AstraZeneca pauses coronavirus vaccine trial, shares slip on rollout doubts

A man receives the AstraZeneca COVID-19 vaccine as part of a clinical trial for a study by UW Health and the University of Wisconsin School of Medicine and Public Health. (File/AFP)
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Updated 09 September 2020
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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

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.


Wave of pro-Palestinian campus protests in US meets forceful response

Updated 51 min 28 sec ago
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Wave of pro-Palestinian campus protests in US meets forceful response

  • Students protesters tasered and teargassed in Atlanta and "swept away" in Austin, Texas
  • More than 530 arrests have been made in the last week across major US universities in relation to protests over Gaza

NEW YORK: Fresh clashes between police and students opposed to Israel’s war in Gaza broke out on Thursday, raising questions about forceful methods being used to shut down protests that have intensified since mass arrests at Columbia University last week.

Over the past two days, law enforcement at the behest of college administrators have deployed Tasers and tear gas against students protesters at Atlanta’s Emory University, activists say, while officers clad in riot gear and mounted on horseback have swept away demonstrations at the University of Texas in Austin.
At Columbia, the epicenter of the US protest movement, university officials are locked in a stalemate with students over the removal of a tent encampment set up two weeks ago as a protest against the Israeli offensive.
The administration, which has already allowed an initial deadline for an agreement with students to lapse, has given protesters until Friday to strike a deal.
Other universities appear determined to prevent similar, long-running demonstrations to take root, opting to work with police to shut them down quickly and in some cases, with force.
Overall, more than 530 arrests have been made in the last week across major US universities in relation to protests over Gaza, according to a Reuters tally. University authorities have said the demonstrations are often unauthorized and called on police to clear them.

Police officers arrest a demonstrator during a pro-Palestinian protest against the war in Gaza at Emory University on April 25, 2024, in Atlanta, Georgia. (AFP)

At Emory, police detained at least 15 people on its Atlanta campus, according to local media, after protesters began erecting a tent encampment in an attempt to emulate a symbol of vigilance employed by protesters at Columbia and elsewhere.
The local chapter of the activist group Jewish Voice for Peace said officers used tear gas and Tasers to dispense the demonstration and take some protesters into custody.
Video footage aired on FOX 5 Atlanta showed a melee breaking out between officers and some protesters, with officers using what appeared to be a stun gun to subdue a person and others wrestling other protesters to the ground and leading them away.
“Several dozen protesters trespassed into Emory University’s campus early Thursday morning and set up tents,” the school wrote in response to an emailed request for comment. It described the protesters as “activists attempting to disrupt our university,” but did not comment directly on the reports of violence.
Atlanta police did not immediately respond to inquiries about the number of protesters who were detained or about reports over the use of tear gas and stun guns.
Similar scenarios unfolded on the New Jersey campus of Princeton University where officers swarmed a newly-formed encampment, video footage on social media showed.
Boston police earlier forcibly removed a pro-Palestinian encampment set up by Emerson College, arresting more than 100 people, media accounts and police said. The latest clashes came a day after police in riot gear and on horseback descended on hundreds of student protesters at the University of Texas at Austin and arrested dozens of them.

Police arrest a protester at the University of Texas on April 24, 2024, in Austin, Texas. (Austin American-Statesman via AP)

But prosecutors on Thursday dropped charges against most of the 60 people taken into custody, mostly on misdemeanor charges of criminal trespassing and disorderly conduct, and said they would proceed with only 14 of those cases.
In dropping the charges, the Travis County district attorney cited “deficiencies in the probable cause affidavits.”

‘Alarming reports’
Human Rights Watch and the American Civil Liberties Union have condemned the arrest of protesters and urged authorities to respect their free speech rights.
But some Republicans in Congress have accused university administrators of allowing Jewish students to be harassed, putting increasing pressure on schools to tightly control any demonstrations and to block any semi-permanent encampment.
US Education Secretary Miguel Cardona on Thursday said his department was closely monitoring the protests, including what he called “very alarming reports of antisemitism.”
In response, activist groups have strongly denied that the protests are antisemitic. Their aim is to pressure universities from divesting from companies that contribute to the Israeli military actions in Gaza, they say.
Even so, protest leaders have acknowledged that hateful rhetoric has been directed at Jewish students, but insist that people who tried to infiltrate and malign their movement are responsible for any harassment.

