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Novavax expected to be approved as fourth Covid vaccine in UK | Vaccines and immunisation



Pfizer, AstraZeneca, Moderna. Britons have become so accustomed to the three Covid vaccines available in the UK that most have forgotten about another jab, Novavax – even though the government has ordered 60m doses and hundreds of British jobs depend on it.

Late last month the US company, with a factory on Teesside primed to manufacture doses, submitted final data to UK regulators and a positive decision is anticipated within days or weeks. It will bring to an end what feels like a long wait compared with the speedy development and approval of the other jabs, including for those who took part in trials.

So what difference would this additional weapon make to the UK’s vaccination armoury? Novavax’s offering is a protein-based jab – similar to those used to protect against flu, and for routine childhood vaccination against pertussis (whooping cough) or meningococcal infection.

Other protein-based Covid vaccines are also in late-stage clinical trials, including one being developed by Sanofi and GSK, again with 60m orders from the UK. Final data from its phase 3 trial is expected any day now, paving the way for the companies to seek regulatory approval.

Whereas existing UK Covid-19 jabs instruct our cells to manufacture the coronavirus spike protein, protein-based vaccines deliver pre-made fragments of it alongside an immune-stimulating adjuvant.

Clinical trials suggest that two doses of the Novavax jab have an efficacy of about 90% against symptomatic Covid – similar to the other approved UK vaccines. It is also undergoing “mix and match” testing with the Oxford/AstraZeneca or Pfizer/BioNTech jabs and preliminary data suggest it generates a robust immune response when given as the second dose.

But it is the emerging signs of reduced side-effects that could make Novavax particularly attractive.

Trial data appear to show the potential for lower “reactogenicity” compared with existing jabs, meaning side-effects such as injection-site swelling, fatigue, headaches and muscle pain occur less frequently. No direct head-to-head comparisons have yet been done, however, and further studies are needed.

“Lower reactogenicity becomes particularly important in groups such as children, where the balance between vaccination and not vaccination becomes a little less clear, simply because, for example, in young children the likelihood of them having severe Covid-19 is so small,” said Prof Paul Heath, the director of the Vaccine Institute at St George’s, University of London, and chief investigator of Novavax’s UK trial.

However, a caveat with any new vaccine is that rarer side-effects may not become apparent until a vaccine is used widely, said Azeem Majeed, professor of primary care and public health at Imperial College London. “Post-marketing surveillance would be needed to identify any previously unknown side-effects,” he said.

The fact that it uses a more established vaccine technology could also make it more appealing. Heath said: “It may well be that those people who have been hesitant about receiving other Covid vaccines may be more open to receiving a vaccine that uses this protein adjuvant technology; it may be something that’s more familiar to them, and therefore will be happy to receive.”

Majeed is less convinced Novavax will make much difference to uptake but can see other benefits to such protein-based vaccines. It can be stored in a standard vaccine fridge at 2C to 8C, making it easier to transport and store than mRNA-based vaccines. He said: “The AstraZeneca vaccine has similar storage requirements to Novavax but the UK government seems to have largely stopped using it.”

Access to a broader range of vaccines would also be helpful if regular booster shots are needed in the future. “Because of Novavax’s simpler storage requirements, it would be easier to use in GP surgeries and pharmacies,” said Majeed.

This combination of easier transport and storage is even more important in developing countries, where low temperature-controlled supply chains are less well established. “Worldwide, the more vaccines the better, particularly if they are low cost and don’t require freezing for storage and delivery,” said Brendan Wren, professor of microbial pathogenesis at the London School of Hygiene and Tropical Medicine.

Jobs could come alongside the new jab, too: in March, Boris Johnson announced that 60m doses would be made in north-east England. Fujifilm Diosynth would manufacture them at its plant in Billingham, while GSK would fill and finish them – package them up in vials – at its operation in Barnard Castle.

About 300 people at FujiFilm are said to have been working on the vaccine, though delays had prompted concerns that jobs would be hit. Fujifilm last month said manufacturing was unaffected by the delay, and it planned to expand its workforce in the years to come.

