Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11

WASHINGTON (Reuters) -Pfizer Inc and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday.

The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.

The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.

The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna vaccine and the single-dose Johnson & Johnson version, neither of which has won full regulatory approval for any age group.

A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.

The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in 5 to 11 year old’s in a 2,268-participant clinical trial, the companies said on Sept. 20.

The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter.

The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on CNN.

Once the authorization is granted, Zients said: “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”

The United States leads the world in COVID-19 cases and deaths.

Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.

While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

A Pfizer spokesperson said the application to the FDA has been completed.

(Reporting by Susan Heavey in Washington and Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Will Dunham, Timothy Heritage and Saumyadeb Chakrabarty)

Biden’s CIA director creates high-level unit focusing on China

By Mark Hosenball

WASHINGTON (Reuters) – The career diplomat U.S. President Joe Biden named to lead the Central Intelligence Agency is creating a high-level unit aimed at sharpening the agency’s focus on China, at a time of tense relations between the world’s two largest economies.

CIA Director William Burns said on Thursday that the China Mission Center he was setting up “cuts across all of the agency’s mission areas,” while noting that the CIA’s concern is that “the threat is from the Chinese government, not its people.”

A senior CIA official compared Burns’ creation of the China unit to the agency’s tight focus on Russia during the Cold War and to its concentration on counter-terrorism following the Sept. 11, 2001 attacks on New York and Washington. No such high-level unit focusing explicitly on China had previously been set up by the agency, even in the wake of harsh attacks on China by former President Donald Trump and his aides.

The new China unit was one of several re-shuffles resulting from a broad review the agency launched last spring, the senior official said, speaking on condition of anonymity.

In the Biden administration’s first months, relations with Beijing soured over deep differences on many issues including human rights, Hong Kong and the South China Sea. But top officials from both countries met this week to improve communication and set the stage for a virtual meeting of presidents by the end of the year.

Other agency moves include merging an Iran Mission Center set up by the Trump administration into a broader Middle East unit and merging a unit focusing on Korea with a broader East Asia-Pacific unit, the official said.

Burns said the CIA also was creating a position for a Chief Technology Officer as well as a new office called the Transnational and Technology Mission Center. This unit, the senior official said, would enable the agency to focus more tightly on issues such as global health, climate change, humanitarian disasters and disruption caused by new technologies.

The agency will also create a program under which it would encourage qualified employees to serve as “technology fellows” for a year or two in private industry.

The senior official said the agency had also set up an “incident cell” to oversee responses to the mysterious illness known as “Havana Syndrome” which has affected numerous diplomats and CIA employees, some of whom have been “diagnosed with real harm.”

(Reporting By Mark Hosenball; editing by Mary Milliken and Richard Pullin)

Exclusive-Cash airlifts planned to bypass Taliban and help Afghans – sources

By Robin Emmott, John O’Donnell and Jonathan Landay

BRUSSELS/FRANKFURT/WASHINGTON (Reuters) – As desperate Afghans resort to selling their belongings to buy food, international officials are preparing to fly in cash for the needy while avoiding financing the Taliban government, according to people familiar with the confidential plans.

Planning for the cash airlifts is going ahead against the background of a rapidly collapsing economy where money is short, although diplomats are still debating whether Western powers can demand that the Taliban make concessions in return, according to internal policy documents seen by Reuters.

The emergency funding, aimed at averting a humanitarian crisis in the face of drought and political upheaval, could see U.S. dollar bills flown into Kabul for distribution via banks in payments of less than $200 directly to the poor – with the Taliban’s blessing but without their involvement.

As well as flying in cash to stem the immediate crisis, donor countries want to set up a “humanitarian-plus” trust fund that would pay salaries and keep schools and hospitals open, two senior officials said.

Many Afghans have started selling their possessions to pay for ever scarcer food. The departure of U.S.-led forces and many international donors robbed the country of grants that financed 75% of public spending, according to the World Bank.

The West’s unorthodox strategy reflects the dilemma it faces. Still eager to help Afghanistan after two decades of war, and to prevent mass migration, it is also loathe to give money to the Taliban, who seized power in August and have yet to show significant change from the harsh way they ruled the country between 1996-2001.

