EU watchdog okays two Covid antibody treatments – latest updates

Thursday, November 11, 2021

EU watchdog endorses drugs from Regeneron-Roche, Celltrion

Regeneron-Roche's antibody cocktail, Ronapreve, has been backed by the human medicines committee of the European Medicines Agency (EMA) for treating adults and adolescents who do not require oxygen support and are at high risk of severe disease.

Celltrion's Regkirona, however, has been recommended only for adults with similar conditions.

While the evaluation of formal applications for authorising the medicines is under way, the two drugs are already available to some patients in the European Union as the EMA assisted member states on early use in some cases.

Britain reports 195 deaths

Britain has reported 42,408 new Covid-19 cases and a further 195 deaths from the disease, government figures showed.

Reported cases have now risen for four days in a row, but cases over the last seven days are down 12 percent compared to the previous seven. 

Dutch report record daily new cases

The Netherlands has reported a record daily number of new Covid cases, as the government considered reimposing restrictions to curb the spike in infections.

The 16,364 new cases over the previous 24 hours, announced by the RIVM public health institute, smashed the previous record of 12,997 set on December 20 last year.

EU lists rare spinal condition as side-effect of J&J shot

Europe's drug regulator has recommended adding a rare type of spinal inflammation called transverse myelitis as a side-effect of Johnson & Johnson's single-dose Covid-19 vaccine.

Reports of this serious neurological illness was also at the heart of trial halts in the early stages of development for both AstraZeneca and J&J's shots, which are based on similar technology.

Giving updates on the safety of all coronavirus shots, EMA said it was assessing reports of a rare blood condition known as capillary leak syndrome (CLS) following inoculation with Moderna's vaccine.

The EMA said it had recorded six cases of CLS and was assessing all data, but it was not yet clear if there was a causal association between the reports and the vaccine.

In CLS, fluids leak from the smallest blood vessels causing swelling and a drop in blood pressure. The condition has also been studied with vaccines from AstraZeneca and J&J.

Turkey registers 197 deaths

Turkey's Health Ministry has recorded 24,898 new Covid-19 cases, 197 deaths, and 24,360 recoveries over the past day.

Turkey has administered over 118 million doses of Covid-19 vaccines since it launched an immunisation drive in January, according to official figures.

Myanmar rebels lock down town on China border 

A Myanmar ethnic rebel group has locked down a town on the porous China border following a Covid-19 spike, it said.

Almost 2,000 cases had been detected in the town of Laiza, said a spokesman for the Kachin Independence Army (KIA), a rebel group that controls swathes of territory bordering China's Yunnan province.

The KIA has imposed a lockdown on the remote town of about 20,000 people since November 2 to contain the outbreak, Colonel Hein Wawm told AFP.

Pakistan vows free vaccination for Afghans at border crossings

Pakistan will provide free Covid-19 vaccines to all Afghans coming into the country, Prime Minister Imran Khan announced.

Khan said his government has assured Afghanistan’s acting Foreign Minister Amir Khan Muttaqi that Pakistan “will provide all possible humanitarian aid to Afghanistan.”

“We are sending essential food items, emergency medical supplies & winter shelters to provide immediate relief to Afghan ppl.

We will also provide free Covid-19 vaccines to all Afghans travelling across the border into Pak,” he said on Twitter.

WHO: Diabetes problem makes Africa more vulnerable to Covid death

Death rates from Covid-19 infections are much higher in patients with diabetes in Africa, where the number of people with diabetes is growing rapidly, the World Health Organization said.

A WHO analysis of data from 13 African countries found a 10.2 percent case fatality rate in patients with diabetes, compared with 2.5 percent for Covid-19 patients overall.

"Covid-19 is delivering a clear message: fighting the diabetes epidemic in Africa is in many ways as critical as the battle against the current pandemic," said Matshidiso Moeti, WHO regional director for Africa, in a statement.

US announces deal to bring vaccines to conflict zones

US Secretary of State Antony Blinken has announced a deal to bring Covid-19 vaccines into conflict zones, where paltry numbers of people have been inoculated.

In a virtual ministerial meeting on the pandemic on Wednesday, Blinken said the United States had worked with Covax, the international vaccine alliance to support developing nations, on providing the single-dose Johnson & Johnson shots to areas of conflict and other humanitarian distress.

"We're eager for people in these difficult circumstances to get protection against Covid-19 as soon as possible," Blinken said.

"We know the urgency of this fight. We know what we need to do to stop the pandemic. Now, we've got to do it," he said.

Gavi, the public-private partnership that co-leads Covax, said that the United States brokered an agreement to waive indemnification requirements on the Johnson & Johnson vaccines.

Manufacturers have required governments to pay any legal penalties for incidents from vaccination, creating hurdles for poor nations and especially for aid groups operating in conflict zones.

"We warmly welcome the US government's role in helping broker the agreement between J&J and Covax," a Gavi spokesperson said in Geneva.

The spokesperson called on other vaccine manufacturers to join Johnson & Johnson and China's Sinovac in waiving indemnification requirements for humanitarian agencies.

Details on how many doses would be distributed were not immediately announced. 

Denmark to impose Covid-19 isolation for travelers from Singapore

Denmark will impose self-isolation requirements on travelers from Singapore, its embassy in the city-state has said, following a surge in coronavirus infections.

Singapore was removed this week from a European Union list of non-EU countries for which travel restrictions should be lifted.