The local Labour MP, Alex Cunningham, who represents Stockton North, met with a representative of Novavax and said he felt reassured. “I don’t know how long the approvals process will take but hope production will get up and running soon,” he said.

The Novavax jab has already been approved for use in the Philippines and Indonesia. On 4 November, the company submitted an emergency use application to the World Health Organization. If approved, it would be the first protein-based vaccine to be recommended by the WHO.

Novavax told the Guardian that it was now routinely producing high-quality product at commercial scale at multiple sites across the world. The Serum Institute of India is also manufacturing doses, 20m of which have been approved for export to Indonesia.

Silvia Taylor, the senior vice-president of global corporate communications and investor relations at Novavax, said: “Now that the submission [to the UK Medicine and Healthcare products Regulatory Authority] is complete, the timeline is in the hands of the regulatory agencies.”

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Chucky Season 1 Ending Solves Child's Play's 33-Year-Old Plot Hole – Screen Rant



Chucky Season 1 Ending Solves Child’s Play’s 33-Year-Old Plot Hole  Screen Rant

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On Golden Pond play in PG looking to cast boys aged 11 to 15



Miracle Theatre is holding auditions during the first half of December in Prince George for boys aged 11 to 15 for their upcoming On Golden Pond play.

Two young actors will be cast as 13 year old Billy, and Director Ted Price hopes to get some people registering for auditions this week.

“If we get phone calls right through these coming days and into the weekend that would work out really nicely to time it out.”

Price said that this is an excellent opportunity for kids to experience something new.

“You know, each kid is different, but I’ve got to say that over the years I’ve found that the kids find this a really rewarding experience.”

He added that not only does this teach them a bit about responsibility, but also gives them a great experience working with professional actors.

“And so it’s really a kind of learning experience, really kind of wonderful adventure for the kids. It can really help them too with their self confidence, and just a sort of maturing experience, because there is a kind of responsibility and expectation.”

The show is fully cast, except for one of the adult roles, and Billy is double cast to make sure the strain isn’t too hard on parents.

“They’re not there for all the rehearsals and when they are there they tend to be there an hour or two so that it’s nice kind of bite sized portions for the kids.”

Price added that they can be split up so that they aren’t there for every single performance as well.

“If a kid really wants to do this and they get the opportunity, I’ve never come across a youngster who’s regretted it, or ever wanted to, halfway through, say oh, well I don’t want to do this anymore. It’s actually always the opposite.”

The play is slated to run from February 16th to March 13th, and anyone wanting to register their kids, or who wants more information, can contact Miracle Theatre’s Producer, Anne Laughlin, at 250-563-6937.

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FIFA 22 Team of the Group Stage: Release date & predictions



Ultimate Team players were spoiled throughout the Black Friday event, receiving several excellent Signature Signings player items. Here are a few of the new faces set to dominate FIFA 22. 

Ultimate Team’s Signature Signings player items are designed to celebrate some of the most successful transfers in recent times. Some key players have made their mark at their clubs and have earned drastic upgrades. Furthermore, these upgrades are of a permanent variety. 

The following payers enjoyed extraordinary debut seasons at their current club. Here’s a list of the best FUT Signature Signings from worst to best. 

Best FUT Signature Signings: ranked list

EA sports black friday FUT promo

If you were lucky enough to get one of the 14 Signature Signings player items available in packs, chances are you’ve got an above-average player on your hands.

Even if you’ve packed one of the early names on this list, many of the current SBCs available require a Signature Signings item. Therefore, even a Signature Signings player you don’t intend on using has a lot of value.

  1. Raul Jiménez
  2. Jesper Karlsson
  3. Ridle Baku
  4. Andrej Kramaric
  5. Marcus Edwards
  6. Gelson Martins
  7. Axel Witsel
  8. Edouard Mendy
  9. Diego Carlos
  10. Milan Škriniar
  11. Youcef Atal
  12. Rúben Dias
  13. Marcos Llorente
  14. Renato Sanches
  15. Kevin De Bruyne
  16. Wissam Ben Yedder

The five best Signature Signings in Ultimate Team

5. Rúben Dias

Signature Signings Dias

The 2020/2021 Premier League defender of the year is the first of two Manchester City players to earn a Signature Signings item. This 89 overall Dias is a monstrous defender. The Portuguese international is available at around 310,000 coins.

