The World Health Organisation (WHO) has updated its living guidelines on COVID-19 therapeutics to include a “conditional recommendation” on Merck & Co’s Covid drug Molnupiravir, a new antiviral medicine. Under this conditional approval, Merck’s Covid-19 antiviral pill was approved for patients who are in the early stages of the disease.
As per the global health body, Molnupiravir should only be “provided to non-severe COVID-19 patients” with the highest risk of hospitalisation. Patients who come in this category are those who have not received a COVID-19 vaccination, older people, people with immunodeficiencies and people living with chronic diseases like diabetes.
As this is a new drug, the WHO has recommended active monitoring for drug safety, along with other strategies to mitigate potential harms.
“Children, pregnant and breastfeeding women should not be given the drug. People who take Molnupiravir should have a contraceptive plan. Health systems should ensure access to pregnancy testing and contraceptives at the point of care,” WHO has said.
The WHO has also updated its recommendation on Casirivimab-imdevimab, a monoclonal antibody cocktail.
“Based on evidence that this combination of drugs is ineffective against the Omicron, WHO now recommends that it is only given when the COVID-19 infection is caused by another variant,” WHO said.
Molnupiravir has ‘major safety concerns’: Centre
The government in January had also not added the coronavirus pill in its national treatment protocol for the disease due to some “major safety concerns”, Balram Bhargava, head of the state-run Indian Council of Medical Research, had clarified. “We have to remember that this drug has major safety concerns … so it is not included in the national task-force treatment,” Bhargava said.
Last year, Dr Reddy’s entered into a non-exclusive voluntary licensing agreement with MSD to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs).
What is Mulnupiravir
According to the Union health ministry, Molnupiravir is an antiviral drug that inhibits SARS-CoV-2 replication by viral mutagenesis.
This anti-covid pill got the Drug Regulator General of India’s (DRGI) approval on 28 December for restricted use in emergencies. Mutagenesis is a process by which the genetic information of an organism is changed by the production of mutation.
The UK Medicines and Healthcare products Regulatory Agency had on 4 December had granted approval for Molnupiravir under special conditions for treatment of mild to moderate covid-19 in adults.
The United States Food and Drug Administration (USFDA) on 23 December granted Emergency Use Authorisation for the drug for treating mild-to-moderate covid-19 in adults.
With PTI inputs