Author Archives: Reuters News Agency

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

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.

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.

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.

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.

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)

In Kabul children’s hospital, medics struggle with staff shortages

By Gibran Naiyyar Peshimam

KABUL (Reuters) – In Kabul’s main children’s hospital, the crumbling of Afghanistan’s health system is reflected in the eyes of exhausted staff as they eke out fast-diminishing stocks of medicines.

As crowds of mothers and sick children fill waiting rooms in the Indira Gandhi Children’s Hospital, medical staff are squeezing three babies into a single incubator and doubling them up in cot-like infant warmer beds.

Nurses who once took care of three or four babies each are now having to look after 20 or more to make up for the absence of staff who fled the country when the Taliban seized power in August.

“We tell each other that we have do this work, if we don’t do it, these problems will become big, it’s a loss for ourselves, our society and for our country,” said Dr. Saifullah Abassin as he moved from bed to bed in the crowded intensive care unit.

Although the number of blast victims and war wounded have fallen since the fighting ended, Afghanistan’s hospitals are grappling with the fallout of a rapidly spreading economic crisis that has threatened millions with hunger.

U.N. agencies say as much as 95% of the population does not regularly have enough to eat and last month, the head of the World Health Organization warned the health system was on the brink of collapse as international aid has dried up.

Lack of support for the $600 million Sehatmandi health service project administered by World Bank, has left thousands of facilities unable to buy supplies and pay salaries, threatening health services at all levels from village clinics to hospitals offering caesarian sections.

STAFF NOT PAID IN MONTHS

For the medical team, it is the acute staff shortage that is causing the heaviest strain. They have not been paid in months and often struggle even to pay their car fare to work.

“We only ask from the government firstly that, they should increase our staff,” says Marwa, the nursing supervisor in the nursery ward. “Because of the changes, most of our colleagues left the country.”

Nurses who would normally be taking care of three or four babies for each nurse are now handling 23. “It is a lot of load on us,” she said.

Mohammad Latif Baher, assistant director of the Indira Gandhi Children’s Hospital, said officials from the U.N. children’s agency UNICEF have given some help but more is needed quickly to fill the shortage of medicines and supplies to treat malnourished children.

“They (international organizations) have promised more aid. And we hope that they will keep their promises,” Baher says.

The hospital, built during the Soviet era in 1985 and financed by Indian aid money, has 360 beds but is operating well over capacity because of the lack of functioning clinics in the provinces around Kabul.

With a heavy flow of families coming in, the hospital has admitted 450 children and turned others away, he said.

Arzoo, who brought her eight-month-old daughter Sofia in for treatment, already lost one of her five children to malnourishment-related illness and is desperate not to lose another.

“We had a water tank at home – we sold that and used that for treatment,” she said, even though the cost means Sofia’s four siblings at home do not have much to eat.

“Their father came in the morning and told me the kids don’t have anything. When they (hospital) provide some food, I portion it out and send some home to the kids.”

(Reporting by Gibran Peshimam, Editing by William Maclean)

New York City police union files lawsuit to block vaccine mandate

By Kanishka Singh

(Reuters) – New York City’s police union filed a lawsuit on Monday against a vaccine mandate for municipal workers ordered last week by Mayor Bill de Blasio.

The mayor on Wednesday ordered all city employees to show proof of inoculation against COVID-19 or be placed on unpaid leave, drawing the union’s ire.

The Police Benevolent Association of the City of New York said on Twitter that it had filed a suit in the state Supreme Court. It asked the court for a temporary restraining order to halt the mandate while the suit remains pending.

The union added on Twitter that there was “still no written, NYPD-specific policy guidance on how the mandate will be implemented.”

The mayor set a deadline of 5 p.m. this coming Friday for employees to show proof of inoculation to a supervisor. Over 70% of all 160,000 New York City workers, including a similar percentage in the police department, have already received at least one dose, the mayor said.

Patrick Lynch, president of the Police Benevolent Association representing the city’s 50,000 active and retired officers, said they should have the opportunity to choose whether to get the vaccine.

De Blasio cited overtime and redeployments as contingency plans should a large contingent of those officers and other unvaccinated city workers refuse to comply with the mandate.

Municipalities, school districts and other jurisdictions throughout the country are grappling with masking and vaccination requirements. The number of new COVID-19 cases has steadily declined in the United States since a surge caused by the Delta variant of the virus during the summer.

