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U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

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October 26, 2021

By Manas Mishra and Michael Erman

(Reuters) -An expert panel will weigh authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for U.S. children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the federal Food and Drug Administration.

An authorization is an important regulatory step toward reaching about 28 million children of these ages, most of them back in school for in-person learning.

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The FDA need not follow the advice of its outside experts, but usually does.

While children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.

The age group is “far from being spared from the harm of COVID-19,” with the virus now one of the top 10 causes of deaths in American children, FDA official Peter Marks told the panel. He said there had been close to 100 deaths in that age group so far, and 1.9 million infections.

“In addition, infections have caused many school closures and disrupted the education and socialization of children,” he said.

FDA staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.

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Only a few other countries, including China, Cuba and the United Arab Emirates, have cleared COVID-19 vaccines for children in this age group and younger.

Since May, the World Health Organization has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX scheme for poorer countries.

The advisers are expected to pay close attention to the rate of the rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

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After the FDA, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.

Top U.S. infectious disease expert Anthony Fauci said on Sunday that it was likely the vaccine will be available to children in the first week or two of November.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

“No matter what size of the safety database, there will always be uncertainties regarding benefits and risks, including for example, the risk of vaccine-associated myocarditis,” said Doran Fink, the FDA’s deputy director for vaccine development.

These uncertainties have to be addressed in surveillance data and studies following authorization, Fink told the panel.

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Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Caroline Humer, Richard Chang and Jonathan Oatis)

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Malaysia court upholds guilty verdict for former PM Najib in 1MDB-linked case

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December 8, 2021

By Rozanna Latiff

KUALA LUMPUR (Reuters) – A Malaysian appeals court on Wednesday upheld former premier Najib Razak’s guilty verdict in a case linked to a corruption scandal at state fund 1Malaysia Development Bhd (1MDB).

Najib was sentenced to 12 years in prison and fined $50 million last year by a high court after being found guilty of criminal breach of trust, abuse of power and money laundering for illegally receiving about $10 million from SRC International, a former unit of now-defunct 1MDB.

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He had pleaded not guilty and consistently denied any wrongdoing.

Judge Abdul Karim Abdul Jalil said he agreed with the high court judge on the conviction and sentencing over all seven charges against Najib.

“We dismiss the appeal on all seven charges and affirm the conviction on all seven charges,” the judge said.

Najib has been free on bail pending the appeal.

His lawyer Shafee Abdullah told the court the former premier would appeal the verdict at the Federal Court, Malaysia’s top tribunal.

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The judge allowed Najib’s request for a stay on the sentence and Najib will be released on bail.

Wearing a black suit, Najib showed no emotion as the judgment was read out and was seen taking notes occasionally during the hearing.

Najib and his lawyers joined the proceedings via Zoom after a member of his legal team tested positive for COVID-19.

The former prime minister remains influential within his party, the United Malays National Organisation (UMNO), which returned to power in August after being voted out three years earlier amid widespread corruption allegations.

Najib told Reuters in September he has not ruled out seeking re-election to parliament, a move that would require his conviction to be overturned.

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U.S. and Malaysian authorities say $4.5 billion was believed to have been stolen from 1MDB, and that more than $1 billion made its way into Najib’s personal accounts.

(Reporting by Rozanna Latiff; Editing by Ed Davies and Stephen Coates)

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Australia joins diplomatic boycott of Beijing Winter Games

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December 8, 2021

By Renju Jose and Gabriel Crossley

SYDNEY/BEIJING (Reuters) – Australia will join the United States in a diplomatic boycott of the Winter Olympic Games in Beijing, Prime Minister Scott Morrison said on Wednesday, as other allies weighed similar moves to protest China’s human rights record.

The United States on Monday said its government officials will boycott the Beijing Olympics nL1N2SR0F6 because of China’s human rights “atrocities”, just weeks after talks aimed at easing tense relations between the two superpowers.

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China said the U.S. will “pay the price” nL1N2SS22N for its decision and warned of “resolute countermeasures” in response.

Morrison said the decision was made because of Australia’s struggles to reopen diplomatic channels with China to discuss alleged human rights abuses in Xinjiang and Beijing’s moves to slow and block imports of Australian goods.

