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As Delta spreads, some travelers double up on COVID-19 vaccine in U.S.

WASHINGTON, Aug 16 (Reuters) – Alison Toni felt lucky to get Sinovac’s COVID-19 vaccine in Chile earlier this year. A month later, she was in Minnesota getting vaccinated again.

Toni, an American living in Chile, was visiting her parents in Minneapolis in April when she got her first Pfizer shot at a CVS pharmacy. She traveled back for the second dose in June. She did not disclose being previously vaccinated.

“They didn’t ask, and I didn’t tell,” said Toni, 55. She took that step after reading that China’s Sinovac vaccine had a lower efficacy than the Pfizer Inc shot, developed with German partner BioNTech, and the Moderna Inc shot, both widely available in the United States. She also consulted with her doctor beforehand.

Toni is among the group of people coming from abroad who have been vaccinated a second time, or plan to do so, in the United States.

Their reasons range from concerns that the vaccines immediately available to them were not effective enough, fears that they require extra protection against the fast-spreading Delta variant, or a need to meet specific requirements for work or travel. Some are seeking medical advice, others are relying on their own research.

A few countries are also beginning to offer a third booster dose to their citizens based on evidence that the initial protection from vaccines wanes over time, or that an extra shot may help prevent infection against Delta, particularly for older people or those with weak immune systems.

Public health officials have not determined if booster doses are needed for the general population, and there is not yet much data on the relative risks and benefits of complete revaccination.

“It is probably more than is needed,” said Jason Gallagher, an infectious diseases expert at Temple University’s School of Pharmacy. “A fourth dose is probably a waste; a third dose is probably unnecessary for a lot of people.”

The World Health Organization (WHO) has urged countries to hold off on boosters while many people worldwide wait to receive their first doses.

Thirty-six-year-old Chilean engineer Ricardo Dayne, who first received Sinovac’s vaccine at home in April got his first Pfizer shot in New York in June.

“Everyone was also talking about the need to have a booster, so I decided to have it.”

‘PROCESS NEEDS TO BE FIXED’

The U.S. Food and Drug Administration (FDA) last week authorized a third vaccine dose for immunocompromised people. Government health officials have estimated that would apply to less than 3% of the adult U.S. population, but have said that eventually, boosters may be required more broadly.

In the meantime, a surplus of vaccines in the United States, along with a decentralized healthcare system, has made it easier for people to show up at pharmacies and vaccination centers for extra doses. The U.S. Centers for Disease Control and Prevention estimates that over 1.2 million Americans have already received at least one extra dose following their initial inoculation.

When asked about travelers doubling up on vaccines, Moderna told Reuters its vaccine is not authorized for this purpose and J&J directed Reuters to the FDA and CDC. Pfizer did not immediately respond to a request for comment.

A CVS Health Corp spokesperson said the company’s policy is to turn away patients who have been fully vaccinated at one of its pharmacies, or who disclose that they have been fully vaccinated elsewhere. A Walgreens spokesperson said its pharmacies ask patients if they have been vaccinated during the appointment process and have alerts in place to check.

Graduate student Jing Wu, 22, said he had no choice. Wu received the Sinovac vaccine in December while in China before moving to the United States to attend Princeton University.

He heard Princeton was planning to require proof of an FDA-approved vaccine. The university’s health service urged him to get vaccinated again and said it would be safe.

He was not reassured.

“I was nervous and stressed about it, but in April I got vaccinated (again),” he said, this time with the Johnson & Johnson shot.

Princeton announced the policy on April 20 but later decided to accept any WHO-approved vaccine, including Sinovac. The university’s health website still states that “there is no known harm from taking additional” vaccines.

The university did not respond to requests for comment.

“If I knew back then the Chinese vaccine would be enough, I wouldn’t have done it,” Wu said.

The United States is developing a plan to require nearly all foreign visitors be fully vaccinated, potentially creating similar issues for many people inoculated with vaccines not approved by the FDA.

Britain and the European Union’s lists of approved vaccines do not include shots made in Russia or China, which have been used in many countries.

Governments should standardize their definition of fully vaccinated to include shots that may not be approved in their countries, but which are still effective, said Dr Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.

“This whole process needs to be fixed, otherwise, as we get more vaccines and more people traveling, this will only happen more,” Adalja said.

Reporting by Ahmed Aboulenein; Additional reporting by Aislinn Laing in Santiago, Carl O’Donnell and Michael Erman in New York; Editing by Michele Gershberg and Aurora Ellis

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Exclusive: India enforcement agency threatens Flipkart, founders with $1.35 bln fine

Small toy shopping cart is seen in front of displayed Flipkart logo in this illustration taken, July 30, 2021. REUTERS/Dado Ruvic/Illustration

NEW DELHI, Aug 5 (Reuters) – India’s financial-crime agency has asked Walmart’s (WMT.N) Flipkart and its founders to explain why they shouldn’t face a penalty of $1.35 billion for alleged violation of foreign investment laws, three sources and an agency official told Reuters.