De Blasio had said employees will no longer have the option to be regularly tested instead of getting the vaccine, but added the city will still grant medical and religious exemptions.

(Reporting by Kanishka Singh in Bengaluru; Editing by Howard Goller)

Cuba-U.S. tensions mount over pending protests on Communist-run island

HAVANA (Reuters) – Cuban President Miguel Diaz-Canel warned the U.S. embassy in Havana against fomenting protests by dissidents on the Communist-run island, the latest flashpoint between the longtime rivals ahead of fresh rallies slated for Nov. 15.

Cuba has said the planned demonstrations – scheduled for the same day the Caribbean island will reopen its borders to tourism – are illegal and blames the United States for underwriting them. The United States has threatened Cuba with further sanctions should the government jail protesters.

In a speech to Communist party stalwarts late on Sunday, Diaz-Canel doubled down on allegations of U.S. subterfuge, accusing the U.S. embassy of playing a role in fanning protests.

“Their embassy in Cuba has been taking an active role in efforts to subvert the internal order of our country,” Diaz-Canel said. “U.S. diplomatic officials meet frequently with leaders of the counterrevolution, to whom they provide guidance, encouragement, and logistical and financial support.”

The embassy could not immediately be reached for comment.

The U.S. diplomatic headquarters in Havana has operated with a skeleton crew since 2017, after employees fell ill with what is now known as ‘Havana Syndrome.’

Scaled-back operations have hobbled diplomacy between the two Cold War foes and have forced Cubans seeking consular services from the embassy to travel to Guyana instead.

Diaz-Canel said the embassy was nonetheless leveraging social media communications to criticize Cuba in “open interference in the internal affairs of our country.”

The embassy in recent weeks has highlighted on social media the cases of several Cubans detained and jailed following the biggest anti-government demonstrations in decades on July 11. The posts on Twitter call in Spanish for the release of dissidents and use the hashtag “#Presosporque,” or “Why are they prisoners?”

Cuban authorities said those arrested in July were guilty of crimes including public disorder, resisting arrest, and vandalism.

Juan Gonzalez, a top adviser on Latin America to U.S. President Joe Biden, told news agency EFE last week that the United States would respond if protesters were again jailed in November.

“Those individuals who are involved in violating the fundamental and universal rights of the Cuban people… we have made it very clear that we have every intention of responding,” Gonzalez said.

The outcome of the showdown between the Cuban government and increasingly bold dissidents will likely dictate the Biden administration’s policy towards the island nation going forward, said William LeoGrande, a professor of government at American University in Washington.

The Biden administration’s “hostile rhetoric and support for dissidents has led the Cuban government to give up on any hope of better relations with Washington,” LeoGrande said. “Ironically, that gives the Cuban government no incentive to treat the upcoming march or its organizers with tolerance.”

(Reporting by Marc Frank and Dave Sherwood, Editing by Rosalba O’Brien)

Factbox – Latest on the worldwide spread of the coronavirus

(Reuters) – Moderna Inc said on Monday its COVID-19 vaccine generated a strong immune response in children aged six to 11 years and that it plans to submit the data to global regulators soon.

EUROPE

* The European Union’s drug regulator said it has concluded in its review that Moderna’s COVID-19 booster vaccine may be given to people aged 18 years and above, at least six months after the second dose.

** Russia reported a record high number of daily COVID-19 cases and some central European countries imposed fresh restrictions on Monday, as a new wave of the pandemic gathered pace.

* Spain reached the grim milestone of 5 million COVID-19 cases during the pandemic.

* The Dutch government may impose new coronavirus restrictions to reduce pressure on hospitals struggling to deal with a swelling number of COVID-19 patients.

AMERICAS

* U.S. President Joe Biden on Monday signed an order imposing new vaccine requirements for most foreign national air travelers and lifting severe travel restrictions on China, India and much of Europe effective Nov. 8.

* The Biden administration said it will invest $70 million to boost the availability and lower costs of rapid, over-the-counter COVID-19 tests in the United States.

* Venezuela reopened public schools and universities which serve more than 11 million students, though some schools remained closed for repairs or because of lack of staff.

