The World Health Organization (WHO) on Thursday conditionally recommended antiviral drug molnupiravir for non-severe COVID-19 patients who are at highest risk of hospitalisation.
A WHO Guideline Development Group of international experts said that the recommendation is based on new data from six randomised controlled trials involving 4,796 patients. This is the largest dataset on this drug so far.
Moderate certainty evidence from clinical trials suggested that molnupiravir reduces the risk of hospital admission (43 fewer admissions per 1,000 patients at highest risk) and time to symptom resolution (average 3.4 fewer days), while low certainty evidence suggests a small effect on mortality (6 fewer deaths per 1,000 patients), the apex global public health agency said. Molnupiravir works by stopping SARS CoV2 -- the virus which causes COVID-19 -- from growing and spreading. Used as early as possible after infection, it can help prevent more severe symptoms developing, the WHO said.
The WHO recommendation may bring some changes in COVID-19 treatment protocols in India as, despite over a dozen domestic pharmaceutical companies manufacturing the anti-viral drug on affordable prices, the Indian government has been against including it in the treatment protocol over safety issues. The drug had also failed to convince the Indian Council of Medical Research (ICMR) for giving it a green signal for inclusion in India's national COVID-19 treatment protocol, although the drug has received an emergency use authorization (EUA) from the Indian drug regulator, the Central Drugs Standard Control Organisation (CDSCO).
The recommendations also published in the in The British Medical Journal (BMJ), said that the patients who are at highest risk of hospitalisation typically include those who are unvaccinated, older people, and those with weak immune systems or chronic diseases. However, the panel said that the young and healthy patients, including children, and pregnant and breastfeeding women should not be given the drug due to potential harms.
The panel made no recommendation for patients with severe or critical illness as there are no trial data on molnupiravir for this population. The recommendations are part of a living guideline, developed by the World Health Organization with the methodological support of MAGIC Evidence Ecosystem Foundation, Norway-based NGO.
Molnupiravir is not widely available but steps have been taken towards increasing access, including the signing of a voluntary licensing agreement. The Access to COVID-19 Tools Accelerator (ACT-A) is making a limited supply available to countries with access constraints, the WHO said.
WHO has also invited manufacturers to submit their products for prequalification, with a number of manufacturers of molnupiravir going through assessment now. WHO evaluates the quality, safety and efficacy of medical products for United Nations and other large suppliers to low- and middle-income countries. More WHO quality-assured manufacturers mean that countries have a greater choice of products and more competitive prices.
The United States Food and Drug Administration (FDA), the federal agency of the Department of Health and Human Services, earlier in January issued an EUA to the drug. Following this, the drug also received approval in several countries, including India.
In India, at least 13 firms i.e. Dr Reddy's, BDR Pharma, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Strides, Emcure, Cipla, Sun Pharma, Torrent are manufacturing the drug in India, starting from Rs 35 per capsule. But the real fate of molnupiravir hangs in balance until its inclusion in India's national COVID-19 treatment protocol.
Along with a recommendation on molnupiravir, this ninth update of WHO’s living guideline on therapeutics included an update on casirivimab-imdevimab, a monoclonal antibody cocktail. Based on evidence that this combination of drugs is ineffective against the Omicron variant of concern, WHO now recommends that it is only given when the infection is caused by another variant the UN health agency said in a statement.
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