Merck pill seen as ‘a huge advance’, raises hope of preventing COVID-19 deaths

An antiviral pill developed by US drugmaker Merck & Co. could half the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19. (Reuters)
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Updated 01 October 2021

Merck pill seen as ‘a huge advance’, raises hope of preventing COVID-19 deaths

  • If it gets authorization, molnupiravir, would be the first oral antiviral medication for COVID-19
  • Merck and partner Ridgeback Biotherapeutics said they plan to seek US emergency use authorization for the pill

WASHINGTON: An antiviral pill developed by US drugmaker Merck & Co. could half the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, with experts hailing it as a potential breakthrough in how the virus is treated.
If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.
Merck and partner Ridgeback Biotherapeutics said they plan to seek US emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.
“An oral antiviral that can impact hospitalization risk to such a degree would be game changing,” said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.
Current treatment options include Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.
“This is going to change the dialogue around how to manage COVID-19,” Merck Chief Executive Robert Davis told Reuters.
Existing treatments are “cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that,” Adalja added.
The results from the Phase III trial, which sent Merck shares up more than 9 percent, were so strong that the study is being stopped early at the recommendation of outside monitors.
Shares of Atea Pharmaceuticals Inc, which is developing a similar COVID-19 treatment, were up around 20 percent on the news.
Shares of COVID-19 vaccine makers Pfizer Inc. and Moderna Inc. were off more than 2 percent and 14 percent, respectively.
Michael Yee, a biotechnology analyst at Jefferies, said the share move indicated that investors believe “people will be less afraid of COVID and less inclined to get vaccines if there is a simple pill that can treat COVID.”
Pfizer and Swiss drugmaker Roche Holding AG are also racing to develop an easy-to-administer antiviral pill for COVID-19. For now, only antibody cocktails which have to be given intravenously are approved for non-hospitalized patients.
A planned interim analysis of 775 patients in Merck’s study looked at hospitalizations or deaths. It found that 7.3 percent of those given molnupiravir were hospitalized and none had died by 29 days after treatment, compared with hospitalization of 14.1 percent of placebo patients. There were also eight deaths in the placebo group.
“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said in a statement.
Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world.
“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID,” said Peter Horby, a professor of emerging infectious diseases at the University of Oxford.
In the trial, which involved patients from around the world, molnupiravir was taken every 12 hours for five days.
The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.
Merck said viral sequencing done so far shows molnupiravir is effective against all variants https://www.reuters.com/business/health care-pharmaceuticals/merck-says-research-shows-its-covid-19-pill-works-against-variants-2021-09-29 of the coronavirus including the highly transmissible Delta, which has driven the recent worldwide surge in hospitalizations and deaths.
It said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age in the study could be pregnant and also had to use birth control.
Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more coming next year.
The company has a US government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.
Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on country income criteria.
Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a Phase III trial for preventing infection in people exposed to the coronavirus.
Merck officials said it is unclear how long the FDA review will take, although Dean Li, head of Merck’s research labs, said, “They are going to try to work with alacrity on this.”


