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Friday, November 20, 2020, 23:00
EU says no change to uses of remdesivir after WHO guidance
By Agencies
Friday, November 20, 2020, 23:00 By Agencies

This April 8, 2020 photo shows a vial of the drug Remdesivir pictured during a press conference at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany. (PHOTO / AFP)

LONDON / NEW YORK / ROME / BERLIN / MEXICO CITY / SAO PAULO / CAIRO / BRUSSELS / BELGRADE / BUCHAREST / MINSK - The European Commission on Friday said there had been no change in the authorised uses of Gilead’s remdesivir after the World Health Organization advised against using the antiviral for treating hospitalised COVID-19 patients.

“We take note that the WHO has now updated its guidelines on the use of remdesivir,” a Commission spokesman said in an email.

The European drugs regulator has requested full data from the WHO-led Solidarity trial into the drug and will assess the evidence, together with other available data, to see if any changes are needed to its market authorisation, he said.

Gilead’s drug remdesivir is not recommended for patients hospitalised with COVID-19, regardless of how ill they are, as there is no evidence it improves survival or reduces the need for ventilation, a World Health Organization panel said on Friday.

“The ... panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others,” the guideline said.

The advice is another setback for the drug, which grabbed worldwide attention as a potentially effective treatment for COVID-19 in the summer after early trials showed some promise.

At the end of October, Gilead cut its 2020 revenue forecast, citing lower-than-expected demand and difficulty in predicting sales of remdesivir.

The antiviral is one of only two medicines currently authorised to treat COVID-19 patients across the world, but a large WHO-led trial known as the Solidarity Trial showed last month that it had little or no effect on 28-day mortality or length of hospital stays for COVID-19 patients.

EU

BioNTech SE and Moderna Inc could receive conditional European Union marketing authorization for their COVID-19 vaccines in the second half of next month, according to the head of the EU’s executive arm, putting the bloc on track to start distributing the shots at the same time as the US.

The European Medicines Agency is in daily contact with the US Food and Drug Administration about the evaluation of the vaccines in order to “synchronize” assessment, said European Commission President Ursula von der Leyen. 

The speedy regulatory assessment comes as many European countries battle fierce new waves with the onset of colder weather, forcing governments to impose new lockdowns over weary populations. 

The EU could pay more than US$10 billion to buy hundreds of millions of doses of the vaccine jointly developed by Pfizer Inc. and BioNTech as well as that of CureVac NV, Reuters said Friday, citing an EU official it didn’t name. The price it agreed for the Pfizer-BioNTech shot is 15.50 euros (US$18.34) per dose, less than what the US is paying, the newswire said.

The European Union must only lift coronavirus restrictions slowly and gradually to avoid another wave of infections, the head of the bloc's executive said on Thursday. 

Ursula von der Leyen spoke after the 27 national leaders discussed stepping up joint testing efforts in the bloc, doling out vaccines and coordinating easing lockdowns as a second wave of the pandemic weighs on Europe. 

"We have all learned from the experience in the summer that the exit from a wave ... is very difficult and that ... lifting measures too hastily has had a very bad impact on the epidemiological situation in summer and fall," she said.

In this July 27, 2020 file photo, a nurse prepares a shot that is part of a possible COVID-19 vaccine developed by the National Institutes of Health and Moderna Inc, in Binghamton, New York, the United States. (HANS PENNINK / AP)

Roche

Roche Holding AG is working hard to rapidly boost supply of COVID-19 antibody treatments and will be able to make its first deliveries in the first quarter of next year, according to Chief Executive Officer Severin Schwan.

US biotech Regeneron Pharmaceuticals Inc has filed in the US for emergency authorization for an antibody cocktail it’s working on with Roche and that could be granted “very soon,” Schwan said Friday in an interview with Bloomberg Television.

The two companies’ combined capacity next year will be about 2 million doses, Schwan said. That’s about half the number of new COVID-19 cases identified around the world last week, according to the World Health Organization.

The need for a broad range of treatment options has come into increased focus as some hoped-for therapies, including Gilead Sciences Inc’s antiviral remdesivir, fall short.

Global tally

The number of coronavirus cases recorded across the world has surpassed 56.8 million while the global death toll has exceeded 1.35 million, according to data compiled by Johns Hopkins University.