The Enforcement Directorate agency has been investigating e-commerce giants Flipkart and Amazon.com Inc (AMZN.O) for years for allegedly bypassing foreign investment laws that strictly regulate multi-brand retail and restrict such companies to operating a marketplace for sellers.

The Enforcement Directorate official, who declined to be named, said the case concerned an investigation into allegations that Flipkart attracted foreign investment and a related party, WS Retail, then sold goods to consumers on its shopping website, which was prohibited under law.

A so-called “show cause notice” was issued in early July by the agency’s office in southern city of Chennai to Flipkart, its founders Sachin Bansal and Binny Bansal as well as current investor Tiger Global, to explain why they should not face a fine of 100 billion rupees ($1.35 billion) for the lapses, said the agency official and the sources, who are all familiar with the content of the notice.

A Flipkart spokesperson said the company is “in compliance with Indian laws and regulations”.

“We will cooperate with the authorities as they look at this issue pertaining to the period 2009-2015 as per their notice,” the spokesperson added.

The Indian agency does not make public such notices issued to parties during an investigation.

One of the sources said Flipkart and others have around 90 days to respond to the notice. WS Retail ceased operations at the end of 2015, the person added.

Tiger Global declined to comment. Binny Bansal and Sachin Bansal did not immediately respond to requests for comment. The Enforcement Directorate also did not respond outside regular business hours.

Walmart took a majority stake in Flipkart for $16 billion in 2018, its biggest deal ever. Sachin Bansal sold his stake to Walmart at the time, while Binny Bansal retained a small stake. Walmart did not respond to a request for comment.

Flipkart’s valuation doubled to $37.6 billion in less than 3 years at a $3.6 billion funding round in July, during which SoftBank Group (9984.T) reinvested in the company ahead of an expected market debut. read more

The notice is the latest regulatory headache for the online retailer, which is already facing tougher restrictions and antitrust investigations in India, and a growing number of complaints from smaller sellers.

India’s brick-and-mortar retailers say Amazon and Flipkart favour select sellers on their platforms and use complex business structures to bypass the foreign investment laws, hurting smaller players. The companies deny any wrongdoing.

In February, a Reuters investigation based on Amazon documents showed it had given preferential treatment for years to a small group of sellers, publicly misrepresented ties with them and used them to bypass Indian law. Amazon says it gives no preferential treatment to any seller.

Reporting by Aditya Kalra, Aftab Ahmed and Sanjeev Miglani in New Delhi; Additional reporting by Sankalp Pharityal; Editing by Kirsten Donovan

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U.S. states to unveil $26 billion opioid settlement with drug distributors, J&J – sources

A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake

July 19 (Reuters) – U.S. state attorneys general are expected this week to unveil a $26 billion settlement resolving claims that three major drug distributors and drugmaker Johnson & Johnson helped fuel a nationwide opioid epidemic, people familiar with the matter said on Monday.

Distributors McKesson Corp (MCK.N), Cardinal Health Inc (CAH.N) and AmerisourceBergen Corp (ABC.N) would pay a combined $21 billion, while Johnson & Johnson (JNJ.N) would pay $5 billion. New York on Tuesday is expected to announce the distributors have agreed to a $1 billion-plus settlement with the state, a source said.

The ultimate settlement pricetag could fluctuate depending on the number of states and political subdivisions that agree to the deal or reject it and pursue litigation on their own in hopes of a bigger payout down the line.

More than 40 states are expected to support the nationwide settlement, two sources said. States will have 30 days to decide whether to join the global accord then more time to try to convince their cities and counties to participate in the deal, the sources said.

McKesson has previously said that of the $21 billion the three distributors would pay over 18 years, more than 90% would be used to remediate the opioid crisis while the rest, about $2 billion, would be used to pay plaintiffs’ attorney fees and costs.

Several states have passed laws or reached agreements with their political subdivisions to govern how settlement proceeds would be allocated in the event of a nationwide settlement.

The financial terms are in line with prior disclosures by the three distributors and J&J about what they expected to have to pay following long-running settlement talks.

“There continues to be progress toward finalizing this agreement and we remain committed to providing certainty for involved parties and critical assistance for families and communities in need,” J&J said in a statement.

McKesson and Cardinal Health had no comment while AmerisourceBergen said it does not comment on “rumor and speculation.” They have all previously denied wrongdoing.

Nearly 500,000 people died from opioid overdoses in the United States from 1999 to 2019, according to the U.S. Centers for Disease Control and Prevention (CDC). The opioid crisis appeared to worsen during the COVID-19 pandemic.

The CDC last week said provisional data showed that 2020 was a record year for drug overdose deaths with 93,331, up 29% from a year earlier. Opioids were involved in 74.7%, or 69,710, of those overdose deaths. read more

The distributors were accused of lax controls that allowed massive amounts of addictive painkillers to be diverted into illegal channels, devastating communities, while J&J was accused of downplaying the addiction risk.

Governments have said the money will be used to fund addiction treatment, family support programs, education and other health initiatives to address the crisis.

