Tag Archives: decide

US FDA Sets January Target to Decide on Approval of Pfizer’s COVID-19 Shot

(Reuters) – The U.S. health regulator will review Pfizer and German partner BioNTech’s application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said on Friday.

The target action date does not mean the approval will not happen before January, the U.S. Food and Drug Administration’s Acting Commissioner Janet Woodcock said on Twitter.


https://bit.ly/36Ixfkm

“Quite to the contrary, the review of this BLA (biologics license application) has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date.”

The vaccine is among the three being used in the United States under the FDA’s emergency use authorization, alongside shots from Johnson & Johnson and Moderna Inc.

If approved, it would be the first shot to get the agency’s full approval based on longer-term data on safety and effectiveness, potentially helping ease vaccine hesitancy as the country witnesses new outbreaks in some parts, mainly due to the highly infectious Delta coronavirus variant. 

Over 85 million Americans have been fully vaccinated with Pfizer’s vaccine, according to latest government data.

Pfizer/BioNTech finished submitting their application for a full U.S. approval in May and the agency will review the data under its “priority review” pathway.

The FDA in May expanded the emergency use of the two-shot vaccine to children 12 through 15 years of age.

The companies said on Friday they intend to submit an application to support approval of the vaccine in this age group once the required data is available six months after the second dose.

Moderna filed for full U.S. approval of its COVID-19 vaccine for adults early in June.

Reuters Health Information © 2021 Reuters Ltd.

Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Read more
This post originally posted here Medscape Medical News

Best England football song – You decide in our Euro 2020 poll

Euro 2020: Is football coming home for England?

This weekend England fans witnessed the national team triumph over Ukraine in a stunning display. The Euro 2020’s quarter-finals ended with Kane’s boys winning 4-0 to line up a semi-final clash with Denmark on Wednesday. At 8pm Gareth Southgate’s side go up against Denmark in the semi-final, and they will need all the support they can get from England fans – and what better way than to chant one of the country’s legendary songs?

With so many iconic tracks to choose from, scroll down to have your say on which song is the best in our poll.

Best England football song

Three Lions (Football’s Coming Home)

When football fans are keen to show their support for England at the World Cup or the Euros, they would be hard-pressed to not think of David Baddiel and Frank Skinner’s legendary 1996 anthem.

The comedy duo worked with The Lightning Seeds’ Ian Broudie to write the track to commemorate the 1996 Euros which was hosted in England – the first time since 1966.

Although Germany ultimately won the competition, England claimed the top scorer accolade, with Alan Shearer scoring five goals throughout the event.

England was knocked out in the semi-finals after playing Germany. The teams drew 1-1 and went to penalties, which the Germans won 6-5.

Is Three Lions (Football’s Coming Home) your favourite football song? Vote in the poll at the bottom of this article.

Vindaloo

British band Fat Les, containing actor Keith Allen and Alex James of Blur fame, wrote Vindaloo.

The track was written and released to commemorate England’s participation in the 1998 World Cup.

The iconic song is instantly recognisable and utilises the timeless “nah nah nah”s that are still screamed in football stadiums to this day.

The anthem reached number two in the UK Singles Chart. However, it was just beaten by Three Lions ’98, the revitalisation of the Three Lions (Football’s Coming Home) song from two years prior.

Is Vindaloo your favourite football song? Vote in the poll at the bottom of this article.

https://youtu.be/3v-Z9avPN0c

Atomic Kitten – Whole Again (Gareth Southgate Version)

England fans were extremely hopeful during the 2018 FIFA World Cup.

Although England ultimately came fourth in the competition, the support surrounding the team was stronger than ever.

A lot of the encouragement was aimed at England’s waistcoat-clad manager, Gareth Southgate.

The pop hit Whole Again by Atomic Kitten has been adopted as a symbol of support for Southgate.

The lyrics croon: “Looking back on when we first met / I cannot escape and I cannot forget / Southgate, you’re the one / You still turn me on / Football’s coming home again.”

Meat Pie, Sausage Roll

British comedian Smug Roberts contributed to the football anthem discography in 1998 with Meat Pie, Sausage Roll.

The hilarious track was performed and released by one of Smug Roberts’ personas, Grandad Roberts.

Despite the song originally beginning on Smug Roberts’ comedy radio show on Key 103, it has become a staple chant in almost every football event.

