WASHINGTON: US pharmaceutical giant Pfizer expects to file for emergency use authorization for its Covid-19 vaccine in late November, around two weeks after the November 3 US presidential election, it said Friday.
The company said it hopes to move ahead with the vaccine after safety data is available in the third week of November, immediately lifting the company’s shares two percent in the US.
“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” the company’s chairman and CEO Albert Bourla said in an open letter.
The announcement means the United States could have two vaccines ready by the end of the year, with Massachussetts biotech firm Moderna aiming for November 25 to seek authorization.
The Food and Drug Administration (FDA), which authorizes pharmaceuticals for distribution in the US - asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.
The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large scale production.
Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses.
They aim to be in a position to deliver tens of millions of doses to the US by the end of the year.
Bourla said the Pfizer trial, involving 30,000 participants, might produce results on the vaccine's efficacy within the next two weeks.
"I've said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," Bourla said.
Pfizer, which is partnering with German company BioNTech on the research, gained more than two percent in online trading ahead of the opening of US markets.
Pfizer plans to seek authorization for Covid-19 vaccine in November
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Pfizer plans to seek authorization for Covid-19 vaccine in November
- Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses
- They aim to be in a position to deliver tens of millions of doses to the US by the end of the year
Tens of thousands protest Germany’s far right as Musk backs AfD
- The protests passed off peacefully, with banners saying “Nazis out” or “AfD is not an alternative,” a reference to the far-right party’s full name “Alternative for Germany”
HALLE (Saale), Germany: Tens of thousands of Germans rallied Saturday against the far right ahead of next month’s legislative elections, as US tech billionaire Elon Musk again endorsed the anti-immigrant AfD party.
Musk, speaking by video link, told thousands of AfD supporters gathered in the eastern city of Halle that their party was “the best hope for the future of Germany.”
AfD supporters at the rally shouted their approval as party co-leader Alice Weidel looked on smiling.
Meanwhile, protesters against the AfD turned out in cities across Germany.
The largest gatherings took place in Berlin and Cologne, with some 35,000 and 20,000 demonstrators, respectively, said police. Organizers in Berlin claimed that 100,000 people attended the protests in the capital.
The protesters there used their mobile phones to form “a sea of light for democracy” in front of the Brandenburg Gate, brandishing letters forming the word “Resistance.”
AfD is polling at around 20 percent ahead of Germany’s February 23 elections, a record for a party that has already shattered a decades-old taboo in post-war Germany against supporting the far right.
The mainstream conservative CDU/CSU alliance leads on about 30 percent, with CDU leader Friedrich Merz the favorite to become chancellor after the elections.
Musk, a close associate of US President Donald Trump, told the AfD rally: “I think this election coming up in Germany is incredibly important.
“I think it could decide the entire fate of Europe, maybe the fate of the world.”
Musk has rattled European politicians in recent weeks with comments on his social platform X supporting AfD and far-right politicians in other countries, including Britain.
He also drew attention this week for making a public gesture some observers interpreted as a straight-armed Nazi salute, a claim he himself dismissed as a smear.
Like Trump, the AfD opposes immigration, denies climate change, rails against gender politics and has declared war on a political establishment and mainstream media it claims limit free speech.
The anti-AfD rallies took place in some 60 towns following calls from a variety of organizations, attracting more people than the police had initially expected.
The protests passed off peacefully, with banners saying “Nazis out” or “AfD is not an alternative,” a reference to the far-right party’s full name “Alternative for Germany.”
The CDU’s Merz also came in for criticism. Many protesters fear he is tempted to break his party’s policy of refusing to enter into coalition talks with the AfD.
There was also a protest in the southern city of Aschaffenbourg, where a deadly knife attack this week by an Afghan migrant further inflamed the debate over immigration.
A few thousand also turned out in the eastern city of Halle, where the AfD rally was addressed by Musk.
“The German people are really an ancient nation which goes back thousands of years,” Musk told them.
“I even read Julius Caesar was very impressed by the German tribes,” he said, urging the supporters to “fight, fight, fight” for their country’s future.
He said the AfD wanted “more self-determination for Germany and for the countries in Europe and less from Brussels,” a reference to his criticism of what he sees as heavy handedness from the European Union authorities.
Weidel told her rally that migrants in Germany had to be sent home.
“We need re-migration to live safely in Germany,” she said.
Congo severs ties with Rwanda as rebels close in on Goma
- M23 is one of about 100 armed groups vying for a foothold in the mineral-rich region
GOMA: Congo has severed diplomatic ties with Rwanda as fighting between Rwanda-backed rebels and government forces rages around the key eastern city of Goma, leaving at least 13 peacekeepers and foreign soldiers dead and displacing thousands of civilians.
