FDA expected to issue stricter guidelines on vaccine emergency approval, Washington Post reports

The FDA is expected to ask the manufacturers applying for approval to follow people in the study for a median of at least two months, beginning with their second vaccine shot, the newspaper reported, citing two people familiar with the situation.

The agency also is likely to look for at least five severe Covid-19 cases in patients who got the placebo and not the vaccine, and some cases of the disease in older people, the Post reported.

That would make it difficult to have a vaccine available by the time of the November 3 election, the Post pointed out.

The country should have good data on the safety and effectiveness of a vaccine sometime in November, Dr. Ashish Jha told the US Joint Economic Committee Tuesday, adding he believes there will be a vaccine before the end of the year.

Jha, dean of Brown University’s public health school, said he has been “immensely supportive” of Operation Warp Speed, the White House’s efforts to speed up the production of vaccines and Covid-19 treatments.

“I think that’s been the right thing to do, because once we have the evidence of safety and efficacy we will not want to wait,” Jha said.

A recent poll from the Kaiser Family Foundation found that more than half of respondents — 54% — said they would not get the vaccine if it was available for free before the November 3 presidential election. Along party lines, 60% of Republicans and 56% of independents said they would not. Half of Democrats said they would.

The new guidance may be issued this week, according to the Washington Post. CNN has reached out to the FDA for comment.

A call for vaccine trials for children

The development came as the US passed 200,000 deaths due to Covid-19 on Tuesday. So far, more than 6.89 million Americans have been infected since the start of the pandemic and at least 200,710 have died, according to Johns Hopkins University.

Vaccine developers should begin testing their vaccines in children, a group of pediatric infectious disease specialists said.

200,000 people have died from Covid-19 in the US. That's more than the US battle deaths from 5 wars combined

There are three large-scale vaccine trials for adults in the US, but none has begun for children, who are “stuck in neutral,” eight physicians said in a commentary published Friday in the medical journal Clinical Infectious Diseases.

“This is really a call to say rather than waiting to see if we have an effective vaccine for adults, let’s begin that work of at least evaluating the vaccines in adolescents and ever-decreasing ages, so that we get a good bead on the dosing, the dose schedule, and the potential effectiveness of that kind of a vaccine,” said Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University and one of the authors of the commentary.

Pfizer, who is in the last phase of trials for its vaccine, is “working actively with regulators on a potential pediatric study plan,” a spokesperson for the company told CNN.
Moderna, another company with a vaccine in Phase 3 trials in the US, plans to start pediatric trials “in the near future, subject to regulatory approval,” a spokesperson said in a statement to CNN.

Fauci: Country’s division is hampering the messaging

The country’s current divided state is one of the things that’s getting in the way of clear and consistent messaging when it comes to Covid-19 in the US is the country’s current divided state, Dr. Anthony Fauci said.

“We are in such a divisive state in society that it tends to get politicized,” the country’s leading infectious disease expert said Monday night on “The Daily Show with Trevor Noah.”

“It’s almost the one side versus the other,” Fauci said.

The US is now months-deep into navigating the Covid-19 pandemic and several safety measures remain points of contention — including face masks. While many across the country have embraced experts’ recommendations to wear face coverings to protect against the virus’ spread, others have protested their use.
CDC abruptly removes guidance about airborne coronavirus transmission, says update 'was posted in error'

“People take sides, like wearing a mask or not is a political statement and that’s really unfortunate, totally unfortunate because this is a purely public health issue. It should not be one against the other,” Fauci said.

But even Americans who want to follow guidance from experts about Covid-19 ran into a muddied message this week. The US Centers for Disease Control and Prevention updated its guidance to say Covid-19 can spread through the air but days later abruptly reverted back to guidance posted months ago — saying the virus is thought to spread mainly between people in close contact and “through respiratory droplets produced when an infected person coughs, sneezes or talks.”
Several studies have shown the virus can spread through small particles in the air.

“It’s extremely confusing,” Dr. Leana Wen, a CNN medical analyst and emergency medicine physician at George Washington University, told CNN. “And that type of whiplash — especially without an explanation directly from the CDC — creates confusion and unfortunately leads to lack of trust in the CDC overall.”

