(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.
“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.
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Arsenal have signed Nuno Tavares and are hopeful of adding both Ben White and Albert Sambi Lokonga in the coming days and weeks as they step up their transfer business – but they have yet to find a new long-term option in the No 10 role; another of their summer priorities.
Of their possible options for the position, Martin Odegaard has returned to Real Madrid after his Emirates loan while James Maddison is tied down for the long term at Leicester and free agent Hakan Calhanoglu swapped AC Milan for Inter Milan.
Houssem Aouar of Lyon is another target with his price tag having been slashed due to financial difficulties and the Gunners having wanted him last summer, but The Athletic say interest from the north Londoners has actually now cooled.
Per their reports, the Arsenal boardroom have not reached a complete consensus over whether or not the Frenchman is the right attack-minded fit for Mikel Arteta’s team.
The Gunners will therefore have to move on to alternative targets. Express Sport takes a look at five players who could provide feasible options this summer as Arteta seeks a player who can dovetail with Emile Smith Rowe as well as occasionally operating as the side’s only playmaker.
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Out of contract in a year’s time, Isco could be on the move this summer and for a bargain price unless he shows a willingness to sign a new contract.
Some reports have claimed the 29-year-old, with 336 Real Madrid appearances and 38 Spain caps, could be available for as little as £6million.
Carlo Ancelotti more recently has more recently hinted that he could get a chance, hailing his “great desire, excitement and hunger” in training.
Still, a bid might tempt Los Blancos to part ways with the classy long-serving attacker who can also operate as a central midfielder or as a winger, given he totalled just 1,092 minutes across 29 games last term for an average of just 38 minutes per appearance.
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Former Paris Saint-Germain academy talent Nkunku was looked at by Unai Emery in his early days at Arsenal with the pair having worked together in the French capital.
Nkunku has since spent the past two seasons with RB Leipzig having played in just about every role imaginable from central midfield, attacking midfield, right wing, left wing and centre-forward.
The dynamic 23-year-old Frenchman has produced 12 goals and 27 assists for Leipzig and a £27m price tag has previously been mooted for the player.
Nkunku’s versatility makes him one of Arsenal’s most exciting options although Leipzig have already lost several key players this summer in Dayot Upamecano and Ibrahima Konate.
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Paqueta only joined Lyon from AC Milan in the summer of 2020 but enjoyed a strong first season at the club, contributing 10 goals and six assists in 34 games.
The Brazilian, rated at around £31.5m by Transfermarkt, is under contract until 2025 but Lyon’s financial problems might tempt them into parting ways after only 12 months.
Still just 23, Paqueta – who scored Brazil’s winner as they reached the Copa America final earlier this month – has impressed in France after struggling to establish himself in Italy.
A quick and direct attacker, Paqueta’s struggles in Milan do not fairly summarise his talents and he can play as a No 10 in a 4-2-3-1 system or as a deeper midfielder in a 4-3-3.
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Long linked to the Premier League, Fekir almost joined Liverpool in 2018 and has been heavily tipped to move to the Emirates over the past two years. He’s currently out in Spain with Real Betis, where he has spent the past two seasons.
The ex-Lyon attacking midfielder, a World Cup winner with France, produced 11 direct goal contributions in 38 games last term after 14 in 33 the previous season.
The 27-year-old might be gettable given Betis finished 10th in La Liga last term though they’d likely still want to make a profit on the £17.7m they paid two years ago.
Fekir’s stock is not as high as it once was but he’s still a very talented forward who can play on the right or the left as well as centrally or as a centre-forward or a second striker.
Turning 22 on the first day of August, the Austrian international has enjoyed an excellent last two seasons with Hoffenheim and even scored for his country at Euro 2020 in a 1-0 win over Ukraine.
Another versatile player, with Baumgartner capable of playing wide left, in central midfield, as an advanced midfielder or as a striker or second striker, he contributed nine goals and seven assists in 41 games last season.
Linked with Liverpool and Manchester United, Baumgartner has spent four years in Germany but said last month: “My clear plan is to play for Hoffenheim next season. I believe I have the biggest opportunity to develop further here. For me, that means playing consistently at a high level with more room for improvement.”
