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
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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
France returns ancient artifacts to Ethiopia
- The artifacts currently stored at the French Embassy in Addis Ababa will be delivered to the Ethiopian Heritage Directorate on Tuesday
ADDIS ABABA: France on Saturday began the return of some 3,500 archeolo-gical artifacts to Ethiopia, which Paris held since the 1980s for study.
French Foreign Minister Jean-Noel Barrot handed over two prehistoric stone axes, bifaces, and a stone cutter to Ethiopia’s Tourism Minister Selamawit Kassa during a visit to the National Museum in Addis Ababa.
The tools are “samples of nearly 3,500 artifacts from the excavations carried out on the Melka Kunture site,” a cluster of prehistoric sites south of the capital excavated under the direction of a late French researcher, Barrot said.
France and Ethiopia hold a longstanding bilateral agreement to cooperate in archeology and paleontology.
The artifacts stored at the French Embassy in Addis Ababa will be delivered to the Ethiopian Heritage Directorate on Tuesday.
“This is a handover, not a restitution, in that these objects have never been part of French public collections,” said Laurent Serrano, culture adviser at the French Embassy.
“These artifacts, which date back between 1 and 2 million years, were found during excavations carried out over several decades at a site near the Ethiopian capital,” he added.
Concern grows over rise in fatal migrant shipwrecks in Greece
- UNHCR representative: ‘Counting lives lost at sea cannot become a norm’
ATHENS: The UN refugee agency has voiced concern at a rise in deaths of migrants trying to reach Greece by sea in small boats from Turkiye, following two fatal shipwrecks this week.
The UNHCR said in a statement Friday that 17 people have died in such accidents this month, while the total so far this year is at least 45 deaths.
Some 56,000 people have illegally entered Greece since Jan. 1, mostly by sea. That’s a five-year high, and the number has already exceeded government estimates of some 50,000 arrivals by the year’s end in October.
The UNHCR representative in Greece, Maria Clara Martin, said the migrant deaths “highlight the urgent need for long-term responses and safer and credible alternatives” for people fleeing conflict, persecution, violence, or human rights violations.
“Counting lives lost at sea cannot become a norm — we should not get used to it,” she said.
The UN agency said that this week’s two fatal accidents off the eastern Aegean Sea island of Samos, which is close to the Turkish coast, saw a mother lose three of her children, while another survivor lost his wife and daughter.
Greek authorities have attributed this year’s rise in migrant arrivals to conflicts in the Middle East.
While there’s been a surge in people attempting the long and dangerous Mediterranean Sea crossing from Libya to the southern Greek island of Crete, most migrants pay smuggling gangs to ferry them from Turkiye to the eastern Aegean islands.
On Friday, the Greek coast guard said it arrested a 17-year-old Turkish youth on suspicion of having landed 16 migrants — including three children — on the eastern island of Chios.
Tunisia and Libya have become vital departure points for migrants, often from other African countries, who risk perilous Mediterranean Sea journeys in the hopes of reaching better lives in Europe.
Each year, tens of thousands of people attempt to make the crossing. Italy, whose Lampedusa island is only 150 km from Tunisia, is often their first port of call.
In the latest incident reported on Friday, two unidentified bodies were recovered off Tunisia’s eastern coast after a migrant boat capsized, with one person still missing and 28 rescued.
The boat had set sail from Teboulba, a coastal town some 180 km south of Tunis.
In late October, the bodies of 15 people believed to be migrants were recovered by authorities in Monastir, eastern Tunisia.
And in late September, 36 would-be migrants — mainly Tunisians — were rescued off Bizerte in northern Tunisia.
Since Jan. 1, at least 103 makeshift boats have capsized, and 341 bodies have been recovered off Tunisia’s coast, according to the Interior Ministry.
Kenyan, Ugandan presidents to mediate Ethiopia-Somalia dispute
- Somaliland has struggled to gain international recognition despite governing itself and enjoying comparative peace and stability since declaring independence in 1991
NAIROBI: Kenya’s President William Ruto said on Saturday he and Ugandan President Yoweri Museveni would help mediate a dispute between Ethiopia and Somalia, threatening the region’s stability.
Landlocked Ethiopia, which has thousands of troops in Somalia to fight Al-Qaeda-linked insurgents, has fallen out with the Mogadishu government over its plans to build a port in the breakaway region of Somaliland in exchange for possible recognition of its sovereignty.
Somaliland has struggled to gain international recognition despite governing itself and enjoying comparative peace and stability since declaring independence in 1991.
The spat has drawn Somalia closer to Egypt, which has quarreled with Ethiopia for years over Addis Ababa’s construction of a vast hydro dam on the Nile River, and Eritrea, another of Ethiopia’s foes.
Somaliland has struggled to gain international recognition despite governing itself and enjoying comparative peace and stability since declaring independence in 1991.
“Because the security of Somalia ... contributes significantly to the stability of our region, and the environment for investors, business people, and entrepreneurs to thrive,” he told a news conference.
Several attempts to resolve the feud in Ankara, Turkiye, failed to make a breakthrough.
Ethiopia’s government and foreign affairs spokespeople did not immediately respond to requests for comment.
Somalia’s foreign minister could not immediately be reached by Reuters.
The government of Somalia’s semi-autonomous Jubbaland state said earlier it was suspending relations and cooperation with the federal government in Mogadishu following a dispute over regional elections.
Jubbaland, which borders Kenya and Ethiopia and is one of Somalia’s five semi-autonomous states, reelected regional president Ahmed Mohammed Islam Madobe for a third term in elections on Monday.
However, the national government based in Mogadishu, led by President Hassan Sheikh Mohamud, opposed the election, saying it was held without federal involvement.
