COVID-19: First Authorized Therapy for Coronavirus by FDA

Source: People's Daily, Xinhua, CGTN, China Daily, Global Times, iFeng, Baidu, AP, CNN, Global  News Agencies, Majdi


Remdesivir Granted Emergency FDA Authorization

One vial of the drug Remdesivir, shown during a press conference about the start of a study in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany on April 8, 2020.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for an experimental anti-viral drug remdesivir to treat COVID-19. Stephen Hahn, the agency's commissioner, announced at the White House on Friday.

"This is an important clinical advance," Hahn said about remdesivir, calling it "the first authorized therapy for COVID-19."

Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug is still being studied.

Remdesivir was shown in a clinical trial to shorten the time to recovery in some people.

There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19. Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an EUA, said the agency. 

Possible side effects of remdesivir include infusion-related reactions and increases in levels of liver enzymes, according to the FDA.

An FDA Emergency Use Authorization allows physicians to prescribe the treatment on an expedited timeline, without the lengthy reviews typically required.

According to a release of the NIAID, hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo.

Expert Report Predicts up to Two More Years of Pandemic Misery

The new coronavirus is likely to keep spreading for at least another 18 months to two yearsuntil 60% to 70% of the population has been infected, a team of longstanding pandemic experts predicted in a report released Thursday in the US.

"This thing's not going to stop until it infects 60 to 70% of people," Mike Osterholm, who directs the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, told CNN. "The idea that this is going to be done soon defies microbiology."

Osterholm has been writing about the risk of pandemics for 20 years and has advised several presidents and wrote the report along with several epidemiologists and a historian.

Because Covid-19 is new, no one has any immunity, they said.

A Rush of Local News

One new confirmed imported COVID-19 case was reported on the Chinese mainland on Friday, according to China's National Health Commission.

The commission also reported 20 new asymptomatic patients, two suspected cases and no new deaths.

Hubei Province announced on Friday that it is to lower the public emergency response level for COVID19 from level one to two starting from May 2, according to a press conference on Friday That means 31 provinces in China have deactivated their first level public emergency response.

Aid to Ethiopia and Djibouti: China's team of medical experts concluded the aid mission in Ethiopia to help the country respond to the coronavirus outbreak on Thursday and moved to Djibouti to continue its task. The team comprises of 12 experts from medical institutions across China's Sichuan Province.

A Rush of News

Azerbaijan has extended partial lockdown measures to tackle an outbreak of the coronavirus until May 31, the government has said.

Indian authorities plan to make a contact-tracing mobile app mandatory for everything from taking public transit to going to work.

The Hungarian Formula One Grand Prix scheduled for August can only go ahead without spectators, organisers said in a statement. 

Spain's gross domestic product (GDP) will contract 9.2 percent this year, Economy Minister Nadia Calvino said, as the coronavirus pandemic battered the economy.

South Africa has begun to gradually loosen its strict coronavirus, allowing some industries to reopen after five weeks of restrictions. Winter clothing, textile and packaging manufacturing are among the industries permitted to reopen factories. Restaurants will also open, but only for takeaway deliveries. Outdoor cycling, walking and running will be allowed - but for just three hours in the morning. Bans on the sale of cigarettes and alcohol will remain in effect.

Irish low-cost carrier Ryanair said it plans to axe up to 3,000 pilot and cabin crew jobs, with air transport paralysed by the coronavirus pandemic.

London's Heathrow Airport, traditionally the busiest in Europe, said passenger numbers were expected to be down by around 97% in April.

Malaysia will allow most businesses to reopen starting on Monday, May 4, subject to some conditions. Economic sectors that involve large gatherings of people such as cinema and bazaars, however, will not be allowed to reopen.

Gilead's antiviral drug remdesivir has been authorized by US regulators for emergency use on coronavirus patients, President Donald Trump has announced. US medical officials have announced evidence from a trial that remdesivir helped patients with serious cases of COVID-19 recover faster.

Zimbabwe's President Emmerson Mnangagwa extended a coronavirus lockdown by two more weeks.

Kazakh airlines made their first regular domestic flights in more than a month on Friday, with rows of passengers seated alongside empty middle seats, The first route to reopen was between Almaty and the capital Nur-Sultan, three domestic carriers - Air Astana, SCAT, Qazaq Air - said, adding that other routes would follow from Monday. Passengers were required to present certificates confirming they had tested negative for COVID-19, which are valid for a week, and undergo temperature checks at the airport.

US: About 3% of workers in over 100 meat processing plants surveyed across the U.S. have tested positive for the coronavirus, according to a new report published by the Centers for Disease Control and Prevention. 

Hard-Hit Countries/Regions Official Announcements

Note: The news under this section are according to official reports in these countries; the numbers might not necessarily correspond to the data in the Global table, at the top of this article, which is calculated based on Beijing 24 hours time zone at around 10:00 AM. 

Netherlands: The number of cases has risen by 475 to 39,791 health authorities said, with 98 new deaths. The death toll stands at 4,893, the Netherlands' Institute for Public Health (RIVM) said in its daily update.

Iran's death toll increased by 63 in the past 24 hours to 6,091, Ministry of Health spokesman Kianush Jahanpur said in a statement on state TV. The number of cases has reached 95,646, including 2,899 in critical condition, he added.