That might make it tricky for Arsenal to prise him, although an offer being tabled could sway the player’s thinking, and Hoffenheim would surely sell for a handsome profit on the nominal fee they will have paid AKA St Polten for him in 2017.
Hackers began a global ransomware attack on Friday, hitting more than 1,000 companies, and forcing Sweden’s Coop grocery chain to close hundreds of stores.
In what appears to be one of the largest supply chain attacks to date, hackers compromised Kaseya, an IT management software supplier, in order to spread ransomware to the managed service providers that use its technology, as well as to their clients in turn.
Cyber security group Huntress Labs said on Saturday that it had identified 20 compromised managed service providers, with more than 1,000 of its clients falling victim to ransomware attacks — where data is encrypted by hackers and only released if a ransom is paid.
Among them, Coop in Sweden said it had closed all but five of its 800 stores on Saturday, after the attack meant its cash register system and self-service checkouts had stopped working. Coop was affected after its managed service provider Vissma Escom was hit, it said.
The incident is the latest example of hackers weaponising the IT supply chain in order to attack victims at scale, by breaching just one provider. Last year, it emerged that Russian state-backed hackers had hijacked the SolarWinds IT software group in order to penetrate the email networks of US federal agencies and corporations.
Kaseya said in a blog post that it had been the victim of a “sophisticated cyber attack” and that around 40 of its direct 36,000 customers had been affected. It urged those using the compromised “VSA server” tool, which provides remote monitoring and patching capabilities, to shut it down immediately.
“We have been advised by our outside experts, that customers who experienced ransomware and receive communication from the attackers should not click on any links — they may be weaponised,” it said.
“We believe that we have identified the source of the vulnerability and are preparing a patch to mitigate it for our on-premises customers that will be tested thoroughly,” the company added.
Allan Liska of Recorded Future’s computer security incident response team said that the clients of managed service providers tended to be small and medium size companies seeking IT support, with the attacks highlight the risks of relying on centralised third parties.
“We’ve essentially handed over too much trust so that if something happens to them, it becomes a catastrophic event for your organisation through no fault of your own,” he said.
In an alert on Friday, the Cybersecurity and Infrastructure Security Agency said that it was “taking action to understand and address the recent supply-chain ransomware attack”.
The campaign is the latest in a series of audacious ransomware attacks this year, including one on America’s Colonial Pipeline, which have prompted pledges from the Biden administration to crack down on perpetrators.
At last month’s Geneva summit, president Joe Biden urged Russian president Vladimir Putin to rein in ransomware hackers, many of which are believed to operate with impunity in the country.
Harry Kane spelled out before England‘s sleepy-eyed, wake-up call against Scotland that he regards reaching the Euro 2020 semi-finals as a bare minimum for his side. They will not do so unless he springs to life.
The substitution of the England captain for the second game running against the admirable Scots underscored his underperformance at this tournament so far.
Much was made ahead of it on England’s embarrassment of creative riches but one goal in two matches is a source of concern. Kane is their primary goal source but has delivered a resounding raspberry so far.
In 155 minutes on the field at Wembley he has managed just three goal attempts, two of which went wide and one of which was blocked. There has been nothing on target which, for Kane, over a span of two matches is almost unheard of.
It isn’t as if he is making up for his lack of effectiveness in front of goal in other areas. A largely anonymous Friday evening against Scotland saw him touch the ball just 19 times.
Something is missing. There are three possible explanations.
The first is that he is simply knackered after the congested domestic season but then that could apply to most players at the Euros.
The second is that he is carrying an injury of some sort. His history of ankle issues at Spurs stretches back five years. There have been two more this year including one as recently as April, sustained against Everton.
The third is the one which looks most compelling, that the uncertainty over his future is weighing him down. Kane is the consummate professional but he is not a robot even if he sometimes sounds like one. Next season’s Premier League fixtures are already out and he does not know for certain where he will be playing his club football. Tottenham face Manchester City on the opening weekend. He could be running out for either team.
