WASHINGTON — The Food and Drug Administration reiterated Thursday that the newly authorized Pfizer-BioNTech coronavirus vaccine should continue to be used with no new restrictions despite several reports of health-care workers who had a severe allergic reaction after receiving the injection.

Two of those incidents happened in the United Kingdom last week, and a third in Alaska on Tuesday. Another Alaska hospital employee had a brief but much less serious reaction on Wednesday.

The FDA said it is closely monitoring these situations and is teaming with the Centers for Disease Control and Prevention to investigate what incited these responses. While that is being investigated, the FDA is working with Pfizer to update fact sheets and prescribing information to reflect the evolving information. The FDA said that would underscore an existing requirement – that facilities administering the vaccine must be capable of immediately treating any severe allergic reaction.

The vaccine developed by the pharmaceutical giant Pfizer and the German company BioNTech passed strict safety reviews during months-long randomized clinical trials involving tens of thousands of people. But three incidents of anaphylaxis – a sudden allergic response that can be reversed quickly with medication – are a complication for officials hoping to gain public acceptance of the vaccine.

They’re also a biochemical mystery. No one knows what component of the vaccine incited the anaphylactic reactions.

Read the full story here.

California hospitals buckle under surge in nation’s new hot spot

LOS ANGELES — Hospitals across California have all but run out of intensive care beds for COVID-19 patients, ambulances are backing up outside emergency rooms, and tents for triaging the sick are going up as the nation’s most populous state emerges as the latest epicenter of the U.S. outbreak.

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Medical personnel treat a COVID-19 patient at Providence Holy Cross Medical Center in Los Angeles on Nov. 19. Hospitals across California have all but run out of intensive care beds for COVID-19 patients as the nation’s most populous state emerges as the latest epicenter of the U.S. outbreak. Associated Press/Jae C. Hong

On Thursday, the state reported a staggering 52,000 new cases in a single day – equal to what the entire U.S. was averaging in mid-October – and a one-day record of 379 deaths. More than 16,000 people are in the hospital with the coronavirus across California, more than triple the number from a month ago.

While the surging virus has pushed hospitals elsewhere around the country to the breaking point in recent weeks, the crisis is deepening with alarming speed in California, even as the nationwide rollout of COVID-19 vaccinations this week and the impending release of a second vaccine have boosted hopes of eventually defeating the scourge.

Intensive care unit capacity is at less than 1% in many California counties, and morgue space is also running out, in what is increasingly resembling the disaster last spring in New York City.

At St. Mary Medical Center in Southern California’s Apple Valley, patients are triaged outside in tents, and the hospital put up temporary walls in its lobby to make more room to treat those with COVID-19. Patients are also being treated in the halls on gurneys or chairs, sometimes for days, because there is nowhere else to put them, said Randall Castillo, the hospital’s chief executive.

Dr. Nasim Afsar, chief operating officer at UCI Health in Orange County, described an unrelenting churn of patients, many of them left to wait in the ER until a bed elsewhere in the hospital opens up.

“Every day we work through and we discharge the appropriate number of people, and by the next day all of those beds are again filled up,” she said. “Where the bottleneck is is the large number of patients who come to the emergency room and need to be admitted and there’s not a bed for them.”

Dr. Denise Whitfield, an emergency room physician at Harbor-UCLA Medical Center, said ambulance crews are left waiting around for patients to be seen.

“Over the last nine months that we’ve been dealing with this COVID pandemic, I can say that it’s been the worst that I’ve seen things in terms of looking at our capacity to care for our patients,” she said.

Authorities plan to erect field hospitals in multiple locations in the state, with three set to go up in Orange County.

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While other states rush to give shots, Tennessee is stockpiling them

NASHVILLE, Tenn. — As states rush to inoculate health care workers on the front lines of the coronavirus pandemic, only Tennessee has prioritized building its own emergency reserve of the coveted vaccine.

An Associated Press review of each state’s COVID-19 vaccine distribution plans shows that Tennessee alone has specified it will hold back a small portion in “case of spoilage of vaccine shipped to facilities.” The state’s initial shipment of the Pfizer-BioNTech vaccine that arrived Monday was not distributed for inoculation, so health care workers had to wait until the second shipment arrived days later.

The move has baffled health care leaders, who say medical workers should take priority, especially as the state hits record case numbers.

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A vial of the Pfizer-BioNTech COVID-19 vaccine rests on a table at the University of Texas Health Austin Dell Medical School on Tuesday, Dec. 15. Jay Janner/Austin American-Statesman via AP

“Given the extremely high case counts right now, our frontline health care workers are at higher risk than ever, I would personally advocate for those doses being used rather than stockpiled,” said Dr. Isaac Thomsen, who leads the Vanderbilt Vaccine Research Program Laboratory.