READ MORE: UNICEF calls for averting lost COVID-19 generation

Johnson & Johnson

Johnson & Johnson expects to know the efficacy of its COVID-19 vaccine candidate come January or February, Chief Scientific Officer Paul Stoffels said at a Reuters health conference.

Johnson & Johnson anticipates it will have all 60,000 participants enrolled in the final-stage study by the year’s end.

US

US non-essential travel restrictions across its borders with Canada and Mexico will be extended through Dec. 21 due to COVID-19, US Acting Homeland Security Secretary Chad Wolf said on Thursday.

The number of people hospitalized with COVID-19 in the United States has jumped nearly 50 percent in the last 14 days, straining the nation's healthcare system and forcing states to impose new restrictions to curb the alarming spread of the coronavirus. 

California Governor Gavin Newsom imposed a curfew on the majority of residents to stymie the virus’s transmission, boosting measures to stop an outbreak while stopping short of a full lockdown. The move reflects growing alarm among state officials as the third wave of coronavirus cases to hit California gains momentum.

UK

Britain will set up dozens of mass vaccination centres to immunize people against coronavirus as soon as vaccines are available, the Telegraph reported. One of the first locations for administering Pfizer Inc vaccine from mid-December has been confirmed as being in Derby, the newspaper added.

Britain recorded a further 501 deaths within 28 days of a positive COVID-19 test on Thursday, a decrease from 529 a day earlier, government figures showed. 

There were 22,915 people who tested positive for COVID-19 in the latest daily figures, an increase from the 19,609 cases recorded on Wednesday.

Italy

Italy has registered 36,176 new coronavirus infections over the past 24 hours, the health ministry said on Thursday, up from 34,283 the day before. 

The ministry also reported 653 COVID 19-related deaths, down from 753 on Wednesday. 

Italy was the first Western country to be hit by the virus and has seen 47,870 COVID-19 fatalities since its outbreak emerged in February, the second highest toll in Europe after Britain's. It has also registered 1.309 million cases.

The authors of a study showing that the new coronavirus was circulating in Italy earlier than experts had previously believed said on Thursday their data did not dispute the origins of COVID-19 as they defended the accuracy of their findings. 

The Italian researchers' findings showed that 11.6 percent of 959 healthy volunteers enrolled in a lung cancer screening trial between September 2019 and March 2020 had developed coronavirus antibodies well before February.

Ireland 

Irish finance minister Paschal Donohoe says he expects public health guidance to be changed shortly, signaling the nation’s lockdown is likely to be eased in December. He cited improving case numbers in comments in Newstalk radio interview.

France

France reported 21,150 new confirmed COVID-19 cases on Thursday, down from 28,383 on Wednesday as pressure on the hospital system continued to ease. 

Health ministry data showed the number of people in hospital with the virus dropped by 497 to 32,345, while the number of people in intensive care with COVID-19 dropped by 122 to 4,653 over the past 24 hours. 

The total number of confirmed coronavirus cases now stands at 2,086,288. The number of people who have died from the disease this year rose by 429 to 47,127.

Germany

The number of confirmed coronavirus cases in Germany increased by 23,648 to 879,564, data from the Robert Koch Institute (RKI) for infectious diseases showed on Friday. The reported death toll rose by 260 to 13,630, the tally showed.

Russia

Russia registered 24,318 COVID-19 cases over the past 24 hours, setting a new all-time high as the pandemic resurged, the country's COVID-19 response center said Friday.

Russia's cumulative number of coronavirus cases has grown to 2,039,926, including 35,311 deaths and 1,551,414 recoveries, the center said in a statement.

Moscow reported most of the new cases with 6,902 infections, reaching a cumulative case count of 539,970, the center said.

Meanwhile, the developers of Russia's second vaccine against COVID-19 on Friday said mass production would begin in 2021. 

A worker wearing a protective mask pushes a cart in San Francisco, California, US, on Nov 18, 2020. (PHOTO / BLOOMBERG)

Spain

Spain's health ministry on Thursday lowered a price cap on health masks used to curb COVID-19 contagion to 0.62 euros (US$0.73) per mask to take into account a cut in value-added tax announced this week. 

The use of masks covering the nose and the mouth to prevent coronavirus contagion has been mandatory for months in Spain for people from the age of six. 