Shanghai, Beijing order new round of mass COVID-19 testing

Updated 7 sec ago

Shanghai, Beijing order new round of mass COVID-19 testing

  • Shanghai has only just emerged from a strict lockdown that confined most of its 24 million residents to their homes for weeks
BEIJING: Residents of parts of Shanghai and Beijing have been ordered to undergo further rounds of COVID-19 testing following the discovery of new cases in the two cities, while tight restrictions remain in place in Hong Kong, Macao and other Chinese cities.
Shanghai has only just emerged from a strict lockdown that confined most of its 24 million residents to their homes for weeks and the new requirements have stirred concerns of a return of such harsh measures.
The latest outbreak in China’s largest city, a key international business center, has been linked to a karaoke parlor that failed to enforce prevention measures among employees and customers, including the tracing of others they came into contact with, according to the city health commission. All such outlets have been ordered to temporarily suspend business, the city’s department of culture and tourism said.
Shanghai’s lockdown prompted unusual protests both in person and online against the government’s harsh enforcement, which left many residents struggling to access food and medical services and sent thousands to quarantine centers.
Beijing has also seen a recent outbreak linked to a nightlife spot. It has been conducting regular testing for weeks and at least one residential compound in the suburb of Shunyi, which is home to many foreign residents, has been locked down with a steel fence installed over its entrance to prevent residents from leaving.
Enforcement in China’s capital has been far milder than in Shanghai, although officials continue to require regular testing and prevention measures.
In the northern city of Xi’an, whose 13 million residents endured one of China’s strictest lockdowns over the winter, restaurants have been restricted to takeout only and public entertainment spots closed for a week starting Wednesday.
A notice on the city government’s website said the measures were only temporary and intended to prevent the chance of a renewed outbreak. It said supermarkets, offices, public transport and other facilities are continuing to operate as normal, with routine screening including temperature checks and people being required to show an app proving they are free of infection.
Neighboring Hong Kong has also seen a rising trend of coronavirus infections since mid-June. In the past seven days, daily infections reported averaged about 2,000 a day.
The city’s new leader, John Lee, said Wednesday that Hong Kong must not “lie flat” when it comes to COVID-19, rejecting the “living with the coronavirus” mentality that most of the world has adopted.
His comments echo the sentiments of Chinese authorities, who have stuck with their “zero-COVID” policy that has become closely identified with President and head of the ruling Communist Party Xi Jinping.
However, Lee has said that Hong Kong authorities are exploring options, including shortening the duration of mandatory quarantine for incoming travelers. Currently, travelers must test negative for COVID-19 before flying and quarantine for seven days in designated hotels upon arrival.
The city, once known as a bustling business hub and international financial center, has seen tourism and business travel crippled by its tough entry restrictions.
The strict measures have remained in place despite relatively low numbers of cases and the serious negative effects on China’s economy and global supply chains.
The World Health Organization recently called the policy unsustainable, a view Chinese officials rejected outright even while they say they hope to minimize the impact.
While China’s borders remain largely closed, cutting off both visitors from abroad and outbound tourism, officials have cautiously increased flights from some foreign countries, most recently Russia.
Mainland China reported 353 cases of domestic transmission on Wednesday, 241 of them asymptomatic.
Shanghai announced just 24 cases over the past 24 hours, and Beijing five. Anhui announced 222 cases in what appears to be the latest cluster, prompting the inland province to order mass testing and travel restrictions in Si county, where the bulk of cases have been reported.

Hundreds urged to evacuate as Russians advance in Ukraine’s Donbas

Updated 55 min 26 sec ago

Hundreds urged to evacuate as Russians advance in Ukraine’s Donbas

  • Sloviansk has been subjected to “massive” Russian bombardment in recent days
  • Two Ukrainian Red Cross minibuses were heading there to evacuate willing civilians

SLOVIANSK: Ukrainian officials have called on civilians to urgently evacuate the city of Sloviansk as Russian troops press toward it in their campaign to secure the Donbas region.
Sloviansk has been subjected to “massive” Russian bombardment in recent days, with at least two people killed and seven others wounded in an attack on a marketplace Tuesday.
Pavlo Kyrylenko, governor of the Donetsk region, which includes Sloviansk, told Ukrainian media his “main advice is evacuate!“
“This week there hasn’t been a day without shelling,” he said Tuesday evening, adding that the city was now within range of Russian multiple-rocket launchers.
“The enemy is shelling chaotically, the attacks are aimed at destroying the local population,” he said
“So, once again, the main advice is to evacuate.”
AFP journalists on the ground in Sloviansk saw rockets slam into the marketplace and surrounding streets, with firefighters scrambling to put out the resulting fires.
Kyrylenko also reported shelling across “the entire frontline” in the eastern Donbas region, where Russia has refocused its efforts since abandoning its initial aim of capturing Kyiv, following tough Ukrainian resistance.
Donbas is mainly comprised of Lugansk, which Russian forces have almost entirely captured, and Donetsk to its southwest — the current focus of Moscow’s attack
The fall of Lysychansk in the region on Sunday, a week after the Ukrainian army also retreated from the neighboring city of Severodonetsk, has freed up Russian troops to advance on Kramatorsk and Sloviansk.
On Tuesday, they were first closing in on the smaller city of Siversk — which lies between Lysychansk and Sloviansk — after days of shelling there.
Two Ukrainian Red Cross minibuses were heading there to evacuate willing civilians, according to AFP reporters.

Two Ukrainian Red Cross minibuses were heading there to evacuate willing civilians, according to AFP reporters. (File/AFP)


“Heavy fighting is taking place on the outskirts of Lugansk region near Lysychansk,” Lugansk governor Sergiy Gaiday said on Telegram.
“The occupiers are withdrawing equipment to the Donetsk region.”
To the southwest, in the Moscow-occupied Kherson region, Russian troops have deployed helicopters and artillery to try to stem Ukrainian counter-attacks.
A spokesman for Ukraine’s defense ministry said Tuesday that Russian forces outside Donbas were “trying to bind our troops in order to prevent them from moving to the battle areas.”
Kherson city, which lies close to Moscow-annexed Crimea, was the first major city to fall to Russian forces in February, and has seen a campaign of so-called Russification since.
Ukrainian President Volodymyr Zelensky, speaking in his evening address Tuesday, said he was continuing to press for upgraded anti-missile systems as air siren alerts sounded across much of the country, including the capital.
“The Russian army does not take any breaks,” he said.
“Our task is to hold on.”


