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The latest: FDA panel rejects plan for Pfizer booster shots

PAGO PAGO, AMERICAN SAMOA -- American Samoa reported its first case of coronavirus on Friday.

The U.S. territory’s acting governor and health officials said the islands’ first case of COVID-19 was of a resident who returned to America Samoa from Hawaii this week.

The infected traveler flew in on Monday, the first day of newly resumed commercial flights from Honolulu to Pago Pago. The route had been suspended since March 2020.

Officials say the resident was fully vaccinated and had traveled to Hawaii and the U.S. mainland. They say the traveler tested negative for COVID-19 before boarding the flight back to American Samoa.

American Samoa requires all travelers to be vaccinated and to quarantine.

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MORE ON THE PANDEMIC:

— FDA advisory panel rejects widespread Pfizer booster shots

— Biden faces limits of $1.9T COVID aid as some states resist

— England simplifies COVID-19 rules for international travelers

— Trial begins over coronavirus outbreak at Austrian ski resort in 2020

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— See AP coverage at https://apnews.com/hub/coronavirus-pandemic

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HERE’S WHAT ELSE IS HAPPENING:

BATON ROUGE, La. -- A child is among the latest to die from COVID-19 in Louisiana, state health officials said Friday.

Heath department figures showed the state death toll from the illness grew by 52. One of the victims was a child between the ages of 5 and 11.

It was the 15th death of someone younger than 18 in Louisiana since the pandemic began early last year. And it’s the sixth pediatric death since a fourth surge began this summer.

Coronavirus hospitalizations continued to drop. They fell to 1,367 in Friday’s figures, 64 fewer than the previous day. Hospitalizations are down from a peak of more than 3,000 in August but still well above the pre-surge levels of mid-summer.

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WASHINGTON — After overwhelmingly rejecting a plan to give Pfizer booster shots against COVID-19 to most Americans, an influential federal advisory panel has approved the extra shots for those who are 65 or older or run a high risk of severe disease.

The twin votes Friday represented a blow to the Biden administration’s sweeping effort to shore up nearly all Americans’ protection amid the spread of the highly contagious delta variant. The decision was made by a committee of outside experts who advise the Food and Drug Administration.

The vote recommending the booster shots for older Americans and other high-risk groups helps salvage part of the White House’s campaign but is still be a huge step back from the sweeping plan proposed by administration a month ago to offer booster shots of both the Pfizer and Moderna vaccines to nearly all Americans eight months after they get their second dose.

During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to nearly everyone.

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WASHINGTON — The White House says President Joe Biden will host a virtual summit next week aimed at “calling the world to account” on defeating the COVID-19 pandemic.

The meeting, to take place on the margins of the United Nations General Assembly, is meant to encourage more countries to do more to vaccinate the world against COVID-19 and improve coronavirus treatments.

Press secretary Jen Psaki says Biden “will be asking participants to commit to of a higher level of ambition” on global vaccinations and therapeutics, along with preparing for the next pandemic.

The U.S. has committed to donating the more COVID-19 vaccine doses than any other nation to the rest of the world, and Biden is expected to ask other well-off nations to make bolder vaccine sharing commitments.

The White House says world leaders, philanthropists, industry representatives and non-governmental organizations will participate.

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BEND, Oregon — Dozens of people in Oregon have contacted the state’s poison center after self-medicating against COVID-19 with a drug used to treat parasites, with five becoming hospitalized and two of them winding up in intensive care units, authorities said Friday.

The drug they used was ivermectin, which has no proven use against the coronavirus and is instead approved to treat some parasites in people and some animals.

“COVID-19 is a devastating disease and can be very frightening, but the public does not need to use -- nor should it use -- unproven and potentially dangerous drugs to fight it,” said Robert Hendrickson, medical director of the Oregon Poison Center at Oregon Health & Science University.

Between Aug. 1 and Sept. 14, the Oregon Poison Center at OHSU managed a total of 25 cases. Five of those cases involved hospitalization, and two people were so severely ill that they had to be admitted to an intensive care unit.