Players may have concerns with his 76 pace but the defender truly doesn’t feel that heavy or clunky. His defending and physical stats are out of this world. There are a ton of great options at right-back to pair with Dias. His Manchester City teammates João Cancelo and Kyle Walker are fantastic choices.

The center-back boasts a high defensive work rate and is easy to link thanks to his Premier League association. Also, an underrated short passing stat of 87 makes him feel like a confident option on the ball. 

4. Marcos Llorente

Signature Signings Llorente

Marcos Llorente’s base card was one of the best midfield options at launch. This special item expands on much of what made him a stellar choice. This card works best at CM thanks to the high attacking work rate.

His pace is excellent for a central midfielder. Llorente is the ideal all-rounder at his position. He does most things really well without truly being exceptional in one given category. He can recover lost balls, dribble past the opponent, and set up goals for your forwards.

The one glaring issue is the fact that this card’s price is currently inflated. Players can scoop up Llorente for around 490,000 coins. This is a steep price for a card that boasts minor upgrades. 

3. Renato Sanches

Signature Signings Sanches

Although Renato Sanches’ overall is not as high as most of the players on this list, his current valuation of around 750,000 should tell you a little bit about how excellent this item is. For starters, the high/high work rate is exceptional for a midfielder that can be utilized on both sides of the pitch.

The ability to excel on offense or defense depending on your play style and squad is incredibly valuable. The midfielder’s pace, dribbling, and physicality are top tier while above-average passing stats are also a welcome sight.

Sanches is no slouch in front of goal either – 93 shot power and 84 long shots mean he can strike from distance. With Ligue 1 items running rampant this year, Sanches is an incredibly popular choice as a CDM, CM, or CAM. 

2. Kevin De Bruyne

Signature Signings De Bruyne

After much deliberation, De Bruyne slots in at the number 2 spot. His influence on the current state of FUT is going to be powerful. Without a doubt, Signature Signings De Bruyne is one of the best midfielders in the game.

Firstly, he’s quite easy to link with his ties to Manchester City. 5* weak foot is a wonderful trait for high-level players to have. This makes De Bruyne a dual-threat driving up the middle of the pitch. Just because De Bruyne’s passing is absurdly excellent, don’t think you won’t be taking your chances in front of goal. The midfielder is more than capable of netting his own goals thanks to amazing shooting stats.

De Bruyne is best utilized as a CAM or CM. Make sure to boost his pace with a chemistry style given that it is the only area that needs an increase. The Belgian is one of the smoothest midfielders in FUT at the moment. 

1. Wissam Ben Yedder

Signature Signings Ben Yedder

Given how amazing De Bruyne’s item is, this may seem like a controversial decision. However, Ben Yedder has all of the qualities to effortlessly torment opposing defenders. One look at the card and it’s clear that Ben Yedder is going to be a nightmare in the Weekend League.

Signature Signings Ben Yedder has received one of the most significant upgrades in comparison to his base card. It’s always nice when a hefty price tag of around 860,000 is justified by a massive upgrade. Still, this item remains an unattainable luxury for most players. Those lucky enough to get their hands on him have a top-class striker at their disposal.

His links to Ligue 1 and his French nationality make him supremely easy to build a team around. The high/low work rate and 5* weak foot is the best possible combination for a striker. A striker’s three most important categories are dribbling, pace, and shooting. Suffice to say, Ben Yedder excels at all three.

Increasing pace and shooting with a hunter chemistry style is going to result in goal after goal for your team. Ben Yedder is an extremely meta option for high-level players and is the best card of the Signature Signings promo. 

The positive reception of Ultimate Team’s Black Friday content has FIFA 22 players excited at what’s to come next. Hopefully, EA continues to deliver quality player items that are accessible through various means. 

For all of the latest FIFA 22 news keep an eye on Charlie INTEL. 

Image Credits: EA

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