How confusion could contribute to spike

With fall rolling in, the US is heading into what CDC Director Dr. Robert Redfield predicted could be one of the “most difficult times” in American public health. One expert told CNN this week the next months may make for an “apocalyptic fall.”
New signs of Covid-19 complacency even as the American death toll nears another dreaded milestone

“It’s happening because we’re forcing schools to reopen in areas of high transmission,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “We’re forcing colleges to reopen, and we don’t have the leadership nationally, telling people to wear masks and to social distance and do all the things we need to do.”

The US could see another surge of cases and that surge could come on top of flu season, which health officials have warned could complicate things — greatly. At least 24 states are now reporting an uptick in new cases compared to the previous week, according to data from Johns Hopkins University — many of them across America’s heartland and Midwest.

Why?

Dr. Jeanne Marrazzo, an infectious diseases expert at the University of Alabama at Birmingham, says there are several factors that could be contributing to the rise in numbers — including the public’s fatigue of pandemic-like conditions.

“And then the second thing is … the completely contradictory messages that we’re getting — not just the misinformation, but also the confusion about how things are spread.”

More than 4,000 students and school staff infected in Texas

A rise in cases also comes after many students across the country returned to class — both in schools and colleges.

Colleges and universities across all 50 states have reported infections — prompting local leaders to set new measures in place in hopes of controlling the spread of the virus on college campuses and in college towns.

Baltimore educators are tracking down students to fight low virtual attendance

Infections have increased among younger students as well — and those around them.

In Texas, there have been more than 4,500 positive cases of Covid-19 among students and staff in the state’s public schools since the new academic year kicked off, according to data from the Texas Education Agency.

More than 2,300 of those cases are students.

In Florida, the number of children under 18 who have contracted the virus has jumped 26% since many of the state’s public schools opened.
Experts are still studying the role children play in the transmission of the virus but several studies have shown they can spread it too — often, just as much as adults.
And a report recently released by the CDC suggests that not only can children spread the virus but they can do so even when they show mild symptoms or none at all.

CNN’s Steve Almasy, John Bonifield, Shelby Lin Erdman, Jamie Gumbrecht, Madeline Holcombe and Holly Yan contributed to this report.

Tesco, SPAR and Waitrose issue urgent food recall due to undeclared egg – full list

This could be dangerous for those who have an intolerance to egg.

The product is sold by retailers including Tesco, Waitrose and Ocado.

The stores have been given point-of-sale notices to be displayed with more information.

Shoppers should beware of products that are 100 grams with the best before date of April 30, 2021.

No other batches of the Melba Thins are known to be affected.



Virgin Media just fixed the biggest issue with its broadband but it's not all good news

Explaining more about the update, Gregg Pearce, Director of SOHO at Virgin Media, said: “Our new 4G Start-up and Back-up services provides complete reassurance for businesses wanting to get online and stay connected no matter what. We know that providing a reliable and always-on connection is essential and are pleased to be supporting UK small business to rebound with disruption-free connectivity they can depend on.”

Although this service won’t be appearing in your home anytime soon Virgin says it does offer consumers other options for staying online.

Oomph users (those people who have taken a SIM and speed boost) already benefit from something very similar through Virgin’s service promise.



'They are done' – Meghan and Harry issue 'clear warning' as they cut final royal ties

Meghan Markle and Prince Harry have repaid their £2.4 million taxpayer-funded renovation of Frogmore Cottage, their UK residence. The New York Times also reports that the Sussexes are no longer receiving any income from Prince Charles’ Duchy of Cornwall. ITV Royal Rota podcast hosts Chris Ship and Lizzie Robinson discussed how the couple’s financial independence is sending a stark message.

Mr Ship told listeners: “I suppose what they’re kind of trying to do is deny any justification for any media intrusion.

“They’re not taking taxpayers’ money, they’re not working members of the Royal Family, they’ve set up their own business, they are working with Netflix and taking money from them.

“There is no justification to hover cameras over their house and try and take pictures of Archie, not that there ever was to be fair.

“A lot of the commentary around this was that this couldn’t be a clearer sign that they are done, cut ties with their lives as working members of the Royal Family.”

READ MORE: Meghan Markle sparks online frenzy as Duchess spills personal tips

Ms Robinson added: “Lots of people are saying this is significant because there are no ties anymore, they’re not coming back.

