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US FDA authorizes Pfizer COVID-19 vaccine for emergency use

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The Pfizer Global Supply Kalamazoo manufacturing plant is shown in Portage, Michigan, on Dec. 11, 2020. (AP Photo/Paul Sancya)
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The Pfizer Global Supply Kalamazoo manufacturing plant is shown in Portage, Michigan, on Dec. 11, 2020. (AP Photo/Paul Sancya)
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Updated 12 December 2020
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US FDA authorizes Pfizer COVID-19 vaccine for emergency use

  • Saudi Arabia among the first to approve roll out of the Pfizer-BioNTech jab, along with Bahrain, Britain and Canada
  • France’s Sanofi and Britain’s GSK said on Friday their vaccine would not be ready until the end of 2021
Updated 12 December 2020
Reuters AFP

WASHINGTON/PARIS: The US Food and Drug Administration said it authorized the use of Pfizer Inc’s COVID-19 vaccine on Friday, with the first inoculations expected within days, marking a turning point in the United States where the pandemic has killed more than 295,000 people.
The US Food and Drug Administration granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95% effective in preventing the disease in a late-stage trial.
The FDA said the vaccine can be given to people aged 16 and older. Healthcare workers and elderly people in long-term care facilities are expected to be the main recipients of a first round of 2.9 million doses.
“The first vaccine will be administered in less than 24 hours,” US President Donald Trump said in a video posted on Twitter. “I am proud to say we have made sure this vaccine will be free for all Americans.”
The US government has said it will begin distributing the vaccine around the country immediately after FDA authorization and that the first inoculations would happen early next week.
Millions of Americans could begin getting vaccinated this month, especially if a second vaccine from Moderna Inc. is quickly approved.
The Pfizer/BioNTech vaccine was first approved in Britain earlier this month, and UK residents began receiving the shots on Tuesday. Canada also authorized the vaccine and expects to start inoculations next week.
Mexico and Bahrain have also approved the vaccine.
The FDA authorization, known as an EUA, comes at a time when infections, hospitalizations and deaths are soaring to record levels in the United States, which has failed to mount a coordinated effort to slow the spread of the virus. Earlier this week, the one-day COVID-19 death total topped 3,000, while hospital intensive care units across the country are nearing capacity, threatening to overwhelm health care systems.
“The EUA was anticipated and it is one step in a sequence of steps that will bring this pandemic to an end,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
“I’m not going to feel that there is an EUA tomorrow when I’m taking care of COVID-19 patients. A lot of people will be infected, a lot will be hospitalized and a lot will die before the vaccine is able to have a meaningful impact on spread,” he added.
Others with vaccines in advanced development include Moderna, which could win emergency US authorization as soon as next week, AstraZeneca Plc with Oxford University, and Johnson & Johnson.
BioNTech began developing the vaccine in January, using a technology called synthetic messenger RNA (mRNA) that had yet to produce an approved product. The technology uses a chemical messenger to instruct cells to make proteins that mimic part of the new coronavirus, which the immune system learns to recognize as an invader. BioNTech struck a development deal with Pfizer in March.
The vaccine comes with complex distribution challenges as it must be shipped and stored at -70 Celsius (-94 F), requiring specialized ultra-cold freezers or supplies of dry ice.
Moderna’s vaccine employs the same technology but does not need to be stored at sub-Arctic temperatures.

The first shots
Pfizer has developed a special shipping container that will be filled with dry ice to keep the vaccine from spoiling. Many states are concerned about whether there is enough dry ice for shipments to rural areas that lack the specialized freezers, but Pfizer believes there should be sufficient supply.
The US quest for a vaccine has been the central response to the pandemic from a Trump administration that has mostly otherwise left states to fend for themselves. It has said it will have enough to supply all of the 330 million US residents who wish to be vaccinated by the middle of 2021.
The government has ordered 100 million doses of the Pfizer vaccine — enough to inoculate 50 million people — through its Operation Warp Speed virus development program and could negotiate for more. The status of those talks are unclear.
Pfizer board member and former FDA commissioner Scott Gottlieb said in an interview with CNBC earlier this week that the company had offered to sell the United States more doses as recently as last month but had been turned down.
The United States has agreed to buy 200 million doses of Moderna’s two-dose vaccine. The government also has supply deals with J&J and AstraZeneca, but authorization of those vaccines are not imminent.
Top US infectious diseases expert Dr. Anthony Fauci said if distribution goes well and enough Americans agree to get vaccinated, relief for a pandemic weary nation may be on the horizon.
“If we do it efficiently enough by the second quarter of 2021, and by the end of summer or end of third quarter, we may actually have enough herd immunity protecting our society,” he said. “And as we get to the end of 2021, we could approach very much some degree of normality that is close to where we were before.”