ASIA-PACIFIC

* China’s latest COVID-19 outbreak is increasingly likely to spread further, a health official said on Sunday, as authorities urged all regions to step up monitoring and called for a reduction in travel across provinces.

* Competitors in the Beijing 2022 Winter Olympics will be subject to daily tests for COVID-19 and will be required to remain in a closed loop that includes transport between the various games venues.

* Indonesia is “finalizing” a deal with Merck & Co to procure its experimental antiviral pills to treat COVID-19 ailments.

MIDDLE EAST AND AFRICA

* South Africa’s Aspen Pharmacare is aiming to ramp up its COVID-19 vaccine manufacturing capacity to 1.3 billion doses a year by February 2024, up from a current annual output of around 250 million doses, the company’s CEO told Reuters.

* Namibia will suspend its rollout of Russia’s Sputnik V COVID-19 vaccine, days after the drugs regulator in neighboring South Africa flagged concerns about its safety for people at risk of HIV.

MEDICAL DEVELOPMENTS

* Scientists at the U.S. Food and Drug Administration said the likely benefits of giving the Pfizer/BioNTech COVID-19 vaccine to 5 to 11 year old’s clearly outweigh the risks of rare cases of heart inflammation.

* COVID-19 patients who require surgery appear to face fewer complications if they have previously been vaccinated against the flu, new data suggest.

* U.S. drugmaker Merck & Co Inc said the European Union’s drug regulator has initiated a real-time review of its experimental COVID-19 antiviral drug for adults.

ECONOMIC IMPACT

* Global equity markets rose, while U.S. Treasury yields dipped as investors were buoyed by a better-than-expected U.S. corporate earnings season that kicks into gear this week.

* The European Union disbursed 600 million euros ($698 million) to Ukraine, the second tranche of an aid program to help its eastern European neighbor through the economic shock of the pandemic.

(Compiled by Aditya Soni and Uttaresh. V; Editing by Anil D’Silva and Arun Koyyur)

Hurricane Rick loses steam as it moves further inland Mexico

MEXICO CITY (Reuters) -Hurricane Rick’s strong winds lost some steam as the storm moved further inland on Monday, though its heavy rains still had the potential to trigger flash flooding and mudslides, the U.S. National Hurricane Center (NHC) and local authorities said.

Rick was packing maximum sustained winds of 80 miles per hour (130 km/h), down from 105 mph, and was some 40 miles (65 kilometers) north of the port of Lazaro Cardenas in Michoacán state as of 10:00 A.M. local time (1500 GMT), the Miami-based NHC said in a public advisory.

The storm came ashore on Mexico’s Pacific coast earlier in the day.

“Rapid weakening is expected today while Rick continues to move over land, and Rick is forecast to dissipate over the mountainous terrain of southern Mexico tonight or Tuesday,” the NHC said.

Rick is forecast to move farther inland over southern Mexico throughout Monday and possibly into Tuesday, and is expected to produce 5 to 10 inches of rain, with isolated storm total amounts of 20 inches across parts of the Mexican states of Guerrero and Michoacán through Tuesday.

The heavy rains “will likely produce flash flooding and mudslides,” the NHC said.

The heavy rains may trigger landslides, raise the water levels of rivers and streams, and cause flooding in low-lying areas, Mexico’s National Water Commission, CONAGUA, said in a statement.

CONAGUA urged residents in the southern parts of those states to heed the civil protection agency warning to stay indoors as of Sunday evening.

Guerrero’s education ministry said classes in the coastal area would be suspended on Monday, warning of intense rain, strong gusts of wind and high waves in the Costa Grande region.

Officials in Guerrero and Michoacán as well as the coastal states of Colima, Jalisco and Nayarit were opening shelters in areas expected to get downpours, a government official told Televisa News.

(Reporting by Anthony Esposito; editing by Barbara Lewis and Chizu Nomiyama)

Poland’s push-back policy leaves migrants facing an uncertain future as winter looms

By Joanna Plucinska and Kacper Pempel

Near SIEMIANOWKA, Poland (Reuters) – Somali migrant Abdi Fitah’s bid to cross into Poland from Belarus ended with him barefoot and freezing after he lost his shoes in a river and wandered for days in the woods along the border.

The 23-year-old is one of thousands of people, including children, from the Middle East, Africa and Afghanistan who have tried to enter Poland from Belarus in recent weeks, with charities saying they face harrowing conditions on the border.