World in Motion

Before being featured in Gavin & Stacey, New Order’s iconic World in Motion changed the game for football anthems.

Not only was it extremely catchy, but it also included a guest rap from England footballer John Barnes.

Barnes has since laid down his historic bars on various occasions, proving that World in Motion is still a contender in the football song world.

Barnes even beat other members of the team to claim the featured spot, including Peter Beardsley, Paul Gascoigne and Chris Waddle.

The song was the anthem for the 1990 World Cup in Italy, which saw England crash out on penalties against old foe Germany.

Ant & Dec – We’re On The Ball

The Newcastle duo has been a part of TV and music culture in the UK for decades and their 2002 hit We’re On The Ball was another example of their popularity.

The song was a smash hit to English audiences as it reached number three in the UK Singles Chart.

The cheeky tune was the England football team’s “official song” of the 2002 FIFA World Cup.

In their music video for the track Ant & Dec dressed up as then-football manager Sven-Göran Eriksson.

The Farm – All Together Now

The song was written originally about the World War One Christmas truce between German and British troops in the trenches in 1914. It was released back in 1990 and soon become an anthem in clubs up and down the United Kingdom.

Then, in 2004, the song was re-released for the European Championships in Portugal, peaking in the UK Singles Chart at number five – one lower than its 1990 performance.

The song would later be re-worked by Atomic Kitten for the 2006 World Cup.

Author: Callum Crumlish
Read more here >>> Daily Express

Dr Chris highlights four coronaviruses that decide when Brits will need boosters

During February to June 2021, 60 percent of people who caught coronavirus were not vaccinated against Covid.

In the same time period, only eight percent of fully vaccinated people caught the virus.

Dr Chris added that if the UK achieves its aim of having all adults vaccinated by the late summer, alongside booster jabs, “we’ll be in really good shape later this year”.

This will mean “we don’t see cases turning into causalties”.

Author: Chanel Georgina
Read more here >>> Daily Express :: Health
Read More

Leander voters will decide whether to keep Capital Metro

KXAN Live’s Will DuPree has a live interview with new Leander Mayor Christine Sederquist at 1:30 p.m. that will be broadcast on KXAN.com and on our Facebook page.

LEANDER (KXAN) — Leander’s decision over whether to keep or ditch Capital Metro is now in the hands of voters. The Leander City Council voted 6-1 Thursday night to put the Capital Metro’s future relationship with Leander on an upcoming ballot.

If voters decide to cut ties with CapMetro, that would end the city’s bus and train service immediately.

This vote took place as one of the last acts of outgoing Leander Mayor Troy Hill. Incoming Mayor Christine Sederquist and Council Member Becki Ross were sworn in right after the CapMetro vote.

Voting as a Leander City Council member and not as mayor, Sederquist was the lone person to vote against the ballot item. Mayor Hill and Council Members Kathryn Pantalion-Parker, Annette Sponseller, Jason Shaw, Chris Czernek and Marci Cannon voted in favor.

The City Council still has to order an election before it can place the Capital Metro item on the ballot. That’s expected to happen by Aug. 16 to get this on the November ballot.

Why Leander would ditch Capital Metro

Leander’s Capital Metro station. (KXAN Photo)

In July 2019, Leander seriously considered ending its run as a member city with Capital Metro due to the cost. Currently, Leander pays for CapMetro through a one percent sales tax. In 2018, that translated to about $ 5 million.

But at the time, then-Mayor Hill said this accounted for half of Leander’s annual sales tax revenue. He said he did not think the service the city was receiving was worth the cost. Hill suggested Leander leave as a member city and then contract with CapMetro, similar to what Round Rock does for bus service. He said that financial obligation would not be as large.

If a member city leaves Capital Metro, the Texas Transportation Code requires it to still pay off millions in financial obligations. In 2019, that would have been $ 9.1 million. KXAN will ask Friday what that penalty would be in 2021.

Leander added train stops — but then the pandemic hit

After meeting with CapMetro, Leander ultimately decided not to pull out of its agreement with CapMetro, and CapMetro announced extra services for the city, including more rail stops, and the introduction of its Pickup Service to request rides within six miles of the train station.

CapMetro reacts to Leander City Council’s decision

In a statement, Capital Metro questioned the way the Leander City Council went about this decision, saying it did so with no public notice or public input. It also mentioned the recent return of Saturday rail service and service from Leander to the Domain and Austin FC’s Q2 Stadium.

