LONDON: AstraZeneca has suspended global trials of its experimental coronavirus vaccine after an unexplained illness in a participant, knocking the British drugmaker's shares on Wednesday as prospects for an early rollout dimmed.
The vaccine to combat COVID-19, which AstraZeneca is developing with the University of Oxford, has been described by the World Health Organization as probably the world's leading candidate and the furthest developed.
However, AstraZeneca said on Tuesday it had paused trials, including late-stage ones, to allow an independent committee to review safety data, and it was working to minimise any potential impact on the timeline.
The suspension triggered a 3% fall in AstraZeneca's shares, which have the second biggest weighting in the FTSE 100 index and were trading 1.4% lower at 1006 GMT.
"It is obviously a challenge to this particular vaccine trial," Britain's Health Secretary Matt Hancock told Sky News.
The pause follows reports that the United States was aiming for fast-track approval before November's presidential election.
The stakes are high because AstraZeneca, Britain's largest drugmaker by market value, has already agreed to supply close to three billion doses to governments across the globe.
This is more than any other vaccine project, but asked whether the pause would set back the development process, Britain's Hancock said: "Not necessarily, it depends on what they find when they do the investigation".
Most states will contribute financially to developing the vaccine, even if the trial fails.
Britain's medical regulator said it is urgently reviewing information available to determine whether trials can restart as quickly as possible.
A New York Times report citing a person familiar with the situation said a participant based in Britain was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.
Whether this was directly linked to AstraZeneca's vaccine remains unclear, it said. AstraZeneca declined to comment.
A person familiar with the situation told Reuters the illness occurred in the British trial which began in May with more than 12,000 participants, from 5 years old to beyond 70.
The US trial, with a targeted 30,000 participants, was launched last week for the vaccine AZD1222, which is also in late-stage clinical trials in Brazil and South Africa.
Additional trials are planned in Japan and Russia, with a targeted 50,000 participants globally.
South Korea said it would look into the suspension and review its plan to participate in manufacturing the vaccine and health ministry official Yoon Tae-ho added such suspensions of clinical trials were not rare "as various factors interact".
This was echoed by Germany's Leukocare, which is working on a vaccine similar to AstraZeneca's but is at an earlier stage.
"When you are inoculating 20,000 people, it is a foregone conclusion that at some point you will have severe adverse events. As soon as a link to the vaccine can clearly be ruled out, the trial continues," CEO Michael Scholl said.
Immune related conditions such as inflammations, however, would be subject to particular scrutiny, he added.
The Oxford vaccine is designed to instruct human cells to make distinguishing parts of the coronavirus. That allows the immune system to build an arsenal against future infections.
A harmless virus known as adenovirus is used to bring the genetic instruction into the body, an approach which is also being pursued by China's CanSino, Russia's Gamaleya institute or Johnson & Johnson.
Backers of the Gamaleya candidate, the first Russian COVID-19 vaccine, underscored the difference between their jab, based on a adenovirus in humans, and the British contender with an adenovirus found in monkeys.
"We have consistently drawn attention to human adenoviral platform being much safer and much more studied than any other new platform," the head of Russia's sovereign wealth fund Kirill Dmitriev told Reuters.
In choosing a monkey virus, AstraZeneca, as well as Leukocare, are trying to avoid the risk of the immune system attacking the vector, due to a previous bout with an adenovirus.
The decision to put the trial on hold has impacted clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.
Serum Institute of India said its trials of AstraZeneca's vaccine were ongoing and had not faced any issues.
The US National Institutes of Health, which is providing funding for AstraZeneca's trial, declined to comment.
Moderna said in an emailed statement it was "not aware of any impact" to its ongoing COVID-19 vaccine study.
Leading US and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines.
Nine companies, including AstraZeneca, Moderna and Pfizer, issued an "historic pledge" after concerns that safety standards might slip under political pressure to rush out a vaccine.
The other signatories were Johnson & Johnson, Merck & Co , GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech.