CASH DROPS

The United Nations has warned that 14 million Afghans face hunger. Mary-Ellen McGroarty, U.N. World Food Program Afghanistan director, said the economy could collapse in the face of the cash crisis.

“Many parents are foregoing food so that their children can eat,” she has said.

In recent days, Western diplomats and officials have stepped up efforts to establish a cash lifeline.

The United Nations World Food Program has distributed about 10 million Afghanis ($110,000) in cash via a local bank and intends to disburse more soon, said one person with knowledge of the situation.

The cash runs are a trial for larger air deliveries of dollars from Pakistan, the person said.

A senior diplomat said two approaches are under consideration that would inject cash into the Afghan economy. Both are in the planning stages.

Under the first plan, the World Food Program would fly in cash and distribute it directly to people to buy food, expanding on something the agency already has been doing on a smaller scale.

The second approach would see cash flown in to be held by banks on behalf of the United Nations. That would be used to pay salaries to the staff of U.N. agencies and non-governmental organizations, the diplomat said.

A third person said U.N. officials had talked with Afghan banks about opening up cash distribution channels.

“If the country collapses, we will all pay the consequences,” said a senior European Union official. “No one wants to rush into a recognition of the Taliban, but we need to deal with them. The question is not if … but how.”

A spokesperson for the World Food Program said it had helped almost 4 million people in September, nearly triple the August number, chiefly with food, and some cash assistance had been given out in Kabul. The spokesperson said the cash shortage was also affecting the millers and truckers it worked with.

NINE-BILLION-DOLLAR LEVERAGE

Separately, the European Union, Britain and the United States have discussed setting up an international trust fund to bypass the Afghan government and help finance local services, according to two officials with knowledge of the matter.

The Taliban did not immediately respond to requests for comment on the cash airlift plans.

A U.S. Treasury spokesperson said it would allow humanitarian assistance through independent international and non-governmental organizations while “denying assets” to the Taliban and sanctioning its leaders.

The Kabul government has little to fall back on. The central bank, with assets of $9 billion frozen offshore, has burnt through much of its reserves at home.

Shah Mehrabi, an official who helped oversee the bank before the Taliban took over and is still in his post, recently appealed for a release of the overseas reserves.

“If reserves remain frozen, Afghan importers will not be able to pay for their shipments, banks will start to collapse, food will be become scarce,” he said.

But there is also a debate about whether strings should be attached to cash releases.

In a paper written last month and seen by Reuters, French and German officials outline their aim of using money as a “lever” to pressure the Taliban.

“Countries could condition recognition of the political … legitimacy of the Taliban to the commitments they would be ready to take,” officials said in the two-page report.

“Economic and trade levers are among the strongest we have,” the note said, raising the prospect of releasing the Afghan reserves held abroad.

In a separate diplomatic note, French and German officials outline five demands that could be made of the Taliban.

Those include allowing Afghans who want to leave the country to do so, “breaking ties with … terrorist organizations,” allowing access to humanitarian aid, respect for human rights and establishing an “inclusive government.”

(Additional reporting by Stephanie Nebehay, Michelle Nichols and Rupam Jain; Writing by John O’Donnell; Editing by Giles Elgood)

U.S. to invest another $1 billion in rapid COVID-19 tests

By Carl O’Donnell and Alexandra Alper

(Reuters) -The U.S. government is committing to purchase an additional 180 million rapid COVID-19 tests for $1 billion, adding to the $2 billion test buying plan it announced in September, a top U.S. health official said on Wednesday.

The combined purchases will help quadruple the United States’ test output by December to around 200 million tests per month, Jeff Zients, the White House coronavirus response coordinator, said during a press call.

“We’ll continue to pull every lever to expand manufacturing production of tests which will have the impact of driving down the cost per test and making sure that tests are widely available and convenient,” Zients said.

The government will also double the number of pharmacies it partners with to provide free COVID-19 tests to 20,000 pharmacies, Zients added.

Surging demand for COVID-19 tests from U.S. employers has exacerbated a nationwide shortage of rapid tests in recent weeks and is driving up costs for state and local testing programs.