Across the country, calls to poison control centers regarding ivermectin overdoses or exposures has increased five-fold from the pre-pandemic level, according to the U.S. Centers for Disease Control and Prevention.

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WASHINGTON — An influential federal advisory panel has overwhelmingly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans, dealing a heavy blow to the Biden administration’s effort to shore up people’s protection amid the highly contagious delta variant.

The vote by the committee of outside experts assembled by the Food and Drug Administration was 16-2, with members expressing frustration that Pfizer had provided little data on the safety of extra doses. Many also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.

In an extraordinary move, both FDA leaders and the panel indicated they were likely to take a second vote Friday afternoon on recommending the booster shots for older Americans and other high-risk groups.

That would help salvage part of the Biden administration’s campaign but would still be a huge step back from the sweeping plan proposed by the White House a month ago to offer booster shots of both the Pfizer and Moderna vaccines to nearly all Americans eight months after they get their second dose.

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MEMPHIS, Tenn. — A federal judge has again blocked Tennessee Gov. Bill Lee from allowing parents to opt out of school mask requirements aimed at limiting coronavirus infections.

U.S. District Judge Sheryl Lipman issued a preliminary injunction on Friday for schools in Shelby County, Tennessee’s largest county. Parents in two Memphis suburbs are suing on behalf of their children with health problems.

They argue the Republican governor’s executive order has endangered these students and harmed their ability to attend classes in person by allowing others to opt out of a mask mandate and spread infections.

“It is that unmasked presence that creates the danger to these Plaintiffs,” the judge wrote Friday.

Lipman had already issued a temporary restraining order on Sept. 3 stopping schools from allowing parents to opt-out. It was set to expire Friday. The preliminary injunction continues blocking the governor’s order as the federal lawsuit proceeds.

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ISLAMABAD — The British government took Pakistan off from its travel ban list starting next Wednesday, a move which was welcomed by Pakistani authorities.

The announcement was made by the top British diplomat to Pakistan, Christian Turner and the British Transport Secretary Grant Shapps on Twitter. Pakistan was added to the red list in April, and people traveling from Pakistan to Britain had to quarantine and pay for a 10-day stay in a government-approved hotel.

On Friday, Turner in a tweet said he was pleased to confirm Pakistan is off the red list, saying “I know how difficult the last 5 months were for so many who rely on close links” between the two countries.

Pakistan’s planning minister Asad Umar took to Twitter to welcome the British government’s decision. The country is currently facing a fourth wave of coronavirus, which has started subsiding.

Pakistan has reported 1.2 million confirmed cases and 27,072 confirmed deaths since the start of the pandemic.

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YUMA, Ariz. — An Arizona couple was sentenced after coughing on Walmart employees who asked them to wear masks and for fighting with police.

A judge sentenced 39-year-old Frank Robert Montoya to 18 months in state prison minus 113 days served. Victoria Parra-Carranza, 25, received 30 days in the county jail and a three-year probation term.

Both were convicted in April of aggravated assault on a police officer, resisting arrest and other crimes for the incident in 2020, the Yuma Sun reported.

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WASHINGTON — The federal government is spending $2.1 billion to improve infection control procedures in health care settings, aimed at preventing the transmission of diseases inside hospitals, dialysis centers and other facilities.

The Centers for Disease Control and Prevention is allocating the funding from the $1.9 trillion COVID-19 relief bill that was signed into law by President Joe Biden this year.

Of the new funding, $500 million will create and train “strike teams” to help facilities with known or suspected COVID-19 outbreaks.

CDC director Dr. Rochelle Walensky says the funding “will dramatically improve the safety and quality of the health care delivered in the United States during the pandemic and in the future.”

Nearly $900 million will be spent over the coming years to support research and training on new ways to control the spread of infections.

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NEW DELHI — India officials say a record 21 million vaccine doses were given across the country in a special drive on Friday, a birthday gift to Prime Minister Narendra Modi who turned 71.

India has vaccinated 770 million people, 20% fully vaccinated and 62% with single doses, according to the Health Ministry.

The ministry advised people to take precautions to avoid another deadly surge during the upcoming October-November festival season. India was hit by a devastating surge of infections from April to June this year, overwhelming hospital beds and oxygen supply in hospitals.

