Manas Dasgupta
NEW DELHI, Nov 4: Even as the World Health Organisation warned of an approaching catastrophe in Europe over the rising number of Covid-19 case, Britain on Thursday became the first country in the world to approve a conditional authorization to an antiviral pill for the treatment of the Coronavirus infection.
The pill jointly developed by U.S.-based Merck and Ridgeback Biotherapeutics, could potentially become a game-changer in the given world-wide pandemic situation with double-prone attack on the Coronavirus, treatment through the medicine if have a bout of Covid-19 and prevention through vaccination. So far, no country in the world has developed any treatment technique for the virus and was solely depending on mass vaccination to prevent its spread.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, Molnupiravir, be used as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, citing clinical data.
It is the first country to OK the treatment, although it was not immediately clear how quickly the pill would be available.
The pill was licensed for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. The drug is intended to be taken twice a day for five days by people at home with mild to moderate COVID-19.
An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations
The pill got the recognition from the British government even as the WHO cautioned that the rising number of cases of Covid-19 in Europe was of “grave concern” and the region could see another half a million deaths by early next year.
“The current pace of transmission across the 53 countries of the European Region is of grave concern,” WHO Europe director Hans Kluge told a press conference, adding that one reliable projection would mean “another half a million COVID-19 deaths,” by February if the current trajectory continued. The WHO’s European Region spans 53 countries and territories and includes several nations in Central Asia.
The WHO warning followed Germany on Thursday seeing its biggest daily rise in Covid-19 cases since the pandemic began, figures from the Robert Koch Institute (RKI) health agency showed. The country recorded 33,949 new cases in the past 24 hours, the RKI said, beating the previous daily record of 33,777 on December 18, 2020. Cases have been rising sharply over the past few weeks, with Health Minister Jens Spahn warning on Wednesday that a fourth wave was raging “with exceptional force”.
Molnupiravir is the first oral antiviral treatment for COVID-19 to get approved, with the green light coming ahead of potential U.S. regulatory clearance. U.S. advisers will meet this month to vote on whether Molnupiravir should be authorized.
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. The drug, to be branded Lagevrio in Britain, is designed to introduce errors into the genetic code of the virus that causes COVID-19 and is taken twice a day for five days.
The British government and the country’s National Health Service (NHS) will confirm how the treatment will be deployed to patients in “due course.” “We are working at pace across the government and with the NHS to set out plans to deploy Molnupiravir to patients through a national study as soon as possible,” health secretary Sajid Javid said in a statement. The speedy approval in Britain comes as the government struggles to tame soaring infections.
The country has about 40,000 daily cases of COVID-19, according to the latest seven-day average. That total is second only to the roughly 74,000 a day in the United States, which has five times more people. 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.
Pressure is growing on the government to implement its “Plan B” aimed at protecting the NHS from unsustainable demands, involving mask mandates, vaccine passes and work-from-home orders. Last month, Britain agreed a deal with Merck to secure 480,000 courses of Molnupiravir.
In a separate statement, Merck said it was expecting 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. The U.S. based drugmaker’s shares were up 2.1% at $90.54 before the market open.
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. Merck’s Molnupiravir is also being studied in a late-stage trial for preventing infection.
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 hospitalizations and deaths recently.
Initial supplies will be limited. Merck has said it can produce 10 million treatment courses through the end of the year, but much of that supply has already been purchased by governments worldwide. In October, U.K. officials announced they secured 480,000 courses of Molnupiravir and expected thousands of vulnerable Britons to have access to the treatment this winter via a national study.
“Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19,” said Sajid Javid. While it is not yet clear when Merck will deliver doses to Britain, the company has said it is committed to providing timely access to its drug globally with plans for tiered pricing aligned with a country’s ability to pay. Merck is also in talks with generic drugmakers about expanding manufacturing licences to build supply of the treatment. Antibody cocktails like those from Regeneron and Eli Lilly have also been approved for non-hospitalised COVID-19 patients, but have to be given intravenously.
As the number of cases kept rising in Germany, the government blamed it at the country’s relatively low vaccination rate with just 66.9 percent of the population fully inoculated as of Thursday, according to official figures. Health professionals say unvaccinated people account for the majority of patients in intensive care, with numbers rising rapidly.
“We are currently experiencing mainly a pandemic of the unvaccinated and it is massive,” Spahn said on Wednesday, warning that “in some regions in Germany intensive care beds are running out again.”
The Covid surge comes as Germany is in political limbo following September’s general election, with the winning Social Democrats hoping to have a new coalition government in place by early December. The incoming coalition parties have so far ruled out mandatory jabs and said there will be no new lockdowns — at least not for the vaccinated. However, under Germany’s federal system, regional states have significant powers to decide their own Covid approach, at times leading to a confusing patchwork of regulations.
Angela Merkel’s chief of staff Helge Braun on Wednesday called for an urgent meeting between the caretaker government and the leaders of Germany’s 16 states to agree common rules. Some states, including Baden-Wuerttemberg, Saxony and Bavaria, have already agreed or introduced tougher restrictions on the unvaccinated.
Merck and its partner Ridgeback Biotherapeutic have requested clearance for the drug Molnupiravir with regulators around the world to treat adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalisation. That’s roughly the same group targeted for treatment with infused COVID-19 antibody drugs, the standard of care in many countries for patients who don’t yet require hospitalisation.
Merck announced preliminary results last month showing its drug cut hospitalisations and deaths by half among patients with early COVID-19 symptoms. The results have not yet been peer reviewed or published in a scientific journal.
The company also did not disclose details on Molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.
The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors.
Britain’s Medicines and Healthcare products Regulatory Agency said Molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it was not found to pose a risk to humans.
“Studies in rats showed that (Molnupiravir) may cause harmful effects to the unborn offspring, although this was at doses which were higher than those that will be given to humans, and these effects were not observed in other animals,” the agency said in an email.
In company trials, both men and women were instructed to either use contraception or abstain from sex. Pregnant women were excluded from the study. Merck has stated that the drug is safe when used as directed.
Molnupiravir was initially studied as a potential flu therapy with funding from the US government. Last year, researchers at Emory University decided to repurpose the drug as a potential COVID-19 treatment. They then licensed the drug to Ridgeback and its partner Merck.
Last week, Merck agreed to allow other drugmakers to make its COVID-19 pill, in a move aimed at helping millions of people in poorer countries get access. The Medicines Patent Pool, a United Nations-backed group, said Merck will not receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be a global emergency.