The White House in September said it plans to mandate weekly testing for unvaccinated staff at businesses with more than 100 employees.

The U.S. government agreed in September to purchase $2 billion worth of rapid COVID-19 tests from Abbott Laboratories and Celltrion Inc to ship to nursing homes and other high risk populations as part of President Joe Biden’s plans to increase vaccinations and tests.

The U.S. government also has agreements to purchase tests from other manufacturers, including Quidel Corp., OraSure Technologies, and Intrivo.

Earlier this week, U.S. regulators authorized another rapid test from Acon Technologies that can be taken at home. Zients said the test will retail for around $10 per test.

The average number of daily U.S. coronavirus cases dropped by 12% over the last seven days to nearly 98,000, and hospitalizations dropped 14% to 7,400, said U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky said during the briefing.

She cautioned that deaths remained constant at 1,400 per day.

(Reporting by Carl O’Donnell; Editing by Leslie Adler and Aurora Ellis)

Lebanese PM says he signs bill lifting immunity in Beirut blast case -Sky News Arabia

Cairo (Reuters) -Lebanese Prime Minister Najib Mikati said in a Sky News Arabia interview on Wednesday he had signed a bill that lifts immunity on “everyone” who might have borne responsibility for the Beirut port blast, saying they must be held accountable.

The disastrous Aug. 4, 2020 explosion left more than 200 people dead and devastated swathes of the Lebanese capital.

Mikati added in the interview that Lebanon’s constitution stipulated that senior government officials must be tried in front of a special tribunal.

The investigation into the explosion, one of the biggest non-nuclear blasts in history, has made little headway amid a smear campaign against investigation Judge Tarek Bitar and pushback from powerful Lebanese factions.

He said the government will extend help to the families of the blast’s victims, adding that a plan has been formulated to reconstruct the port, a vital lifeline to the country’s economy.

Many in Lebanon, particularly families of the victims of the blast, are furious that no senior official has been held accountable more than a year later.

Bitar’s efforts to question former and serving state officials – including the prime minister at the time of the blast, ex-ministers and senior security officials on suspicion of negligence – have been repeatedly denied.

(Reporting by Lilian Wagdy; Editing by Mark Heinrich)

WHO backs rollout of malaria vaccine for African children

By Maggie Fick and Aaron Ross

NAIROBI (Reuters) -The World Health Organization (WHO) said on Wednesday the only approved vaccine against malaria should be widely given to African children, potentially marking a major advance against a disease that kills hundreds of thousands of people annually.

The WHO recommendation is for RTS,S – or Mosquirix – a vaccine developed by British drugmaker GlaxoSmithKline.

Since 2019, 2.3 million doses of Mosquirix have been administered to infants in Ghana, Kenya and Malawi in a large-scale pilot program coordinated by the WHO. The majority of those whom the disease kills are aged under five.

That program followed a decade of clinical trials in seven African countries.

“This is a vaccine developed in Africa by African scientists and we’re very proud,” said WHO director-general Tedros Adhanom Ghebreyesus.

“Using this vaccine in addition to existing tools to prevent malaria could save tens of thousands of young lives each year,” he added, referring to anti-malaria measures like bed nets and spraying.

Malaria is far more deadly than COVID-19 in Africa. It killed 386,000 Africans in 2019, according to a WHO estimate, compared with 212,000 confirmed deaths from COVID-19 in the past 18 months.

The WHO says 94% of malaria cases and deaths occur in Africa, a continent of 1.3 billion people. The preventable disease is caused by parasites transmitted to people by the bites of infected mosquitoes; symptoms include fever, vomiting and fatigue.

The vaccine’s effectiveness at preventing severe cases of malaria in children is only around 30%, but it is the only approved vaccine. The European Union’s drugs regulator approved it in 2015, saying its benefits outweighed the risks.

“This is how we fight malaria, layering imperfect tools on top of each other,” said Ashley Birkett, who leads global malaria vaccine work at Path, a non-profit global health organization that has funded the development of the vaccine with GSK and the three-country pilot.