The country has the second-highest number of cumulative infections in western Europe. 

On Thursday, the Health Ministry reported an increase of 16,233 cases versus Wednesday to hit a cumulative total of 1,541,574, while the death toll rose by 252 to 42,291 compared to figures from the previous day.

ALSO READ: Pfizer, BioNTech plan filing as vaccine proves 95% effective

Portugal

Portugal's president asked parliament on Thursday to back an extension of a state of emergency imposed to fight the coronavirus for an additional 15 days from next week as the number of new daily infections reached a record high. 

The nationwide state of emergency, which came into force on Nov. 9, includes a night-time curfew and a half-day lockdown on weekend days across 191 of Portugal's 308 municipalities. 

It is due to expire on Nov. 23 but lawmakers are likely to approve the request by President Marcelo Rebelo de Sousa for an extension on Friday. 

Under Portuguese law, the state of emergency is limited to 15 days but can be extended indefinitely in 15-day periods.

Czech Republic

The Chamber of Deputies of the Parliament of the Czech Republic on Thursday voted to extend the country's COVID-19 state of emergency until Dec. 12.

The government's original proposal aimed to extend the state of emergency -- previously set to expire on Nov. 20 -- to Dec. 20.

The deputies were split over the decision, but they eventually accepted a compromise proposal submitted by the Communist Party of Bohemia and Moravia (KSCM).

The daily increase in COVID-19 cases has slowed down in response to the government's strict measures, but officials, among them Health Minister Jan Blatny, have warned that the situation is still not under control.

On Thursday, the country's infection risk index stood at 62 on the 0-100 scale, down from 70 on Wednesday.

On Wednesday, the Czech Health Ministry confirmed 5,515 new coronavirus infections.

Slovenia 

Slovenia on Thursday reported 2,064 new COVID-19 cases in the past 24 hours, taking the national tally of confirmed cases to 60,887.

The country conducted 6,806 coronavirus tests on Wednesday, 30.33 percent of which came back positive. A total of 1,238 patients were being treated in hospitals (42 fewer than the day before), 205 of them in intensive care, four fewer than the day before, as 78 were discharged home. Forty-five new deaths took the toll to 964.

"We're all deeply worried, in particular doctors and other health personnel, what the situation will be in a few days," government spokesperson Jelko Kacin said at a press briefing, urging people to stay at home as much as possible.

Croatia

Croatian Health Minister Vili Beros has tested positive for COVID-19 and is in self-isolation, the Croatian government announced on Thursday.

It is presumed that Beros became infected during a recent visit to Varazdin, where he visited a hospital. For now, he has mild respiratory symptoms, is feeling well and will be working from home, a government statement said.

The health minister has attended government sessions via video link this week.

At a session of the Croatian government held on Thursday, Prime Minister Andrej Plenkovic said that the coronavirus situation was serious and that the National Civil Protection Headquarters was preparing a new package of measures.

"Times are demanding. We need the responsibility and solidarity of all our fellow citizens, so I urge us to follow the recommendations and adhere to them as the National Civil Protection Headquarters makes them and will bring them in the coming days," the prime minister said.

Ukraine 

A total of 598,085 COVID-19 cases and 10,598 deaths have been registered in Ukraine as of Friday, while 274,324 patients have recovered, according to the country's health ministry.

A record 14,575 people tested positive for COVID-19 in the country in the past 24 hours, while 7,845 patients have recovered and 1,728 were hospitalized, the ministry added.

According to Ukrainian Health Minister Maxym Stepanov, COVAX, a global initiative backed by the World Health Organization, plans to provide Ukraine with about 8 million doses of vaccine against coronavirus infection, which will allow up to 20 percent of Ukrainians to be vaccinated free of charge.

"Our country will receive vaccine with several tranches. The first one will be about 1,200,000 doses. The priority of the first stage of vaccination is health workers," Stepanov said on his Facebook page on Thursday.

Lithuania

Lithuanian Parliament Speaker Viktorija Cmilyte-Nielsen and Acting Minister of Defense Raimundas Karoblis have tested positive for COVID-19, Lithuanian news agency ELTA reported on Thursday.

