there is much about the latest research that is to be commended—the trial was registered, interim data were analysed and an independent data monitoring committee acted on the results.4 5 Nevertheless, scientific announcements on the drug’s efficacy have been delivered by press release and through social media, and there is a paucity of detailed information available in the public domain. At the time of writing, a search for molnupiravir on Google gave 14 million results and yet we currently have no published peer-reviewed outcome data and only one phase I clinical trial was available through PubMed. As a result, there has been no opportunity to scrutinise, assess or comment on the full data for molnupiravir. The Government’s ongoing reliance on press releases to provide important scientific information does a disservice to the public and the scientific community. We call on the MHRA and the Department of Health and Social Care to support such high-profile announcements with more timely access to the research and licensing data.
Competing interests None declared. Refer to the online supplementary files to view the ICMJE form(s).
Provenance and peer review Commissioned; externally peer reviewed.
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