AstraZeneca pauses coronavirus vaccine trial, shares slip on rollout doubts
https://arab.news/6hed9
AstraZeneca pauses coronavirus vaccine trial, shares slip on rollout doubts
- AstraZeneca said on Tuesday it voluntarily paused trials, including late-stage ones, after an illness in a participant
- It was working to expedite the review to minimize any potential impact on the trial timeline
Gaza truce bittersweet for Biden as Trump takes credit
- Trump had warned Hamas of “hell to pay” if it did not agree to a deal
WASHINGTON: The Gaza ceasefire clinched Wednesday was a bittersweet victory for US President Joe Biden days before he hands over the White House to Donald Trump, who claimed credit — and, most experts say, deserves some.
Biden first proposed the outlines of the deal between Israel and Hamas on May 31 but diplomatic efforts repeatedly came up short, even when Secretary of State Antony Blinken warned in Tel Aviv in August that it may have been the last chance for a deal.
Trump’s Middle East envoy Steve Witkoff marched into Netanyahu’s office on Saturday, forcing the Israeli leader to break the sabbath, and pushed to seal the ceasefire.
The timing has echoes of a 1981 deal on US hostages in Iran, freed from 444 days of captivity moments after Republican Ronald Reagan succeeded Democrat Jimmy Carter, although this time the outgoing and incoming administrations worked together.
In scenes unprecedented in recent US history, Witkoff and Biden’s Middle East adviser Brett McGurk met jointly with the emir of Qatar — a key intermediary between Israel and Hamas — when sealing the deal.
Trump quickly boasted that the “epic” deal “could only have happened” due to his election as US president in November.
Asked if Trump deserved credit, Biden quipped: “Is that a joke?“
Speaking hours before a previously scheduled farewell address to the nation, the outgoing president said he included the Trump team in negotiations so that the United States was “speaking with one voice.”
White House Press Secretary Karine Jean-Pierre said it was not unexpected for all sides to seek credit for positive news.
“What I can say is, the president got it done,” she said, referring to Biden.
State Department spokesman Matthew Miller said the Trump team’s presence was about demonstrating “continuity” rather than the Republican exerting new pressure.
Biden faced heated criticism from the left of his Democratic Party during its unsuccessful election year over his staunch support of Israel since Palestinian group Hamas’s October 7, 2023, attack.
Biden authorized billions of dollars in weapons for Israel’s relentless retaliatory campaign on Gaza, despite criticizing the strategic US ally for the civilian death toll — which authorities in Gaza say is in the tens of thousands.
“The Biden administration was terrified of the political cost of being seen to be pressing Israel in any way,” said Sarah Leah Whitson, executive director of the rights group Democracy for the Arab World Now.
Trump, while vowing to be even more pro-Israel, was able to make clear to Netanyahu that “I do not want to inherit this,” Whitson said.
“It made me think that all of this would have been possible months ago and we could have saved thousands of Palestinian lives,” she said.
Trump had warned Hamas of “hell to pay” if it did not agree to a deal, which includes in its first phase the release of 33 hostages seized on October 7.
David Khalfa, an expert on Israel at the Jean Jaures Foundation in Paris, said that Trump’s unpredictability likely impacted Hamas.
He also pointed to Netanyahu’s political position heading a hard-right but shaky coalition government.
“There is today an ideological alignment between the American populist right and the Israeli prime minister. So he has very weak room to maneuver against a Trump who doesn’t face the pressures of reelection,” said Khalfa.
Brian Katulis, a senior fellow at the Washington-based Middle East Institute, said a desire by Israel and others for the right optics as Trump takes over could have played a role in sealing the deal.
But a larger factor than Trump was the changing dynamics in the region — the major blows inflicted both on Hamas and its patron Iran, he said.
Israel has devastated Iranian ally Hezbollah in Lebanon and Iran’s own air defenses, with Tehran’s main ally in the Arab world, Syria’s Bashar Assad, ousted last month by rebel forces.
“I don’t think any of the threats and bluster that we saw from Trump were a huge factor on either side. I think it’s mostly a baby that’s fathered by Biden and his team,” Katulis said.