Jakub Sieczko, a medical doctor and coordinator of the Medycy na Granicy (Medics on the Border) aid group, said he feared there would be more deaths as temperatures drop.

“There are more and more people who are hungry and dehydrated…The conditions are getting worse,” Sieczko told Reuters, adding that many migrants are from warm countries and unprepared for the cold.

Ibrahim, who said he left Somalia 15 days ago, thought he was having a heart attack while walking through the woods with a group of fellow migrants, before receiving medical help for hypothermia at the border.

“The conditions are very cold, (we’re) not wearing shoes,” he said, explaining how he lost his shoes in the river. “The leg is a big problem. I’m not wearing (enough) clothes…(or) shoes.”

He crossed the border with six other Somalis. Three of them ended up in an ambulance due to their health problems, which included a sprained ankle and symptoms of hypothermia.

Four were driven off in a border guard truck. It’s unclear if they went to a detention center or were pushed back to the border.

The United Nations High Commissioner for Refugees (UNHCR) has said Poland is in breach of international law in its efforts to force migrants back into Belarus instead of offering them asylum.

Poland says it is respecting its international obligations while trying to stem the flow of migrants who, it says, often do not want asylum in Poland but rather in western Europe.

The European Union accuses Belarus of orchestrating the flow to put pressure on the bloc in retaliation for sanctions slapped on Minsk over human rights abuses.

MORE AND MORE MIGRANTS

Polish authorities say more than 15,000 attempts to cross the border have been made since early August, mostly by Iraqi, Afghan and Syrian nationals. The attempts have become more frequent and now exceed 500 a day.

Under EU rules, migrants should in principle apply for asylum in the first country they enter, but the bloc is planning reforms to ensure asylum obligations are more evenly spread.

Franek Sterczewski, a Polish parliamentary deputy with leading opposition group Civic Coalition, said more migrants were being turned back by border guards into the woods.

“(The Somali migrants) were sent back to the border seven times,” he said. “They’ve been wandering the forest for weeks, the temperature at night is around zero degrees, it’s raining and it’s very cold. Pushing them back will put their health and life at risk.”

(Reporting by Joanna Plucinska and Kacper Pempel; Writing by Michael Kahn; Editing by Mike Harrison)

Biden signs order imposing new international travel vaccine rules, lifting restrictions

By David Shepardson

WASHINGTON (Reuters) -U.S. President Joe Biden on Monday signed an order imposing new vaccine requirements for most foreign national air travelers and lifting severe travel restrictions on China, India and much of Europe effective Nov. 8, the White House said.

The extraordinary U.S. travel restrictions were first imposed in early 2020 to address the spread of COVID-19. The rules bar most non-U.S. citizens who within the last 14 days have been in the United Kingdom, the 26 Schengen countries in Europe without border controls, Ireland, China, India, South Africa, Iran and Brazil.

“It is in the interests of the United States to move away from the country-by-country restrictions previously applied during the COVID-19 pandemic and to adopt an air travel policy that relies primarily on vaccination to advance the safe resumption of international air travel to the United States,” Biden’s proclamation says.

The White House confirmed that children under 18 are exempt from the new vaccine requirements as are people with some medical issues. Non-tourist travelers from about 50 countries with nationwide vaccination rates of less than 10% will also be eligible for exemption from the rules. Those receiving an exemption will generally need to be vaccinated if they intend to remain in the United States for more than 60 days.

The White House first disclosed on Sept. 20 it would remove restrictions in early November for fully vaccinated air travelers from 33 countries.

The Biden administration also detailed requirements airlines must follow to confirm foreign travelers have been vaccinated before boarding U.S.-bound flights.

One concern among U.S. officials and airlines is making sure foreign travelers are aware of the new vaccine rules that will take effect in just two weeks.

The U.S. Centers for Disease Control and Prevention (CDC) is issuing on Monday new contact tracing rules requiring airlines to collect information from international air passengers as needed “to follow up with travelers who have been exposed to COVID-19 variants or other pathogens.”

The CDC said this month it would accept any vaccine authorized for use by U.S. regulators or the World Health Organization and will accept mixed-dose coronavirus vaccines from travelers.

Foreign air travelers will need to provide vaccination documentation from an “official source” and airlines must confirm the last dose was at least two weeks earlier than the travel date.

