COVID vaccine developers pledge to uphold testing rigour

Top executives of nine drugmakers likely to produce the first vaccines against the new coronavirus said that they will stick to the highest ethical and scientific standards in testing and manufacturing and will make the well-being of those getting vaccinated their top priority. (File/AP)
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Updated 08 September 2020
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COVID vaccine developers pledge to uphold testing rigour

  • The pledge was prompted by rising concern that political and economic factors may cause companies to rush vaccine development
  • The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

FRANKFURT: Nine leading US and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations will be held against in the global race to contain the coronavirus pandemic.
The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a “historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.
The companies said in a statement they would “uphold the integrity of the scientific process as they work toward potential global regulatory filings and approvals of the first COVID-19 vaccines.”
The other signatories were Johnson & Johnson, Merck & Co, Moderna, Novavax, Sanofi and BioNTech.
The promise to play by established rules underlines a highly politicized debate over what action is needed to rein in COVID-19 quickly and to jumpstart global business and trade.
The head of the US Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials — large-scale testing intended to demonstrate safety and efficacy — as long as officials are convinced the benefits outweigh the risks.
This prompted a call for caution from the World Health Organization (WHO).
Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticize a lack of testing.
The head of China’s Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country’s emergency-use program.
Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.
“We want it to be known that also in the current situation we are not willing to compromise safety and efficacy,” said co-signatory Ugur Sahin, chief executive of Pfizer’s German partner BioNTech.
“Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here.”
BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the center of bitter US politics before the Nov. 3 presidential election.
President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.
The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.
Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.
BioNTech’s Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.
The development race has intensified safety concerns about an inoculation, polls have shown.
Western regulators have said they would not cut corners but rather prioritize the review workload and allow for development steps in parallel that would normally be handled consecutively.
Sahin declined to comment on regulators specifically or on what events prompted the joint statement.
The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.
“What Russia did — and maybe also there are tendencies in the US to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk,” said CEO Michael Scholl.
“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general.”
Leukocare is working with Italy’s ReiThera and Belgium’s Univercells to produce a COVID-19 vaccine currently in phase I testing. 


Mozambique death toll from Cyclone Chido rises to 120

Updated 13 sec ago
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Mozambique death toll from Cyclone Chido rises to 120

  • The cyclone not only ravaged Mayotte’s fragile infrastructure but also laid bare deep-seated tensions between the island’s residents and its large migrant population

MUPATO: The death toll from Cyclone Chido in Mozambique rose by 26 to at least 120, the southern African country’s disaster risk body said on Monday.

The number of those injured also rose to nearly 900 after the cyclone hit the country on December 15, a day after it had devastated the French Indian Ocean archipelago of Mayotte.

The cyclone not only ravaged Mayotte’s fragile infrastructure but also laid bare deep-seated tensions between the island’s residents and its large migrant population.

Thousands of people who have entered the island illegally bore the brunt of the storm that tore through the Indian Ocean archipelago. Authorities in Mayotte, France’s poorest territory, said many avoided emergency shelters out of fear of deportation, leaving them, and the shantytowns they live in, even more vulnerable to the cyclone’s devastation.

Still, some frustrated legal residents have accused the government of channeling scarce resources to migrants at their expense.

“I can’t take it anymore. Just to have water is complicated,” said Fatima on Saturday, a 46-year-old mother of five whose family has struggled to find clean water since the storm.

Fatima, who only gave her first name because her family is known locally, added that “the island can’t support the people living in it, let alone allow more to come.”

Mayotte, a French department located between Madagascar and mainland Africa, has a population of 320,000, including an estimated 100,000 migrants, most of whom have arrived from the nearby Comoros Islands, just 70 kilometers away.

The archipelago’s fragile public services, designed for a much smaller population, have been overwhelmed.

“The problems of Mayotte cannot be solved without addressing illegal immigration,” French President Emmanuel Macron said during his visit this week, acknowledging the challenges posed by the island’s rapid population growth,

“Despite the state’s investments, migratory pressure has made everything explode,” he added.