“But I think the sense that there were big question marks on what was coming might have motivated those who were stonewalling,” he said.
Jon Alterman, director of the Middle East program at the Center for Strategic and International Studies, agreed that the uncertainty following Trump’s victory contributed to the deal.
Israel and Hamas were negotiating “under the terms that each side had become familiar with” and knew there was a high risk “that the parameters were about to change.”
And if the deal falls apart?
“Then it doesn’t matter who implemented it; there will be plenty of blame to go around,” Alterman said.
Pro-Palestinian protesters target military and defense industry recruiters at UK universities
- Activists confront Royal Air Force recruiters at careers fairs in Newcastle, Glasgow, York and Cardiff
- About 20 defense companies reportedly forced to steer clear of events because of security risks
LONDON: The UK’s military and defense industries are being forced to avoid university careers fairs because of pro-Palestinian protesters.
Student activists have targeted representatives of the Royal Air Force in recent months during events at which they were attempting to recruit graduates, The Times newspaper reported.
Videos and images shared on social media show RAF recruiters shutting down display stands or leaving them while the protests take place.
About 20 defense companies have stopped attending university careers events because of security concerns about the protests, it was reported last week.
The demonstrations are part of the widespread activism in the UK in response to Israel’s military operations in Gaza that have killed more than 46,000 Palestinians since the Oct. 7, 2023, Hamas-led attacks on Israel in which about 1,200 people were killed and at least 250 taken hostage.
Protesters have also targeted the factories of UK defense companies that supply Israel, and called on the British government to halt arms deliveries.
One protest group, called “Newcastle Apartheid Off Campus,” claimed to have shut down a recruitment fair at Newcastle University at which the RAF and defense firm BAE Systems were represented.
And about 20 students surrounded the recruitment stands of GE Aerospace, the RAF and BAE Systems at Glasgow University in October.
“The students managed to kick out BAE Systems, RAF and (defense and intelligence company) CGI,” the Glasgow University Justice for Palestine Society said in a message posted on Instagram.
“Shame on Glasgow University, we continue to demand divestment and cutting all ties with these genocidal companies.”
Similar disruptions took place at a recruitment fair at York University in October and during an RAF talk at Cardiff University the same month.
In a letter to ministers, Lord Walney, the UK government’s independent adviser on political violence and disruption, warned that the protests go beyond peaceful assembly and could “seriously undermine our nation’s security and technical edge.”
A Ministry of Defence spokesperson told The Times: “We continue to engage widely with our industry partners to highlight the importance and significant benefits of a career in the defense sector.
“This government recognizes the vital role of the defense sector as an engine for growth, strengthening our security and economy.”
Los Angeles firefighters brace for threat of more powerful winds
- Local officials urged residents to stay vigilant throughout the day on Wednesday and be prepared to evacuate at a moment’s notice
- Some 6.5 million people remained under a critical fire threat
LOS ANGELES: The threat of powerful wind gusts combined with bone-dry humidity in Los Angeles on Wednesday could pose a severe test for firefighters who have been battling to keep monstrous fires in check since last week.
Local officials urged residents to stay vigilant throughout the day on Wednesday and be prepared to evacuate at a moment’s notice, even after tamer-than-expected winds over the last 24 hours.
“We want to reiterate the particularly dangerous situation today. Get ready now and be prepared to leave,” County Supervisor Lindsey Horvath said during a news conference on Wednesday.
Some 6.5 million people remained under a critical fire threat as winds were forecast to be 20 to 40 miles (32-64 km) an hour with gusts up to 70 mph and humidity dropping into the single digits during the day, the National Weather Service said.
The combination of low humidity and strong winds has further dried out the brush, increasing the risk of fire, Los Angeles City Fire Chief Kristin Crowley said.
“The danger has not yet passed,” she said, noting that firefighters have seen up to 40 mph winds on Wednesday.
