Merck’s Covid-19 pill gets UK approval, as WHO raises fears over surging new cases in Europe

Britain, Thursday, became the first country in the world to approve a potentially game-changing Covid-19 antiviral pill jointly developed by United States-based Merck and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, Molnupiravir, for use in people with mild to moderate Covid-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.

It will be administered as soon as possible following a positive Covid-19 test and within five days of the onset of symptoms, the regulator said, citing clinical data.

The green light is the first for an oral antiviral treatment for Covid-19 and the first for a Covid-19 drug that will be administered widely in the community.

Treatments to tackle the pandemic, which has killed more than 5.2 million people worldwide, have so far focused mainly on vaccines. Other options, including Gilead’s infused antiviral Remdesivir and generic steroid Dexamethasone, are generally only given after a patient has been hospitalised.

Merck’s Molnupiravir has been closely watched since data last month showed it could halve the chances of dying or being hospitalised for those most at risk of developing severe COVID-19 when given early in the illness.

Molnupiravir, which will be branded as Lagevrio in Britain, is designed to introduce errors into the genetic code of the coronavirus that causes COVID-19 and is taken twice a day for five days.

Professor Stephen Powis, national medical director for the National Health Service (NHS) in England, said the drug would be administered to patients at higher risk of complications as Britain heads into one of the most challenging winters ever.

A wider rollout will follow if it is clinically and cost effective in reducing hospitalisations and death, he added.

“We are now working across government and the NHS to urgently get this treatment to patients initially through a national study so we can collect more data on how antivirals work in a mostly vaccinated population,” UK vaccines minister Maggie Throup told parliament.

The speedy approval in Britain, which was also the first Western country to approve a Covid-19 vaccine, comes as it struggles to tame soaring infections.

Britain has about 40,000 daily cases of Covid-19, according to the latest seven-day average. That is second only to the roughly 74,000 a day in the United States, which has five times more people, and has fuelled criticism of the government’s decision to abandon most pandemic-related restrictions

Data released on Wednesday night showed COVID-19 prevalence in England hit its highest level on record last month, led by a high numbers of cases in children and a surge in the south-west of the country.

Many other big economies, including Germany, France and Israel, have either retained some basic Covid-19 measures like mask mandates or reintroduced them in response to rising cases.

Last month, Britain agreed a deal with Merck to secure 480,000 courses of molnupiravir.

In a separate statement, Merck said it expected to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.

Pfizer and Roche are also racing to develop easy-to-administer antiviral pills for COVID-19. Pfizer last month began a large study of its oral antiviral drug for the prevention of COVID-19 in people exposed to the coronavirus.

Viral sequencing done so far has shown Molnupiravir is effective against all variants of the coronavirus, Merck has said, including the more-infectious Delta, which is responsible for the worldwide surge in hospitalisations and deaths recently.

Meanwhile, European countries must work harder to prevent the coronavirus spreading further as deaths and new cases surge, the World Health Organization’s Europe head said on Thursday.

Current transmission rates in 53 European countries are of “grave concern” and new cases are nearing record levels, exacerbated by the more transmissible Delta variant of the virus, the WHO’s Hans Kluge told a media briefing.

“We must change our tactics, from reacting to surges of COVID-19, to preventing them from happening in the first place,” he said.

The region saw a 6% increase in new cases last week of nearly 1.8 million new cases, compared to the week before. The number of deaths rose 12% in the same period.

If the region follows its current trajectory, Kluge said, another 500,000 COVID-19 related deaths could occur in the region by February next year.

“Today every single country in Europe and Central Asia is facing a real threat of COVID-19 resurgence or already fighting it.”