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World Health Organization

World Health Organization suggests Molnupiravir for patients at high risk of Covid

by Pragati Singh
written by Pragati Singh

The use of Merck & Co Inc’s COVID-19 antiviral tablet for high-risk patients was endorsed by a World Health Organization (WHO) panel on Wednesday.

The medication, molnupiravir, is conditionally recommended for patients with non-severe sickness who are at high risk of hospitalisation, such as the immunocompromised, the unvaccinated, the elderly, and those with chronic disorders, according to the expert panel.

New data from six clinical studies including 4,796 individuals supported the suggestion.

Since its approval in the United States in December, molnupiravir has seen a drop in demand among COVID-19 patients due to its low effectiveness and potential safety concerns for some populations.

The WHO panel is also drafting recommendations for Paxlovid, Pfizer Inc’s COVID-19 antiviral tablet.

In comparison to molnupiravir, Pfizer’s tablet was shown to be approximately 90% effective in avoiding COVID-19 hospitalizations and fatalities.

The WHO’s Guideline Development Group (GDG) guidelines are aimed at assisting clinicians in providing the best care for patients in fast-moving circumstances like the COVID-19 pandemic.

Molnupiravir should not be administered to young or healthy individuals, including children, pregnant or nursing women, or pregnant or breastfeeding women, according to the panel, because of potential concerns such as abnormalities in a developing baby, as established in animal studies.

The WHO recommendations, which were published in the British Medical Journal, said that there was no recommendation for molnupiravir usage in patients with severe or critical disease because no trial evidence was available.

In addition, the panel amended its recommendations for using Regeneron Pharmaceuticals Inc’s COVID-19 antibody cocktail. The medicine is now exclusively recommended for those who are not infected with Omicron, according to fresh preclinical research, as it is ineffective against the variation.

The panel approved using Eli Lilly’s baricitinib in conjunction with corticosteroids for patients with severe COVID-19 in January, and conditionally endorsed GlaxoSmithKline and Vir Biotechnology’s antibody treatment for non-severe individuals at the highest risk of hospitalisation.

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Covid News and Updates

Molnupiravir effective against Omicron, can reduce deaths: Study

by Vaishali Sharma
written by Vaishali Sharma

According to a new study, a five-day course of the antiviral medicine Molnupiravir may be effective against the highly contagious Omicron and other strains of concern (VOCs).

Molnupiravir may be superior to monoclonal antibodies and Remedivisir, according to the study.

“From the available evidence, Molnupiravir appears to be a reasonably useful drug in reducing deaths and hospitalisation in adult patients with COVID-19 having high risk, with a relatively lower cost. Molnupiravir could be a useful drug in non-pregnant unvaccinated adults with COVID-19 who are at increased risk of severity including hospitalization,” said Dr. Anoop Misra, Padma Shri, Executive Chairman and Director, Diabetes and Endocrinology, Fortis C- DOC.

The study, published in the journal, Diabetes & Metabolic Syndrome: Clinical Research & Reviews, was conducted by a team of doctors at Fortis C-DOC, GD Hospital and Diabetes Institute, Jawaharlal Nehru Medical College and Hospital, and the Diabetes Foundation.

It pointed out that “subgroup analysis found Molnupiravir was effective irrespective of strain although no data is available for its effect on Omicron in particular”, stated the study.

“Unlike monoclonal antibodies, the mechanism of action of Molnupiravir is independent of mutations in the spike protein, and it is expected to work against Omicron, theoretically. Indeed, in vitro study of VeroE6-GFP cells does indicate that Molnupiravir retain their activity against VOCs of Alpha, Beta, Gamma, Delta, and Omicron,” the journal added.

“However, Molnupiravir is effective only when used within five days from the onset of Omicron symptoms. Inappropriate use without assessing risk may pose an unknown long-term risk of public concern,” cautioned Dr. Misra.