Another vaccine against malaria, developed by scientists at Britain’s University of Oxford and called R21/Matrix-M, showed up to 77% efficacy in a year-long study involving 450 children in Burkina Faso, researchers said in April, but it is still in the trial stages.

GSK also welcomed the WHO recommendation.

“This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled,” Thomas Breuer, Chief Global Health Officer, said in a statement.

GSK shares held steady in New York following the announcement, which came after the close of trading in its London-listed shares.

FUNDING CHALLENGE

The recommendation was jointly announced in Geneva by the WHO’s top advisory bodies for malaria and immunization, the Malaria Policy Advisory Group and the Strategic Advisory Group of Experts on Immunization.

Experts said the challenge now would be mobilizing financing for production and distribution of the vaccine to some of the world’s poorest countries.

GSK has to date committed to produce 15 million doses of Mosquirix annually, in addition to the 10 million doses donated to the WHO pilot programs, up to 2028 at a cost of production plus no more than 5% margin.

A global market study led by the WHO this year projected demand for a malaria vaccine would be 50 to 110 million doses per year by 2030 if it is deployed in areas with moderate to high transmission of the disease.

The GAVI vaccine alliance, a global public-private partnership, will consider in December whether and how to finance the vaccination program.

“As we’ve seen from the COVID vaccine, where there is political will, there is funding available to ensure that vaccines are scaled to the level they are needed,” said Kate O’Brien, Director of WHO’s Department of Immunization, Vaccines and Biologicals.

A source familiar with planning for the vaccine’s development said the price per dose was not yet set, but would be confirmed after GAVI’s funding decision and once there is a clear sense of demand for the vaccine.

The WHO’s decision had personal meaning for Dr. Rose Jalong’o, a vaccinology specialist at the Kenyan health ministry.

“I suffered from malaria as a child and during my internship, and during my clinical years I attended to children in hospital because of severe malaria who needed blood transfusion and unfortunately some of them died.”

“It’s a disease I have grown up with and, seeing all this in my lifetime, it’s an exciting time.”

(Reporting by Maggie Fick in Nairobi and Aaron Ross in Dakar; Editing by Katharine Houreld, Mark Potter and Emelia Sithole-Matarise)

Shooting suspect in custody after fight at Texas school injures four

By Peter Szekely

(Reuters) -Authorities arrested an 18-year-old male in connection with a Texas high school shooting that left four people injured after a fight broke out in a classroom on Wednesday morning, police said.

The suspect, who fled the Timberview High School in Arlington, after the shooting, was taken into custody after a brief manhunt and will be charged with three counts of aggravated assault with a deadly weapon, police said.

At least two of the four injured people, one of whom did not require hospitalization, suffered gunshot wounds, police said. One of the victims remains in critical condition.

“What we believe happened, preliminarily, is that there was a fight between a student and another individual in a class and a gun was used, and there are four victims,” Arlington Assistant Police Chief Kevin Kolbye told reporters

The incident, first reported at about 9:15 a.m. local time, on the second floor of the school, prompted a lockdown and a massive police response to secure the building before students were placed on buses and taken off the campus.

The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives said its agents were also on the scene.

Timberview is part of Mansfield Independent School District, a large district in the Dallas-Fort Worth metropolitan area comprised of 49 schools serving more than 35,000 students.

Kolbye said two officers from the Mansfield Police Department were based in the school and immediately responded.

So far this year, there have been at least 101 incidents involving gunfire on U.S. school grounds, resulting in 21 deaths and 56 injuries, according to Everytown for Gun Safety, a gun violence prevention organization.

The group recorded at least 96 such incidents, resulting in 23 deaths and 43 injuries, in 2020.

(Reporting by Peter Szekely and Maria Caspani in New York and Rich McKay in Atlanta; Additional reporting by Colleen Jenkins in Winston-Salem, North Carolina; Editing by David Gregorio and Lisa Shumaker)

Wandering dog is Istanbul commuters’ best friend

ISTANBUL (Reuters) – In a packed Istanbul passenger ferry between Europe and Asia, all eyes turn to one commuter enjoying the view from his window.

Boji, a street dog, has become a regular sight on ferries, buses and metro trains in Europe’s largest city. A devoted commuter, the dog enjoys long journeys on public transport, up to 30 kilometers (20 miles) on a regular week day.