Two vaccines hit snags

Two vaccine candidates, meanwhile, stumbled Friday in the race among researchers to combat Covid-19, a setback for the global immunization effort.
The mixed news on the vaccine front comes as infections accelerated fast in North America and parts of Africa but started to stabilize in Europe and drop in Asia and the Middle East.
Around the world more than 1.58 million lives have been lost to Covid-19 since it emerged in China a year ago, according to an AFP tally from official sources.
While the record-fast development of vaccine options has brought hope to the planet, some candidates are suffering setbacks.
France’s Sanofi and Britain’s GSK said on Friday their vaccine would not be ready until the end of 2021.
New results showed a low immune response in older adults, researchers said.
And in Australia, the development of a vaccine in phase one trials at The University of Queensland was abandoned Friday after clinical trials produced a false positive HIV result among subjects involved in early-stage testing.
Yet inoculation plans with other vaccines are picking up pace.
President-elect Joe Biden hailed the “bright light in a needlessly dark time” in the US, which is home to the world’s highest death toll at nearly 300,000.
The country hopes to start vaccinating 20 million people this month, starting with long-term care facility residents and health workers.
Britain this week became the first Western country to roll out the Pfizer-BioNTech jab, which Canada, Bahrain and Saudi Arabia have also approved.
The first vaccine shipments to 14 sites across Canada are scheduled to arrive Monday with people receiving shots a day or two later.
“I’m really excited. I want to get vaccinated as soon as possible, because I have a new baby,” Michelle, a Toronto resident, told AFP.
Israel, which accepted its first shipment of the Pfizer vaccine on Wednesday, is targeting a rollout on December 27.
And Hong Kong said Friday it had struck deals for two vaccines — one from Pfizer and the other from Beijing-based Sinovac — with plans to launch a campaign in early 2021.
A new combined approach is also being tested by AstraZeneca, whose Russian operation said it would mix its shot with the locally-made Sputnik V vaccine in clinical trials.
“Combinations of different Covid-19 vaccines may be an important step in generating wider protection through a stronger immune response and better accessibility,” the pharma giant said in its statement.
Russia and China have already begun inoculation efforts with domestically produced vaccines that have seen less rigorous vetting, while EU countries are eagerly awaiting clearance on two options.
The EU’s watchdog said it would deliver decisions on the Pfizer and Moderna vaccines in late December and early January respectively.
Yet many lingering questions about the vaccines remain.
Key issues include whether more side effects will emerge with longer follow-up, how long the vaccine remains effective, whether it will limit transmission and how it will work in children, pregnant women, and immunocompromised patients.

More lockdowns in Europe
As Europe’s surge eases off slightly, France is planning to lift a six-week-long lockdown from Tuesday but impose a curfew from 8 pm, including on New Year’s Eve.
Greece also announced new plans Friday to slash quarantine time for incoming travelers and reopen churches for Christmas, while some small shops such as hair salons and bookstores can open for business from Monday.
But Switzerland, which is seeing a sharp resurgence in cases, announced a 7 p.m. curfew for shops, restaurants and bars.
“Our hospitals and our health workers are being stretched to the limit. We couldn’t wait any longer,” President Simonetta Sommaruga told a news conference in the capital Bern.
While lockdowns have brought economic pain, boredom and myriad other woes, the effect on the environment has been more positive.
Carbon emissions fell a record seven percent in 2020 as countries imposed lockdowns, according to the Global Carbon Project.
The biggest drops were recorded in the US, down 12 percent, and the European Union, down 11 percent.
And in the sporting world, Formula One world champion Lewis Hamilton was given the green light to return to racing at the season-ending Abu Dhabi Grand Prix after recovering from his own bout with the virus.

