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Moderna Says Will Request US, Europe Vaccine Authorization Monday


US firm Moderna said it would file requests for emergency authorization of its Covid-19 vaccine in the United States and Europe on Monday, after full results confirmed a high efficacy estimated at 94.1 percent.

The highly-anticipated news comes as the US braces for a supercharged post-Thanksgiving coronavirus surge.

More than 265,000 Americans have died from the disease and 93,000 are currently hospitalized.

"We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death," said the company's CEO Stephane Bancel.

If the US Food and Drug Administration agrees it is safe and effective, the first of the drug's two doses could be injected into the arms of millions of Americans by the middle of December.

American pharmaceutical Pfizer and Germany's BioNTech applied for similar approvals last week, and their vaccine could be greenlit in the US shortly after December 10.

The Moderna vaccine, which was co-developed with the US National Institutes of Health, is being studied in a clinical trial with more than 30,000 participants across the United States.

An interim analysis announced earlier this month was based on 95 patients who fell sick with Covid-19.

The final analysis was based on 196 cases, 185 of which were observed in a group assigned a placebo versus 11 who received the shots.

Thirty people had severe cases -- all of whom were in the placebo group -- which also included one person who died.

Significantly, efficacy was uniform across age, race, ethnicity and gender, the company said.

The 196 Covid-19 cases included 33 adults over the age of 65, and 42 participants identifying as being from diverse communities (including 29 Hispanic, six Black, four Asian Americans and three multiracial participants).

Moderna's headquarters in Cambridge, Massachusetts -- the company will file for emergency authorization of its Covid-19 vaccine in the United States and EuropeModerna's headquarters in Cambridge, Massachusetts -- the company will file for emergency authorization of its Covid-19 vaccine in the United States and Europe Photo: AFP / Joseph Prezioso

The vaccine was generally well tolerated, with the most common side effects including injection site pain, fatigue, muscle pain, joint pain, headache, and redness at the site.

These increased in frequency and severity after the second dose in the vaccinated group.

The press statement included the line: "no new serious safety concerns have been identified by the Company" -- but it did not explicitly say whether serious concerns have been flagged previously.

Outside experts welcomed the new results, particularly the absence of any severe Covid-19 cases in the vaccine group.

"Prevention of severe disease and hospitalization can be expected to significantly reduce pressure on overstretched health services, provided that a sufficient proportion of the high risk population can be vaccinated," said Penny Ward, a visiting professor in pharmaceutical medicine at King's College London.

Both the Moderna and Pfizer vaccines are based on a new technology that uses mRNA (messenger ribonucleic acid) to deliver genetic material to the body that makes human cells create a protein from the virus.

This trains the immune system to be ready to attack if it encounters SARS-CoV-2.

But Moderna's vaccine can be kept in long term storage at -20 degrees Celsius (-4 degrees Fahrenheit) while Pfizer's requires -70 degrees Celsius (-94 degrees Fahrenheit).

Moderna said it expects to have approximately 20 million doses of the vaccine, called mRNA-1273, available in the US by the end of the year.

It also expects to manufacture 500 million to 1 billion doses globally in 2021.

Top US scientist Anthony Fauci warned on Sunday of a "surge upon a surge" in Covid-19 cases after millions of Americans travelled and socialized over the Thanksgiving holiday.

Copyright AFP. All rights reserved.


Source: Moderna Says Will Request US, Europe Vaccine Authorization Monday

UK woman who has travelled Europe for six years goes missing in Pyrenees


A British woman who has spent six years travelling across Europe has gone missing while on a solo hiking tour in the French Pyrenees.

Esther Dingley, 37, had been travelling with her partner, Dan Colegate, since 2014, with the couple’s travel adventures well-documented in a blog and in the national press. She had embarked on a month-long solo trip when she went missing.

Dingley, originally from Durham, had taken their van on the lone adventure, which was due to come to an end on Wednesday, while her partner stayed in Gascony, France.

An urgent search is now under way after Dingley last spoke to Colegate via WhatsApp last Sunday when she was atop Pic de Sauvegarde on the French-Spanish border. According to him, they discussed how excited they were to see each other as she was on her last trip before driving back.

The previous day, Dingley walked from Benasque, Spain and planned to spend Sunday night at Refuge Vénasque in France. She was last seen at about 4pm last Saturday, with Colegate saying there had been no sign of her since.

The Peloton de Gendarmerie de Haute Montagne confirmed it was searching for Dingley.

In a Facebook post on Saturday, Colegate shared the last picture Dingley sent him before she vanished.

Esther Dingley and Dan Colegate. Photograph: www.estheranddan.com

“The only purpose of this post is to ask for prayers, thoughts, candles and whatever you have,” he wrote. “I’ve not been saying anything, but this wonderful person believes in the power of positive thought and right now I’ll take anything if it means that she can be found.

“I need her back. I can’t face the alternative. I’m heading back up searching now so I can’t reply to comments or messages. Sorry for the haste and inadequacy of these words.”

The couple, who have been together for 18 years, hit the road in 2014 with their five dogs after Colegate almost died of an infection following surgery.

They regularly posted about their adventures on their blog, Esther and Dan, and seven days ago they were featured in a BBC article discussing how they swapped their careers and a permanent home for motoring through the mountains, valleys and coastlines of Europe.

Colegate said he had joined French police teams using helicopters and dogs in the search for Dingley. “She always tried to keep in touch but sometimes on her hikes was out of contact for a couple of days,” he said. “This is not looking good.”


