Taking too long? Close loading screen.
Connect with us

World

Coronavirus vaccine trial halted after participant gets sick

Published

on

Phase 3 trial aims to enrol up to 60,000 volunteers across more than 200 sites in the US and around the world.

Johnson & Johnson announced that it had temporarily halted its COVID-19 vaccine trial because one of its participants had become sick.

“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company was quoted by the AFP news agency as saying.

The pause means the enrolment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.

J&J said that serious adverse events (SAEs), such as accidents or illnesses, are “an expected part of any clinical study, especially large studies”.

But Dr William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, told the Reuters news agency that “everybody is on the alert” because of what happened with the AstraZeneca, adding that it could take a week to gather information.

“It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes or a heart attack – they wouldn’t stop it for any of those reasons. This is likely to be a neurological event,” he said.

Company guidelines allow them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.

60,000 volunteer participants

The J&J Phase 3 trial had started recruiting participants in late September with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world, the company and the US National Institutes for Health (NIH), which is providing funding, said.

The other countries where the trials were taking place were Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

With the move, J&J became the 10th manufacturer globally to conduct a Phase 3 trial against COVID-19.

The US has given J&J about $1.45bn in funding under Operation Warp Speed.

The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

J&J used the same technology in its Ebola vaccine which received marketing approval from the European Commission in July.

Pre-clinical testing on rhesus macaque monkeys that were published in the journal Nature showed it provided complete or near-complete protection against virus infection in the lungs and nose.

Like several other Phase 3 trials that are under way, its primary objective is to test whether the vaccine can prevent symptomatic COVID-19.

In September, trials on the coronavirus vaccine created by AstraZeneca and Oxford University were paused after a UK volunteer developed an unexplained illness.

The vaccine is one of the most advanced Western projects, having already been tested on tens of thousands of volunteers worldwide.

Trials resumed earlier this month in Japan except for the United States, where AstraZeneca is working with regulators.

Source

Continue Reading
Advertisement
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

World

US to base Coast Guard ships in western Pacific to tackle China

Published

on

The United States will deploy Coast Guard patrol ships in the western Pacific to counter what it described as “destabilizing and malign” activities in the region by China, the country’s top security adviser said on Friday.

The US Coast Guard was “strategically homeporting significantly enhanced Fast Response Cutters … in the western Pacific,” White House National Security Advisor Robert O’Brien said in a statement.

Describing the US as a Pacific power, the statement added that China’s “illegal, unreported, and unregulated fishing, and harassment of vessels operating in the exclusive economic zones of other countries in the Indo-Pacific threatens our sovereignty, as well as the sovereignty of our Pacific neighbors and endangers regional stability”.

It said US efforts, including by the Coast Guard, were “critical to countering these destabilizing and malign actions.”

The Coast Guard did not immediately respond to a request for comment on the statement, which came just ahead of a planned visit to Asia by US Secretary of State Mike Pompeo.

US Secretary of State Mike Pompeo (left) and Australia’s Foreign Minister Marise Payne pose prior to their bilateral meeting in Tokyo on October 6, 2020 ahead of the four Indo-Pacific nations’ foreign ministers meeting. – (Photo by CHARLY TRIBALLEAU / POOL / AFP)

Pompeo led a meeting of the so-called Quad in Tokyo this month. Washington hopes the grouping of the US, Japan, India and Australia can act as a bulwark against China’s growing assertiveness and extensive maritime claims in the region, including to nearly all of the South China Sea.

On Sunday, Pompeo will begin a five-day tour of India – where he will be accompanied by US Defense Secretary Mark Esper – and then he will continue on to Sri Lanka, Maldives, and Indonesia. Maritime security and a “free and open Indo-Pacific” will be high on the agenda, the State Department said.

Incursions

In July, Esper condemned a “catalogue of bad behaviour” in the South China Sea over the previous months, accusing the Chinese military of having sunk a Vietnamese fishing boat, harassing Malaysian oil and gas vessels and escorting Chinese fishing fleets into Indonesia’s exclusive economic zone.

O’Brien added that the Coast Guard, which is under the Department of Homeland Security (DHS), was also studying whether to permanently station several of its patrol ships in the area of American Samoa in the South Pacific.