Topics: Coronavirus Pfizer-BioNTech

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As Philippines picks up from Usagi, a fresh storm bears down

Updated 3 sec ago
AFP
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As Philippines picks up from Usagi, a fresh storm bears down

  • Typhoon Usagi blew out of the Philippines early Friday as another dangerous storm drew closer
  • Scores were killed by flash floods and landslides just weeks ago, the weather service said
Updated 3 sec ago
AFP
MANILA: Typhoon Usagi blew out of the Philippines early Friday as another dangerous storm drew closer, threatening an area where scores were killed by flash floods and landslides just weeks ago, the weather service said.
As Usagi — the archipelago nation’s fifth storm in three weeks — headed north to Taiwan, rescuers worked to reach residents stranded on rooftops in northern Luzon island, where herds of livestock were devastated.
The recent wave of disasters has killed at least 159 people and prompted the United Nations to request $32.9 million in aid for the worst-affected regions.
On Thursday, flash floods driven by Usagi struck 10 largely evacuated villages around the town of Gonzaga in Cagayan province, local rescue official Edward Gaspar told AFP by phone.
“We rescued a number of people who had refused to move to the shelters and got trapped on their rooftops,” Gaspar added.
While the evacuation of more than 5,000 Gonzaga residents ahead of the typhoon saved lives, he said two houses were swept away and many others were damaged while the farming region’s livestock industry took a heavy blow.
“We have yet to account for the exact number of hogs, cattle and poultry lost from the floods, but I can say the losses were huge,” Gaspar said.
Trees uprooted by flooding damaged a major bridge in Gonzaga, isolating nearby Santa Ana, a coastal town of about 36,000 people, Cagayan officials said.
“Most evacuees have returned home, but we held back some of them. We have to check first if their houses are still safe for habitation,” Bonifacio Espiritu, operations chief of the civil defense office in Cagayan, told AFP.
By early Friday, Usagi was over the Luzon Strait with a reduced strength of 120 kilometers (75 miles) an hour as it headed toward southern Taiwan, where authorities had downgraded the typhoon to a tropical storm.
But the streak of violent weather was forecast to continue in the central Philippines, where Severe Tropical Storm Man-yi is set to reach coastal waters by Sunday.
The weather service said it could potentially strike at or near the heavily populated capital Manila.
A UN assessment said the past month’s storms damaged or destroyed 207,000 houses, with 700,000 people forced to seek temporary shelter.
Many families were without essentials like sleeping mats, hygiene kits and cooking supplies, and had limited access to safe drinking water.
Thousands of hectares of farmland were destroyed and persistent flooding was likely to delay replanting efforts and worsen food supply problems, the report added.
About 20 big storms and typhoons hit the Southeast Asian nation or its surrounding waters each year, killing scores of people and keeping millions in enduring poverty, but it is unusual for multiple such weather events to take place in a small window.
The weather service said this tends to happen during seasonal episodes of La Nina, a climatic phenomenon in the Pacific Ocean that pushes more warm water toward Asia, causing heavy rains and flooding in the region and drought in the southern United States.

North Korea tests exploding drones as Kim Jong Un calls for mass production

Updated 39 sec ago
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North Korea tests exploding drones as Kim Jong Un calls for mass production