 

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Covid News and Updates

Molnupiravir approved, but not recommended

by Vaishali Sharma
written by Vaishali Sharma

Molnupiravir, an antiviral medicine manufactured by US firms Merck and Ridgeback, has been removed off the Indian Council of Medical Research’s recommended treatment plan just a week after it was authorised for early-stage Covid-19 patients (ICMR). The medicine posed “major safety concerns,” according to Dr. Balram Bhargava, the chairman of the ICMR. As a result, an embarrassing scenario has arisen: The substance is legal to take, but it is not advised.

Molnupiravir is a repurposed Covid drug, originally developed to treat influenza. It is meant for mild or moderately ill Covid-19 patients who are at risk of developing serious illness. The pill, if administered during the first five days after contracting the infection, has the potential to prevent serious illnesses.

The pill is among the first few therapeutics now being deployed for treatment of Covid-19. Molnupiravir was first cleared for use in the UK in November, and more recently in the US.

There have been concerns on two counts — low effectiveness, and some potential side-effects. Both were taken into account by drug regulating agencies while approving them.

Molnupiravir was found to be only 30% effective in trials, much lower than earlier indications. Besides, there have been been worries over its mechanism: The drug molecule incorporates itself into the RNA of the virus, inducing mutations with the objective of hampering replication. But this carries the risk of introducing mutations that can make the virus stronger and more dangerous. A bigger worry is the risk of the drug creating mutations in the human DNA itself.

These risks, very low by all accounts, have been considered by the drug regulators while approving the drug, which means that these have not been assessed to be significant enough. The prescribed five-day dosage is not considered large enough to pose any serious health concern.

Also, N K Ganguly, former head of ICMR, pointed out, there are several drugs for other diseases in the market that pose similar risks.

“Those drugs are frequently prescribed in specific situations based on the clinical assessment of the patients, if the benefits from the drugs are considered by the doctor to be outweighing these risks,” he said.

In the case of molnupiravir, it seems, going by the argument of Dr Bhargava, the benefits do not very clearly outweigh the risks, considering the low effectiveness of the drug.

In the case of molnupiravir, it seems, going by the argument of Dr Bhargava, the benefits do not very clearly outweigh the risks, considering the low effectiveness of the drug.

 

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vaccination
Pharma News

Covovax, Corbevax and Molnupiravir pill receive Centre’s nod in a single day

by Vaishali Sharma
written by Vaishali Sharma

Today, the centre approved two additional vaccines and one antiviral medicine to help battle the COVID-19 pandemic. Corbevax and Covovax are the two most recent vaccinations approved by India. During an emergency, the antiviral medication Molnupiravir can be utilised.

In a tweet, the minister said, “Congratulations India. Further strengthening the fight against COVID-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for: – CORBEVAX vaccine – COVOVAX vaccine – Anti-viral drug Molnupiravir For restricted use in an emergency situation”.

The announcement by Union Health Minister Mansukh Mandaviya on Tuesday came a day after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.

It also had recommended granting restricted emergency use approval to the drug Molnupiravir for treatment of adult patients with COVID-19 and who have high risk of progression of the disease.

With this approval, the number of Covid vaccines which have received emergency use authorisation in the country has increased to eight.

So far six COVID-19 vaccines — Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V and the US-made Moderna and Johnson and Johnson — have received emergency use authorisation from the Indian drug regulator.

CORBEVAX Covid vaccine: CORBEVAX vaccine is India’s 1st indigenously developed RBD protein sub-unit vaccine against COVID19, Made by Hyderabad-based firm Biological-E.

COVOVAX Covid vaccine: The Nanoparticle Vaccine, COVOVAX, will be manufactured by Pune-based firm Serum Institute of India.

Molnupiravir covid pill: Molnupiravir, an antiviral drug, will now be manufactured in the country by 13 companies for restricted use under emergency situation for the treatment of adult patients with COVID-19 and who have a high risk of progression of the disease.

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