Gareth Southgate has plenty on his plate after the Scotland game but none more important than rebooting his World Cup Golden Boot winner and this is a subject on which he could help having put in a transfer request of his own at Aston Villa just before the 2000 Euros. He ended up staying but he too had it hanging over him during the tournament.
While Southgate had, by that stage of his career, already had experience of a transfer having been sold by Crystal Palace five years previously, this is virgin territory for Kane. He had his loan spells early on in his career but essentially he has been a one-club man and his emotional investment in Spurs is deep. The wrench will be a big one if he leaves and not just for football reasons with a wife and three children to relocate.
Two quiet – make that silent – games in a row for Kane and there has been knee-jerk talk of axing him from the starting line-up. No-one is undroppable as Kane himself said after the Croatia win but that way insanity lies.
The England system has been built around Kane. Dismantling it now – in a tournament in which the side remains unbeaten and still on course to qualify for the knockout stages – would be crazy.
His only like-for-like replacement, Dominic Calvert-Lewin has scored four goals for England; Kane has scored 34. He is England’s totem.
Unless he does have an injury, he has to start Tuesday’s game against the Czech Republic and try to play his way back into form.
Kane has been binge-watching Game of Thrones episodes in his down time at this tournament. If he has reached season six he will have come across Jon Snow being brought back from the dead.
Kane’s situation is not quite so extreme but his resurrection against the Czechs is critical for the health of England’s tournament.
Madrid have already partly addressed the situation by signing David Alaba from Bayern Munich, but are keen to maximise their return for Varana as they look to offset their huge debts, which are thought to stand at around £770million.
Real president Florentino Perez has already stated that the club will have to sell if they are to finance any major signings later in the summer.
And Kylian Mbappe is still a player of interest to the Bernabeu board, with PSG likely to demand a huge fee for the France forward.
However, both United and PSG find themselves in a game of cat-and-mouse with Madrid, with both interested clubs knowing that Varane is out of contract, and potentially available for free, next summer.
“However, it doesn’t mean we should give up trying to make the most of our savings, because you can still get 50 times the interest just by moving from your high street easy access savings account paying 0.01 percent to one with a newer online bank.
“This should be the home for your emergency savings of three to six months’ worth of essential expenses (or one to three years for those in retirement).
“We should also be bucking the trend towards leaving all our savings in easy access, especially now that fixed rate savings accounts, fixed for one, two or three years, have become more competitive in recent weeks.
“Smaller and newer banks have needed to top up their assets and attract more funds at roughly the same time, so we’re seeing them jostle for the top of the price comparison tables.
“This won’t last forever, so it’s worth taking advantage of these rates while you can.”
The personal finance analyst also pointed out investment may be an option for some, although it’s crucial to be aware with investing, capital is at risk.
“For money we plan to hold for five to ten years or more, it’s worth considering investment,” she said.
Counseling the vaccine-hesitant on the benefits of COVID-19 immunization can at times be uncomfortable or even combative. Experts in the United Kingdom propose clinicians and public health officials keep ‘5 Cs’ in mind to increase the likelihood of a fruitful discussion.
Even with an estimated 52% of American adults now fully vaccinated — and states and companies offering creative incentives like $ 1 million lotteries, shotgun giveaways and, yes, free beer — some people remain reluctant to join the vaccinated majority.
“The take-home message for discussing vaccination and engaging with patients is to conduct it in an open, honest, nonjudgmental manner,” lead author of a new commentary Mohammad Razai, MD, told Medscape Medical News.
Dr Mohammad Razai
The ‘Elicit-Share-Elicit’ approach can be useful, for example, he said. “This is where the healthcare worker asks open-ended questions to identify concerns, then offers to share his or her expertise about this concern,” added Razai, a general practitioner and researcher at St. George’s University in London.
Start by addressing the first ‘C’, confidence, suggests Razai, senior author Melinda Mills, MBE, and colleagues in a Commentary published online June 2 in the Journal of the Royal Society of Medicine.
People believing in the safety, efficacy and importance of vaccines is “crucial,” Razai and colleagues note. Recent attention to rare but serious blood clot events potentially associated with AstraZeneca and Johnson and Johnson COVID-19 vaccines could have a detrimental effect on such confidence, they add.