The M23 rebel group has made significant territorial gains along the border with Rwanda in recent weeks, closing in on Goma, the provincial capital that has a population of around 2 million and is a regional hub for security and humanitarian efforts.
Congo, the US and UN experts accuse Rwanda of backing M23, which is mainly made up of ethnic Tutsis who broke away from the Congolese army more than a decade ago. It’s one of about 100 armed groups that have been vying for a foothold in the mineral-rich region, where a long-running conflict has created one of the world’s largest humanitarian crises.
Rwanda’s government denies backing the rebels, but last year acknowledged that it has troops and missile systems in eastern Congo to safeguard its security, pointing to a buildup of Congolese forces near the border. UN experts estimate there are up to 4,000 Rwandan forces in Congo.
The Congolese Foreign Ministry said late Saturday it was severing diplomatic ties with Rwanda and pulling out all diplomatic staff from the country “with immediate effect.”
Rwanda’s Foreign Minister Olivier Nduhungirehe said on Sunday the decision to sever diplomatic ties was a unilateral move by Congo “that was even published on social media before being sent to our embassy.”
“For us, we took appropriate measures to evacuate our remaining diplomat in Kinshasa, who was under permanent threat by Congolese officials. And this was achieved on Friday, one day before the publication of this so-called note verbale on social media,” he said.
The UN Security Council moved up an emergency meeting on the escalating violence in eastern Congo to Sunday. Congo requested the meeting, which had originally been scheduled for Monday.
On Sunday morning, heavy gunfire resonated across Goma, just a few kilometers from the front line, while scores of displaced children and adults fled the Kanyaruchinya camp, one of the largest in eastern Congo, right near the Rwandan border, and headed south to Goma.
“We are fleeing because we saw soldiers on the border with Rwanda throwing bombs and shooting,” said Safi Shangwe, who was heading to Goma.
“We are tired and we are afraid, our children are at risk of starving,” she added.
Some of the displaced worried they will not be safe in Goma either.
“We are going to Goma, but I heard that there are bombs in Goma, too, so now we don’t know where to go,” said Adèle Shimiye.
Hundreds of people attempted to flee to Rwanda through the “Great Barrier” border crossing east of Goma on Sunday. Migration officers carefully checked travel documents.
“I am crossing to the other side to see if we will have a place of refuge because for the moment, security in the city is not guaranteed,” Muahadi Amani, a resident of Goma, said.
Earlier in the week, the rebels seized Sake, 27 kilometers from Goma, as concerns mounted that the city could soon fall.
Two children die in Mediterranean shipwreck, 17 rescued, NGO says
- The rescue took place in the early hours of Sunday morning in the Maltese Search and Rescue area
- Survivors told rescuers that the boat set off with 21 people, while two passengers were still missing
MILAN: Seventeen migrants were rescued after a shipwreck in the Mediterranean, while two children died, the German NGO Sea Punks said on Sunday.
The rescue took place in the early hours of Sunday morning in the Maltese Search and Rescue (SAR) area, Sea Punks said in a statement.
One child was recovered deceased, while the Sea Punks crew medical team performed a cardiopulmonary resuscitation (CPR) on two other children, saving one’s life.
A Maltese rescue helicopter evacuated a pregnant woman and a seriously injured man, while an Italian coast guard vessel picked up the other 15 survivors and the bodies of the two children.
Survivors told rescuers that the boat set off with 21 people, Sea Punks added, leaving two missing.
Earlier, Italian news agency ANSA reported that 15 migrants had been rescued and three were found dead, with three others still missing.
Indonesian president is India’s Republic Day chief guest as Asian giants forge new partnerships
- Indonesia’s first president Sukarno was the chief guest in India’s first Republic Day celebration in 1950
- A 350-member contingent from Indonesian military also joined the Republic Day parade on Sunday
NEW DELHI: India celebrated its 76th Republic Day on Sunday with a colorful parade in New Delhi displaying its military might and Indonesian President Prabowo Subianto as the guest of honor.
Thousands of people gathered in the capital to watch the long parade commemorating the official adoption of India’s Constitution on Jan. 26, 1950, after gaining independence from British colonial rule in 1947.
Indian troops and their bands were marching on the Kartavya Path, or the Boulevard of Duty, as the 90-minute parade showcased motorbike stunts and a number of cultural performances involving thousands of artists in colorful costumes.
A contingent comprising about 350 members from the Indonesian military also participated in the parade, marking the first time that troops from Southeast Asia’s biggest economy have joined any foreign parade.