The cyclone further exacerbated the island’s issues after destroying homes, schools, and infrastructure.

Though the official death toll remains 35, authorities say that any estimates are likely major undercounts, with hundreds and possibly thousands feared dead. Meanwhile, the number of seriously injured has risen to 78.


Zelensky says North Korea could send more troops, military equipment to Russia

Updated 23 December 2024
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Zelensky says North Korea could send more troops, military equipment to Russia

  • More than 3,000 North Koreans killed and wounded, Kyiv says
  • North Korean soldiers fighting in Russia’s Kursk region
  • Zelensky warns of more N.Korean troops, weapons supplies to Russia

KYIV: Ukrainian President Volodymyr Zelensky said on Monday that more than 3,000 North Korean soldiers have been killed and wounded in Russia’s Kursk region and warned that Pyongyang could send more personnel and equipment for Moscow’s army.
“There are risks of North Korea sending additional troops and military equipment to the Russian army,” Zelensky said on X after receiving a report from his top military commander Oleksandr Syrskyi.
“We will have tangible responses to this,” he added.
The estimate of North Korean losses is higher than that provided by Seoul’s Joint Chiefs of Staff (JCS), which said on Monday at least 1,100 North Korean troops had been killed or wounded.
The assessment was in line with a briefing last week by South Korea’s spy agency, which reported some 100 deaths with another 1,000 wounded in the region.
Zelensky said he cited preliminary data. Reuters could not independently verify reports on combat losses.
Russia has neither confirmed nor denied the presence of North Koreans on its side. Pyongyang initially dismissed reports about the troop deployment as “fake news,” but a North Korean official has said any such deployment would be lawful.
According to Ukrainian and allied assessments, North Korea has sent around 12,000 troops to Russia.
Some of them have been deployed for combat in Russia’s Kursk region, where Ukraine still holds a chunk of land after a major cross-border incursion in August.
JCS added that it has
detected signs
of Pyongyang planning to produce suicide drones to be shipped to Russia, in addition to the already supplied 240mm multiple rocket launchers and 170mm self-propelled howitzers.
Kyiv continues to press allies for a tougher response as it says Moscow’s and Pyongyang’s transfer of warfare experience and military technologies constitute a global threat.
“For the world, the cost of restoring stability is always much higher than the cost of effectively pressuring those who destabilize the situation and destroy lives,” Zelensky said.


Trump says it could be worth keeping TikTok in US ‘for a little while’

Updated 23 December 2024
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Trump says it could be worth keeping TikTok in US ‘for a little while’

  • Senate passed law in April requiring TikTok’s parent company to divest the app, citing national security concerns
  • TikTok’s owners have sought to have the law struck down and the US Supreme Court has agreed to hear the case

President-elect Donald Trump indicated on Sunday that he favored allowing TikTok to keep operating in the United States for at least “a little while,” saying he had received billions of views on the social media platform during his presidential campaign.

Trump’s comments before a crowd of conservative supporters in Phoenix, Arizona, were one of the strongest signals yet that he opposes a potential exit of TikTok from the US market.

The US Senate passed a law in April requiring TikTok’s Chinese parent company, ByteDance, to divest the app, citing national security concerns.

TikTok’s owners have sought to have the law struck down, and the US Supreme Court has agreed to hear the case. But if the court does not rule in ByteDance’s favor and no divestment occurs, the app could be effectively banned in the United States on Jan. 19, one day before Trump takes office.

It is unclear how Trump would go about undoing the TikTok divestiture order, which passed overwhelmingly in the Senate. 

“I think we’re going to have to start thinking because, you know, we did go on TikTok, and we had a great response with billions of views, billions and billions of views,” Trump told the crowd at AmericaFest, an annual gathering organized by conservative group Turning Point.

“They brought me a chart, and it was a record, and it was so beautiful to see, and as I looked at it, I said, ‘Maybe we gotta keep this sucker around for a little while’,” he said.

Trump met with TikTok’s CEO on Monday. Trump said at a news conference the same day that he had a “warm spot” for TikTok thanks to his campaign’s success on the app.

