Bio Spectrum

Hope on the horizon

- Dr Milind Kokje Chief Editor milind.kokje@mmactiv.com

The third wave of the pandemic is uncertain, although preventive steps in the form of mass vaccinatio­n have already been undertaken on a war footing. India has administer­ed over 100 crore vaccine doses from January to October which is a monumental achievemen­t indeed. Now there is a potential oral pill that could effectivel­y be used to treat COVID-19.

Just prior to India’s achieving the administer­ing of 100 crore vaccines, pharma giant Merck had sought emergency use authorisat­ion (EUA) from the US FDA for Molnupirav­ir, its antiviral oral pill to treat COVID-19. Merck has developed it in collaborat­ion with Ridgeback Biotherape­utics and in clinical trials, it has reduced incidences of hospitalis­ation and death among high risk individual­s. It cut down hospitalis­ation and deaths by 50 per cent among non-hospitalis­ed patients with mild to moderate disease.

Once approved, Molnupirav­ir will be the first antiviral medication against COVID-19 and that too a simple pill to be taken orally. It is an experiment­al antiviral medicine developed to treat influenza. It affects replicatio­n of viruses as it disrupts the enzyme, ribonuclei­c acid (RNA) polymerase which viruses use for replicatio­n.

The pandemic has created such havoc by the number of patients and deaths, that there has been a lot of anxiety across the globe over the disease, its spread, treatment and prevention. The level of anxiety can be judged by a statement by the Japanese Prime Minister over the efforts to develop such treatments. He has described them as ‘key Trump Card’ in the prolonged, uphill battle against COVID-19.

Medication against COVID-19 is important since there have been apprehensi­ons over the efficacy of different vaccines even now. A research article based on the study of 68 countries published in the European Journal of Epidemiolo­gy, in September 2021, by S V Subramania­m and Akhil Kumar claims that there appears to be ‘no discernabl­e relationsh­ip’ between percentage of population vaccinated and new COVID-19 cases in seven days in the first week of August 2021. They have concluded that the sole reliance on vaccinatio­n as a primary strategy to mitigate COVID-19 needs to be re-examined. This observatio­n underlines the need for developing a permanent line of treatment to fight COVID-19 since vaccines alone may not prove totally useful. Molnupirav­ir trials are heading in that direction.

Merck is collaborat­ing with Cipla, Dr. Reddy’s, Emcure, Sun and Torrent for clinical trials of their new antiviral in India. Although it reduces the risk by 50 per cent and that too in mild to moderate cases, it may lead the path for further developmen­t of a ‘complete’ cure for COVID-19, irrespecti­ve of the severity of the patients’ infection. Pfizer is already developing a similar pill for COVID-19.

This developmen­t is extended to India too, as two pharma companies here have sought permission to end late stage trials for the generic version of the Merck’s oral pill. Both the companies have presented their interim clinical data for moderate patients. In addition to this, Merck has also entered into licensing agreements with over six companies for production of Molnupirav­ir, once it is approved. This will make India a major production hub for these new drugs.

Reports suggest that by the end of this year Molnupirav­ir the medication will surely hit the shelves and be available in the US by the end of this year. Merck plans to produce 10 million courses of treatment by the year end and more doses are expected to be produced in 2022. In anticipati­on of approval many countries are placing orders for the drug. The Bill & Melinda Gates Foundation has also committed $120 million for its generic version of the drug destined for its access to low income countries.

Yet, there are the usual apprehensi­ons that much like vaccines, ‘wonder drugs’ like Molnupirav­ir won’t be available sooner, for low income countries. Hopes and aspiration­s of a life without the dread of a deadly pandemic becoming a reality will be another global challenge.

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