  • Tensions in the region have escalated as Kim flaunts his advancing nuclear and missile program
Updated 39 sec ago
AP
SEOUL: North Korea tested exploding drones designed to crash into targets and leader Kim Jong Un called for accelerating mass production of the weapons, state media said Friday.
The country’s latest military demonstration came as the United States, South Korea and Japan engaged in combined military exercises involving advanced fighter jets and a US aircraft carrier in nearby international waters, in a display of their defense posture against North Korea.
North Korea’s official Korean Central News Agency published photos of Kim talking with officials near at least two different types of unmanned aerial vehicles. They included those with X-shaped tails and wings that look similar to the ones the country disclosed in August, when Kim inspected another demonstration of drones that explode on impact.
The drones flew various routes and accurately struck targets, KCNA said. Its images showed what appeared to be a BMW sedan being destroyed and old models of tanks being blown up.
Kim expressed satisfaction with the weapons’ development process and stressed the need to “build a serial production system as early as possible and go into full-scale mass production,” noting how drones are becoming crucial in modern warfare.
KCNA paraphrased Kim as saying drones were easy to make at low cost for a range of military activities. The report didn’t say if Kim spoke directly about rival South Korea, which the North Korean drones are apparently designed to target.
North Korea last month accused South Korea of sending its own drones to drop anti-North Korean propaganda leaflets over the North’s capital of Pyongyang, and threatened to respond with force if such flights occur again. South Korea’s military has refused to confirm whether or not the North’s claims were true.
Tensions in the region have escalated as Kim flaunts his advancing nuclear and missile program, which includes various nuclear-capable weapons targeting South Korea and intercontinental ballistic missiles that can potentially reach the US mainland.
Kim is also allegedly sending military equipment and troops to Russia to support President Vladimir Putin’s war on Ukraine, which raised concerns in Seoul that he would get Russian technology in return to further develop his arsenal.
In addition to his intensifying nuclear threats, Kim has also engaged in psychological and electronic warfare against South Korea, such as flying thousands of balloons to drop trash in the South and disrupting GPS signals from border areas near the South’s biggest airport.
South Korean officials say North Korea will be a key topic in a trilateral summit between South Korean President Yoon Suk Yeol, US President Joe Biden and Japanese Prime Minister Shigeru Ishiba this week at the Asia-Pacific Economic Cooperation meetings in Peru.
South Korean Foreign Minister Cho Tae-yul and US Secretary of State Antony Blinken met on the margins of the APEC on Thursday and discussed “strong concerns” over deepening ties between Pyongyang and Moscow, particularly the deployment of North Korean troops to support Russia’s war against Ukraine, the US State Department said.

Rebel attacks blamed on Pakistan keep Indian-administered Kashmir on the boil

Updated 9 min 33 sec ago
AFP
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Rebel attacks blamed on Pakistan keep Indian-administered Kashmir on the boil

  • India blames Pakistan for arming militants and helping them “infiltrate” across the militarzed border
  • Pakistan denies it supports militants, says it only offers moral and diplomatic support to Kashmiri people
Updated 9 min 33 sec ago
AFP

SRINAGAR, India: Ambushes, firefights and a market grenade blast: headline-grabbing attacks in Indian-administered Kashmir are designed to challenge New Delhi’s bid to portray normality in the disputed territory, Indian security officials say.
Kashmir has been divided between nuclear-armed rivals India and Pakistan since their partition at the chaotic end of British rule in 1947, and both countries claim the territory in full.
“The attacks are not merely about killing, but also to set a narrative to counter the Indian narrative — that everything is fine,” said the former head of India’s Northern Command forces, retired general Deependra Singh Hooda.
Half a million Indian troops are deployed in the far northern region, battling a 35-year insurgency in which tens of thousands of civilians, soldiers and rebels have been killed, including at least 120 this year.
Prime Minister Narendra Modi’s Hindu nationalist government canceled the Muslim-majority region’s partial autonomy in 2019, a decision accompanied by mass arrests and a months-long communications blackout.
The territory of around 12 million people has since been ruled by a governor appointed by New Delhi, overseeing the local government that voters elected in October in opposition to Modi.
New Delhi insists it helped bring “peace, development and prosperity” to the region.
But military experts say that small bands of rebels — demanding either independence or Kashmir’s merger with Pakistan — use attacks to contradict the claims.
“The larger message being sent out is that the problem in Kashmir is alive,” Hooda said.
India blames Pakistan for arming militants and helping them “infiltrate” across the militarzed dividing line to launch attacks, an allegation Islamabad denies.
A “spurt in infiltration” this year by insurgents was “not possible without Pakistan’s army actively allowing it,” Hooda charged.
Many clashes take place in forested mountains far from larger settlements.
But the huge military presence visible in sprawling camps and roadblocks, roughly one in every 25 people in Kashmir is an Indian soldier, serves as a constant reminder.
Many are frustrated by traffic jams caused by military orders that civilian cars stay at least 500 meters (1,640 feet) away from army vehicles.
Yet those who have long lived under the shadow of the grinding insurgency seemingly shrug off the threat.
When an attacker this month hurled a grenade at security forces in a busy market — killing a woman and wounding 11 civilians — shoppers returned within a couple of hours.
This month, thousands attended an army recruitment drive, even as soldiers battled gunmen in a nearby district. 
Attacks appear dramatic, including a gunbattle in downtown Srinagar in early November that police said killed a commander of the Pakistan-backed Lashkar-e-Taiba militant group.
Earlier this year, attacks in the Jammu area — a Hindu-majority region — prompted the army to supply thousands of militia forces, dubbed village defense guards, with rifles.
But the death toll of 120 civilians, soldiers and rebels killed this year is, so far, similar in intensity to 2023, when 130 people died, according to the South Asia Terrorism Portal, a New Delhi-based monitoring group.
“It will remain like this on low boil, as long as Kashmir is divided (between India and Pakistan),” a security official said, speaking on condition of anonymity because they were not authorized to talk to journalists.
“We control it here; they (Pakistan) will activate it from there.”
The Indian army says around 720 rebels have been killed in the past five years.
Regional army commander MV Suchindra Kumar said in October he believed fewer than 130 remained in the fight.
Another security official, who spoke on the condition of anonymity, said those include “highly trained and well-armed” fighters who had crossed from Pakistan.
“They are causing some damage by surprise attacks,” the official said. “But the situation is under control.”
Hooda, drawing on his long experience as a general, predicts little change as long as violence serves the agenda of India’s rival Islamabad.
“I don’t see this coming down immediately,” he said, referring to the number of attacks.
“Pakistan has always felt that ratcheting up attacks will bring the spotlight on Kashmir.”

