As we move towards the completion of two years since the onset of the COVID-19 pandemic, the world has reported close to 250 million positive cases and 5 million deaths. Nearly half a million positive cases are still being reported every day. We have face masks, vaccines, and steroids to fight the pandemic. We also have the expensive injectable antiviral drug Remedesivir and the monoclonal antibody cocktail for those who can afford these. Most of the oral drugs, including chloroquine, ivermectin, anti-HIV drugs, anti-hepatitis drugs did not stand the scrutiny of scientific studies. Some others had weak evidence to be of large-scale use.
Ribonucleic acids are the basic building blocks of coronaviruses. Analogues of these can produce mutations that are lethal to the virus. Remedesivir is an analogue and is demonstrated to reduce hospital stay in moderately ill patients with COVID-19. However, it is expensive and has to be given through the intravenous route.
Molnupiravir was earlier developed as an oral drug against influenza. It is also an analogue of ribonucleic acids, similar to Remedesivir. In a preprint published in June, virus isolation was noted in 1.6 percent of those patients receiving Molnupiravir compared to 16.7 percent of those receiving a placebo on day 3 and 0 percent and 11.1 percent respectively on day 5.
Merck and Ridgeback have announced on October 11, the submission of an emergency use authorization (EUA) application to the US FDA for the treatment of mild to moderate cases (room air oxygen saturation more than 93 percent at rest). The submission is based on positive results from a planned interim analysis from the phase 3 MOVe-OUT clinical trial, which evaluated Molnupiravir in non-hospitalized adults with mild to moderate Covid illness who were at risk to progress to severe Covid requiring hospitalization. At the interim analysis, there was 50 percent reduction in risk of hospitalization or death (7.3 percent with drug vs 14.1 percent with placebo) with Molnupiravir. Full results of the trial are awaited as on October 16.
Despite the development of COVID-19 vaccines in a record time period, the world continues to witness daily positive cases of half a million. While vaccines have been effective against moderate to severe illness, they have not been as effective against the spread of the virus. In addition, the efficacy is lower against certain new variants. Another growing concern has been the rapid decline in neutralizing antibodies within six months after the second dose necessitating the booster dose in people at high risk. Lastly the inequity in access to vaccines has been glaring within and between countries. The news of an effective oral drug assumes significance in the above context.
Merck has previously announced that it has entered into non-exclusive voluntary licensing agreements for Molnupiravir with six established Indian generic manufacturers to accelerate the availability of the drug in more than 100 low- and middle-income countries (LMIC), following approval or EUA by their respective regulatory bodies.
The arrival of an effective and affordable oral drug has long been awaited in our fight against COVID-19 across the world and more so in LMICs which are yet to receive sufficient quantities of vaccines. There is growing concern about the duration of efficacy of the vaccines and their efficacy against new variants. Many rich countries have started booster doses while many LMIC countries are still waiting for their first doses. India is in a unique position to supply the needed vaccines to LMIC countries and also the affordable generic oral Molnupiravir to these countries. It can derive significant geopolitical mileage from this position.
Inching closer to the milestone of one billion vaccine doses, India has exhibited remarkable resilience despite the devastating second wave that was driven by the Delta variant. It has restarted its vaccine exports to other countries. It is in a position to start exports of the new effective oral drug that the world has been eagerly awaiting. The economy too has been witnessing a rebound in GDP growth. Full monsoon adds to the festive mood that the country is in.
Dr Krishna Reddy Nallamalla
Regional Director, South Asia, ACCESS Health International
Photo Credits: Sonis Photography