Thousands more flee as Sydney floods track north

Updated 06 July 2022

Thousands more flee as Sydney floods track north

  • New South Wales authorities issued fresh flood alerts north of Australia’s largest city
  • 85,000 people have been told to leave their homes immediately or be ready to depart imminentl

SYDNEY: Thousands of people on Australia’s east coast fled their homes Wednesday as torrential rains tracked north after unleashing floods in Sydney that submerged communities, roads and bridges under mud-brown water.
New South Wales authorities issued fresh flood alerts north of Australia’s largest city and warned that rising, rain-swollen rivers still posed a danger in parts of Sydney despite easing rainfall in the city.
“This event is far from over,” the state’s Premier Dominic Perrottet said.
Since the floods began over the weekend, emergency services have issued more than 100 evacuation orders.
A total 85,000 people have been told to leave their homes immediately or be ready to depart imminently so they will not be stranded by rising floodwaters.
Across Sydney’s western fringe, rivers broke their banks and large areas have been transformed into inland lakes, with mud-brown waters invading homes while cutting off roads and bridges.
Prime Minister Anthony Albanese visited the affected area Wednesday, promising to look for “long-term solutions” after multiple flooding disasters across Australia’s east coast in the past 18 months.
Albanese said that while “Australia has always been subject of floods, of bushfires,” scientists have warned climate change would make such events more frequent and intense.
“What we are seeing, unfortunately, is that play out,” he said.
There were 21 flood rescues across New South Wales overnight, and on Wednesday more than 1,000 emergency service workers were in the field.
The federal government has declared a natural disaster in 23 flooded parts of the state, unlocking relief payments to stricken residents.
Many people affected have lived through successive east coast floods that struck in 2021 and then again in March this year when more than 20 people were killed.
Australia’s Bureau of Meteorology said the weather system was expected to move off coast later this week.
Andrew Hall, chief executive of the Insurance Council of Australia, said he expected the Sydney floods would be declared a “catastrophe” by the insurance industry.
He said 2,700 insurance claims have been lodged by Tuesday from Sydney alone, and more were anticipated as people were able to return to their homes.
Hall said there had been Aus$5 billion ($3.4 billion) in catastrophe claims made in Australia this year.
It was “untenable” for homes that had flooded four times in the past 18 months to remain in the insurance pool, Hall said, adding: “We’ve got to stand back and ask the question, ‘Have we built homes in the wrong spot?’”


UK PM Johnson names Zahawi as new finance minister

Updated 06 July 2022

UK PM Johnson names Zahawi as new finance minister

  • The 55-year-old co-founded the prominent polling company YouGo
  • Won widespread praise for overseeing Britain’s pandemic vaccines rollout.

LONDON: British Prime Minister Boris Johnson late Tuesday named his Iraqi-born education secretary, Nadhim Zahawi, as finance minister after the shock resignation of Rishi Sunak.
Downing Street said Queen Elizabeth II had approved the appointment of Zahawi, who came to Britain as a child with his Kurdish family not speaking any English, before forging a lucrative business career.
The 55-year-old co-founded the prominent polling company YouGov and was active in local Conservative politics in London, before becoming an MP in 2010.
He won widespread praise for overseeing Britain’s pandemic vaccines rollout.
But like Sunak, his private wealth has drawn adverse attention, including when he claimed parliamentary expenses for heating his horse stables in 2013.
Zahawi refused to comment to reporters as he left a meeting in 10 Downing Street, including on whether he will uphold Sunak’s pleas for fiscal discipline against Johnson’s free-spending instincts.
The prime minister named another loyalist, Michelle Donelan, to take Zahawi’s place at the education ministry.


2 key UK Cabinet ministers quit Boris Johnson’s government

Updated 05 July 2022

2 key UK Cabinet ministers quit Boris Johnson’s government

  • Treasury chief Rishi Sunak and Health Secretary Sajid Javid resigned within minutes of each other
  • Sunak and Javid have been seen as possible leadership contenders within the Conservative Party if Johnson is forced out