Topics: Srinagar

Trump meets with Argentina’s president, the first foreign leader he’s met with since election

Updated 10 min 57 sec ago
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Trump meets with Argentina’s president, the first foreign leader he’s met with since election

  • Javier Milei, a self-described ‘anarcho-capitalist’, is a frequent recipient of Trump praise
  • The Argentine president is known for his eccentric personality
Updated 10 min 57 sec ago
AP
PALM BEACH, Florida: Donald Trump met Thursday at his Mar-a-Lago club with Argentine President Javier Milei, the first foreign leader to meet with the president-elect since his victory in last week’s election.
The meeting was confirmed by a person who insisted on anonymity to discuss an event that hadn’t yet been announced publicly. The person said the meeting went well and said Milei also met with investors.
A short time later, Milei, a self-described “anarcho-capitalist” and frequent recipient of Trump praise, addressed the America First Policy Institute gala at Mar-a-Lago. He spoke briefly in English, then gave a longer speech in Spanish, pausing to allow an interpreter to translate, in which he slammed left-wing ideologies and saluted Elon Musk, the owner of X, saying his social media site is helping to “save humanity.”
Milei criticized a political ruling class that he said was responsible for a system that used unfair tax systems to force “the redistribution of wealth at gunpoint.”
The president of Argentina also congratulated Trump on his “resounding victory” in the election, saying, “Today the winds of freedom are blowing much stronger” and calling the victory “proof positive that the forces of heaven are on our side.”
Trump also spoke to the gala crowd, congratulating Milei “for the job you’ve done for Argentina” and saying it was an “honor” to have Argentina’s president at his club.
“The job you’ve done is incredible. Make Argentina Great Again, you know, MAGA. He’s a MAGA person,” Trump said to applause. “And you know, he’s doing that.”
Shortly after Milei’s election in November 2023, Trump posted on social media, “You will turn your country around and truly Make Argentina Great Again!”
Milei first met Trump in February at the Conservative Political Action Conference, or CPAC, in the Washington area. He has openly declared his admiration for Trump and when he saw him, he rushed to him screaming “president!” and gave him a close hug before they posed for pictures.
The Argentine president is known for his eccentric personality and first made a name for himself by shouting against Argentina’s “political caste” on television. The right-wing populist campaigned with a chainsaw as his prop to symbolize his plans to slash public spending and scrap government ministries.