International air travelers will need to provide proof of a negative COVID-19 test taken within 72 hours of departure. The White House said unvaccinated Americans and foreign nationals receiving exemptions will need to provide proof of a negative COVID-19 test within 24 hours of departing.

(Reporting by David Shepardson; Editing by Simon Cameron-Moore and Chizu Nomiyama)

Russia close to using natural gas as weapon in Europe’s gas crunch – Biden energy adviser

By Timothy Gardner

WASHINGTON (Reuters) -U.S. President Joe Biden’s global energy security adviser said on Monday that Russian President Vladimir Putin is getting close to using natural gas as a political tool if Russia is holding back fuel exports to Europe as it suffers an energy crunch.

“I think we are getting close to that line if Russia indeed has the gas to supply and it chooses not to, and it will only do so if Europe accedes to other demands that are completely unrelated,” Amos Hochstein, Biden’s adviser, told reporters, when asked if Putin was using gas as a weapon.

Hochstein said gas prices in Europe have been driven higher not just by events in the region but also by a dry season in China that has reduced energy output from hydropower and increased global competition for natural gas.

Still, while several factors have led to the European gas crisis, Russia is best placed to come to the aid of Europe, he said.

“There is no doubt in my mind, and the (International Energy Agency) has itself validated, that the only supplier that can really make a big difference for European energy security at the moment for this winter is Russia,” Hochstein said. Russia can increase upstream production of gas, and should do it quickly through existing pipelines, he said.

Putin has rejected suggestions that Moscow was squeezing supplies for political motives, saying it will increase flow as much as partners ask.

Putin has blamed record high prices on the EU’s energy policy and said Russia can boost supplies to Europe once its Nord Stream 2 gas pipeline gets approved.

Yuriy Vitrenko, the head of Ukraine’s state energy company Naftogaz, this month said Russia was trying to blackmail Europe into certifying its Nord Stream 2 gas pipeline by keeping fuel supplies low. The pipeline, which Washington opposes because it would circumvent Ukraine, is finished but needs approvals from Germany to start delivering Russian gas under the Baltic Sea to Europe.

Approvals from Germany and the European Commission for Nord Stream 2 will likely take until March, so if Russia says it can quickly boost gas flow through Nord Stream 2, it should be able to do so now through existing pipelines, Hochstein said.

“You can’t have it both ways,” Hochstein said

(Reporting by Timothy Gardner; Editing by Mark Porter)

Thousands stranded as Afghan-Pakistan border crossing stays closed

QUETTA, Pakistan (Reuters) – Hundreds of trucks and other vehicles waited at one of the main crossings between Pakistan and Afghanistan on Monday as the border closed again after a brief opening the day before, despite promises that it would reopen, traders said.

The Chaman border crossing, the second-largest commercial border point between the two countries after Torkham in Khyber Pakhtunkhwa, links with Spin Boldak in the Afghan province of Kandahar, and is regularly used by thousands of laborers and traders from both countries.

The crossing, a vital source of customs revenue for the cash-strapped government in Afghanistan, has been closed for about three weeks, despite repeated protests by truckers and others stuck waiting at the border.

“We also have a life. We have children and we need money,” said truck driver Turyalai.

As Afghanistan sinks deeper into economic crisis, neighboring countries have been increasingly worried about a mass movement of refugees.

But the closure of Chaman and interruptions to traffic at Torkham as well as the suspension of Pakistan Airlines flights from Kabul have left Afghanistan largely cut off.

Originally closed by Pakistani authorities due to security threats, disputes over issues ranging from COVID-19 to the validity of Afghan travel documents have prevented the re-opening of the Chaman crossing, despite severe hardship to truckers and local farmers.

The border was briefly opened on Sunday to let people with urgent medical needs into Pakistan, which has a much more developed health system than Afghanistan. But it was quickly closed again, leaving many stranded.

“Many people, some of them sick, were left here,” said Mohammad Younus, from the southern Afghan province of Helmand, who was trying to return home from Quetta in Pakistan when the border was sealed.

He said security forces had dispersed waiting crowds with baton charges and it was unclear when the border would re-open.

“Some people are saying the border will open (again), others are saying it will not,” he said.

(Reporting by Gul Yousafzai; writing by James Mackenzie; editing by Nick Macfie)