“Yes, the ties have been well and truly severed.

“So Harry and Meghan are now setting out as former royals with a very lucrative deal with a private media company, Netflix.

“They’re living in a mansion which they are funding themselves in Los Angeles, technically Montecito.”

The Sussexes announced their signing of a multi-million pound deal with US streaming giant, Netflix.

The former working royals will be producing and possibly starring in documentaries, feature films and children’s’ programmes.

The deal is reported to be worth between £100 and £150 million.

In their statement announcing their departure from the monarchy, the Sussexes stated that they would “work to become financially independent”.

They also promised to reimburse the sovereign grant for Frogmore, which they have done.



New Sony Xperia smartphone launching this week could fix the Xperia 1's biggest issue

Sony has confirmed plans to hold an event for a brand-new Xperia device this week. Scheduled for Thursday September 17, the Japanese company is being a little coy about exactly what will be announced at the event. In fact, the only clues on the invite itself are the social hashtag #SonyXperia and the tagline “Xperia New Product Announcement.” Unlike Apple, which is also holding an online media event a few days earlier to unveil its latest iPhone (as well as a host of other gadgets) and always drops a few hints (usually in the form of a pun) about what we’ll see during the keynote, Sony is keeping its card very close to its chest.

The rest of the invite to the Xperia event is taken up with a series of blurred horizontal streaks. And that’s it. Fortunately, impatient Xperia fans will be pleased to know that there have been a number of whispers around a forthcoming launch from Sony, so we have a pretty solid idea of what might be unleashed during the event.

According to sources, Sony Xperia 5 II is due to be available to pre-order on September 17, 2020. Given that’s the same day Sony is now holding an Xperia-themed event, we’d say there’s a pretty good chance that we’re going to see the follow-up to the Xperia 5 unleashed during the event.

Like the Xperia 1 II (pronounced “Xperia One Mark 2”) before it, Sony seems to be sticking with its new naming convention, which takes inspiration from its line of best-selling cameras and adds a Roman Numeral to the end of the brand name each year, instead of changing the entire branding, like its counterparts. This does make sense – after all, it’s not immediately clear that Samsung Galaxy S20 is the follow-up to the Galaxy S10, or that iPhone 11 is the successor to the iPhone Xs.

Unlike the Xperia 1 II, this all-new handset will have a more reasonable price tag – something we had a real problem with during our time with the Xperia 1. 

Like the first-generation Xperia 5, we’re expecting to see a display with a 21:9 aspect ratio. This is one of the main differentiators between Sony and its main rivals. According to Sony, the 21:9 is better for watching movies and cinematic television shows on-the-move as there’s no black borders around the action. And when holding the phone in a portrait orientation, the tall screen is perfect for stacking two apps to run simultaneously.

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With the Xperia 5 II, rumours suggest the 6.1-inch display will be upgraded to a 120Hz panel. For those who don’t know, that means it will refresh twice as frequently as a standard 60Hz display – like the one likely found on your current smartphone or television. These high-refresh displays make the operating system feel more responsive, animations seem slicker, and fast-paced games feel even more frantic.

Powering the Xperia 5 II will be the Qualcomm Snapdragon 865, coupled with a very generous 4,000mAh battery. That should be more than enough to handle graphic-intensive games, side-by-side apps throughout the day.

Of course, these are only rumours, so it’s worth taking it all with a generous pinch of salt. Fortunately, there’s not long to wait before we find out whether there’s any truth in these reports. Sony will hold its new Xperia product announcement on September 17, 2020 at 8am GMT / 9am CEST / 3am ET and 12am PT. Express.co.uk will have all of the latest information, so stay tuned.



Afghan translators ‘who risked their lives’ for Britain issue desperate plea for help

More than 100 former translators have urged the UK not to abandon them, as they live in fear the Taliban will hunt them down. The Afghan translators, who served with the British military, say they are in grave danger as a direct result of aiding British troops during 13 years of conflict.

In a letter to be handed into the British embassy in Kabul today, the translators plead for sanctuary in the UK.

The letter, entitled “Interpreters’ Lives Matter”, warns of the dangers that those “who risked their lives and futures to help the British” face.

