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Pfizer, BioNTech Follow Moderna in Filing for Approval of COVID-19 Booster

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2

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Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and will follow that with filings in Europe and elsewhere in the world in the coming weeks. The move comes a few days after both the FDA and the Centres for Disease Control and Prevention (CDC) cleared emergency use of third doses of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with “moderately to severely” weakened immune systems as well as solid organ transplant recipients. Mixing of the two mRNA vaccines is permitted for the third shot if the original vaccine received by a person is not available, according to the agency. The results of the safety and immunogenicity study show a favourable safety profile and “robust” immune responses after a third dose, said Pfizer and BioNTech in a statement. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,” said Pfizer chief executive Albert Bourla. The study involved adults who had received two doses of BNT162b2 in the original phase 1 trials of the shot, and were then given a third dose between eight and nine months later. According to the companies, the third dose stimulated significantly higher neutralising antibodies against the original ‘wild-type’ SARS-CoV-2 virus than after the two-dose regimen, as well as against the beta variant and the highly infectious delta strain. “Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalisation – and its profound impact on protecting lives is indisputable,” continued Bourla. “Still, with the continuing threat of the delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” he added. Data from a larger phase 3 study of the third dose is also expected shortly and will be submitted to the FDA when available, said the drugmakers. CureVac, GSK say new-generation jab is much improved There was also encouraging news for CureVac and GlaxoSmithKline’s COVID-19 vaccine programme, after the two partners said a new, improved version of their shot was much better at protecting against the virus in preclinical testing than their first effort. Their first mRNA-based candidate was found to be just 47% effective in a phase 3 trial reported in June, below the threshold efficacy level for a vaccine laid out by the World Health Organisation (WHO) in the early stages of the pandemic and well short of rival shots. The new CV2CoV version – which achieved “faster response onset, higher titres of antibodies, and stronger memory B and T cell activation” than its predecessor – is set to start human testing in the fourth quarter of this year. It is designed to simultaneously tackle multiple variants of SARS-CoV-2, including beta, delta and lambda – which some studies suggest is even more transmissible than delta. Feature image copyright BioNTech SE 2020, all rights reserved
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International

This is the biggest money mistake you’re making during travel

A retail expert talks of some common money mistakes travelers make on their trips.

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Travel is expensive. Despite the explosion of travel demand in the two years since the world opened up from the pandemic, survey after survey shows that financial reasons are the biggest factor keeping some from taking their desired trips.

Airfare, accommodation as well as food and entertainment during the trip have all outpaced inflation over the last four years.

Related: This is why we're still spending an insane amount of money on travel

But while there are multiple tricks and “travel hacks” for finding cheaper plane tickets and accommodation, the biggest financial mistake that leads to blown travel budgets is much smaller and more insidious.

A traveler watches a plane takeoff at an airport gate.

Jeshoots on Unsplash

This is what you should (and shouldn’t) spend your money on while abroad

“When it comes to traveling, it's hard to resist buying items so you can have a piece of that memory at home,” Kristen Gall, a retail expert who heads the financial planning section at points-back platform Rakuten, told Travel + Leisure in an interview. “However, it's important to remember that you don't need every souvenir that catches your eye.”

More Travel:

According to Gall, souvenirs not only have a tendency to add up in price but also weight which can in turn require one to pay for extra weight or even another suitcase at the airport — over the last two months, airlines like Delta  (DAL) , American Airlines  (AAL)  and JetBlue Airways  (JBLU)  have all followed each other in increasing baggage prices to in some cases as much as $60 for a first bag and $100 for a second one.

While such extras may not seem like a lot compared to the thousands one might have spent on the hotel and ticket, they all have what is sometimes known as a “coffee” or “takeout effect” in which small expenses can lead one to overspend by a large amount.

‘Save up for one special thing rather than a bunch of trinkets…’

“When traveling abroad, I recommend only purchasing items that you can't get back at home, or that are small enough to not impact your luggage weight,” Gall said. “If you’re set on bringing home a souvenir, save up for one special thing, rather than wasting your money on a bunch of trinkets you may not think twice about once you return home.”

Along with the immediate costs, there is also the risk of purchasing things that go to waste when returning home from an international vacation. Alcohol is subject to airlines’ liquid rules while certain types of foods, particularly meat and other animal products, can be confiscated by customs. 