"Singapore is now considered a high risk country for travel to Europe," the embassy of Denmark in Singapore on Thursday posted on Facebook.

The EU's safe list of countries is reviewed every two weeks and is not legally binding on member nations.

Last month, the United States advised citizens against travel to Singapore, raising the alert level to its highest.

Singapore detected 3,481 new cases of Covid-19 on Wednesday.

But most of its recent new cases are asymptomatic or mild, with 85 percent of the 5.45 million population vaccinated. 

Japanese airline asks government to boost travel during Covid-19 lull

Japan's biggest airline, ANA Holdings, has asked the government to ease curbs on overseas visitors, and seeks a revival of domestic tourism subsidies to spur travel as pandemic infections fall, its chief executive said.

Coronavirus immigration curbs in Japan have led to a drop of about 95 percent in the number of passengers on international flights, but daily infections have dropped to fewer than 200 this month, from an August peak of more than 20,000.

"When we are able to make money we should be allowed to," Shinya Katanozaka, chief executive of the carrier that has had seven consecutive quarters of losses, told Reuters in an interview.

"It will give us the strength to weather things in the future."

Last December, as Covid-19 infections began to rise, Japan halted a programme of subsidies for hotels and travel tickets that had helped ANA and rival Japan Airlines Co. boost passenger numbers on domestic flights.

The government could resume travel subsidies as soon as next month and ease entry limits for overseas visitors to 3,500 a day, Katanozaka said. 

Germany set to plan new virus measures as numbers spike

Germany’s national disease control center has reported a record-high number of more than 50,000 daily coronavirus cases as the country’s parliament was set to discuss legislation that would provide a new legal framework for coronavirus measures.

The Robert Koch Institute registered 50,196 new cases on Thursday, up from 33,949 daily cases a week earlier. Infections have risen so quickly in recent days that hospitals in especially affected regions canceled planned surgeries again so medical personnel could focus on Covid-19 patients.

The institute also reported 237 daily deaths, bringing Germany’s pandemic death toll to 97,198.

One of the country's top virologists, Christian Drosten, warned Wednesday that another 100,000 people could die in coming months if the country's vaccination rate didn't accelerate quickly.

Unlike some other European countries, Germany has balked at making vaccinations mandatory for certain categories of workers. Yet the country has struggled to find ways to persuade more people to get shots voluntarily. 

At least 67 percent of the population of 83 million is fully vaccinated, according to official figures.

Germany has a caretaker national government following a September parliamentary election. 

The parties that are expected to form the next government plan to introduce legislation that would allow an “epidemic situation of national scope” declaration, in place since March 2020, to expire at the end of the month. 

They want to replace it with a new legal framework for instituting coronavirus measures.

Russia's daily deaths hover near record high

Russia has reported 1,237 coronavirus-related deaths in the last 24 hours, close to a record one-day toll recorded the previous day, amid a nationwide surge in cases.

The government coronavirus task force said on Thursday it had recorded 40,759 new infections nationwide, down from a record tally of 41,335 on Saturday.

India reports over 13,000 new cases

India's daily Covid-19 cases have risen by 13,091 to reach a total of 34.40 million. 

The health ministry said the deaths rose by 340, bringing the total death toll to 462,189.

Brazil has 280 Covid deaths

Brazil has had 12,273 new cases of the novel coronavirus reported in the past 24 hours, and 280 deaths from the virus, the health ministry said.

The South American country has now registered 21,909,298 cases since the pandemic began, while the official death toll has risen to 610,036, according to ministry data, in the world's third worst outbreak outside the United States and India and its second-deadliest.

Mexico reports 264 deaths

Mexico reported 264 new confirmed deaths from the virus, bringing the country's official death toll from the pandemic to 290,374, according to health ministry data.

Officials have said the ministry's figures likely represent a significant undercount of deaths.

Australian firm recalls over 2M US tests

An Australian medical tech manufacturer has recalled more than two million at-home tests shipped to the United States after finding an increased chance of false positives.

The US Food and Drug Administration issued an alert that the company, Ellume, had recalled 2.2 million tests since the issue was detected last month.

A false positive test result indicates that a person has coronavirus when they do not.

Berlin to exclude unvaccinated from bars, cinemas, hairdressers

Germany's capital Berlin will from Monday tighten the screws on unvaccinated people by denying them access to indoor dining, bars, gyms and hairdressers in an effort to contain a virus resurgence.

Under new rules in the city, only fully vaccinated people and those who can show proof of recovery from the virus can enter leisure facilities and a list of other selected venues – a system known as "2G" in Germany.

The move comes in response to "the rising number of virus cases and the increasing pressure on intensive care units", the Berlin senate said in a press release.

Bahrain to cancel working with its travel red list

Bahrain will cancel working with its virus travel red list from November 14, the health ministry said.

Bahrain will also require unvaccinated travellers to quarantine in their places of residence. They will not have to mandatory quarantine in designated licensed places.

Sixteen countries were on Bahrain's travel red list, including Iraq, Iran, Tunisia, and Malaysia.

Israel pandemic advisory panel backs vaccine for young children

Israel's pandemic advisory board backed administering Pfizer's and BioNTech's vaccine to children age 5-11, health officials said, as a fourth wave of infections subsides nationwide.

The Health Ministry is widely expected to accept the panel's recommendation and begin rolling out the shots this month.

The US Food and Drug Administration has granted emergency use authorisation of the vaccine for the age group at a 10-microgram dose.

The original shot given to those aged 12 and older is 30 micrograms.