Over 100 men have signed the letter and say they are stuck in Afghanistan.

It will be handed in by five former interpreters in Kabul, and also sent to Boris Johnson, Home Secretary Priti Patel and Defence Secretary Ben Wallace.

The men urge the UK Government to “pay attention” to the threats they face on a daily basis.

The translators fear they will be hunted down by the Taliban because of their “devoted service to the UK”.

Their families also face persecution.

They warn the political group are a real and imminent threat to their lives, as peace talks have resulted in the release of thousands of gunmen.

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“Now many of us are forced to live with fear of attack, blamed by the Taliban and insurgents for the deaths or imprisonment of their colleagues.

“We receive death threats, our families have become targets, people will not employ us, our own communities have turned against us and we are forced to give up our family lands and move home many times.”

Those stuck in Afghanistan fear they are now at greater risk after a recent peace deal backed by the US gives power and influence back to the military group.

The letter states: “Thousands of Taliban prisoners, who we helped fight and send to jail, are being released.

“They told us we were traitors and they would never forget.

“Are you now telling us it is safe to live side-by-side with them?”

The Government has come under increased pressure in recent months to resettle Afghan interpreters in the UK.

An official spokesperson said: “We remain committed to ensuring a fair system for the resettlement of Afghan interpreters.

“Claims are being processed as rapidly as possible.”



Russia vaccine shows signs of promise but UK scientists issue warning

However the Lancet report is based upon phase one and two trials, the vaccine has yet to be tested in a phase 3 trial. A stage 3 trial is a much larger trial, often involving hundreds, possibly thousands of participants coming from a range of different countries. The Lancet reported the Russia scientists finding the vaccine stimulated an immune response and did not cause any serious health issues.

The news comes amid intelligence reports of a Russian cyberattack on Oxford University where scientists are developing an almost identical vaccine.

This raised speculation that Moscow had tried to steal UK research.

Russia’s new vaccine was approved for mass use last month by Vladimir Putin.

The hasty move by Mr Putin caused alarm initially, but now two early clinical trials, published today in The Lancet, indicate it’s safe and effective.

Its approval was announced by President Vladimir Putin in August.

Mr Putin said: “I know the vaccine works quite effectively, helps to develop strong immunity, and has gone through all the necessary tests.”

At the the Russian president revealed his daughter received the vaccine.

Mr Putin said: “She feels well, and the concentration of antibodies is high.

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Writing in The Lancet Peter Openshaw, professor of experimental medicine at Imperial College London said: “Immune response might not be directly proportional to the degree of protection—you can only find this out in large-scale trials.”

Scientists from outside Russia have now said the results are “somewhat reassuring”.

US and Uk scientists said the results were “encouraging” and that the vaccine showed “promise”.

However, they have warned the trials were too small and narrow to be announced as a complete success,

As yet only 76 people have been injected with the vaccine.



Volvo set to recall over 30,000 UK models after windscreen wiper safety issue

Volvo has confirmed to Express.co.uk that a total of 31,778 models in the UK may suffer from the gulch and will be recalled for repairs. The recall involves an issue with the front windscreen wiper arm on their popular XC60 model range

Volvo says the windscreen wiper arm could come loose from its assembly, causing a safety risk.

They warn this may have been caused by the wiper not being tightened correctly when the car was built.

Volvo says affected drivers will hear an “unusual noise” while driving their car as the loose windscreen wiper makes contact with the vehicle.

Volvo says they have received no reports of any injuries related to the faulty and confirms owners will shortly be contacted.

READ MORE: Volvo recall 160,000 UK cars over seat belt failure 

Repairs will be made free of charge at Volvo retailers who will ensure cars are repaired back to safe standards.

In a statement provided to Express.co.uk, a Volvo spokesperson said: “Investigations by Volvo Cars have identified an issue with a front windscreen wiper arm on XC60 models on the SPA platform produced between 2017 and 2020.

“The nut securing the wiper arm may not have been tightened sufficiently during the manufacturing process, potentially causing the arm to come loose from its assembly.

Possible symptoms of the issue are an unusual noise due to the wiper arm being in contact with the bonnet, or reduced or no wiping function.

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There are no reports of any personal injuries connected to this issue.