Source: UK woman who has travelled Europe for six years goes missing in Pyrenees

Christmas, coronavirus and fear of no-deal Brexit push Europe's warehouses to the limit


a large orange building: Christmas, coronavirus and fear of no-deal Brexit push Europe's warehouses to the limit © Reuters/EUROPA WORLDWIDE GROUP Christmas, coronavirus and fear of no-deal Brexit push Europe's warehouses to the limit

By Victoria Waldersee

CONSTELLATION BRANDS, INC.

LISBON (Reuters) - Retailers worldwide have never had more reason to pack warehouses to the brim and keep stock closer to shoppers who continue to buy a record number of items online.

As well as stocking up for Christmas and any potential coronavirus-related lockdowns, Europe and the UK will soon have Brexit to deal with.

British companies are bringing as much as possible into the country before potential disruptions in January, while their European counterparts are piling up goods in pan-European distribution hubs close to ports like Hamburg or Rotterdam.

E-commerce management platforms including ZigZag and Global-e-- which serve Forever 21, Boohoo, Gap, Selfridges and Hugo Boss --- said around 30-35% of UK retailers' sales are to customers in continental Europe. Brands popular in the UK like Chinese e-commerce retailer Shein or American sportswear brand Under Armour are currently stocked exclusively in the EU, ZigZag CEO Al Gerrie said.

a harbor filled with lots of luggage: FILE PHOTO: Stockpiling ahead of Brexit is seen in a warehouse in Rotterdam © Reuters/PIROSCHKA VAN DE WOUW FILE PHOTO: Stockpiling ahead of Brexit is seen in a warehouse in Rotterdam

The rise in e-commerce throughout the year as a consequence of the pandemic had already pushed warehouse space to the limit.

"Most carriers already operated at Christmas volumes during the first wave. If you now add the Christmas effect on top, it's just getting even more challenging," CFO of European e-commerce retailer Zalando, David Schroeder, said in November.

Demand for storage space after Brexit could shoot up even further as retailers seek to avoid customs checks and, if no deal is struck, tariffs.

"Retailers won't want to be caught out again," said Nick Cook, head of Europe for warehouse owner GLP, referring to the potential supply shocks Brexit could bring. Their warehouses, covering 3.3 million square metres in continental Europe and 700,000 in the UK leased to companies including H&M, Amazon and DHL are currently 97% occupied.

STOCKING UP

In the UK, leasing volumes for commercial warehouse space are at record levels of 32.5 million square feet and projected to grow to 40 million by the end of the year, according to real estate advisory firm CBRE.

Logistics operator Europa Worldwide Group, which delivers goods for retailers and third parties like DHL and Amazon, is holding 60% more e-commerce products than this time last year, the company said.

Shoe producer Vivo Barefoot said it was shipping as many shoes as possible from its Portugal manufacturing site to its UK warehouse ahead of December.

M&S, Next, and Primark said earlier this year their warehouses were still holding unsold summer clothing.

Even after the pandemic, demand for warehouse space is expected to remain high as customers now used to ordering online continue to do so. E-commerce generally requires around three times as much warehouse capacity as physical retail, according to figures from Prologis.

SPREADING OUT

Warehouse developer Panattoni Chief Executive Robert Dobrzycki said pandemic border closures spurred retailers to separate stock by country instead of stocking for several countries in one shared warehouse space.

"We're seeing a move away from just-in-time logistics strategies and increasingly towards just-in-case," said Andrew Jones of property firm Londonmetric in a November earnings call. "Not only in the period we're all living through at the moment, but also the period we're going to live through post-Brexit." Retailers could also seek to split logistics operations across the UK and EU to avoid charges.

Even with a deal, cross-border traders will have to pay charges on goods travelling between the UK and EU and track every order with commercial paperwork. Britain’s logistics industry estimates that 250 million customs declarations a year will be needed for EU trade.

Holding stock in both markets would eliminate that problem and is a solution the biggest players have opted for. Amazon said in July that from December 28 onwards it would no longer distribute goods for merchants between the UK and the EU – instead, they would have to send their stock separately to fulfilment centres in both regions.

Meanwhile other industry players are beginning to discuss options like converting agricultural buildings, empty space on run-down high streets or vacant basements into warehouse space, according to research by firms including Savills and JLL.

But the construction and conversion process is slow and has been hit by delays during the pandemic and many plans are still a pipe dream.

"At this point, you may just need to choose your market," Tim Crighton, head of EMEA at real estate advisory Cushman & Wakefield, said.

Parker Lane Group, a UK-based returns facility with offices in Barcelona and Warsaw, said some clients were positioning goods to mitigate tariffs but others said very few of their customers had made any arrangements yet.

"Retailers haven't pulled the trigger just yet, because of the uncertainty around Brexit," Al Gerrie of ZigZag said.By the time they do, there may not be much space left to lease.

"If people want warehousing today, you're looking at older, second-hand, more functionally awkward space, without the same height or loading doors of newbuilds,” Paul Weston, head of Prologis for the UK, said.

(Reporting by Victoria Waldersee in Lisbon, Michael Kahn in Prague, Sonya Dowsett in Madrid; Additional reporting by James Davey; Editing by Vanessa O'Connell, Elaine Hardcastle)


Source: Christmas, coronavirus and fear of no-deal Brexit push Europe's warehouses to the limit



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