Other settlements are also being negotiated, with the opioid makers Purdue Pharma and Mallinckrodt Plc (MCDG.MU) now working through the bankruptcy courts to secure support for settlements worth more than $10 billion and $1.6 billion, respectively. read more

The distributors have been in the midst of two trials nationally in the litigation, one in New York and one in West Virginia. They have now agreed to resolve the New York case, a person briefed on the matter said.

The deal with New York Attorney General Letitia James and the populous Long Island counties of Nassau and Suffolk comes three weeks into the first jury trial accusing companies of profiting from a flood of addictive painkillers that devastated communities. read more

Closing arguments are expected in the West Virginia trial next week. Local West Virginia communities had opted out of the proposed nationwide deal to pursue one on their own.

The New York trial will continue against three drugmakers accused of deceptively marketing their painkillers – Endo International Plc (ENDP.O), Teva Pharmaceutical Industries Ltd (TEVA.TA) and AbbVie Inc’s (ABBV.N) Allergan unit.

Reporting by Nate Raymond in Boston; Editing by Sandra Maler, Bill Berkot and Cynthia Osterman

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Britain’s Morrisons agrees $8.7 bln offer from Fortress-led group

A Morrisons store is pictured in St Albans, Britain, September 10, 2020. REUTERS/Peter Cziborra//File Photo

  • Fortress-led group offers 254 pence a share
  • Tops CD&R’s proposal of 230 pence
  • Some investors want 270 pence
  • Morrisons says Fortress would be suitable owner
  • Fortress says it will be ‘good steward’

LONDON, July 3 (Reuters) – Morrisons has agreed to a takeover led by SoftBank (9984.T) owned Fortress Investment Group, valuing Britain’s fourth largest supermarket chain at 6.3 billion pounds ($8.7 billion) and topping a rival proposal from a U.S. private equity firm.

The offer from Fortress, along with Canada Pension Plan Investment Board and Koch Real Estate Investments, exceeds a 5.52 billion pound unsolicited proposal from Clayton, Dubilier & Rice (CD&R), which Morrisons (MRW.L) rejected on June 19. read more

Including Morrisons’ net debt of 3.2 billion pounds, Fortress’ offer gives the group an enterprise value of 9.5 billion pounds.

“We have looked very carefully at Fortress’ approach, their plans for the business and their overall suitability as an owner of a unique British food-maker and shopkeeper with over 110,000 colleagues and an important role in British food production and farming,” said Morrisons Chairman Andrew Higginson.

“It’s clear to us that Fortress has a full understanding and appreciation of the fundamental character of Morrisons.”

The Fortress deal underlines the growing appetite from private funds for British supermarket groups, seen as attractive because of their cash generation and freehold assets.

Fortress, an independently-operated subsidiary of Japan’s SoftBank Group Corp, is a global investment manager with about $53 billion in assets under management as of March. It purchased British wine seller Majestic Wine in 2019.

“We are committed to being good stewards of Morrisons to best serve its stakeholder groups, and the wider British public, for the long term,” said managing partner, Joshua A. Pack.

Fortress intends to retain Morrisons’ existing management team led by CEO David Potts and execute its existing strategy. It said it was not planning any material store sale and leaseback transactions.

RECOMMENDATION

Under the terms of the deal, which Morrisons’ board is recommending to shareholders, investors would receive 254 pence a share, comprising 252 pence in cash and a 2 pence special cash dividend. CD&R’s proposal was 230 pence a share, worth 5.52 billion pounds.

Last week JO Hambro, a top ten shareholder in Morrisons, said any suitor for the group should offer about 270 pence a share or 6.5 billion pounds. read more

Morrisons, based in Bradford, northern England, started out as an egg and butter merchant in 1899. It now only trails market leader Tesco (TSCO.L), Sainsbury’s (SBRY.L) and Asda in annual sales.

Morrisons owns 85% of its nearly 500 stores and has 19 mostly freehold manufacturing sites. It is unique among British supermarkets in making over half of the fresh food it sells.

It said the Fortress offer represented a premium of 42% to its closing share price of 178 pence on June 18 – the day before CD&R’s proposal. The stock closed at 243 pence on Friday.

Morrisons’ directors, who own 0.23% of the group’s equity, would make 14.3 million pounds from selling their shares to Fortress.

CD&R, which under British takeover rules has until July 17 to come back with a firm offer, had no immediate comment.

Morrisons has a partnership agreement with Amazon (AMZN.O) and there has been speculation it too could emerge as a possible bidder.

FIVE PROPOSALS

Morrisons said an initial unsolicited proposal was received from Fortress on May 4 at 220 pence a share. This offer was not made public. Fortress then made four subsequent proposals before it offered a total value of 254 a share on June 5.

The bids for Morrisons follow February’s purchase by Zuber and Mohsin Issa and private equity firm TDR Capital of a majority stake in Asda from Walmart (WMT.N). The deal valued Asda at 6.8 billion pounds. read more

That transaction followed Sainsbury’s failure to take over Asda after an agreed deal was blocked by Britain’s competition regulator in 2019.

In April, Czech billionaire Daniel Kretinsky raised his stake in Sainsbury’s to almost 10%, igniting bid speculation.

read more

($1 = 0.7235 pounds)

Reporting by James Davey; Editing by Jane Merriman

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