The Justice Department has argued that Chinese control of TikTok poses a continuing threat to national security, a position supported by most US lawmakers.

TikTok says the Justice Department has misstated the social media app’s ties to China, arguing that its content recommendation engine and user data are stored in the United States on cloud servers operated by Oracle Corp, while content moderation decisions that affect US users are made in the United States.


Indian brothers seek to preserve fading Urdu with app-based learning

Updated 23 December 2024
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Indian brothers seek to preserve fading Urdu with app-based learning

  • Urdu has faced multiple threats from communal politics, economic issues
  • New app seeks to provide a platform for people to explore the language

NEW DELHI: Part-time musician Aniruddha Pratim was always interested in learning Urdu, believing that it was key to better understanding the range of music from the subcontinent.

For the past few weeks, the Delhi-based consultant has been spending his free time and coffee breaks glued to an app called Humzaaban, which allows him to learn the language that was for centuries used prominently in Indian culture and poetry.

“I’ve always been a little keen about Urdu. I feel like it sounds very poetic, sounds very soulful,” Pratim told Arab News.

“I open (the app) whenever I get a chance to … It has got a very interactive user interface with a lot of audio-visual cues and everything, so it’s a fun app to use,” he said. “Maybe someday I can write a poem of my own in Urdu.”

Humzaaban is the brainchild of Tausif and Tanzil Rahman, who set out to preserve and promote the language they grew up with at a time when interest in speaking Urdu was waning among people in India.

Despite Urdu’s prominent role throughout Indian history, the language has been facing multiple threats from communal politics and the quest for economic prosperity in more recent decades.

Urdu has been stigmatized as foreign, the language of India’s archrival Pakistan, while families increasingly choose to enroll their children in schools that teach English or other Indian languages to better equip them for the job market.

While millions still speak Urdu today, they make up less than 5 percent of India’s 1.4 billion population. The language is also no longer taught in the majority of schools across the country.

“There has been a consistent decline in Urdu (following the independence) of India,” Tausif told Arab News, adding that the economic value of learning English has naturally led it to become preferred over Urdu.

“Urdu has lost its economic value; none of the business transactions are being done in Urdu.”

Yet the language still holds significance for many people across India, the wider subcontinent and the diaspora, who grew up humming songs from Bollywood musicals that draw heavily on Urdu poetry.

For Tausif, the motivation to create an app dedicated to learning Urdu stemmed out of his own passion for Urdu poetry.

“We speak Urdu at home, and we were discussing the future of Urdu in India and outside India,” he said.

“We decided to create a beautiful learning app, which will enable you to read and write Urdu, to understand what is happening in the Urdu world … and with this idea and with this vision, we started our journey.”

After five years of research, trial and error, the brothers, whose day jobs are in the corporate world, launched Humzaaban in October to reach a wider audience.

Tanzil said interest in Urdu transcended generations, as he saw diverse participation at an offline Urdu learning program he teaches on the weekends.

“The program participation from across generations, communities and professions gave us confidence that there is a yearning to explore this language,” he said.

The Rahman brothers believe that Urdu has the potential to flourish and made a dedicated app that they claim is more comprehensive than others in the market.

With around 3,000 Humzaaban users and counting, many said they were drawn to the app because of its interactive features and user-friendly design.

“There are very few platforms that focus on Urdu learning … but after looking into the Humzaaban app, I am very impressed,” Mohd. Azam, a Delhi-based marketing professional, told Arab News.

“I am very interested in poetry, (and) Urdu has very beautiful words … which inspire me a lot, so I want to learn from this app and maybe write some poetry.”

For Sahar Rizvi, who is based in London, the app has served as a bridge to reconnect with her roots. After learning Urdu as a child, she lost touch with the language as she grew up and forgot the basics.

“My father mentioned the Humzaaban app, and it has been awesome to catch up again. It teaches right from the beginning! I often play around with it during my time on the train,” Rizvi said.

“I’m re-learning to read Urdu … It’s a beautiful language, and I do want to incorporate it in my daily usage.”