Columbia University students participate in an ongoing pro-Palestinian encampment on their campus in New York City on April 25, 2024, following last week's arrest of more than 100 protesters. (Getty Images/AFP)

Friday deadline at Columbia
At Columbia, officials have given protesters until 4 a.m. on Friday to reach an agreement with the university on dismantling dozens of tents set up on the New York City campus in a protest that started a week ago.
An initial deadline of midnight Tuesday came and went without an agreement, but administrators extended it for 48 hours, citing progress in the talks.
The university already tried to shut the protest down by force. On April 18, Columbia President Minouche Shafik took the unusual move of asking police to enter the campus, drawing the ire of many rights groups, students and faculty.
More than 100 people were arrested and the tents were removed from the main lawn. But within a few days, the encampment was back in place, and the university’s options appeared to narrow.
Protesters have vowed to keep the protests going until their universities agree to disclose and divest any financial holdings that might support the war in Gaza, and grant amnesty to students suspended from school during the demonstrations.
Student protesters have also demanded that the US government rein in Israeli strikes on civilians in Gaza, which have killed more than 34,000 people, according to Palestinian health authorities. Israel is retaliating against an Oct. 7 Hamas attack that killed 1,200 people and led to 253 taken hostage, according to Israeli tallies.


Macron blasts ‘ineffective’ UK Rwanda deportation law

Updated 25 April 2024
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Macron blasts ‘ineffective’ UK Rwanda deportation law

PARIS: French President Emmanuel Macron on Thursday said Britain’s plan to send asylum seekers to Rwanda was “ineffective” and showed “cynicism” while praising the two countries’ cooperation on defense.

“I don’t believe in the model ... which would involve finding third countries on the African continent or elsewhere where we’d send people who arrive on our soil illegally, who don’t come from these countries,” Macron said.

“We’re creating a geopolitics of cynicism which betrays our values and will build new dependencies, and which will prove completely ineffective,” he added in a wide-ranging speech on the future of the European Union at Paris’ Sorbonne University.

British MPs on Tuesday passed a law providing for undocumented asylum seekers to be sent to Rwanda, where their asylum claims would be processed and where they would stay if the claims succeed.

The law is a flagship policy for Prime Minister Rishi Sunak’s government, which badly lags the opposition Labour Party in the polls, with an election expected within months.

Britain pays Paris to support policing of France’s northern coast, which aims to prevent migrants from setting off for perilous crossings in small boats.

Five people, including one child, were killed in an attempted crossing Tuesday, bringing the toll on the route so far this year to 15 — already higher than the 12 deaths in 2023.

But Macron had warm words for London when he praised the two NATO allies’ bilateral military cooperation, which endured through the contentious years of Britain’s departure from the EU.

“The British are deep natural allies (for France), and the treaties that bind us together ... lay a solid foundation,” he said.

“We have to follow them up and strengthen them because Brexit has not affected this relationship,” Macron added.

The president also said France should seek similar “partnerships” with fellow EU members.


US alarmed by signs of ‘imminent military offensive’ in Darfur

Updated 25 April 2024
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US alarmed by signs of ‘imminent military offensive’ in Darfur

WASHINGTON: The US has warned of a looming rebel military offensive on the Sudanese city of El-Fasher. This humanitarian hub appears to be at the center of a newly opening front in the country’s civil war.

After a year of fighting between the armed forces of Gen. Abdel Fattah Al-Burhan and the paramilitaries of the Rapid Support Forces, under Gen. Mohammed Hamdan Dagalo, millions have been displaced in the northeastern African country.

Until recently, El-Fasher — the last Darfur state capital not under RSF control — had been relatively unaffected by the fighting, hosting a large number of refugees.

But since mid-April, bombardments and clashes have been reported in the city and surrounding villages. The US “calls on all armed forces in Sudan to immediately cease attacks in El-Fasher,” the State Department said.

“We are alarmed by indications of an imminent offensive by the Rapid Support Forces and its affiliated militias,” it said, adding that “an offensive against El-Fasher city would subject civilians to extreme danger.”

After several days of “arbitrary shelling and airstrikes” in the city and its outskirts, a pro-democracy lawyers’ committee reported last week that at least 25 civilians had been killed.

Clashes in the eastern and northern parts of the city have already resulted in 36,000 displaced people, according to the UN’s Office for the Coordination of Humanitarian Affairs.

As the war enters its second year, the UN and US have warned the breakdown of the fragile peace in El-Fasher would be catastrophic.

The city functions as the main humanitarian hub in the vast western region of Darfur, home to around a quarter of Sudan’s 48 million people and the site of harrowing violence during this and previous conflicts.

The State Department said it had seen “credible reports” that the RSF and affiliated militias had razed multiple villages west of the city, while it condemned “reported indiscriminate aerial bombardments” in the region by Sudan’s armed forces.


Death toll in migrant boat capsize off Djibouti rises to 24: UN agency

Updated 25 April 2024
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Death toll in migrant boat capsize off Djibouti rises to 24: UN agency

  • 20 remain missing after the boat carrying at least 77 migrants, including children, capsized near the town of Obock

NAIROBI: The death toll from a migrant boat disaster off Djibouti this week has risen to 24, the UN’s migration agency said, highlighting a sharp increase in the number of people returning from Yemen to the Horn of Africa nation this year.

