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Is COVID-19 the dreaded 'disease X' World Health Organization experts predicted years ago? – The Japan Times

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The World Health Organization cautioned years ago that a mysterious “disease X” could spark an international contagion. The new coronavirus, with its ability to quickly morph from mild to deadly, is emerging as a contender.

From recent reports about the stealthy ways the COVID-19 virus spreads and maims, a picture is emerging of an enigmatic pathogen whose effects are mainly mild, but which occasionally — and unpredictably — turns deadly in the second week. In less than three months, it has infected almost 78,000 people, mostly in China, and killed more than 2,300. Emerging hot spots in South Korea, Iran and Italy have stoked further alarm.

“Whether it will be contained or not, this outbreak is rapidly becoming the first true pandemic challenge that fits the disease X category,” Marion Koopmans, head of viroscience at Erasmus University Medical Center in Rotterdam, and a member of the WHO’s emergency committee, wrote Wednesday in the journal Cell.

South Korea and China on Sunday both reported a rise in new cases and a diplomatic row erupted after Israel turned back a South Korean airliner, underscoring fear and tensions over the fast-spreading outbreak, which the South Korean prime minister said has entered a “more grave stage.”

Some virus clusters have shown no direct link to travel to China.

The death toll in Iran climbed to six, the highest outside China, and a dozen towns in northern Italy effectively went into lockdown as authorities tested hundreds of people who came into contact with an estimated 79 confirmed cases there. Two people have died in Italy.

A resident of Codogno, southeast of Milan, wears a protective respiratory mask on Sunday. An Italian man became the first European to die after being infected with the coronavirus on Feb. 21, just hours after 10 towns in the country were locked down following a flurry of new cases. | AFP-JIJI

The Korea Centers for Disease Control and Prevention said that 113 of the 123 new cases came from the fourth-largest city of Daegu and surrounding areas. Centers chief Jeong Eun-kyeong told reporters that 309 of the country’s 556 patients have been confirmed to have links to a branch of the local Shincheonji church in Daegu, which has become the biggest cluster of viral infections. Tests were underway on 6,039 other people.

The disease has now spread to more than two dozen countries and territories. Some of those infected caught the virus in their local community and have no known link to China, the U.S. Centers for Disease Control and Prevention said.

“We are not seeing community spread here in the United States yet, but it’s very possible — even likely — that it may eventually happen,” Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters Friday.

Unlike severe acute respiratory syndrome (SARS), its viral cousin, the COVID-19 virus replicates at high concentrations in the nose and throat akin to the common cold, and appears capable of spreading from those who show mild or no symptoms. That makes it impossible to control using the fever-checking measures that helped stop SARS 17 years ago.

A cluster of cases within a family living in the Chinese city of Anyang is presumed to have begun when a 20-year-old woman carried the virus from Wuhan, the outbreak’s epicenter, on Jan. 10 and spread it while experiencing no illness, researchers said Friday in the Journal of the American Medical Association.

Five relatives subsequently developed fever and respiratory symptoms. COVID-19 is less deadly than SARS, which had a case fatality rate of 9.5 percent, but appears more contagious. Both viruses attack the respiratory and gastrointestinal tracts, via which they can potentially spread.

While more than 80 percent of patients are reported to have a mild version of the disease and will recover, about one in seven develops pneumonia, difficulty breathing and other severe symptoms. About 5 percent of patients have critical illness, including respiratory failure, septic shock and multiorgan failure.

People wearing protective face masks leave a mosque after Friday prayer in Singapore on Friday.
People wearing protective face masks leave a mosque after Friday prayer in Singapore on Friday. | AFP-JIJI

“Unlike SARS, COVID-19 infection has a broader spectrum of severity ranging from asymptomatic to mildly symptomatic to severe illness that requires mechanical ventilation,” doctors in Singapore said in a paper in the same medical journal Thursday. “Clinical progression of the illness appears similar to SARS: patients developed pneumonia around the end of the first week to the beginning of the second week of illness.”

Older adults, especially those with chronic conditions, such as hypertension and diabetes, have been found to have a higher risk of severe illness. Still, “the experience to date in Singapore is that patients without significant co-morbid conditions can also develop severe illness,” they said.