“Capital Metro is committed to continuing to serve the residents of Leander who rely on and enjoy the benefits of our services. We were not notified of this potential action prior to the Leander City Council meeting, as it was not posted in a manner to give public notice or receive public input from the Leander community on this specific action.

“We recently announced the return of Saturday rail service, and we saw our Leander customers respond positively—especially as many people are making summer plans, venturing out to the Domain, and planning their very first trips to Q2 Stadium.

“We look forward to continue working with the new Mayor and council on our partnership.”
Capital Metro

Author: Wes Wilson
This post originally appeared on KXAN Austin

I’m A Celeb bosses under pressure to decide location for new series

I’m A Celeb bosses are reportedly under pressure to make a decision about where the next series of the show will be.

It is claimed they must make a decision within two weeks.

The popular reality TV show is normally held in Australia but the Covid pandemic meant last series was held in a castle in Wales.

And now bosses are set to make a decision, and fast, the Mirror reports.

While Australia is the preferred, there are fears that another Covid outbreak would see the series scrapped all together if it was to return Down Under.

A source told Mail Online that “it’s decision time” for the producers, with Wales pencilled in up to now.

The source added: “However if they choose Australia there is every chance it could be cancelled later down the line because of Covid If they choose Wales, it is guaranteed it will happen.”

They revealed that it costs more to film in Wales due to the fact they’d have to build a set. But they said time is running out to make the decision, with plans in place for both locations.

Earlier this week the Prime Minister of Australia, Scott Morrison, said the country’s borders should remain shut as reopening them too soon would leave the country exposed to a more ruthless outbreak of Covid.

The country’s Finance Minister Simon Birmingham also said to push the date of reopening to 2022.

The contestants of the show would normally fly to Australia in November but Qantas has delayed international flights until late December.

Last week, hosts Ant and Dec said plans were “up in the air” but they admitted that they “would happily go back to Wales”.

Dec told TV presenter Lorraine: “It’s still all up in the air, people are having conversations with Australia to see if they’ll let us in.

“If not, we’ve got a lovely alternative to go back to Wales, which we had a great time there.”

ITV have been contacted for a comment.

Author: [email protected] (Jamie Roberts, Lucy Marshall)
This post originally appeared on Hull Live – Celebs & TV

Chelsea and Man City denied Wembley Champions League final as UEFA decide location

Porto is set to stage the Champions League final between Chelsea and Manchester City, according to reports. UEFA have been forced into a rethink amid Turkey’s ongoing struggle with the coronavirus pandemic, meaning the showpiece is set to move to Portugal from Istanbul for a second successive season.
Turkey was placed on England’s red list at the end of last week meaning fans will be unable to make the journey to support their teams.

Talks were immediately held between UEFA and the UK government about the prospect of bringing the final to England.

Wembley Stadium, where the two sides met in the FA Cup semi-final last month, was reportedly the frontrunner to host the biggest game in club football.

Villa Park and the Tottenham Hotspur Stadium was also said to be under consideration.

However, according to The Telegraph, Porto’s Estadio do Dragao is now set to host the final at the end of the month.

JUST IN: Frank Lampard ‘leading contender’ for Crystal Palace job four months after Chelsea sacking

UEFA were initially planning to hand both clubs at least 4,000 tickets for the final and that will still be the plan if the final moves to Porto.

On the field, the final is nicely poised with Chelsea flying high under Thomas Tuchel and City now officially the Premier League champions once again.

Yet while they may be the best team in England this season, Chelsea appear to have their number since Tuchel replaced Frank Lampard.

He has won both meetings against Guardiola’s side, beating them 1-0 in the FA Cup semi-final and 2-1 at the Etihad Stadium in the Premier League last Saturday.

Pundit Rio Ferdinand believes Tuchel may just be Guardiola’s bogey opponent, something that stands Chelsea in good stead heading into the meeting.

“It seems Tuchel has his number at the moment. If there’s one manager on the planet, then Tuchel is that guy,” Ferdinand said.

“Will there be a bit of a carryover from those two results? I think there will, yeah.

“There will be an underlying uncertainty, there won’t be a pure 100 per cent conviction that they have going into every game usually.

“The only thing I’d say about Chelsea, what he’s been able to do against the top teams and in the Champions League, he’s made teams alter the way they play against them.

