USA: FDA grants emergency authorisation for oral antiviral COVID pill

USA: FDA grants emergency authorisation for oral antiviral COVID pill.

THE United States Food and Drug Administration (FDA) grants emergency authorisation for Merck’s oral antiviral COVID pill – giving the United States a second easy-to-use drug.

In an announcement made on Thursday, December 23, Federal regulators authorised Molnupiravir, developed by Merck – with partner Ridgeback Biotherapeutics LP – which is said to be able to treat Covid in nonhospitalised people 18 and older at risk of developing severe illness.

According to the statement, Molnupiravir is not authorised for use in patients younger than 18 years of age because Molnupiravir may affect bone and cartilage growth.

The Merck pill will potentially cut the risk of hospitalisation and death in high-risk patients by 30 per cent and some experts believe it will be helpful as the Omicron variant, which is resistant to other key treatments, surges.

It is the second COVID pill to be authorised in the US by the Food and Drug Administration.

Patrizia Cavazzoni, M.D., director of the FDA’s Centre for Drug Evaluation and Research said: “Today’s authorisation provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorised treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalisation or death.

“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorisation, while continuing to generate additional data on their safety and effectiveness.”

The FDA however said that “Molnupiravir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”

In related news, the FDA says it now needs 75 years to fully release Pfizer COVID-19 vaccine data to the public – meaning it wouldn’t be fully released until at least 2096.

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