The death toll from the fires stood at 25. The estimate of structures damaged or destroyed held steady at over 12,000, portending a Herculean rebuilding effort ahead. Entire neighborhoods have been leveled, leaving smoldering ash and rubble. In many homes, only a chimney is left standing. Some 82,400 residents were still under evacuation orders with other 90,400 facing evacuation warnings, County Sheriff Robert Luna said.
Winds were tamer than expected on Tuesday, letting firefighters extinguish or gain control of some small brush fires that ignited. No major wildfires erupted in the area, as had been feared.
During the day, the milder-than-expected conditions also allowed some 8,500 firefighters from at least seven states and two foreign countries to hold the line on the Palisades and Eaton fires for the second day running.
The Palisades Fire on the west edge of town held steady at 23,713 acres (96 square km) burned, and containment nudged up to 19 percent — a measurement of how much of the perimeter was under control. The Eaton Fire in the foothills east of the city stood at 14,117 acres (57 sq km) with containment at 45 percent. The fires have consumed an area the size of Washington, D.C.
“In the past 24 hours, there has been little to no fire growth on both incidents,” Cal Fire Incident Commander Gerry Magaña said.
A fleet of aircraft dropped water and retardant into the rugged hills while ground crews with hand tools and hoses have worked around the clock since the fires broke out on Jan. 7, with the aircraft occasionally grounded by high winds.
Crowley and Los Angeles Mayor Karen Bass fielded questions on Wednesday about a Los Angeles Times report that 1,000 firefighters were on standby but not quickly deployed after fire broke out on Jan. 7.
“We did everything in our capability to surge where we could,” Crowley said.
Southern California has lacked any appreciable rain since April, turning brush into tinder as Santa Ana winds originating from the deserts whipped over hilltops and rushed through canyons, sending embers flying up to two miles ahead of the fires.
Private forecaster AccuWeather estimates total damage and economic loss between $250 billion and $275 billion, which would make it the costliest natural disaster in US history, surpassing Hurricane Katrina in 2005.
Danish PM tells Trump it is up to Greenland to decide on independence
- Trump said last week that US control of Greenland was an “absolute necessity“
- Frederiksen also emphasized the importance of strengthening security in the Arctic
COPENHAGEN: Denmark’s Prime Minister Mette Frederiksen said on Wednesday she had spoken on the phone with US President-elect Donald Trump and told him that it is up to Greenland itself to decide on any independence.
Trump, who takes office on Jan. 20, said last week that US control of Greenland was an “absolute necessity” and did not rule out using military or economic action such as tariffs against Denmark to make it happen.
“In the conversation, the prime minister referred to the statements of the Chairman of the Greenlandic Parliament, Mute B. Egede, that Greenland is not for sale,” Frederiksen’s office said in a statement.
“The prime minister emphasized that it is up to Greenland itself to make a decision on independence,” the statement said.
Frederiksen also emphasized the importance of strengthening security in the Arctic and that Denmark was open to taking a greater responsibility, it added.
Russia planned ‘acts of terrorism’ in the air, Polish PM says
- The explosions occurred in depots in Britain, Germany and Poland in July
- Russia has denied involvement in the incidents and Tusk did not mention them specifically
WARSAW: Russia planned ‘acts of terrorism’ in the air against Poland and other countries, Polish Prime Minister Donald Tusk said on Wednesday after meeting Ukrainian President Volodymyr Zelensky in Warsaw.
Security officials have said that parcels that exploded at logistics depots in Europe were part of a test run for a Russian plot to trigger explosions on cargo flights to the United States. The explosions occurred in depots in Britain, Germany and Poland in July. Russia has denied involvement in the incidents and Tusk did not mention them specifically.
“The latest information can confirm the validity of fears that Russia was planning acts of terrorism in the air not only against Poland,” Tusk told a news conference. He did not say what acts he was referring to or elaborate on the contents of the information.
Moscow has regularly denied any involvement in the courier depot explosions, as well as break-ins, arson and attacks on individuals which Western officials say were carried out by operatives paid by Russia. The Russian embassy in Warsaw has not immediately replied to an emailed request for comment on Tusk’s statement.