Despite a federal stockpile created so states can use all of their supplies, Tennessee officials maintain that the reserve is necessary because of the risk of damaging the vaccine, which requires ultracold storage.

“If a hospital receives a case of the vaccine and it’s spoiled or broken, we can immediately deploy that (emergency reserve) to them,” state Health Commissioner Lisa Piercey said.

In contrast, the AP review of vaccine distribution plans across the country shows that other states are stressing the need to quickly distribute every vaccine to those with the highest risk of exposure.

Wisconsin has no mention of an emergency reserve in its distribution plan, and when asked by AP this week, the state health agency responded that it was “not holding any vaccine back.” In Ohio, Republican Gov. Mike DeWine not only touted the arrival of the state’s first vaccines but also praised the rapid administration of the shots to front-line medical workers.

Idaho health experts have allotted some flexibility in their effort to move doses around quickly to ensure they do not end up sitting on shelves.

“What we do not want is any wasted vaccine,” Sarah Leeds, program manager for the Idaho Immunization Program, said earlier this month during the state’s COVID-19 Vaccine Advisory Committee.

In North Carolina, state officials stated in their distribution plan that “no doses will be held back at the jurisdiction or provider level. The federal government will hold back product initially to ensure second doses are available.”

Other states committing to use every dose because the federal government has its own backup supply include Illinois, Iowa, New Mexico, Virginia and Washington.

Yet in Tennessee, the first shipment of 975 Pfizer-BioNTech vaccine doses went into the reserve. The second shipment of 56,500 shots that came in Wednesday was being distributed to more than 70 hospitals across the state.

Read the full story here.

Lockdown looms over Christmas in Bethlehem

RAMALLAH, West Bank  — The Palestinian prime minister on Thursday announced a two-week lockdown in the West Bank that appears certain to curtail Christmas celebrations in the town of Jesus’ birth.

Prime Minister Mohammad Shtayyeh said that with a coronavirus outbreak raging, there will be a nighttime curfew from 7 p.m. to 6 a.m. throughout the West Bank. On Fridays and Saturdays, the local weekend, the lockdown will be around the clock.

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Christmas tree is lit outside the Church of the Nativity, traditionally believed by Christians to be the birthplace of Jesus Christ in the West Bank city of Bethlehem, Saturday, Dec. 5. AP Photo/Majdi Mohammed

The restrictions, which are to be in effect through Jan. 2, will greatly restrict travel throughout the West Bank. Most businesses, with the exception of pharmacies and bakeries, will be forced to close during the curfews, Shtayyeh said.

The lockdown appears to mean that public celebrations in Bethlehem, revered by Christians as Jesus’ birthplace, will be greatly scaled back.

Large crowds usually throng the town on Christmas Eve before Midnight Mass is celebrated at the Church of the Nativity. But the restrictions will prevent people from reaching Bethlehem from either Israel or other parts of the West Bank, and the nighttime curfew will presumably prevent even local residents from celebrating.

Shtayyeh said that “special protocols” were still being sorted out for public prayers, though he didn’t elaborate.

Local officials have already said celebrations would be scaled back in Bethlehem, with prayers likely limited to religious leaders and local dignitaries. Gift shops and hotels have been closed during the normally busy holiday season.

Palestinian officials on Thursday reported 1,134 new cases of the coronavirus, bringing the total number of infections in Palestinian areas of the West Bank to 86,594. Over 860 Palestinians in the territory have died.

UN appeals to rich nations to share vaccines

BERLIN — U.N. Secretary-General Antonio Guterres is appealing to rich nations to support the purchase of coronavirus vaccines for poor countries.

Guterres says the U.N.-backed COVAX program needs $5 billion until the end of January. The program, created to ensure access to COVID-19 vaccines for all countries, currently faces a shortfall of more than $20 billion, he says.

“At the same time, I see countries that have bought more vaccines than several times the volume of their population or at least made the bids in that regard,” said Guterres, urging governments to donate excess doses to COVAX.

He notes it is in the best interest of the world to ensure broad immunization because “nature always strikes back.”

“If we don’t eradicate the disease, a virus can mutate,” he says, “and vaccines that at a certain moment are effective can no longer be effective if things change.”

Watchdog members urge probe of Mnuchin’s shift of pandemic funds

Members of a congressional watchdog panel have asked for an investigation into why Treasury Secretary Steven Mnuchin ended U.S. Federal Reserve emergency lending programs, according to a letter obtained by Bloomberg News.