Spain's coronavirus death toll rose to 24,824 as 281 more people died overnight, the health ministry said. 1,781 new coronavirus cases were reported, bringing the total infections to 215,216.

Indonesia confirmed 433 new infections, taking the total number of cases to 10,551, health ministry official Achmad Yurianto said. Yurianto reported eight new deaths, taking the total to 800.

Russia reported 7,933 new cases, a record daily rise, bringing its nationwide tally to 114,431. The official death toll rose to 1,169 after 96 people died in the last 24 hours, Russia's coronavirus crisis response centre said.

Germany: The number of cases increased by 1,639 to 160,758, data from the Robert Koch Institute (RKI) for infectious diseases showed. The death toll rose by 193 to 6,481.

Mexican health officials have reported 1,425 new cases of the and 127 new deaths in the country, bringing the total to 19,224 cases and 1,859 deaths in the country.

France: The number of people who have died has risen by 218 to 24,594, while hospitalisations for the disease and people in ICU units continued to decline, the public health chief has said. The number of people in hospital fell further to 25,887 from 26,283 on Thursday, and the number of people in intensive care fell to 3,878 from 4,019. Both numbers have been on a downward trend for more than two weeks.

Italy: Deaths has climbed by 269, down from 285 the day before, the Civil Protection Agency said, while the daily tally of new infections stood at 1,965 against 1,872 on Thursday.  The total death toll now stands at 28,236.  The officially confirmed cases was 207,428.

Turkey: The number of people who have died has risen by 84 in the last 24 hours to 3,258, with 2,188 new cases of the virus, according to Health Ministry data. The total number of cases rose to 122,392.

UK: Britain's health minister has said 739 more people had died taking the total toll to 27,711. Matt Hancock also announced that Britain had met its goal of 100,000 tests a day by the end of April, saying that 122,347 tests were achieved on Thursday, calling it an "incredible achievement".

UK: Black Africans Dying at Much Higher Rate Than White Britons

Coronavirus patients from Black African backgrounds are dying in United Kingdom hospitals at more than three times the rate of white British people, according to the Institute for Fiscal Studies (IFS).

Its report on Friday comes amid growing evidence that ethnic minority patients and front-line workers are far more likely to suffer serious consequences from the epidemic in terms of health.

"After stripping out the role of age and geography, Bangladeshi hospital fatalities are twice those of the white British group, Pakistani deaths are 2.9 times as high and black African deaths 3.7 times as high," the IFS said.

India Extends Lockdown by Two Weeks

Punjab police personnel patrol a vegetable market during a government-imposed nationwide lockdown on the outskirts of Amritsar, India, on May 1. Narinder Nanu/AFP/Getty Images

The Indian government has said it will extend its nationwide lockdown for another two weeks after May 4, but would allow "considerable relaxations" in lower-risk districts marked as green and orange zones under the government's plan to fight the novel coronavirus.

Some activities will remain prohibited throughout the country, regardless of the zone, the ministry of home affairs said in a statement.

Those include travel by air, rail and metro and inter-state movement of people by road; and schools and colleges, hotels, restaurants, shopping malls, cinema halls and places of worship will remain closed.

There will be no restriction on movement of goods between states and on the manufacturing and distribution of essential items, the ministry said.

Airline woes:

Passenger planes of German airliner Lufthansa are seen parked at Willy Brandt Berlin Brandenburg International Airport in Schoenefeld, Germany on April 28. Sean Gallup/Getty Images

German airline Lufthansa plans to reduce its fleet by around 100 aircraft, leaving the German airline with 10,000 excess staff. 

700 of Lufthansas roughly 760 aircraft are grounded. The airline, one of the largest in Europe, has had to cancel 3,000 flights a day and is experiencing a 99% decline in passengers, with 80,000 of its staff on reduced working hours.

The General Secretary of the British Airline Pilots' Association warned that the UK aviation industry is about to experience a tsunami of job losses" as Ryanair announced plans to cut up to 3,000 jobs as it seeks to slash costs and British Airways announced plans to cut up to 12,000 jobs.

Amazon Lets Some Employees Work From Home Through Oct. 2 

Amazon employees who can perform their jobs from home will be allowed to continue to work from home until at least Oct. 2. The company said the new timeline applies to workers around the globe, Reuters reported.

Amazon did not provide details about how much of its overall workforce works remotely or which roles are included. On Thursday, Amazon said it will spend all of its profit for the second quarter of 2020, at least $4 billion, on its response to the coronavirus pandemic.

Biotech firms partner to manufacture potential Covid-19 vaccine

A new collaboration has been announced in the world's quest for a potential vaccine against the novel coronavirus.

Biotechnology company Moderna and Switzerland-based Lonza Ltd. said on Friday that they were agreeing to a 10-year collaboration to manufacture a potential Covid-19 vaccine, mRNA-1273. The collaboration would enable both firms to accelerate the manufacturing capacity for mRNA-1273 and other products by a factor of 10. The cooperation goal is to potentially enable manufacturing of up to 1 billion doses of mRNA-1273 vaccine.

The companies plan to establish manufacturing suites at Lonzas facilities in the United States and Switzerland for the manufacture of the potential vaccine.

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