Last month, Indonesia protested after Chinese coastguard ships travelled into its exclusive economic zone, which is situated between its own territorial waters and international waters and where the state claims exclusive rights to develop natural resources.

China claims almost the whole of the South China Sea as its own. Vietnam, Malaysia, Taiwan, and the Philippines also claim the parts of the sea nearest to their shores.

The US Navy regularly conducts what it calls “freedom of navigation” operations in the disputed sea – angering China, which has developed military outposts on islands and islets.

Source

Continue Reading

World

An island built from coral: How Indonesia’s Bajau made a home

Published

on

Bungin Island, Sumbawa, Indonesia – Scattered across many of the islands and coastal communities in Southeast Asia, the Bajau, numbering about one million people, are the world’s largest remaining group of sea nomads. But their culture is under threat.

In the Sulu Sea between Borneo and the Philippines, where the Bajau have roamed the ocean for 1,000 years, insurrection by the Abu Sayyaf armed group has led to an increased military presence and curfews restricting movements on both sides of the border.

On the islands of southern Thailand, where the group are known as Moken, they live in stilt shanties that cling like barnacles to coastlines that are rapidly being consumed by buildings built for tourists.

In Indonesia and peninsula Malaysia, many Bajau have given up ocean-based life by marrying people from local communities and seeking jobs in the cities.

But one Bajau community on the Indonesian island of Sumbawa has preserved its unique way of life by building their own islet out of coral, allowing it to evolve separately from the mainland.

With 3,500 residents on just 8.5 hectares (21 acres) of land, Bungin Island also stands out as the most densely populated of Indonesia’s 17,000 islands.

No crime

When the first Bajau arrived in Sumbawa from the southern Philippines 200 years ago, Bungin Island was just a sandbank on the north coast. In the Bajo language, Bungin means “a mound of white sand”.

Traditionally, the Bajau harvested coral to make foundations for their homes, expanding what was once a sandbank [Ian Neubauer/Al Jazeera]

They built their spartan stilt houses on the sand, but as their numbers grew, they enlarged the island by harvesting coral to build foundations for houses on low-lying sections of the surrounding reef. With the help of relatives and friends, it typically takes a week to build a 70-square metre (172-square acre) plot and structure.

“We have a good life here and we have enough money because all the time, every day and night, we are looking for fish,” said Surat, a Bungin Island elder, who like many Indonesians goes by only one name.

The Bajau are accomplished fishermen and free-divers who can remain underwater for as long as eight minutes on a single breath. Some children have their eardrums pierced to prevent them from bursting from water pressure while diving.

Studies of Bajau who start diving from young have shown their spleens, the organs which store oxygenated red blood cells, are 50 percent bigger than average.

Bungin Island has also developed a strong sense of community. When the heat of the day eases at dusk, people come out onto the tightly packed streets to shop, mingle, eat and pray in the mosque.

The Bajau are renowned for their ability to free dive and are famous for their salted fish [Ian Neubauer/Al Jazeera]

Indonesians are renowned for their hospitality but on Bungin Island they really roll out the red carpet, sharing drinks, meals, laughter and conversation with visitors. And apparently, there is no crime on the islet.

“We don’t have locks on our doors,” said Rizky, Surat’s neighbour. “Everyone knows each other so it’s not possible to steal anything here.”

‘The problem with corona’

The nature of the sea gypsies’ lifestyle means they have missed out on many basic services.

Bajau communities in Indonesia are lacking “in the areas of health and education … [and] many Bajau are illiterate,” found the Joshua Project, a research project focused on Indigenous cultures with Christian minorities.

In the mid-1990s, the Indonesian government embarked on several large infrastructure projects to drag Bungin Island into the 21st century.

It built a wide sand causeway linking the island to the mainland and making it easier for islanders to sell their salted fish at mainland markets.

Nearly all the Bajau on Bungin island are Sunni Muslims [Ian Neubauer/Al Jazeera]

It also built a large government school on the mainland-end of the causeway and connected the islet to the national power grid. And tackled overcrowding by shipping in thousands of tonnes of sand to reclaim an additional 2.5 hectares (6.1 acres) of land from the seafloor.

The causeway also had an unintended effect – it turned Bungin Island into Sumbawa’s leading attraction for domestic tourists who would come to marvel at the paper-eating goats.

