In this photo dated April 22, 2021, a pharmacist reconstitutes the Pfizer-BioNTech COVID-19 vaccine in Worcester, Massachusetts. (JOSEPH PREZIOSO / AFP)
LONDON / ADDIS ABABA / BERLIN / SOFIA / KYIV / PARIS / VATICAN CITY / VIENNA - Pfizer Inc. and partner BioNTech SE said their COVID-19 vaccine was safe and produced strong antibody responses in children ages 5 to 11 in a large-scale trial, findings that could pave the way to begin vaccinating grade-school kids within months.
Pfizer and BioNTech said they plan to submit the data as part of a near-term request for an emergency-use authorization from the U.S. Food and Drug Administration, and to share it with regulators in Europe as well.
The companies said the vaccine generated an immune response in the 5-to-11 year olds in their Phase II/III clinical trial that matched what they had previously observed in 16-to-25 year olds. The safety profile was also generally comparable to the older age group, they said.
"Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination," Pfizer Chief Executive Albert Bourla said in a news release.
"These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency."
COVID-19 hospitalizations and deaths have surged in the United States in recent months due to the highly contagious Delta variant. Pediatric cases are also up, particularly as children under 12 are all unvaccinated, but there is no indication that, beyond being more transmissive, the Delta virus is more dangerous in kids.
The companies expect data on how well the vaccine works in children 2-to-5 years of age and children 6 months-to-2 years of age as soon as the fourth quarter of this year.
The number of confirmed COVID-19 cases in Africa reached 8,146,310 as of Sunday afternoon, the Africa Centers for Disease Control and Prevention (Africa CDC) said.
The Africa CDC, the specialized healthcare agency of the African Union, in its continental COVID-19 dashboard indicated that the death toll from the pandemic across the continent stands at 206,179.
Austria will require protective face masks and COVID-19 passes for the use of ski lifts this winter as it tries to attract foreign skiers for the first time in two years and also prevent coronavirus outbreaks.
The conservative-led government outlined the rules for the coming season at a news conference that underlined the importance of reviving tourism, which directly contributes about 5 percent of economic output in Austria.
The new rules stop short of requiring all skiers to be vaccinated and left many details unclear even though public frustration over confusing coronavirus rules has grown.
Skiers will have to wear face masks on enclosed ski lifts and show they have been vaccinated, tested or have recovered from COVID-19 when they book a ticket, Tourism Minister Elisabeth Koestinger said.
It remained unclear how unvaccinated people on long hotel stays would be asked to keep proving they had recently been tested.
The new measures include classifying apres-ski bars as nightclubs. What counts as an apres-ski bar will be defined locally.
Rules for nightclubs are due to tighten as intensive care units fill up. At their strictest, only patrons who have been vaccinated or have recovered from COVID-19 will be let in.
Belgium will gradually phase out support for businesses affected by the pandemic by year-end, Finance Minister Vincent Van Peteghem said on Flemish TV show De Zevende Dag.
The government hasn’t reached an agreement yet to extend any support measures beyond Sept 30.
A measure that will definitely lapse at the end of this month is the reduced VAT rate of 6 percent for bars and restaurants, Van Petegem said.
Drinks will be subject to a 21 percent VAT rate again as of Oct 1 and prepared food will be taxed at the usual 12 percent.
Bulgaria's COVID-19 death toll has risen to 20,028 after 43 more deaths were reported in the last 24 hours, official data showed on Monday.
The number of confirmed infections rose by 458 to 482,186, according to the country's COVID-19 information portal.
The number of COVID-19 hospitalizations stood at 4,750, the highest figure in four months.
According to the data, only 1,697 doses of coronavirus vaccines were administered in Bulgaria in the past 24 hours, taking the total number of doses administered to 2.46 million.
The Czech Republic started offering third doses of COVID-19 vaccines to people inoculated more than eight months ago. The country had 182 new cases on Sunday, up by 40 from a week ago and 147 hospitalizations.
Prime Minister Andrej Babis said unvaccinated younger people are being affected now, saying the country’s pandemic situation has “stabilized.”