Razai and colleagues define vaccine hesitancy as a delay in acceptance or a refusal to get immunized despite vaccine availability.
Some researchers point to a perception of low risk of COVID-19 coupled with perception of low risk for severe disease — particularly among young people and individuals of lower socioeconomic status — for fueling complacency.
Now that vaccine emergency use authorization has extended to lower age groups, “addressing complacency through repeated risk communication is crucial to facilitate informed decision-making,” the authors note.
If you offer vaccines in a convenient way, they will come — that’s the gist of the third C. Providing COVID-19 immunizations in an easy-to-reach location can boost access and acceptance, Razai and colleagues note. Furthermore, removing financial barriers can also facilitate vaccinations.
For this reason, Razai and colleagues propose that vaccines be distributed to pharmacies, primary care offices, and trusted healthcare professionals to increase acceptance. The fourth C in their strategy involves effective communication and dispelling misinformation.
“It will go wrong if doctors assume that all people need is more facts and evidence,” Razai said. “One-way communication of science without engaging in dialogue will be very unlikely to establish trust or build confidence in vaccines’ safety, importance, or efficacy.”
“The key is to have a dialogue and listen to concerns,” he added.
Addressing any misinformation remains essential. “Misinformation feeds on people’s fears and anxieties about the pandemic to promote anti-vaccination conspiracy theories,” the authors note.
“An excessive amount of information, rapid changes in COVID-19 information and guidance, and lack of certainty has caused misinformation to spread faster than the infection,” they add, “thus creating general distrust and confusion.”
To counter misinformation, a genuine transparent dialogue supported by community engagement could alleviate concerns and build confidence in vaccines, the authors note. Razai addressed these tactics and more in a BMJ paper published on May 20.
“I’d love to see more control regarding dissemination of misinformation through social media,” Ludmila De Faria, MD, told Medscape Medical News when asked to comment. “On the other hand, the paper’s suggestion that ‘the government makes it illegal to share misinformation’ is a slippery slope.”
“In order for public health policies to work, the general population needs to trust those creating policies. Censorship does not breed trust,” added De Faria, chair of the American Psychiatric Association’s Committee on Women’s Mental Health and associate clinical professor of psychiatry at the University of Florida, Gainesville.
Instead, she suggested using well-known and respected ‘ambassadors’ who can disseminate factual information about the COVID-19 vaccine and answer specific concerns. “Hopefully, that would generate the word-of-mouth amplification that is needed to convince other people to get vaccinated as well.”
Putting it all in context is the fifth C. Razai and colleagues believe factors like ethnicity, occupation, and socioeconomic status are often overlooked in vaccine uptake initiatives.
“The problem starts with the term vaccine hesitancy itself,” the authors note. Such wording emphasizes individual behavior and assigns some blame to each reluctant person. This approach does not consider “powerful structural factors such as systemic racism and access barriers.”
Most research on vaccine acceptance is conducted in high-income countries, they add, and as a result few effective strategies have been identified for people in low- and middle-income settings.
“It is therefore essential that along with COVID-19 Vaccines Global Access [COVAX], a mechanism to fairly distribute COVID-19 vaccine doses around the world,” they add, “there is a concerted international effort to understand, analyze, and overcome vaccine hesitancy.”
“Very Helpful” Guidance
“The framework suggested is very helpful,” De Faria said. “It is like motivational interviewing, in the sense of identifying possible barriers to compliance with treatment and addressing them, only expanding it to public health.”
Providing clear information that addresses specific concerns, answering questions, delivering a clear and consistent message that is disseminated through different platforms, and making the process to get the vaccine easy “are really key issues in a successful vaccination campaign,” she added.
Even so, she acknowledged that “there will be a small percentage of the population that will not get vaccinated no matter what strategies are used to convince them, as has been the case for other vaccines in the past.”
Razai and De Faria have disclosed no relevant financial relationships.
J R Soc Med. Published online June 2, 2021. Full text
Damian McNamarais a staffjournalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and critical care. Follow Damian on Twitter: @MedReporter.