Russian missile strike on central Ukraine kills 4: Zelensky
- More than a dozen others were wounded, including a child
- “A rescue operation is currently underway in the Dnipro region,” Zelensky said
KYIV: A Russian missile strike on a town in Ukraine’s central Dnipropetrovsk region on Saturday killed at least four people, President Volodymyr Zelensky said.
More than a dozen others were wounded, including a child, while a residential building and shop were damaged, according to officials.
“A rescue operation is currently underway in the Dnipro region after the missile strike. As of now, it is known that four people were killed,” Zelensky said in his evening address.
Tsarychanka is about 50 kilometers (30 miles) north of the region’s capital Dnipro.
The town had a population of around 7,000 people before the war.
The nearly three-year conflict has seen a sharp escalation in recent days, with Moscow pummelling Ukrainian towns and cities ahead of the winter.
Russia launched more than a hundred drones at Ukraine on Friday, a day after knocking out power to more than a million people with strikes on energy infrastructure.
Zelensky says NATO offer for Ukraine-controlled territory could end ‘hot stage’ of war
- “You can’t give an invitation to just one part of a country,” the Ukrainian president said
- “So legally, by law, we have no right to recognize the occupied territory as territory of Russia”
KYIV: An offer of NATO membership to territory under Kyiv’s control would end “the hot stage of the war” in Ukraine, but any proposal to join the military alliance should be extended to all parts of the country that fall under internationally recognized borders, President Volodymyr Zelensky said in a broadcast interview.
Zelensky’s remarks on Friday signaled a possible way forward to the difficult path Ukraine faces to future NATO membership. At their summit in Washington in July, the 32 members declared Ukraine on an “irreversible” path to membership. However, one obstacle to moving forward has been the view that Ukraine’s borders would need to be clearly demarcated before it could join so that there can be no mistaking where the alliance’s pact of mutual defense would come into effect.
“You can’t give an invitation to just one part of a country,” the Ukrainian president said in an excerpt of the interview with Sky News, dubbed by the UK broadcaster. “Why? Because thus you would recognize that Ukraine is only that territory of Ukraine and the other one is Russia.”
Under the Ukrainian constitution, Ukraine cannot recognize territory occupied by Russia as Russian.
“So legally, by law, we have no right to recognize the occupied territory as territory of Russia,” he said.
Since the start of the war in 2022, Russia has been expending huge amounts of weaponry and human life to make small-but-steady territorial gains to the nearly one-fifth of Ukraine it already controls in east and southern Ukraine.
“If we want to stop the hot stage of the war, we should take under the NATO umbrella the territory of Ukraine that we have under our control. That’s what we need to do, fast. And then Ukraine can get back the other part of its territory diplomatically,” he said.
An invitation for Ukraine to join NATO is one key point of Zelensky’s “victory plan”, which he presented to Western allies and the Ukrainian people in October. The plan is seen as a way for Ukraine to strengthen its hand in any negotiations with Moscow.
Earlier this week, NATO’s new Secretary General Mark Rutte said that the alliance “needs to go further” to support Ukraine in its fight against a Russian invasion. Military aid to Kyiv and steps toward ending the war are expected to be high on the agenda when NATO members’ foreign ministers meet in Brussels for a two-day gathering starting on December 3.
However, any decision for Ukraine to join the military alliance would require a lengthier process and the agreement of all member states.
There is also uncertainty as to the foreign policy stance of President-elect Donald Trump. While Trump vowed on the campaign trail to end Russia’s invasion of Ukraine in a single day, he has not publicly discussed how this could happen. Trump also announced Wednesday that Keith Kellogg, an 80-year-old, highly decorated retired three-star general, would serve as his special envoy for Ukraine and Russia.
In April, Kellog wrote that “bringing the Russia-Ukraine war to a close will require strong, America First leadership to deliver a peace deal and immediately end the hostilities between the two warring parties.”
Meanwhile, during his only campaign debate with Vice President Kamala Harris, Trump twice refused to directly answer a question about whether he wanted Ukraine to win the war — raising concerns that Kyiv could be forced to accept unfavorable terms in any negotiations.
Zelensky’s statement comes as Ukraine faces increasing pressure along the 1,000-kilometer (620-mile) frontline. In its latest report, the Washington-based think tank the Institute for the Study of War said Saturday that Russian forces had recently advanced near Kupiansk, in Toretsk, and near Pokrovsk and Velyka Novosilka, a key logistics route for the Ukrainian military.
Ukraine’s air force announced Saturday that the country had come under attack from ten Russian drones, of which eight were shot down over the Kyiv, Cherkasy, Kirovohrad, Dnipropetrovsk, and Kherson regions. One drone returned to Russian-occupied territory, while the final drone disappeared from radar, often a sign of the use of electronic defenses.
Meanwhile, the Russian Defense Ministry said that 11 Ukrainian drones had been shot down by the country’s air defense systems. Both the mayor of Sochi, Andrey Proshunin, and the head of Russia’s Dagestan region, Sergey Melikov, both in Russia’s southwest, said that drones had been destroyed in their regions overnight. No casualties were reported.
On Friday, the Ukrainian president announced a number of changes to military leadership, saying that changes in personnel management were needed to improve the situation on the battlefield.
General Mykhailo Drapatyi, who led the defense of Kharkiv during Russia’s new offensive on Ukraine’s second-largest city this year, was appointed the new head of Ukraine’s Ground Forces. Oleh Apostol was named as the new Deputy Commander-in-Chief responsible for improving military training.
Commander-in-Chief Oleksandr Syrskyi also announced Friday that he would bolster units in Donetsk, Pokrovsk and Kurakhove with additional reserves, ammunition, weapons and military equipment.