Li Wenliang, the 34-year-old ophthalmologist who was one of the first to warn about the coronavirus in Wuhan, died earlier this month after receiving antibodies, antivirals, antibiotics, oxygen and having his blood pumped through an artificial lung.

The doctor, who was in good health prior to his infection, appeared to have a relatively mild case until his lungs became inflamed, leading to the man’s death two days later, said Linfa Wang, who heads the emerging infectious disease program at Duke-National University of Singapore Medical School.

A similar pattern of inflammation noted among COVID-19 patients was observed in those who succumbed to the 1918 “Spanish flu” pandemic, said Gregory Poland, the Mary Lowell Leary emeritus professor of medicine, infectious diseases, and molecular pharmacology and experimental therapeutics at the Mayo Clinic in Rochester, Minnesota.

“Whenever, you have an infection, you have a battle going on,” Poland said in a phone interview Thursday. “And that battle is a battle between the damage that the virus is doing, and the damage the body can do when it tries to fight it off.”

Doctors studying a 50-year-old man who died in China last month found COVID-19 gave him mild chills and dry cough at the start, enabling him to continue working. But on his ninth day of illness, he was hospitalized with fatigue and shortness of breath, and treated with a barrage of germ-fighting and immune system-modulating treatments.

He died five days later with lung damage reminiscent of SARS and MERS, another coronavirus-related outbreak, doctors at the Fifth Medical Center of PLA General Hospital in Beijing said in a Feb. 16 study in the Lancet medical journal. Blood tests showed an over-activation of a type of infection-fighting cell that accounted for part of the “severe immune injury” he sustained, the authors said.

Codogno, near Lodi, and a dozen other towns in northern Italy, Saturday were in effective lockdown over the emergence of the new coronavirus. | AP
Codogno, near Lodi, and a dozen other towns in northern Italy, Saturday were in effective lockdown over the emergence of the new coronavirus. | AP

Controversially, he had been given 80 milligrams twice daily of methylprednisolone, an immune-suppressing corticosteroid drug that is in common use in China for severe cases, though it has been linked to “prolonged viral shedding” in earlier studies of MERS, SARS and influenza, according to the WHO.

The patient’s doctors recommended corticosteroids be considered alongside ventilator support for severely ill patients to prevent a deadly complication known as acute respiratory distress syndrome.

He was given at least double what would typically be recommended for patients with the syndrome and other respiratory indications, said Reed Siemieniuk, a general internist and a health research methodologist at McMaster University in Hamilton, Ontario. Based on what was observed with MERS, the drug may delay viral clearance in COVID-19 patients, he said.

“Corticosteroids could cause more harm than good because of that risk,” Siemieniuk said in an interview. “I wouldn’t want to let a patient die without trying steroids, but I would wait until patients were extremely ill.”

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Merck’s COVID-19 pill significantly less effective in new analysis

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Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.

The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data nL1N2QX0QJ showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.

The lower efficacy of Merck’s drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc’s trial for its experimental pill, Paxlovid, showed an 89% reduction in hopsitalizations and deaths.

Merck’s shares fell 3.5% to $79.39 in morning trading.

Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.

The agency’s staff did not make their own recommendation as to whether the pill should be authorized.

FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.

They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.

Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates.

EASIER TREATMENT

The Merck and Pfizer pills are cheaper to produce and easier to administer than existing treatment options such as antibody therapies from Regeneron and Eli Lilly, which are mostly administered as intravenous infusions.

The two experimental drugs have different mechanisms of action. Merck’s is designed to introduce errors into the genetic code of the virus. Pfizer’s drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs in order to multiply.

Merck filed for a U.S. authorization of molnupiravir on Oct. 11, following the interim data, and submitted the updated data to the FDA this week.

The molnupiravir arm of the study had a hospitalization and death rate of 6.8%, according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.

One patient in the molnupiravir arm died, versus nine in the placebo group.

The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.

Merck expects 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. It has a contract with the U.S. government to supply as many as 5 million courses at a price of $700 per course. Several other countries have already secured millions of courses of the pill.

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 also had to use birth control.

