If full immunization using any COVID-19 vaccine greatly reduces a person’s risk of serious illness and death, two oral antiviral drugs may be granted emergency-use authorization (EUA) for certain categories of people. The move by the US FDA for the possibility of becoming seriously ill provides a much-needed impetus to fight the disease. Unlike the case with remdesivir, these drugs — Pfizer’s paxlovid and Merck’s mollupiravir — are oral tablets and therefore can be administered outside of a hospital setting. They are for use by people with mild-moderate disease within five days of symptom onset. Paxlovid, an antiviral drug, was granted the EUA for the first time on 22 December, and has been greenlighted for more than 12 years of use; molnupiravir – with the EUA due on 23 December – is for use only for those above 18. Paxlovid has an 88% efficacy in preventing COVID-19-related hospitalization or death, while molnupiravir has only 30% efficacy in achieving the same endpoint. In the final analysis of trial data, the efficacy of molnupiravir fell from 50% during the interim analysis to 30%. The FDA specifically mentions that molanupiravir is recommended when “alternative treatment options are not accessible or medically appropriate”. Both pills are likely to work against Omicron, with the greatest benefit found in people who may lack adequate immune protection despite being fully immunized.
Antivirals can never replace vaccines and, therefore, every eligible person should be fully vaccinated as soon as possible, especially when the highly transmissive omicron variant is circulating. Since treatment must begin within five days of the onset of symptoms, access to testing and turnaround times should be greatly improved. At the same time, indiscriminate use of drugs should be avoided – this will not only lead to complications for individual patients but also drug resistance. Unlike the case of COVID-19 vaccines, where access and availability have become a sore point for many low- and middle-income countries, the two drugs will be far more freely available there. This is because the companies have tied up with the medicine patent pool. According to the agreement, generic manufacturers are allowed to produce and supply paxlovid in 95 low- and middle-income countries, while 105 countries will have access to the generic version of mollupiravir. India should be able to manufacture generic versions of both the drugs and supply them to the approved countries as well as reach here at a lower cost. With increased coverage of vaccinations and easier availability of treatment, the world will be in a better position to deal with the rapidly changing virus.
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