Ethiopia registered 958 new COVID-19 cases in the past 24 hours, taking the nationwide tally to 332,961 as of Sunday evening, the country's Ministry of Health said.
Meanwhile, the ministry also reported 15 new COVID-19 induced deaths and 2,572 more recoveries, bringing the national tally to 5,130 and 300,684, respectively.
The French government's cabinet will review on Oct 13 a draft bill allowing it to extend, if necessary, the country's COVID-19 health pass requirement beyond a Nov 15 deadline, said a source close to Prime Minister Jean Castex.
The pass proves the holder has had the COVID-19 vaccine or has recently tested negative for COVID-19 or recovered from the illness in the last six months, thereby allowing the holder to enter places such as bars and restaurants and sports venues.
A fourth wave of the COVID virus, which first hit France this summer, is starting to recede but the government has nevertheless kept many COVID measures, including the health pass, in place as schools reopened three weeks ago.
Asked on Monday about the draft bill, Health Minister Olivier Veran told BFM television: "The law allows us to require the health pass until Nov 15. After that we need to have a lawthat, without forcing us to use that tool, allows us to use it if the situation requires it."
Veran also said French ministers will review the COVID-19 situation in the country at a special cabinet meeting on Sept 22, to assess "when and if there are reasons to ease some of the measures in place".
The German government was not giving a target date for lifting coronavirus-related social distancing regulations since there was no certainty about how the pandemic would develop this winter, a spokesman said on Monday.
Germany reported 3,736 new coronavirus infections on Monday and a seven-day incidence rate of 71 per 100,000 people, according to the Robert Koch Institute for infectious diseases.
Coronavirus cases worldwide surpassed 228.54 million while the global death toll topped 4.69 million, according to data compiled by Johns Hopkins University.
Italy started giving a third-dose of vaccines against COVID-19 to its most fragile citizens, the country’s Health minister Roberto Speranza said a statement on Monday.
“It’s a step forward to protect those who have a weaker immune system,” he said.
Last week, Italy’s government decided to make COVID-19 “passports” mandatory for all public and private sector workers from Oct 15. The country is boosting its vaccination campaign, said COVID-19 Emergency Czar Francesco Paolo Figliuolo.
A woman is administered a Moderna COVID-19 vaccine dose at the Gaube comprehensive primary health care center in Kuje, Nigeria on Sept 1, 2021. (GBEMIGA OLAMIKAN / AP)
Lagos, Nigeria’s commercial hub and Africa’s biggest city, plans to give COVID-19 shots to 30 percent of residents within a year, Governor Babajide Sanwo-Olu said in an emailed statement.
To be able to do so “the world must ensure that vaccines were available to all, especially poorer countries that had struggled with supply,” he said.
Lagos has vaccinated 1.2 percent of its 24 million residents, far below the recommendation set by the World Health Organization, Sanwo-Olu said.
UK Prime Minister Boris Johnson will urge US President Joe Biden to lift the travel ban and allow fully vaccinated people in the UK to fly into America directly, the Telegraph reported Sunday.
Johnson will make the case at the White House on Tuesday. The plea is one of the key items on his agenda and will come following a boost to the countries’ relationship last week after they signed a three-way defense pact with Australia.
Separately, A vaccine summit being hosted by US President Joe Biden must come up with a plan this week to transfer 100 million stockpiled COVID-19 vaccines to poorer countries before they reach their expiry date, former British Prime Minister Gordon Brown said.
Biden is due to convene a virtual COVID-19 summit on Wednesday on the margins of the UN General Assembly, aimed at boosting vaccinations worldwide with the goal of ending the pandemic by the end of 2022.
Brown said he had sent Biden and fellow G7 leaders research by Airfinity, a scientific information and analytics company, which found 100 million COVID-19 vaccines stockpiled in rich countries in the northern hemisphere would expire by December without being used.
Out of 5.7 billion doses of coronavirus vaccines administered around the world, only 2 percent have been in Africa.
"We need a plan to distribute vaccines quickly," Brown, Britain's finance minister for a decade before serving as prime minister from 2007 to 2010, said in a statement.
