AMSTERDAM — The European Medicines Agency has started an accelerated review process to determine if a common arthritis drug might help people hospitalized with severe COVID-19, months after the drug was granted an emergency use authorization in the U.S.
In a statement Monday, the EU drug regulator said it was assessing an application to extend the use of tocilizumab for adults suffering from severe coronavirus in the hospital, who were already being treated with other steroids or required extra oxygen, including via a ventilator. Tocilizumab is an anti-inflammatory drug currently used to treat adults and children with severe arthritis.
In June, the U.S. Food and Drug Administration granted the drug an emergency use authorization and the World Health Organization recommended its use last month for people who are critically ill with COVID-19. The European regulator said it expected to make a decision by mid-October on tocilizumab, based on data from four large studies. The drug was first licensed in the EU in 2009.
MORE ON THE PANDEMIC:
— Many Bible Belt preachers silent on shots as COVID-19 surges
— Virus claims more young victims as deaths climb yet again
— US mulls COVID vaccine boosters for elderly as early as fall
— Amid a limited supply of vaccines, tensions arise in Africabetween those seeking first and second vaccine shots
— Public forums before local school boards and city councils are the latest source of misinformation about COVID-19
— Fans will not be allowed at the Paralympics starting next week in Japan, which has extended its coronavirus emergency
— Find more AP coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine
HERE’S WHAT ELSE IS HAPPENING:
TOKYO — Japan’s coronavirus state of emergency will continue through Sept. 12 rather than finishing at the end of this month as initially planned, the government decided Monday
With the virus continuing to spread in the country, the state of emergency for Tokyo, Osaka, Okinawa, and three other regions which began in July will be extended and expanded.
The measures were enforced throughout the recently concluded Tokyo Olympics, which took place with no spectators from the general public at many events. With the latest extension, the emergency will remain in force during the Tokyo Paralympics, which open Aug. 24 and close on Sept. 5.
“The surge in infections is reaching alarming record highs,” Prime Minister Yoshihide Suga said after meeting with other ministers about the move.
The emergency measures center on asking eateries and bars to close at 8 p.m. and not serve alcohol. They will be expanded to several more prefectures including Kyoto, Hyogo and Fukuoka, which are currently under a less severe cautionary “quasi-emergency.”
BELGRADE, Serbia — Serbia will start administering a third, or booster, dose of vaccines this week to people who previously were vaccinated at least 6 months ago, after cases of infections have surged in recent days.
Authorities on Monday said that citizens will receive text messages with invitations for booster shots. Initially, heath authorities will contact people with weakened immune systems, the elderly, medical workers and those whose jobs require frequent travel.
Serbia, a Balkan nation of around 7 million people, has vaccinated over 50% of its population.
The country loosened anti-virus rules during the summer which has led to a rise in confirmed new cases and hospitalizations mostly from the highly contagious delta variant.
On Monday, Serbia confirmed 1,288 new cases for the past 24 hours while seven people died. More than 700,000 people have been infected since the start of the pandemic and over 7,000 people died.
COLOMBO, Sri Lanka — Sri Lanka’s president on Monday removed the island nation’s health minister amid a surge of COVID-10 cases and deaths.
The cabinet reshuffle announced by the office of President Gotabhaya Rajapaksa on Monday came as the health ministry is facing mounting criticism over it’s failure to contain COVID-19, which is spreading fast across the Indian Ocean island nation.
Pavithra Wanniarachchi was removed from the Health Minster portfolio and was appointed as Minister of Transport. Media Minister and government spokesman Keheliya Rambukwella was appointed as the new health minister.
Sri Lanka is witnessing an unprecedented surge of COVID-19 cases and deaths over the last two weeks. Doctors have warned that hospitals and morgues are reaching their maximum capacities. The government has ruled out an immediate lockdown despite repeated pleas from doctors because of an ailing economy.
JAKARTA, Indonesia — Indonesia’s president pledged to improve COVID-19 testing and treatment in a speech Monday marking the country’s independence and said the pandemic has changed Indonesian culture in ways that would be a foundation for advancement.
Wearing masks, not shaking hands and avoiding crowds of people were once taboo, while working from home, distance learning, online meetings and online court have become new habits “that we used to be hesitant to do,” President Joko Widodo said in the national address marking the country’s 76th anniversary of independence.
“Amid today’s disruptive world, the spirit to change, the spirit to make changes and the spirit to innovate have become the foundation to build an advanced Indonesia,” Widodo said. “With the COVID-19 pandemic, the acceleration of innovation has become an integrated part of our everyday lives.”
ANKARA, Turkey — Turkey is allowing people who plan to travel to countries which have not approved China’s Sinovac vaccine, to get additional shots of the vaccine developed by Pfizer-Biontech.
Health Minister Fahrettin Koca said on Twitter on Monday that the extra shots were being offered only to people who were vaccinated with the Sinovac vaccine at the start of the inoculation campaign and want to travel to countries where the Chinese vaccine has not been approved.
Koca said people who were not planning to travel to those countries did not need to get an extra shot on top of their third, booster shots.
