Announced on November 4, the regulatory approval for Molnupiravir, an antiviral medicine for COVID-19 developed by Merck and Ridgeback biotherapeutics, was greeted with a sigh of relief across many parts of the world. The United Kingdom’s Medicines and Healthcare products Regulatory Agency conducted a ‘rigorous’ evaluation of the safety, effectiveness and quality of the medicine, and gave its sanction.
This comes at a time when much of Europe is grappling with an uptick in infections, and a subsequent increase in deaths due to COVID-19, despite full vaccination coverage of more than 60 percent in most European Union constituent countries. Though it's not totally unexpected, the rapid increase in the number of COVID-19 cases has placed many governments under significant pressure to bring in restrictions on the movement or gathering of people. This is going to be a challenge when the appetite for restrictions is so low among general public, and small businesses are slowly emerging from a devastating couple of seasons.
Risk Reducer
Molnupiravir became the first oral medication approved for use for COVID-19. The clinical trial had shown remarkable results in reducing hospitalisation, and deaths, so much so that the trial was stopped after an interim analysis of early results. Those patients who had received the medicine were almost 50 percent less likely to get hospitalised, or die of COVID-19. Besides, Molnupiravir showed efficacy across all variants — including the deadlier Delta variant which originated in India.
The fact that all patients who were a part of this trial had at least one risk factor for worsening of COVID-19 shows the relevance of this medicine in the current global context, when we are seeing an increasing number of breakthrough infections in vaccinated individuals. The medicine is supposed to be taken within five days of onset of symptoms in mild and moderate cases of COVID-19.
Justice And Equity
In the United States, the drug is expected to cost $713 (more than Rs 50,000) per person. In the UK, the price of procurement by the National Health Service is expected to be slightly lower. There the medication will be given to people aged 60 years or older or those with comorbid conditions like immunodeficiency, heart disease, etc. The UK has already bought around half a million doses of the medicine, and the US had purchased 1.7 million. Merck has said that they have the capacity to produce around 10 million doses by the end of 2021. Several High-Income Countries are expected to lap up all the supplies of the medicine, even before it reaches the market. So much for the lofty discourses on a fair global system!
This brings us to a question of justice and equity. Will the poorer countries get access to this drug, and will they be able to afford it? The answer is dependent on the success of the Medicines Patent Pool (MPP).
The MPP is a Geneva-based organisation which looks to increase access to critical lifesaving medicines in developing countries, by voluntary licensing and patent pooling. They have been relatively successful in increasing access to several important drugs for treating Human Immunodeficiency Virus (HIV), Tuberculosis and Hepatitis C.
The companies behind Molnupiravir have entered into an agreement with MPP, which gives the latter the right to issue non-exclusive sub-licenses to generic manufacturers to make the medicine. This medicine can be distributed at cheaper prices in 105 low-middle income countries, including India.
If this system of sub licensing works, then we may probably see the medicine in the drug shelves of developing countries sometime in 2022. Otherwise, health systems in poorer countries may be better off in investing in improving systemic capacity for treating patients, building oxygen plants, and, of course, procuring vaccines.
Vaccines, It’s Logical
But can this medicine replace vaccines for COVID-19? The answer is a big No.
Molnupiravir increases our armamentarium against COVID-19, but it cannot replace vaccines. Vaccination is the best strategy that is available to us at this point of time, and a near total coverage of vaccine is the most logical way to contain this pandemic.
India should be able to focus on increasing the vaccine coverage in the next few months, using all kinds of behavioural change, and coercive methods. We have access to proven, safe and efficacious vaccines; and there is no reason why a person should not take it unless medically indicated so. An important strategy for ensuring near-universal vaccine coverage can be creating a social environment by which the society sees vaccination as a socially-appropriate behaviour. Coercive measures such as withdrawing provision of free COVID-19 care to unvaccinated individuals can be considered after due diligence.
New Treatment
Several new treatments for COVID-19 are on its way. Pfizer has announced that its drug Paxlovid, which can stop the replication of the virus, 'significantly reduces’ hospital admission, and death in those with higher risk of severe illness.
The World Health Organization (WHO) has announced the launch of SOLIDARITY-Plus, a clinical trial platform which will evaluate the utility of artesunate, imatinib and infliximab. These drugs are already in the market with artesunate used for severe malaria, imatinib for certain cancers, and infliximab for several immune disorders. The platform was previously used to assess the effectiveness of Remdesivir, hydroxychloroquine, lopinavir and interferons on hospitalised patients with COVID-19, though none of them showed any significant benefit.
The biggest learning point from the resurgence of COVID-19 in Europe is that the disease is here to stay. We have to plan to make sure that our fight to contain the disease is effective, and equitable. The more tools we have with us, the better off we are in the fight. But as Jeremy Farrar, the director of Wellcome Trust which is one of the largest healthcare focused foundations, puts it “Optimism could serve as one of the biggest obstacles to making those plans”.
Philip Mathew is a physician, public health consultant and a doctoral student at Karolinska Institutet, Stockholm. Twitter: @pilimat.
Views are personal and do not represent the stand of this publication.
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