"It will be a profound and collective political tragedy if this summit misses the opportunity to act with doses transferred immediately to poorer countries," he said.
The Airfinity data predicts that, without a speed-up in the vaccine roll-out, there will be 100 million more COVID-19 cases by next summer and one million more deaths from lack of ventilators and oxygen.
"It is unthinkable and unconscionable that 100 million vaccines will have to be thrown away from the stockpiles of the rich countries whilst the populations of the world's poorest countries will pay for our vaccine waste in lives lost," Brown said.
Ukraine has extended a state of emergency that allows regional authorities to impose COVID-19 restrictions until the end of 2021 to tackle a surge in infections, the government said on Monday.
"Due to the worsening epidemic situation, the government at an extraordinary meeting decided to extend the adaptive quarantine until December 31, 2021," it said in a statement.
The state of emergency had been due to expire at the end of September.
The government said it would announce the so-called "yellow" epidemic level from Sept 22, which includes a request to limit the number of visitors to public venues and mass events, in addition to mandatory mask-wearing and distance keeping, although further restrictions would not apply to businesses and schools with fully vaccinated staff.
Over the past week, the number of confirmed new cases of COVID-19 has increased by 68 percent, and hospitalizations by 51 percent, the government said.
So far, Ukraine has registered almost 2.4 million COVID-19 cases and 54,919 related deaths. Fewer than 5.2 million have received two shots of vaccines in the 41-million country.
The US will soon reopen its borders to most foreign travelers as long as they’re fully vaccinated against COVID-19, a top White House official announced Monday.
The new rules for international travel will take effect in “early November,” White House COVID-19 coordinator Jeff Zients said.
Travelers will have to show proof of vaccination to board planes to the US, and the new regime will also involve stricter requirements for coronavirus testing and contact tracing, Zients said. The Centers for Disease Control and Prevention will determine the definition of fully vaccinated, for international travelers, he said. The measures also include stricter testing requirements, including for unvaccinated Americans.
Meanwhile, US regulators are expected to authorize a third booster shot of the Pfizer Inc/BioNTech SE COVID-19 vaccine for older and some high-risk Americans early this week in time for the government to roll them out by Friday as hoped.
The Food and Drug Administration is expected to give the nod to the shots for at least this group in the days ahead of a meeting of advisers to the US Centers for Disease Control and Prevention scheduled for Wednesday afternoon.
The CDC panel will discuss more precise recommendations for how the shots will be administered.
On Friday, an FDA advisory committee voted to recommend emergency authorization of the additional Pfizer shots for Americans 65 and older and those at high risk of severe illness.
The panel had earlier decided against recommending broader approval, saying there was not enough evidence to support broad use, and that they wanted to see more safety data, especially concerning the risk of heart inflammation in younger people after vaccination.
The FDA is not bound to follow the panel's recommendation but usually does.
The agency could revisit the booster shots for a broader authorization in the future. Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency's top scientists arguing they are not needed yet.
Despite the narrowed scope of the proposed authorization, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the US vaccination campaign and whose immunity may be waning.
Norman Baylor, chief executive of Biologics Consulting and former director of FDA’s Office of Vaccines Research and Review, said the decision gives FDA additional time to understand what data is required to approve booster shots broadly.
Health officials signaled they expect boosters will ultimately be recommended for a broad swath of the population, but advised Americans not to seek booster doses until they have the nod from the FDA.
A health certificate showing proof of immunity from COVID-19 immunity will be required to enter the Vatican as of Oct 1, the city state said on Monday.
Residents, workers and visitors will have to carry the co-called "Green Pass" that is already widely used in surrounding Italy, the Holy See said in a statement.
An exception will be made for those attending mass "for the time strictly necessary for the rite".
The Green Pass - originally conceived to ease travel among European Union states - shows that someone has been vaccinated, has tested negative or has recently recovered from the coronavirus.
On Thursday, the Italian government made it obligatory for all workers to show the certificate as of Oct 15, in an effort to boost its vaccination campaign.
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