Pill shown to treat covid-19 authorized by U.K.

LONDON — Britain granted conditional authorization on Thursday to the first pill shown to successfully treat covid-19 so far. It also is the first country to OK the treatment from drugmaker Merck, although it wasn’t 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. Patients with mild-to-moderate COVID-19 would take four pills of the drug, known molnupiravir, twice a day for five days.

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.

Molnupiravir is also pending review with regulators in the U.S., the European Union and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.

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 U.K. is now the first country in the world to approve an antiviral that can be taken at home for covid-19,” British health secretary Sajid Javid said.

“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,” he said in a statement, referring to the U.K.’s National Health Service. Doctors said the treatment would be particularly significant for people who don’t respond well to vaccination.

Merck and partner Ridgeback Biotherapeutic have requested clearance for the drug with regulators around the world for adults with early cases of COVID-19 who are at risk for severe disease or hospitalization. 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 hospitalization.

Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results haven’t yet been peer reviewed or published in a scientific journal.

The company also didn’t 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 wasn’t 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 U. S. 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 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 U.N.-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.

RESURGENCE THREAT

A 53- country region in Europe and Central Asia faces the “real threat” of a resurgence of the coronavirus pandemic in the coming weeks or already is experiencing a new wave of infections, the head of the World Health Organization’s regional office said Thursday.

Dr. Hans Kluge said case counts are beginning to near record levels again and the pace of transmission in the region, which stretches as far east as the former Soviet republics in Central Asia, is of “grave concern.”

“We are at another critical point of pandemic resurgence,” Kluge told reporters from WHO Europe headquarters in Copenhagen, Denmark. “Europe is back at the epicenter of the pandemic, where we were one year ago.”

He said the difference now is that health authorities know more about the virus and have better tools to combat it. Relaxed prevention measures and low vaccination rates in some areas explain the latest surge, he said.

Kluge said hospitalization rates due to COVID-19 in the 53-country region more than doubled over the last week. If that trajectory continues, the region could see another 500,000 pandemic deaths by February, he said.

WHO Europe says the region tallied nearly 1.8 million new weekly cases, an increase of about 6% from the previous week, and 24,000 covid-19 weekly deaths, a 12% gain.

Kluge said the countries in the region were at “varying stages of vaccination rollout” and that regionwide an average of 47% of people were fully vaccinated. Only eight countries had 70% of their populations fully vaccinated.

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

WHO’s headquarters in Geneva on Wednesday reported that cases had risen in Europe for the fifth consecutive week, making it the only world region where COVID-19 is still increasing. The infection rate was by far the highest in Europe, which reported some 192 new cases per 100,000 people.

Several countries in Central and Eastern Europe have seen daily case numbers shoot up in recent weeks.