Former chess grandmaster Cmilyte-Nielsen, who was elected on Friday as speaker of the Lithuanian parliament, said she did not feel any symptoms and followed all the recommendations including wearing a mask at all meetings, keeping social distance and avoiding handshakes.

Earlier on Thursday, former parliament speaker Viktoras Pranckietis was reported to have contracted COVID-19 as well.

Meanwhile, the Defense Ministry announced that Karoblis was diagnosed with COVID-19 and is isolated for treatment and will wait for further instructions from doctors. It added that he "feels good, without symptoms of COVID-19."

Anthony Tata, one of several senior US defense officials who met Karoblis at the Pentagon last week, also tested positive on Thursday, the Pentagon said.

According to the Ministry of Health, Lithuania has to date reported a total of 40,492 confirmed cases of COVID-19, with 341 deaths and 10,008 recoveries.

Georgia 

Georgia reported 3,768 new COVID-19 cases on Friday, bringing its total to 96,860.

A total of 1,443 new cases were confirmed in the capital city of Tbilisi, the National Center for Disease Control and Public Health said.

As of Friday, 77,932 patients have recovered, while 894 others died, said the center.

According to the Georgian Civil Aviation Agency on Thursday, regular international flights will not resume in the country until Dec. 31 due to a spike in new cases in recent days.

Serbia

Patriarch Irinej, the head of the Serbian Orthodox Church, has died after contracting the coronavirus, President Aleksandar Vucic said on Friday. 

Irinej, 90, a conservative who wielded major political influence, was diagnosed with the virus on Nov. 4 and had been in a military hospital in the capital Belgrade since then.

Serbia's number of COVID-19 cases exceeded 100,000 on Thursday after the country registered 6,109 new cases and 29 deaths in a 24-hour span, according to the Health Ministry.

The total number of registered cases in Serbia since the beginning of the pandemic is 104,097, while 1,110 people have died.

Due to the steep increase in record number of cases, a member of the Serbia's crisis response team Mijomir Pelemis told the media that the effectiveness of the existing measures will be estimated in the following days and stricter measures will be made if necessary.

Across Serbia, gatherings are banned, wearing facial masks is mandatory indoors, businesses have to be closed between 9 p.m. and 5 a.m., while the Belgrade Arena and other sport and cultural venues have been turned into COVID-19 hospitals.

Mexico

Mexico, the most populous country in the Spanish-speaking world, is on the brink of recording 100,000 confirmed coronavirus deaths, after passing one million infections several days ago. 

Mexico's official death toll from COVID-19, the respiratory disease caused by the virus, is among the highest in the world, and in the Americas lags only behind the United States and Brazil. 

Mexico, a country of about 125 million, alone accounts for more than 7 percent of confirmed deaths globally, according to a Reuters analysis, while its mortality rate of nearly 10 percent is higher than any other country that has reported more than a million cases.

A man lowers his mask as doctors prepare to take throat and nasal swabs as they conduct a COVID-19 test in his home in the Venustiano Carranza borough of Mexico City, Nov 19, 2020. (PHOTO / AP)

Brazil

The coronavirus has spread rapidly through the Yanomami indigenous reservation in northern Brazil and more than a third of its 27,000 people could have been exposed, according to a report produced by their leaders. 

The Yanomami's territory, which is also home to 600 Ye'kwana people, is the largest indigenous reservation in Brazil.

Brazil recorded 35,918 additional confirmed cases of the novel coronavirus in the past 24 hours and 606 deaths from COVID-19, the Health Ministry said on Thursday. 

Brazil has registered nearly 6 million cases of the virus since the pandemic began, while the official death toll has risen to 168,061, according to ministry data.

Chile

Chile's government said Thursday it will step up lockdown measures in some areas in the south of the country due to the rise in regional cases of the novel coronavirus (COVID-19).

"We have seen a positive evolution in the north ... not so in the south," Deputy Health Minister Paula Daza said.

Due to the increase in cases in Greater Concepcion, the country's third most populated metropolis, officials decided to extend the existing nighttime curfew from five to nine hours, from 8 p.m. to 5 a.m., starting Saturday.

The Ministry of Health reported 1,455 new daily cases of COVID-19 on Thursday, bringing the total caseload to 536,012.

Argentina

Argentina's government plans to vaccinate 10 million people, nearly a quarter of the population, against the novel coronavirus (COVID-19) in the first two months of 2021, President Alberto Fernandez said Thursday.