Istanbul municipality officials who record the dog’s trips with a microchip say he drops by at least 29 metro stations a day and was even tracked at sea, taking a weekend break to the Princes’ Islands off the city’s coast.

With golden-brown fur, dark eyes and floppy ears, Boji started to draw attention two months ago.

“We noticed a dog using our metros and trains and he knows where to go. He knows where to get out,” said Aylin Erol, from Metro Istanbul. “It’s like he has a purpose.”

Data collected from his tracking device shows historic tram lines are Boji’s favorite but he is also a frequent subway commuter. Erol says the dog respects public transport rules and waits for disembarking passengers before hopping on the train.

He enjoys travelling on the middle part of a subway carriage, or boji in Turkish – hence the name which officials gave him.

Erol says he brought color into the lives of 1.3 million commuters of the metropolis. Istanbulites post pictures of him on social media, and his own accounts have more than 50,000 followers.

“You take the train and, suddenly, you see Boji. And look at him. He lies, just like this. You just smile and catch the moment, really. This is what Boji evokes for Istanbulites. He also reminds us that we can still enjoy Istanbul as we rush about.”

(Reporting by Yesim Dikmen; Editing by Gareth Jones)

U.S. to tell critical rail, air companies to report hacks, name cyber chiefs

By Christopher Bing

(Reuters) -The Transportation Security Administration will introduce new regulations that compel the most important U.S. railroad and airport operators to improve their cybersecurity procedures, Homeland Security Secretary Alejandro Mayorkas said on Wednesday.

The upcoming changes will make it mandatory for “higher-risk” rail transit companies and “critical” U.S. airport and aircraft operators to do three things: name a chief cyber official, disclose hacks to the government and draft recovery plans for if an attack were to occur.

The planned regulations come after cybercriminals attacked a major U.S. pipeline operator, causing localized gas shortages along the U.S. East Coast in May. The incident led to new cybersecurity rules for pipeline owners in July.

“Whether by air, land, or sea, our transportation systems are of utmost strategic importance to our national and economic security,” Mayorkas said. “The last year and a half has powerfully demonstrated what’s at stake.”

A key concern motivating the new policies comes from a growth in ransomware attacks against critical infrastructure companies.

“It’s the first of its kind with respect to the cyber focus,” said a senior homeland security official, who declined to be named, about the railway security directive and an update to aviation security programs.

Ransomware, a type of malware variant that encrypts a victimized system until the owner pays a ransom in the form of cryptocurrency to the hacker, has become increasingly common in recent years.

“If transportation does not work, if people can’t go from A to B, then it can create pressure pretty quickly [to pay the ransom],” said the senior official.

The announcement also follows reports in June of a Chinese hacking group infiltrating New York City’s Metropolitan Transportation Authority and an August 2020 ransomware attack https://www.inquirer.com/transportation/septa-malware-attack-employees-riders-app-announcements-20200824.html against the Southeastern Pennsylvania Transportation Authority, causing a disruption to services.

The Homeland Security Department helped investigate the MTA incident alongside other federal agencies, including the FBI.

Last month, the TSA notified the private sector about the impending regulations, said the senior official, and the agency is currently receiving feedback.

The regulations will become active before the end of 2021.

(Reporting by Christopher Bing; editing by Diane Craft)

COVID infections dropping throughout the Americas, says health agency

BRASILIA (Reuters) – The number of new COVID-19 infections has been dropping over the past month throughout the Americas, even though only 37% of the people in Latin America and the Caribbean have been fully vaccinated, the Pan American Health Organization (PAHO) said on Wednesday.

However, Alaska has the most serious outbreak in the United States today that is overwhelming emergency rooms, and while South America is continuing to see a drop in infections, Chile has seen a jump in cases in the capital Santiago and port cities Coquimbo and Antofagasta.

PAHO has closed vaccine supply agreements with Sinovac Biotech Inc and AstraZeneca Plc for delivery this year and next and with China’s Sinopharm for 2022, the agency’s director Carissa Etienne told reporters.

(Reporting by Anthony Boadle)