Meanwhile, youth members of main opposition Congress party clashed with police during a street protest Friday demanding jobs amid massive unemployment triggered by the pandemic.

On Friday, India reported 34,403 new cases and 320 confirmed deaths.

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INDIANAPOLIS — Indiana’s largest hospital system says 125 workers are no longer employed with the health network after they didn’t comply with its mandate for all employees to get vaccinated against COVID-19.

The Indianapolis Business Journal newspaper reported Indiana University Health says the employees left the hospital system after a two-week unpaid suspension period that ended Sept. 14.

The employees represent less than 1% of IU Health’s work force of about 36,000. The health system operates 15 hospitals and dozens of outpatient clinics around the state. IU Health said Sept. 2 it estimated 97% of its employees were vaccinated.

IU Health announced in June it would require all doctors, nurses and other employees be fully vaccinated against COVID-19 by Sept. 1.

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WASHINGTON — Government advisers are debating whether to recommend extra doses of the Pfizer vaccine, a key step toward the Biden administration’s plan to dispense COVID-19 booster shots to most Americans.

Scientists inside and outside the U.S. government have been divided in recent days over the need for boosters and who should get them. A panel of Food and Drug Administration advisers will vote Friday on the safety and effectiveness of boosters.

This week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said continuing studies show the shots are working well despite the delta variant.

A Pfizer study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose and 84% after about six months.

If the FDA approves the extra doses, a separate committee convened by the Centers for Disease Control and Prevention will debate on Wednesday who should get boosters and when. The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults

The World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

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LONDON — The British government says it plans to simplify rules for international travel during the coronavirus pandemic and will make an announcement Friday.

Transport Secretary Grant Shapps says on Twitter he’ll “set out measures to simplify international travel later today in order to reduce costs, take advantage of higher levels of vaccination, and keep us all safe.”

The government is under pressure to scrap its “traffic light” system that ranks countries as red, yellow or green -- high, medium or low risk from the coronavirus.

Airlines and travel businesses say Britain’s requirements are keeping people away and hampering recovery from the pandemic.

At present, people coming from “red list” countries must spend 10 days in a government-approved quarantine hotel. Unvaccinated travelers from yellow list countries must self-isolate for 10 days at home, while fully vaccinated travelers need to take coronavirus tests before and after arriving in Britain.

It’s likely the government will ease the rules that require travelers to take a highly sensitive and pricey PCR test two days after arrival. They could use a cheaper but less sensitive test instead.

Any changes will apply only to England. Scotland, Wales and Northern Ireland set their own policies.

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PHNOM PENH, Cambodia — Cambodia is vaccinating children ages 6 to 11 so students can safely return to schools that have been closed for months due to the coronavirus.

Prime Minister Hun Sen inaugurated the campaign Friday, with his grandchildren and young family members of other senior officials shown being given their shots.

Cambodia already has been vaccinating older children. Hun Sen says he ordered health officials to study if children ages 3 to 5 can be vaccinated.

Nearly 72% of Cambodia’s almost 17 million people have received at least one COVID-19 shot since vaccinations began in February. China’s Sinovac and Sinopharm vaccines account for most inoculations.

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GENEVA — The World Health Organization and United Nations on Friday declined to indicate how many in their workforces have been vaccinated.

“We won’t have that because it’s confidential,” said Dr. Margaret Harris, a WHO spokeswoman.

U.N. Geneva spokeswoman Alessandra Vellucci said: “We don’t disclose this kind of information. It’s something that is said to the medical service. So, no, unfortunately, we won’t be able to give you these numbers.”

Vellucci says she’ll look into whether percentages of staff that had been vaccinated could be provided.

In November, WHO indicated 65 of its staffers had tested positive for COVID-19 at the time, confirming information in an internal e-mail obtained by The Associated Press. The U.N. office in Geneva has often indicated how many of its staff tested positive.

Governments list how many people are vaccinated against the coronavirus, and the WHO compiles the information and reports on it. Some countries and companies require vaccines for their workers to go to their jobs.


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