Still, the FDA said in its briefing document that there are safety concerns about potential birth defects from the drug and asked the panel to discuss whether the drug should be available to pregnant women.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New JerseyEditing by Shounak Dasgupta, Frances Kerry and Emelia Sithole-Matarise)

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Brazil health regulator calls for Africa travel restrictions, Bolsonaro noncommittal

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Brazilian health regulator Anvisa recommended on Friday that travel be restricted from some African countries due to the detection of a new COVID-19 variant, though it was unclear if President Jair Bolsonaro would adopt any measures.

Anvisa said its recommendation, which would need government approval to be implemented, was to immediately suspend flights from South Africa, Botswana, Lesotho, Eswatini, Namibia and Zimbabwe.

The EU and Britain are already tightening border controls as researchers look into whether the new mutation is vaccine-resistant.

Brazil’s Health Ministry said in a separate note that the new B.1.1.529 variant named Omicron poses a potential future threat, but that its epidemiological impact was unclear.

After the Anvisa statement, Bolsonaro told journalists he was considering taking measures related to the variant but continued to emphasize that he was against severe coronavirus-related restrictions.

“Brazil can’t handle another lockdown. There’s no use getting terrified,” he said after a military event in Rio de Janeiro. “I’m going to take rational measures.”

Bolsonaro has been widely criticized by public health experts for his management of the pandemic, railing against lockdowns, often refusing to wear a mask in public and choosing not to get vaccinated. Brazil has the world’s second-highest death toll from the virus, behind only the United States.

The World Health Organization (WHO) has cautioned countries against hastily imposing travel restrictions due to the variant, saying they should take a “risk-based and scientific approach.”

In its technical note, Anvisa said that foreigners who have been to at least one of the six African countries cited in the prior 14 days should not be allowed to land in Brazil, while Brazilians arriving from those nations should be required to quarantine.

The health agency said, “The new variant appears to have a higher transmissibility.”

Anvisa President Antonio Barra Torres told news channel GloboNews that travel restrictions are a necessary preventive measure and he expected the government to make a decision as soon as possible.

The news of the variant hammered travel stocks in Brazil.

(Reporting by Gabriel Araujo in Sao Paulo and Lisandra Paraguassu in BrasiliaAdditional reporting by Rodrigo Viga Gaier in Rio de Janeiro and Eduardo Simoes in Sao PauloWriting by Stephen Eisenhammer and Gram SlatteryEditing by Brad Haynes and Alistair Bell)

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Novavax developing vaccine that targets new COVID-19 variant

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Novavax Inc said on Friday it had started working on a version of its COVID-19 vaccine to target the variant detected in South Africa and would have the shot ready for testing and manufacturing in the next few weeks.

The company’s COVID-19 shot contains an actual version of the virus’ spike protein that cannot cause disease but can trigger the immune system. The vaccine developer said it had started developing a spike protein specifically based on the known genetic sequence of the variant, B.1.1.529.

“The initial work will take a few weeks,” a company spokesperson said. Shares of the company closed up nearly 9% on Friday.

Novavax’s vaccine received its first emergency use approval earlier this month in Indonesia followed by the Philippines.

The company has said it is on track to file for U.S. approval by the end of the year. It has also filed for approvals with the European Medicines Agency as well as in Canada.

Other vaccine developers, including Germany’s BioNTech SE and Johnson & Johnson, have said they are testing the effectiveness of their shots against the new variant, which is named Omicron by the World Health Organisation.

Inovio Pharmaceuticals Inc said it had begun testing its vaccine candidate, INO-4800, to evaluate its effectiveness against the new variant. The company expects the testing to take about two weeks.

Inovio also said it was simultaneously designing a new vaccine candidate that specifically targeted Omicron.

“Best case scenario, INO-4800 … will be completely resilient against omicron, but if that’s not the case then we will have a newly designed vaccine ready to go if need be,” said Kate Broderick, senior vice president of Inovio’s R&D division.

Earlier this month, Inovio resumed a late-stage trial of its vaccine in the United States after 14 months on clinical hold.

(Reporting by Manojna Maddipatla and Mrinalika Roy in Bengaluru; Editing by Anil D’Silva)

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