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Treasury Secretary Steven Mnuchin testifies before a Congressional Oversight Commission hearing on Capitol Hill in Washington, Thursday Dec. 10. Alex Wong/Pool via AP

The move represents the latest standoff between Republicans and Democrats over the use of almost half a trillion dollars in covid-19 aid. Mnuchin said the Cares Act required him to terminate some central bank emergency lending facilities to prop up small businesses, non-profits and state and local government during the pandemic.

The letter, addressed to Treasury’s acting Inspector General Richard Delmar, and signed by the Congressional Oversight Commission’s two Democratic appointees, Bharat Ramamurti and Rep. Donna Shalala of Florida, says there may be “irregularities” in how Mnuchin came to that conclusion, including that he may not have consulted legal counsel before determining that the program should wind down by the end of the year and may have changed his position after Joe Biden won the presidential election.

“We are concerned that the Treasury Department’s decision to terminate the programs may have preceded a comprehensive legal analysis of the Cares Act’s requirements, particularly given the inconsistencies with the Treasury Department’s prior, public positions,” Ramamurti and Shalala wrote.

Delmar said that he has received the request, is reviewing it and will respond to the requesters “as soon as possible.”

Mnuchin in mid-November said he would pull unused money authorized by the March Cares Act to back Federal Reserve emergency-lending facilities at year’s end. The Treasury also unveiled plans to park those funds, along with other left-over lending authorization — some $455 billion in all — into the department’s general fund, over which Congress has authority, rather than the Exchange Stabilization Fund, over which the secretary has greater discretion.

Lawmakers including House Speaker Nancy Pelosi have said that the actions amounted to a misreading of the law and were politically motivated to hamstring the incoming Biden administration.

France’s Macron tests positive for COVID-19

PARIS — France’s Elysee Palace says President Emmanuel Macron has tested positive for COVID-19.

It said the president took a test “as soon as the first symptoms appeared.” The brief statement did not say what symptoms Macron experienced.

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French President Emmanuel Macron speaks during a ceremony marking the 60th anniversary of the creation of the Organization for Economic Co-operation and Development (OECD), at its headquarters in Paris on Dec. 14. Macron has tested positive for COVID-19, the presidential Elysee Palace announced on Thursday. Martin Bureau/ Pool photo via AP, File

It said he would isolate himself for seven days. “He will continue to work and take care of his activities at a distance,” it added.

It was not immediately clear what contact tracing efforts were in progress. Macron attended a European Union summit at the end of last week, where he notably had a bilateral meeting with German Chancellor Angela Merkel. He met on Wednesday with the prime minister of Portugal. There was no immediate comment from Portuguese officials.

Macron on Wednesday also held the government’s weekly Cabinet meeting in the presence of Prime Minister Jean Castex and other ministers. Castex’s office said that the prime minister is also self-isolating for seven days.

The French presidency confirmed that Macron’s trip to Lebanon scheduled for next week is being canceled.

Gaza Strip records more than 1,000 virus cases in a single day

GAZA CITY, Gaza Strip — The Gaza Strip has recorded more than 1,000 coronavirus cases in one day for the first time since an outbreak began there, threatening to further overwhelm the territory’s decrepit health system.

Out of 2,474 tests, 1,015 were positive, the Health Ministry said Thursday. Twelve people have also died in the past 24 hours, the ministry added, raising the death toll to 232.

Gaza has recorded more than 31,000 infections since the virus began to spread in the densely populated Palestinian territory in August.

An Israeli-Egyptian blockade on the Hamas-run territory that limits travel, as well as strict quarantine measures by the militant group, delayed the arrival of the virus. But ever since it began spreading through the population over the summer, the infected have quickly filled up hospitals. The Health Ministry says it has begun transferring COVID-19 patients to wards meant for other patients.

Gaza’s ailing health care system has long been overburdened, gutted for years by the blockade and intra-Palestinian political feuding.

Denmark locks down nationwide

COPENHAGEN, Denmark — Denmark is shutting down nationwide, with shopping malls and department stores ordered to close as of Wednesday and small shops — except for food stores and pharmacies — told to shut as of Dec. 25.

Prime Minister Mette Frederiksen said the restrictions will apply until Jan. 3. Hairdressers and beauty shops will close as of Dec. 21.

Frederiksen said she was “deeply concerned about how it will go in the coming winter months,” adding that Denmark’s “health care system is under pressure.”

“An epidemic that is running out of control will have major consequences, and greater consequences than shutting down now,” she said.

The Scandinavian country has has 119,779 confirmed cases — up nearly 4,000 in the past day — and 975 deaths — up 14.