LONDON: Two of Britain’s most senior Cabinet ministers resigned on Tuesday, a move that could spell the end of Prime Minister Boris Johnson’s leadership after months of scandals.
Treasury chief Rishi Sunak and Health Secretary Sajid Javid resigned within minutes of each other after a day in which the prime minister was forced to acknowledge he had to change his story on the way he handled allegations of sexual misconduct by a senior member of his government.
“It is with enormous regret that I must tell you that I can no longer, in good conscience, continue serving in this government,’’ Javid said in his resignation letter. “I am instinctively a team player but the British people also rightly expect integrity from their government.’’
Sunak said “the public rightly expect government to be conducted properly, competently and seriously.”
“I recognize this may be my last ministerial job, but I believe these standards are worth fighting for and that is why I am resigning,” he added.
Both Sunak and Javid have been seen as possible leadership contenders within the Conservative Party if Johnson is forced out. Their departures were a huge blow to the prime minister, because both were in charge of two of the biggest issues facing Britain right now — the cost of living crisis and the aftermath of the coronavirus pandemic.
The latest scandal saw Johnson hit by allegations he failed to come clean about a lawmaker who was appointed to a senior position despite claims of sexual misconduct.
Johnson has faced pressure to explain what he knew about previous misconduct allegations against lawmaker Chris Pincher, who resigned as deputy chief whip Thursday amid complaints that he groped two men at a private club.
Minutes before the resignations of Javid and Sunak were announced, Johnson told reporters that Pincher should have been fired from the government after a previous 2019 incident.
Asked if it was an error to appoint Pincher to the government, Johnson said “I think it was a mistake and I apologize for it. In hindsight it was the wrong thing to do.”
“I apologize to everybody who has been badly affected by it. I want to make absolutely clear that there’s no place in this government for anybody who is predatory or who abuses their position of power,” Johnson said.
The government’s explanation shifted repeatedly over the past five days. Ministers initially said Johnson wasn’t aware of any allegations when he promoted Pincher to the post in February.
On Monday, a spokesman said Johnson knew of sexual misconduct allegations that were “either resolved or did not progress to a formal complaint.”
That account didn’t sit well with Simon McDonald, the most senior civil servant at the UK Foreign Office from 2015 to 2020. In a highly unusual move, he said Tuesday that the prime minister’s office still wasn’t telling the truth.
McDonald said in a letter to the parliamentary commissioner for standards that he received complaints about Pincher’s behavior in the summer of 2019, shortly after Pincher became a Foreign Office minister. An investigation upheld the complaint, and Pincher apologized for his actions, McDonald said.
McDonald disputed that Johnson was unaware of the allegations or that the complaints were dismissed because they had been resolved or not made formally.
“The original No. 10 line is not true, and the modification is still not accurate,” McDonald wrote, referring to the prime minister’s Downing Street office. “Mr. Johnson was briefed in person about the initiation and outcome of the investigation.
Hours after McDonald’s comments came out, Johnson’s office changed its story again, saying the prime minister forgot he was told that Pincher was the subject of an official complaint.
The latest revelations have fueled discontent within Johnson’s Cabinet after ministers were forced to publicly deliver the prime minister’s denials, only to have the explanation shift the next day.
The Times of London on Tuesday published an analysis of the situation under the headline “Claim of lying puts Boris Johnson in peril.”
Johnson’s authority had already been shaken by a vote of no confidence last month. He survived, but 41 percent of Conservatives voted to remove him from office.
The prime minister’s shifting responses to months of allegations about lockdown-breaking parties in government offices that ultimately resulted in 126 fines, including one levied against Johnson, fueled concerns about his leadership.
Two weeks later, Conservative candidates were badly beaten in two special elections to fill vacant seats in Parliament, adding to the discontent within Johnson’s party.
When Pincher resigned last week as deputy chief whip, a key position in enforcing party discipline, he told the prime minister that he “drank far too much” the previous night and had “embarrassed myself and other people.”
Johnson initially refused to suspend Pincher from the Conservative Party, but he relented after a formal complaint about the groping allegations was filed with parliamentary authorities.
Critics suggested Johnson was slow to react because he didn’t want to be in the position of forcing Pincher to resign his Parliament seat and setting up the Conservatives for another potential special election defeat.
Even before the Pincher scandal, suggestions were swirling that Johnson may soon face another no-confidence vote.
In the next few weeks, Conservative lawmakers will elect new members to the committee that sets parliamentary rules for the party. Several candidates have suggested they would support changing the rules to allow for another vote of no confidence. The existing rules require 12 months between such votes.
Senior Conservative lawmaker Roger Gale, a long-standing critic of Johnson, said he would support a change of the rules of the Conservative 1922 Committee.
“Mr. Johnson has for three days now been sending ministers — in one case a Cabinet minister — out to defend the indefensible, effectively to lie on his behalf. That cannot be allowed to continue,” Gale told the BBC. “This prime minister has trashed the reputation of a proud and honorable party for honesty and decency, and that is not acceptable.”