"Argentina has a vaccination capacity of approximately 5 million people per month, with which we could vaccinate 10 million between January and February, giving priority to healthcare, security and elderly people with prevalent diseases," state news agency Telam cited Fernandez as saying in an interview with local radio station FutuRock.

Fernandez said he will head the vaccination chain of command, which will involve the ministries of health, interior, security and defense.

WHO on African COVID-19 situation

The World Health Organization (WHO) on Thursday urged African countries to intensify vigilance in order to avoid a spike in COVID-19 positive cases during the holiday season.

Matshidiso Moeti, WHO regional director for Africa said the holiday season, whose hallmark is intensive mobility and family reunions, could reverse gains achieved towards the pandemic's containment.

"As we near the time of year when people get on the move to spend their holidays together, there is a bigger risk of COVID-19 transmission," Moeti said in a statement released in Nairobi.

Sudan

The Sudanese government on Thursday decided to postpone the opening of schools for two weeks to curb the COVID-19 pandemic.

Schools across the African country had been scheduled to start the new semester on Nov. 22.

"The decision is to ensure that the educational institutions apply the health directives," said Sudan's Higher Committee for Health Emergencies in a statement.

Meanwhile, Sudan's acting Health Minister Osama Ahmed Abdul Rahim said in a statement that "the country is facing many health challenges including malaria, scarcity of medicines and renewed health issues relating to coronavirus disease."

Zimbabwe

Zimbabwean police have so far arrested 224,037 people for violating COVID-19 lockdown regulations, police spokesperson Paul Nyathi said Thursday.

Zimbabwe imposed a nationwide lockdown in March which has been gradually eased over the months, with most sectors of the economy now fully reopened.

In a statement, Nyathi expressed concern at the growing number of people in the country who are no longer observing COVID-19 safety and preventive measures.

"Police has noted with concern that some sections of the public no longer value the wearing of face masks, observe social distancing guidelines, sanitization and public gathering restrictions," Nyathi said.

Rwanda

Rwanda's ministry of health and Rwanda Correctional Services (RCS) have intensified efforts to contain the further spread of COVID-19 among inmates, a senior official said on Thursday.

George Rwigamba, commissioner general RCS, told reporters that treatment and testing centers have been established in every prison where cases have been reported.

"The ministry of health has deployed medics in affected prisons where they are currently conducting contact tracing and testing in order to ensure that COVID-19 spread is brought under control," said Rwigamba.

He noted that relatives of inmates are not allowed to visit and can only send money through mobile money transactions.

Rwigamba said 192 inmates have so far tested positive to COVID-19 and 12 have died of the virus since the first case was reported in Rwandan prisons.

Serbia

Patriarch Irinej, the head of the Serbian Orthodox Church, has died after contracting COVID-19, President Aleksandar Vucic said on Friday.

Church bells tolled in Belgrade and many people flocked to the capital’s main St Sava cathedral to mark his death at the age of 90, a decade after becoming Patriarch.

A conservative who wielded considerable political influence, Irinej was diagnosed with the novel coronavirus on Nov. 4 and had been in a military hospital in Belgrade since then.

He tested positive after attending the Nov 1 funeral of Metropolitan Amfilohije, the Serbian Orthodox Church’s senior cleric in Montenegro, who also died from COVID-19.

“I was honoured to know you. People like you never depart,” President Vucic wrote on his Instagram account under a black and white photo of Irinej.

In a statement, the Serbian Orthodox Church said the Patriarch “rested with the Lord” and that the public would be informed about the details of the funeral in due course.

COVID-19 has infected more than 104,000 people and killed 1,110 in Serbia, a country of 7.2 million.

Romania

Romania's confirmed coronavirus caseload surpassed 400,000 since the beginning of the COVID-19 pandemic, reaching 403,123, and the death toll is now 9,756, official data showed on Friday.

In the last 24 hours, another 9,272 cases were confirmed and 160 people died, according to the Strategic Communication Group (GCS), Romania's official COVID-19 communication task force.

Belarus

Belarus reported 1,457 new COVID-19 cases on Friday, taking its total to 120,847, according to the country's health ministry.

So far, 1,081 people have died of the disease in the country, including seven over the past 24 hours, it said.


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