Indian brothers seek to preserve Urdu language with learning app

Updated 23 December 2024
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Indian brothers seek to preserve Urdu language with learning app

  • Humzaaban is the brainchild of Tausif and Tanzil Rahman, who set out to preserve and promote Urdu
  • Urdu has faced multiple threats from communal politics, more families choosing English-medium schools

NEW DELHI: Part-time musician Aniruddha Pratim was always interested in learning Urdu, believing that it was key to better understand the range of music from the subcontinent. 

For the past few weeks, the Delhi-based consultant has been spending his free time and coffee breaks glued to an app called Humzaaban, which allows him to learn the language that was for centuries used prominently in Indian culture and poetry. 

“I’ve always been a little keen about Urdu, I feel like it sounds very poetic, sounds very soulful,” Pratim told Arab News. 

“I open (the app) whenever I get a chance to … It has got a very interactive user interface with a lot of audio visual cues and everything, so it’s a fun app to use,” he said. “Maybe someday I can write a poem of my own in Urdu.” 

Humzaaban is the brainchild of Tausif and Tanzil Rahman, who set out to preserve and promote the language they grew up with at a time when interest in speaking Urdu was waning among people in India. 

Despite Urdu’s prominent role throughout Indian history, the language has been facing multiple threats from communal politics and the quest for economic prosperity in more recent decades. 

Urdu has been stigmatized as foreign, the language of India’s archrival Pakistan, while families increasingly choose to enroll their children in schools that teach English or other Indian languages to better equip them for the job market. 

While millions still speak Urdu today, they make up less than 5 percent of India’s 1.4 billion population. The language is also no longer taught in the majority of schools across the country.

“There has been a consistent decline in Urdu post-independence of India and also if you look at the you know (how) English is having all the economic value and it is you know thriving in the world,” Tausif told Arab News. 

“Urdu has lost its economic value, none of the business transactions are being done in Urdu language and because of the same reasons there are not enough jobs available, people are not choosing Urdu as a language.”

Yet the language still holds a special place for many people across India, the wider subcontinent and in the diaspora, who grew up humming songs from Bollywood musicals that draw heavily on Urdu poetry. 

For Tausif, the motivation to create an app dedicated for learning Urdu stemmed out of his own passion for Urdu poetries. 

“We speak Urdu at home and we were discussing about the future of Urdu in India and outside India,” he said. 

“We decided to create a beautiful learning app which will enable you to read and write Urdu, which will enable you to understand what is happening in the Urdu world, what are the trends that are going on, and with this idea and with this vision we started our journey.” 

After five years of research, trial and error, the brothers whose day jobs are in the corporate world launched Humzaaban in October to reach a wider audience. 

Tanzil said interest in Urdu transcended generations, as he saw diverse participation at an offline Urdu learning program he teaches on the weekends. 

“The program participation from across generations, communities and professions gave us confidence that there is a yearning to explore this language that is born out of a long process of fusion and yet is essentially Indian,” he said. 

The Rahman brothers believe that Urdu has a potential to flourish, and made a dedicated app that they claim is more comprehensive than others in the market. 

With around 3,000 Humzaaban users and counting, many said they were drawn to the app because of its interactive features and user-friendly design. 

“There are very few platforms that focus on Urdu learning … but after looking into Humzaaban app I am very much impressed that someone is taking the effort to increase the availability of Urdu from end to end and (through a) step-by-step journey,” Mohd. Azam, a Delhi-based marketing professional, told Arab News. 

“I am very much interested in poetry and all, (and) Urdu has very beautiful words … which inspire me a lot so I want to learn from this app and maybe write some poetry.”

For Sahar Rizvi, who is based in London, the app has been a bridge to reconnect with her roots. After learning Urdu as a child, she lost touch with the language while growing up and had forgotten the basics. 

“My father mentioned about the Humzaaban app and it has been awesome to catch up again. It teaches right from the beginning! I often play around with it during my time on the train,” Rizvi said. 

“I’m re-learning to read Urdu … It’s a beautiful language and I do want to incorporate it in my daily usage.”