Prabowo attended the event as the chief guest and was flanked by India’s premier and president, joining a list of foreign leaders who were invited to witness the spectacle, as per the country’s tradition.
In 1950 — India’s first Republic Day celebration — Indonesia’s first president Sukarno was the chief guest. French President Emmanuel Macron was the guest of honor last year, while former US President Barack Obama had attended in 2015.
The celebrations come a day after Modi and Prabowo agreed to expand ties, signing a series of cooperation agreements on health, defense, digital technology and maritime affairs.
“We discussed ways to deepen India-Indonesia relations in areas such as security, defense manufacturing, trade, fintech, AI and more. Sectors like food security, energy and disaster management are also areas where we look forward to working closely (together),” Modi said following their meeting on Saturday.
Prabowo’s visit to India was his first since becoming Indonesia’s president in October.
“I want to reiterate my commitment, my determination to further develop our cooperation and friendship,” Prabowo said.
“Our (strategic) partnership will be a strong foundation for the two countries to continue moving forward (and) strengthen the friendship that we have had for 75 years.”
Gautam Kumar Jha, an assistant professor at the Center for Chinese and Southeast Asian Studies at Jawaharlal Nehru University, said the two countries have signaled strong interest in increasing cooperation.
“As a former military commander, President Prabowo brings a deep understanding of security and strategic partnerships, enhancing the collaboration between India and Indonesia. His role as the chief guest on India’s Republic Day is particularly significant compared to previous Indonesian presidents who have visited India,” Jha told Arab News.
“President Prabowo’s (priorities in) strengthening Indonesia’s maritime security, trade and social welfare schemes — such as the mid-day meal scheme currently run in India — are crucial for both nations.”
Indonesia is one of India’s largest trading partners among countries of the Association of Southeast Asian Nations, with bilateral trade reaching a record high of $38.8 billion in April 2022-March 2023, Indian government data showed.
India has also agreed to support Indonesia’s ongoing defense modernization program through experience and expertise sharing, according to a joint statement.
“The meeting on Saturday has established a trusted platform, enabling both countries to collaborate for mutual benefit,” Jha said. “This timing is ideal, as both Indian and Indonesian stakeholders are eager to elevate bilateral ties to a new level.”
South Korean president indicted as ‘ringleader of an insurrection’
- Yoon Suk Yeol plunged the country into political chaos with his December 3 bid to suspend civilian rule
- If the court rules against Yoon, he will lose the presidency and an election will be called within 60 days
SEOUL: South Korean prosecutors indicted impeached President Yoon Suk Yeol Sunday for being the “ringleader of an insurrection” after his abortive declaration of martial law, ordering the suspended leader to remain in detention.
Yoon plunged the country into political chaos with his December 3 bid to suspend civilian rule, a move which lasted just six hours before lawmakers defied armed soliders in parliament to vote it down.
He was impeached soon after, and earlier this month became the first sitting South Korean head of state to be arrested.
That came after a weeks-long hold out at his residence where his elite personal security detail resisted attempts to detain him.
In a statement, prosecutors said they had “indicted Yoon Suk Yeol with detention today on charges of being the ringleader of an insurrection.”
He has been held at the Seoul Detention Center since his arrest, and the formal indictment with detention means he will now be kept behind bars until his trial, which must happen within six months.
The indictment was widely expected after a court twice rejected requests by prosecutors to extend his arrest warrant while their investigation proceeded.
“After a comprehensive review of evidence obtained during investigations (prosecutors) concluded that it was only appropriate to indict the defendant,” they said in a statement.
The need to keep Yoon behind bars was justified by a “continued risk of evidence destruction,” they said.
The specific charge — being the ringleader of an insurrection — is not covered by presidential immunity, they added.
The opposition hailed the indictment.
“We need to hold not only those who schemed to carry out an illegal insurrection, but also those who instigated it by spreading misinformation,” said lawmaker Han Min-soo.
Without providing evidence, Yoon and his legal team have pointed to purported election fraud and legislative gridlock at the opposition-controlled parliament as justification for his declaration of martial law.
Yoon has vowed to “fight to the end,” earning the support of supporters who have adopted the “stop the steal” rhetoric associated with US President Donald Trump.
“This indictment will provide a sense of relief, reaffirming that the constitutional order is functioning as it should,” said Bae Kang-hoon, co-founder of political think tank Valid.
Yoon also faces a series of Constitutional Court hearings, to decide whether to uphold his impeachment and strip him formally of the presidency.
If the court rules against Yoon, he will lose the presidency and an election will be called within 60 days.