A spokesperson from China’s embassy in Canberra said “some Australian politicians” were engaged in “political posturing.”

“The blame for the current predicament of China-Australia relations lies squarely on the Australian side,” they added in an online statement.

Other allies have been slow to commit to joining the diplomatic boycott.

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Britain is considering approving limited government attendance at the Feb. 4-20 Beijing Olympics that would stop short of a full diplomatic boycott, The Telegraph reported on Wednesday.

An outright ban on ministerial and diplomatic representation at the Winter Games remains a possibility, the report said.

Japan is considering not sending cabinet members to the Beijing Winter Olympics after the United States announced its diplomatic boycott, Japan’s Sankei Shimbun daily reported on Wednesday, citing unnamed government sources.

President Joe Biden’s administration cited what the United States calls genocide against minority Muslims in China’s far western region of Xinjiang. China denies all rights abuses.

Chinese foreign ministry spokesman Zhao Lijian on Tuesday told a media briefing that his country opposes the U.S. diplomatic boycott and promised “resolute countermeasures” in response.

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“The United States will pay a price for its mistaken acts,” he said, without giving details. “Let’s all wait and see.”

The Winter Games are due to begin about six months after the conclusion of the Summer Games in Tokyo, which were delayed a year because of the COVID-19 pandemic.

“We always ask for as much respect as possible and least possible interference from the political world,” said Juan Antonio Samaranch, the IOC’s coordination commission chief for the Beijing Olympics. “We have to be reciprocal. We respect the political decisions taken by political bodies.”

The United States is set to host the 2028 Summer Olympics in Los Angeles and is preparing a bid to host the 2030 Winter Olympics in Salt Lake City.

Asked whether China would consider a diplomatic boycott of Olympic Games in the United States, Zhao said the U.S. boycott has “damaged the foundation and atmosphere” of sports exchange and cooperation on the Olympics.

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The American diplomatic boycott, encouraged for months by some members of the U.S. Congress and rights groups, comes despite an effort to stabilize ties between the world’s two largest economies, with a video meeting last month between Biden and China’s Xi Jinping.

‘THE ONLY OPTION’

Bonnie Glaser, a China expert at the German Marshall Fund of the United States, told a U.S. congressional hearing on Tuesday that unless other countries join the boycott it would undermine the message that China’s human rights abuses are unacceptable.

“Now I think the only option really that is available to us is to try to get as many countries as we can to stand with us in this coalition,” Glaser said.

Announcing Australia’s plans, Morrison said Beijing had not responded to several issues raised by Canberra including alleged human rights abuses.

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“So it is not surprising therefore that Australian government officials would not be going to China for those Games,” Morrison told reporters in Sydney.

Relations between Australia and China, its top trade partner, are at a low ebb over after Canberra banned Huawei Technologies from its 5G broadband network in 2018 and called for an independent investigation into the origins of COVID-19.

Beijing responded by imposing tariffs on several Australian commodities, including coal, beef, barley and wine.

(Reporting by Gabriel Crossley, and Renju Jose; Editing by Gerry Doyle and Lincoln Feast.)

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Swiss group lights 11,288 candles for COVID-19 victims

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December 8, 2021

BERN (Reuters) – More than 11,000 candles – one for each Swiss victim of the coronavirus pandemic – lit up the December darkness outside the Swiss parliament in Bern on Tuesday.

“We want to create a space to remember and mourn the victims,” Simon Gehren of the “Corona-Mahnwache” (corona vigil) movement told Reuters.

Around 40 volunteers helped light the candles arranged geometrically on the square that is Switzerland’s political centre. The group organised a similar event last year.

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Gehren said the vigil was also an appeal to the government to take firmer action to contain soaring infection numbers.

Switzerland has seen a sharp increase in COVID-19 cases over the last weeks. It tightened measures last week, but has been less strict than neighbouring countries, such as Germany or Austria.

Swiss health authorities said on Tuesday that 11,288 people had died with a laboratory-confirmed COVID-19 since the beginning of the pandemic.

(Reporting by Arnd Wiegmann and Silke Koltrowitz; Editing by Bill Berkrot)

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