WHO says Asian-Pacific countries aren’t guaranteed early access to vaccine

JAKARTA, Indonesia — The World Health Organization says countries in the Asia-Pacific region are not guaranteed to have early access to COVID-19 shots and urged them to adopt a long-term approach to the pandemic.

WHO Regional Director Dr. Takeshi Kasai told reporters in the Indonesian capital, Jakarta, that the development of safe and effective vaccines is one thing. Producing them in adequate quantities and reaching everyone who needs them is another.

Dr. Socorro Escalante, WHO’s coordinator for essential medicines and health technologies, said that while some countries that have independent vaccine purchase agreements might start vaccination campaigns in the coming months, others could see vaccination begin in the middle or late 2021.

“It’s important to emphasize that most, if not all, the countries in the Western Pacific region are a part of the COVAX Facility,” said Escalante. “Within the COVAX Facility we are expecting that the vaccines will be coming in on the second quarter of 2021.”

COVAX was set up by WHO, vaccines alliance GAVI and CEPI, a global coalition to fight epidemics, in an effort to ensure equitable access to vaccines across the world.

WHO representatives also urged that high-risk groups should be prioritized for vaccination as vaccines will only be available in limited quantities.

Saudi Arabia begins vaccination effort

DUBAI, United Arab Emirates — Saudi Arabia has kicked off its COVID-19 inoculation campaign, with the health minister receiving the first dose a week after authorities approved the Pfizer vaccine.

Health Minister Tawfiq al-Rabiah said the government is confident of the safety of the vaccine, and vowed that all citizens in the biggest Gulf Arab state, with a population of 34 million people, will receive injections free of charge.

Al-Rabiah hailed the start of the campaign as “the beginning of the relief of the pandemic crisis.”

Authorities said they will give priority to health workers, citizens and residents over 65 years old and those with underlying health conditions in the first phase of the rollout. The government did not specify how many doses had been received, but said it plans to inoculate at least 70% of the population by the end of next year.

Although cases have declined in recent weeks, Saudi Arabia has struggled to contain a major outbreak that has killed over 6,000 people.

New virus cluster emerges in Sydney

SYDNEY, Australia — Authorities are searching for the source of an emerging COVID-19 cluster in Sydney’s northern coastal suburbs.

Australia’s largest city had gone 12 consecutive days without community transmission until Wednesday when a driver who transported international air crews in a van to and from Sydney Airport tested positive.

By Thursday, six people had been infected with the virus though community transmission in Sydney, as well as six returned travelers who had been infected overseas and tested positive while in hotel quarantine.

The new infections include a woman who works at the Pittwater Palms aged care home, which has since been closed to visitors.

A drummer in a band that had played in several clubs around Sydney in recent days has also been infected.

The New South Wales Health Department said later Thursday that 17 people had been infected in Sydney’s northern coastal suburbs. Residents in the Northern Beaches Local Government Area were advised to work from home and remain at home as much as possible for the next three days. Others were advised to avoid traveling to the area.

Second Alaska health care worker has adverse reaction to vaccine

JUNEAU, Alaska — Health officials in Alaska have reported that a second health care worker had an adverse reaction to a COVID-19 vaccine.

Bartlett Regional Hospital in Juneau says the two workers showed adverse reactions about 10 minutes after receiving the vaccine and were treated. One received the vaccine Tuesday and will remain in the hospital another night under observation while the other, vaccinated Wednesday, has fully recovered.

U.S. health authorities warned doctors to be on the lookout for rare allergic reactions when they rolled out the first vaccine, made by Pfizer and Germany’s BioNTech. Britain had reported a few similar allergic reactions a week earlier.

South Carolina Republican is 3rd lawmaker to test positive for virus

COLUMBIA S.C. — U.S. Rep. Joe Wilson is the latest member of South Carolina’s congressional delegation to test positive for the coronavirus, announcing his test result Wednesday just hours after speaking on the U.S. House floor.

The Republican said in a statement late Wednesday that he tested positive earlier in the day, adding, “I feel fine and do not have any symptoms.”

The 73-year-old Wilson said he would quarantine “through the Christmas holiday.”

Wilson was at the U.S. House on Wednesday, when he wore a face mask as he delivered a floor speech lauding President Donald Trump “for his efforts to bring a vaccine to the United States faster than any other vaccine in history.”

Wilson’s office did not immediately respond to a message regarding other elements of the congressman’s recent schedule.

Elected to a 10th term in November, Wilson is the third of South Carolina’s seven-member U.S. House delegation to contract COVID-19.


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