The capsize on Monday was the second fatal maritime accident in two weeks off Djibouti, which lies on the perilous so-called Eastern Migration Route from Africa to the Arabian Peninsula.

At least 24 people died, and 20 remain missing after the boat carrying at least 77 migrants, including children, capsized near the town of Obock, the International Organization for Migration said.

It said 33 survivors were being cared for at an IOM center in Obock and that local authorities are conducting search and rescue operations in the hope of finding more people alive.

Addis Ababa’s ambassador to Djibouti had said those on the boat were Ethiopian migrants.

Another vessel also carrying mainly Ethiopian migrants sank in the same area on April 8, with a death toll of at least 38.

“The occurrence of two such tragedies within two weeks highlights the dangers faced by children, women, and men migrating through irregular routes, underscoring the importance of establishing safe and legal pathways for migration,” IOM chief of mission in Djibouti, Tanja Pacifico, said.

The IOM said it had recorded a total of 1,350 deaths on the Eastern Route since 2014, not including this year.

In 2023 alone, it said it documented at least 698 deaths along the route, including 105 lost at sea.

The agency believed the people on both ill-fated vessels were attempting to return from Yemen to Djibouti.

Each year, tens of thousands of African migrants brave the Eastern Route across the Red Sea to reach Gulf nations, escape conflict or natural disaster, or seek better economic opportunities.

However, many are unsuccessful and “thousands are stranded in Yemen where they experience extremely harsh conditions,” the IOM said.

Since the start of 2024, the agency said 3,682 migrants have left Yemen for Djibouti, more than double the figure for the same period last year.


155 killed in Tanzania as heavy rains lash East Africa

Updated 25 April 2024
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155 killed in Tanzania as heavy rains lash East Africa

  • Kenyan president convenes emergency multi-agency meeting to respond to crisis after floods cause chaos

DAR ES SALAAM, Tanzania: At least 155 people have died in Tanzania as torrential rains linked to El Nino triggered flooding and landslides, Prime Minister Kassim Majaliwa said on Thursday.

Tanzania and other countries in East Africa — a region highly vulnerable to climate change — have been pounded by heavier than usual rainfall during the current rainy season, with dozens of deaths also reported in Kenya.

Majaliwa said the rains have affected more than 51,000 households and 200,000 people, with 155 fatalities and 236 injuries.

“The heavy El Nino rains, accompanied by strong winds, floods, and landslides in various parts of the country, have caused significant damage,” Majaliwa told parliament in Tanzania’s capital, Dodoma.

He added: “These include loss of life, destruction of crops, homes, citizens’ property, and infrastructure such as roads, bridges, and railways.”

El Nino is a naturally occurring climate pattern typically associated with increased heat worldwide, drought in some parts of the world, and heavy rains elsewhere. 

It can have a devastating impact on East Africa.

In Burundi, around 96,000 people have been displaced by months of relentless rains.

In addition, about 45 people have been killed in Kenya since the start of the rainy season in March, including 13 who lost their lives in flash floods in the capital, Nairobi, this week.

Kenyan President William Ruto convened an emergency multi-agency meeting on Thursday to respond to the crisis after torrential rains triggered floods that caused chaos across the city, blocking roads and bridges and engulfing homes in slum districts.

Kenyans have been warned to stay on alert, with more heavy rains forecast across the country. Officials said people living in the most vulnerable areas would be relocated.

“The government ... will do whatever it takes, apply all the required resources in terms of money and personnel to make sure that lives are not lost and the people of Kenya are protected from this disaster,” Deputy President Rigathi Gachagua told a press briefing.

Meanwhile, the UN humanitarian response agency OCHA said in an update this week that in Somalia, the Gu (April to June) rains are intensifying, with flash floods reported since April 19.

It said four people had been reportedly killed, and at least 134 families or more than 800 people were affected or displaced across the country.

Late last year, more than 300 people died in torrential rains and floods in Kenya, Somalia, and Ethiopia just as the region was trying to recover from its worst drought in four decades that left millions of people hungry.

From October 1997 to January 1998, massive floods caused more than 6,000 deaths in five countries in the region.

In March, the UN’s World Meteorological Organization said that El Nino, which peaked in December, was one of the five strongest ever recorded.

Though the weather pattern is gradually weakening, its impact will continue over the coming months by fueling the heat trapped in the atmosphere by greenhouse gases, it said.

Therefore, the WMO said in a quarterly update that “above normal temperatures are predicted over almost all land areas between March and May.”