As plants cannot grow on the islet, the domesticated goats that roam the streets search instead for paper, cardboard and cloth. For many children, the highlight of visiting the islet was to feed the goats pages from their exercise books. For adults, it was long lazy lunches at Resto Apung, a floating seafood restaurant and fish farm with breathtaking coast and mountain views.

But when Indonesia temporarily banned domestic travel in April to mitigate the spread of COVID-19, tourism came to an end. With Indonesia’s coronavirus outbreak still surging, it has yet to recover.

“We had many tourists before the problem with corona,” said Surat. “But as we live so close together it is impossible to socially distance. The restaurant and our guesthouse had to close.”

Rubbish dump

The causeway has also brought more worrying problems.

Plastic and other household waste has collected around the shore of Bungin Island [Ian Neubauer/Al Jazeera]

Before it was built, islanders ate only seafood, some greens and ric, and used organic materials like coconut shells and palm fronds as bags.

Easy access to the mainland introduced cheap packaged foods, water bottles and plastic bags and no waste management system to deal with it.

The result is that Bungin Island has been turned into a rubbish dump; its shores are carpeted with tonnes of rotting waste – all of which ends up in the delicate marine ecosystem the Bajau depend on to survive.

When asked about the problem, islanders laugh – a typical Indonesian response to awkward questions and social situations.

But a study published by the University of Queensland in July on plastic literacy in remote Indonesian coastal communities found a majority of people in the communities did not see the plastic waste as a threat and believed its only negative effect was to “make the village look dirty”.

The study’s authors suggested a two-pronged solution: the creation of “rubbish banks” – a term used in Indonesia for a recycling facility where plastic can be sold, sorted, shredded and moved down the value chain; and plastic awareness and environmental education.

Goats live on the island subsisting on a diet of paper and cardboard [Ian Neubauer/Al Jazeera]

Awareness initiatives have already led to changes of some centuries-old traditions.

In the past, customary law dictated that young people who wanted to marry had to harvest coral to build a home of their own. The 21st-century residents of Bungin have different ideas.

“Now, if you get married, you stay with your parents and slowly, you save up money to buy a house on Bungin,” said Surat. “Most people do it this way because it’s easier than building with coral and doesn’t hurt the reef where the fish live so we can keep on fishing.”

Source

Continue Reading

World

NIH director says Covid-19 vaccine authorization ‘might not happen’ this year

Published

on

French President Emmanuel Macron (2nd L) chairs a meeting with the medical staff of the René Dubos hospital center, in Pontoise, in the Val d'Oise, on October 23, 2020, as the country faces a new wave of infections to the Covid-19.
French President Emmanuel Macron (2nd L) chairs a meeting with the medical staff of the René Dubos hospital center, in Pontoise, in the Val d’Oise, on October 23, 2020, as the country faces a new wave of infections to the Covid-19. Ludovic Marin/AFP/Getty Images

France reported a new daily record for coronavirus infections with 42,032 new cases in the past 24 hours, according to numbers released by country’s health agency on Friday.

This brings the total number of confirmed cases in France to 1,041,075, according to French government statistics, and marks the first time the government’s coronavirus case tally has surpassed 1 million. 

France also recorded 298 additional coronavirus deaths, bringing the death toll to 34,508, according to the French Health Agency. 

According to government data, an additional 976 coronavirus patients have been admitted to the hospital, and a further 122 coronavirus patients entered intensive care in the last 24 hours. 

Speaking at a health center this afternoon, French President Emmanuel Macron said he expects France will have to live with the virus until at least the summer of 2021.

“When I listen to the scientists, and the Scientific Council, we foresee [living with the virus] at best until next summer,” Macron said. “It is still too early to say whether we are moving towards wider local re-confinements, we will try each time to reduce the places, the moments when we have identified that the virus was circulating a lot. This is the strategy we will pursue.”

Macron added that the government aims to implement new restrictions in the most targeted way possible. 

From midnight on Friday, France’s nighttime coronavirus curfew will be extended more widely, with 46 million French people affected, announced French Prime Minister Jean Castex on Thursday. 

To note: According to the latest data from Johns Hopkins University, France has recorded 1,048,924 coronavirus cases and 34,236 deaths. CNN’s Paris Bureau is working on clarifying the discrepancy between state statistics and the university’s numbers.

Source

Continue Reading

Trending