With schools set to reopen on Sept. 6, the government on Monday also began vaccinating teenagers aged 15 and above as well as children as young as 12 who suffer from chronic diseases. About 53% of the adult population has been fully vaccinated.
BEIJING — China’s most widespread flare-up of COVID-19 since the initial outbreak appears to be waning.
The National Health Commission said Monday that 13 locally spread cases had been confirmed in the preceding 24 hours, down from a peak of more than 100 cases a week ago and the sixth straight day of decline.
A series of recent outbreaks appears to be driven by the delta variant. Nearly 1,300 local cases have been confirmed in 48 cities in 18 provinces.
But most cities are now seeing only sporadic cases, added He Qinghua, a health commission disease control and prevention inspector. He said the risk of a large-scale national epidemic is relatively low.
Another 38 imported cases were confirmed in the latest 24-hour period among people who had entered China recently from abroad. They included 11 who arrived in Yunnan province from neighboring Myanmar from Aug. 10-15.
TEHRAN, Iran — Iran has recorded a record high number of deaths from COVID-19 for a second day in a row.
The official IRNA news agency said Monday that 655 patients died in the previous 24 hours, and health workers found some 41,194 new cases over the same period. On Sunday, Iran reported 620 deaths.
The report came as the country imposed a five-day lockdown starting Monday. It includes a travel ban on personal cars crossing between provinces.
The new surge has been fueled by the contagious delta variant. Iranian authorities say less than 40% of the population follows measures such as wearing face masks and social distancing. Iranian health officials have regularly warned that hospitals in the capital, Tehran, and other major cities are overwhelmed with COVID-19 patients.
This is the fifth wave of coronavirus infections as the country struggles to vaccinate its people. Some 4% of Iranians have been fully vaccinated.
BERLIN — Germany’s standing committee on vaccination, the Stiko, has given the go-ahead for all young people above 12 to get vaccinated against the coronavirus.
The country’s disease control agency said Monday the Stiko found that especially data from the United States, where almost 10 million adolescents have been vaccinated, show that the benefits of the vaccines outweigh the risks for children and teenagers.
The Stiko said that vaccinations are now also recommended because the committee expects that children are at a higher risk of catching COVID-19 during the current fourth wave of infections with the dominant and quickly spreading delta variant in Germany.
In the past months, the Stiko had been reluctant to recommend the vaccination for all youngsters, saying it did not have enough data, and had recommended the shots only for children and teenagers with chronic illnesses. However, earlier this month the German government had pushed to offer COVID-19 shots for all children above the age of 12 and some states had already sent out letters inviting them to local vaccination centers.
SYDNEY — Australia’s most populous state on Monday reported its worst day of the pandemic with 478 new COVID-19 infections and seven deaths.
The previous record daily tally in New South Wales was 466 new cases reported on Saturday.
Two of the dead had taken a single dose of a two-shot vaccine. The rest were unvaccinated, New South Wales Premier Gladys Berejiklian said.
Only 26% of Australians aged 16 and older had been fully vaccinated by Saturday. Australia has one of the slowest vaccine rollouts among wealthy countries, which is making the delta variant outbreak particularly dangerous.
The first shipment of one million Pfizer doses that Australia bought from Poland arrived in Sydney overnight.
Residents aged 16-to-39 in Sydney’s worst-effected suburbs will be given 530,000 of the new doses, the government said. This age group was responsible for most of the virus spread.
AUSTIN, Texas — The Texas Supreme Court has blocked mask mandates ordered by two of the nation’s largest counties that defied Republican Gov. Greg Abbott as COVID-19 cases surge and hospitals are stretched thin.
Sunday’s order by the state’s highest court — which is entirely comprised of elected Republican justices — halts mask requirements that county leaders in Dallas and San Antonio put in place as new infections soar and students begin returning to school. Texas reported more than 11,500 patients hospitalized with the virus Sunday, the most since January.
The ruling is temporary pending a court hearing, though the timing of a final ruling is unclear. Officials in Houston and Austin, as well as public school districts, had also imposed mask mandates despite Abbott prohibiting local governments from reverting back to pandemic restrictions.
White House coronavirus coordinator Jeff Zients said last week that Texas and Florida accounted for nearly 40% of new virus hospitalizations nationwide.
The COVID-19 death toll has started soaring again as the delta variant tears through the nation’s unvaccinated population and fills up hospitals with patients, many of whom are younger than patients during earlier phases of the pandemic.
WASHINGTON — The director of the National Institutes of Health says the U.S. could decide in the next couple weeks whether to offer coronavirus booster shots to Americans this fall.
Dr. Francis Collins tells “Fox News Sunday” that federal health officials are looking at the U.S. numbers “almost daily” but no decision has been made because cases so far still indicate that vaccinated people remain highly protected from COVID-19, including the delta variant.
He acknowledges, though, that there is concern that the effectiveness of the two-dose Pfizer and Moderna vaccines or the one-shot Johnson & Johnson regimen may wane “over months.” If so, Collins says that may necessitate a booster “maybe beginning first with health care providers, as well as people in nursing homes, and then gradually moving forward” with others, such as the elderly.
Collins says because the delta variant only started hitting hard in July, the “next couple of weeks” of case data will help the U.S. make a decision.