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Ben & Jerry’s says parent Unilever silenced it over Gaza stance

Updated 15 November 2024
Reuters
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Ben & Jerry’s says parent Unilever silenced it over Gaza stance

  • The ice cream maker has sued Unilever for selling its business in Israel to its licensee there
Updated 15 November 2024
Reuters

NEW YORK: Ice cream brand Ben & Jerry’s said in a lawsuit filed Wednesday that parent company Unilever has silenced its attempts to express support for Palestinian refugees and threatened to dismantle its board and sue its members over the issue.
The lawsuit is the latest sign of the long-simmering tensions between Ben & Jerry’s and consumer products maker Unilever, which is planning to spin out its ice cream business next year.
The spin-out would include the top-selling Vermont-based maker of Chubby Hubby, although experts on corporate governance said the brand’s board, a centerpiece of the new lawsuit, could present challenges to the deal.
A rift first erupted between Ben & Jerry’s and Unilever in 2021 after the ice cream maker said it would stop selling its products in the Israeli-occupied West Bank because it was inconsistent with its values, a move that led some investors to divest Unilever shares.
The ice cream maker then sued Unilever for selling its business in Israel to its licensee there, which allowed marketing in the West Bank and Israel to continue. That lawsuit was settled in 2022.
In its new lawsuit, Ben & Jerry’s says that Unilever has breached the terms of the 2022 settlement, which has remained confidential. As part of the agreement, however, Unilever is required to “respect and acknowledge the Ben & Jerry’s independent board’s primary responsibility over Ben & Jerry’s social mission,” according to the lawsuit.
But, according to the lawsuit, “Ben & Jerry’s has on four occasions attempted to publicly speak out in support of peace and human rights. Unilever has silenced each of these efforts.”
In response to Reuters’ story, Unilever said in an emailed statement: “Our heart goes out to all victims of the tragic events in the Middle East. We reject the claims made by B&J’s social mission board, and we will defend our case very strongly.”
“We would not comment further on this legal matter,” it added.
Ben & Jerry’s said in an email: “We are confident that these issues will ultimately be resolved. Due to the ongoing nature of the litigation, we are unable to comment on the specifics.”
The lawsuit was filed in New York federal court.
Minor Myers, a professor at the University of Connecticut School of Law, said the tension between Ben & Jerry’s and Unilever would be top of mind in a deal, particularly if Unilever’s ice cream brands are acquired by a private equity firm or competitor company.
“The Ben & Jerry’s situation would be front of mind of any possible buyer,” Myers said. “To the extent that Ben & Jerry’s or a subsidiary wants to be liberated to say (what they want, it) may impact the sales of the flagship ice cream brand.”
That would result in a lower valuation for Unilever’s ice cream brands, Myers said.
There are fewer concerns if the ice cream brands become a separate publicly traded company, Myers said.
Ben & Jerry’s said in the lawsuit it has tried to call for a ceasefire, support the safe passage of Palestinian refugees to Britain, back students protesting at US colleges against civilian deaths in Gaza, and advocate for a halt in US military aid to Israel, but has been blocked by Unilever.
The independent board separately spoke out on some of those topics, but the company was muzzled, the lawsuit says.
Ben & Jerry’s said that Peter ter Kulve, Unilever’s head of ice cream, said he was concerned about the “continued perception of anti-Semitism” regarding the ice cream brand voicing its opinions on Gazan refugees, according to the lawsuit.
Unilever was also required under the settlement agreement to make a total of $5 million in payments to Ben & Jerry’s for the brand to make donations to human rights groups of its choosing, according to the lawsuit.
Ben & Jerry’s selected the left-leaning Jewish Voice for Peace and the San Francisco Bay Area Chapter of the Council on American-Islamic Relations, among others, the filing says.
Unilever in August objected to the selections, saying that Jewish Voice for Peace was “too critical of the Israeli government,” according to the lawsuit.
Ben & Jerry’s has positioned itself as socially conscious since Ben Cohen and Jerry Greenfield founded the company in a renovated gas station in 1978. It kept that mission after Unilever acquired it in 2000.
Unilever’s dozens of products include Dove soap, Hellmann’s mayonnaise, Knorr bouillon cubes, Surf detergent and Vaseline petroleum jelly.

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