“He’s made it scruffy at times, they’re a hard team to play against, they’re rough, ready, aggressive, quick in transitions, they’re not an easy team to turn over.

“Pep knows he’s in for a game this time and tactically Tuchel is an astute manager.”

Author:
This post originally appeared on Daily Express :: Sport Feed

One Question Will Probably Decide the Epic-Apple Lawsuit

The Epic v. Apple antitrust trial is going to be complicated. Experts from each side will present consumer data and economic theories. Executives will be grilled on business practices and forced to explain incriminating emails. Lawyers will put their own spin on what it all means. But, ultimately, the case is likely to come down to a deceptively simple question: What’s the market?

In its lawsuit, Epic Games, the company behind blockbuster video games like Fortnite, accuses Apple of having built a monopoly over iPhone and iPad games by requiring all apps to be downloaded through its App Store. Apple uses that monopoly, the suit alleges, to extract unfairly high fees from developers—up to a 30 percent cut of all transactions—who have no choice but to use Apple’s payment system if they want to reach its users. (Epic makes similar complaints about Android in a lawsuit against Google that doesn’t yet have a trial date.)

In its defense, Apple makes a number of counterarguments, but the most important is this: The App Store is not a monopoly. People can download games in all sorts of other places, like Android phones, gaming consoles, and desktop operating systems. Epic can focus on attracting customers on those platforms if it doesn’t like Apple’s terms of service.

Resolving this dispute comes down to how Judge Yvonne Gonzalez Rogers, presiding over the federal trial that began this week, chooses to define the relevant market. That’s a crucial step in many antitrust cases, because to prove a monopoly, you have to show there’s a market that’s being dominated. If Rogers accepts Apple’s market definition, then Apple wins. In a market that includes Android, Xbox, and laptops, there’s no way to say Apple has a monopoly on game distribution. And if it has no monopoly, Epic’s other allegations don’t matter.

That means Epic needs to convince the judge that the market should be defined more narrowly as, simply, iOS apps. Apple, of course, has a 100 percent market share of distribution of mobile apps on its own platform. (Some owners have hacked their devices to be able to run non-sanctioned apps, a process known as “jailbreaking,” but that’s a tiny fraction of users.) So if Epic wins on the market definition issue, it automatically proves that Apple has a monopoly. That is most likely the biggest legal hurdle it has to clear.

It might sound odd to say that one brand can count as an entire market, but there is precedent for it in antitrust law. In a major 1992 case, Kodak was sued for pushing customers toward its own repair services, squeezing out the independent businesses that provided repairs and equipment for Kodak copy machines. Kodak argued that anyone who didn’t like it could stop buying Kodak machines. But the Supreme Court disagreed. Sometimes, the Court noted, “one brand of a product can constitute a separate market.” In this case, from the customer perspective, once someone owned a Kodak copier it didn’t matter that other brands were on the market. Kodak had created an “aftermarket” for repairs. The key point was something called interchangeability: “service and parts for Kodak equipment are not interchangeable with other manufacturers’ service and parts.”

Epic is making a similar claim about Apple: that the iPhone has created an aftermarket for apps. In that aftermarket, you can’t say that an iPhone game is interchangeable with an Android game, let alone an Xbox download. Some legal experts, however, are skeptical that that argument will work. Paul Swanson, an antitrust attorney in Denver, pointed out that Kodak allowed the third-party repair market to grow for years before deciding to crush its competitors, whereas Apple has designed the iPhone (and iPad) as a walled garden from almost the very beginning: Since the App Store launched in 2008, a year into the iPhone’s existence, developers have always had to go through it and accept its terms before reaching customers. Courts tend to be shy about forcing companies to change their business models.

Author: Gilad Edelman
This post originally appeared on Business Latest

Lubbock voters decide West Texas city become sanctuary city

A sign opposing a proposed city ordinance that would ban abortions inside Lubbock city limits outside of an early voting loc…

A banner supporting a proposed city ordinance that would ban abortions inside Lubbock city limits hangs from Trinity Church …

Groundswell of activism

Kiran Thompson holds a sign supporting Proposition A across from the Lubbock Planned Parenthood location on April 27, 2021, …

The movement spreads

Author: Shannon Najmabadi
This post originally appeared on The Texas Tribune: Main Feed