Volvo Cars does not compromise on safety: we are now contacting owners of all affected cars, asking them to contact their Volvo retailer to have their cars corrected free of charge.

“Affected cars will have the relevant nut tightened with the correct torque.

“The number of cars affected in the UK is 31,778.”

Volvo’s latest notice comes just a couple of weeks since the brand recalled almost 25,000 models in Australia.

This was due to serious seat belt glitches across a range of the film’s most popular models including the XC60.

In a statement, Product Safety Australia warned that the flexible steel cable connected to the seat belts may fatigue and “separate”.

They warned this could result in the seat belt not restraining the occupant properly which could increase serious injuries.

Over 160,000 UK models were recalled with a similar seat belt glitch in July.



Dog theft warning: Police issue alert after suspicious chalk marks seen outside properties

Gloucestershire Police issued a warning to dog owners after the latest pet was snatched. A Rottweiler was reported to have been stolen from a property in Drybrook in the early hours of Sunday morning.

The incident is the latest in a series of dog thefts in Gloucestershire.

Chalk marks were discovered at houses with dogs in Hardwicke earlier this month as two men were seen acting suspiciously in the area.

On August 13, a Labrador cross was pinched from a property in Brookthrope.

Two days later an English Pointer was grabbed from a home in Longney.

An attempt to take a second dog from the address was unsuccessful.

And on August 18, a Collie and her six puppies were taken from a house in Brockworth.

In a Twitter post on Sunday, Glouchestershire Police said: “We’re warning dog owners to continue keeping a close eye on their pets following another report of a theft in Drybrook in the early hours today.

READ MORE: Pets at risk of heat exposure in cars this summer

Properties should have secure gates with bolts at the top and bottom, a padlock and alarm.

It is not recommended to leave dogs unattended in the garden.

Pets should not be tied outside shops or left alone in a car.

Owners can help avoid dog theft on walks by changing the time they go and the location.

Pets should be microchipped so they can be returned if they are found.

Owners are advised to take photos of their dog and to make a note of distinguishing markings.

Anyone with information about the latest theft in Drybrook is asked to contact Gloucestershire Constabulary on 101, quoting incident 120 of 30 August.

It comes as a petition calling for tougher sentences for pet theft has gathered more than 140,000 signatures. 



Samsung may have beaten Apple in fixing the biggest issue with your smartphone

Despite most smartphone manufacturers claiming that their devices are made of ever tougher stuff, smashed screens remain a huge, and very expensive, problem for owners. Getting a display fixed via an official repair is a costly business with Apple and Samsung both charging over £200 to mend displays on their latest phones.

This issue has been made even worse in recent years with the introduction of wireless charging which requires the whole device to be covered in highly breakable glass.

Now it seems Samsung may have finally fixed this nightmare with its latest Note 20 Ultra appearing to cope far better when dropped than Apple’s iPhone 11 Pro Max.

Both of these flagship devices have just been put through their paces by the team at PhoneBuff and the results show a stark difference between the two products.

The Note 20 Ultra and iPhone 11 Pro Max faced a number of gruelling tests including being dropped on their screens, corners and back.

If you’ve ever had your phone slip through your fingers then the YouTube video will bring back terrible nightmares but Samsung should be chuffed to bits with the results.

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Although the Note 20 Ultra didn’t survive completely unblemished it was nowhere near as bad as the damage sustained to the iPhone – which saw cracks and splintered glass across the whole front and rear glass.

It’s worth noting that, after the first round of drops, both devices continued to be fully functional with the cameras and screens all working normally.

However, things didn’t go so well during the final test which saw the phones slammed into the deck 10 times in a row.

The iPhone just about survived this test although pieces of glass began shattering from the rear case and camera stopped working.

Amazingly, the Note 20 Ultra survived the whole experience without any significant damage. The screen stayed crack free and everything including the camera and embedded fingerprint sensor carried on working as it should.

PhoneBuff also noted how impressed they were that the damage sustained in the first drop tests didn’t get any worse during the Ultra’s final grilling.

Of course, this is just one test and we certainly wouldn’t recommend throwing your £1,179 Galaxy Note 20 on the floor to see how well it survives

However, it still appears mightily impressive from Samsung and it seems the Gorilla Glass case it’s wrapped is more than capable of surviving life in your pocket.