While one incident of losing an expensive bottle of liquor or cheese brought back from a country like France will often make travelers forever careful, those who travel internationally less frequently will often be unaware of specific rules and be forced to part with something they spent money on at the airport.

“It's important to keep in mind that you're going to have to travel back with everything you purchased,” Gall continued. “[…] Be careful when buying food or wine, as it may not make it through customs. Foods like chocolate are typically fine, but items like meat and produce are likely prohibited to come back into the country.

Related: Veteran fund manager picks favorite stocks for 2024

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Spread & Containment

As the pandemic turns four, here’s what we need to do for a healthier future

On the fourth anniversary of the pandemic, a public health researcher offers four principles for a healthier future.

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John Gomez/Shutterstock

Anniversaries are usually festive occasions, marked by celebration and joy. But there’ll be no popping of corks for this one.

March 11 2024 marks four years since the World Health Organization (WHO) declared COVID-19 a pandemic.

Although no longer officially a public health emergency of international concern, the pandemic is still with us, and the virus is still causing serious harm.

Here are three priorities – three Cs – for a healthier future.

Clear guidance

Over the past four years, one of the biggest challenges people faced when trying to follow COVID rules was understanding them.

From a behavioural science perspective, one of the major themes of the last four years has been whether guidance was clear enough or whether people were receiving too many different and confusing messages – something colleagues and I called “alert fatigue”.

With colleagues, I conducted an evidence review of communication during COVID and found that the lack of clarity, as well as a lack of trust in those setting rules, were key barriers to adherence to measures like social distancing.

In future, whether it’s another COVID wave, or another virus or public health emergency, clear communication by trustworthy messengers is going to be key.

Combat complacency

As Maria van Kerkove, COVID technical lead for WHO, puts it there is no acceptable level of death from COVID. COVID complacency is setting in as we have moved out of the emergency phase of the pandemic. But is still much work to be done.

First, we still need to understand this virus better. Four years is not a long time to understand the longer-term effects of COVID. For example, evidence on how the virus affects the brain and cognitive functioning is in its infancy.

The extent, severity and possible treatment of long COVID is another priority that must not be forgotten – not least because it is still causing a lot of long-term sickness and absence.

Culture change

During the pandemic’s first few years, there was a question over how many of our new habits, from elbow bumping (remember that?) to remote working, were here to stay.

Turns out old habits die hard – and in most cases that’s not a bad thing – after all handshaking and hugging can be good for our health.

But there is some pandemic behaviour we could have kept, under certain conditions. I’m pretty sure most people don’t wear masks when they have respiratory symptoms, even though some health authorities, such as the NHS, recommend it.

Masks could still be thought of like umbrellas: we keep one handy for when we need it, for example, when visiting vulnerable people, especially during times when there’s a spike in COVID.

If masks hadn’t been so politicised as a symbol of conformity and oppression so early in the pandemic, then we might arguably have seen people in more countries adopting the behaviour in parts of east Asia, where people continue to wear masks or face coverings when they are sick to avoid spreading it to others.

Although the pandemic led to the growth of remote or hybrid working, presenteeism – going to work when sick – is still a major issue.

Encouraging parents to send children to school when they are unwell is unlikely to help public health, or attendance for that matter. For instance, although one child might recover quickly from a given virus, other children who might catch it from them might be ill for days.

Similarly, a culture of presenteeism that pressures workers to come in when ill is likely to backfire later on, helping infectious disease spread in workplaces.

At the most fundamental level, we need to do more to create a culture of equality. Some groups, especially the most economically deprived, fared much worse than others during the pandemic. Health inequalities have widened as a result. With ongoing pandemic impacts, for example, long COVID rates, also disproportionately affecting those from disadvantaged groups, health inequalities are likely to persist without significant action to address them.

Vaccine inequity is still a problem globally. At a national level, in some wealthier countries like the UK, those from more deprived backgrounds are going to be less able to afford private vaccines.

We may be out of the emergency phase of COVID, but the pandemic is not yet over. As we reflect on the past four years, working to provide clearer public health communication, avoiding COVID complacency and reducing health inequalities are all things that can help prepare for any future waves or, indeed, pandemics.

Simon Nicholas Williams has received funding from Senedd Cymru, Public Health Wales and the Wales Covid Evidence Centre for research on COVID-19, and has consulted for the World Health Organization. However, this article reflects the views of the author only, in his academic capacity at Swansea University, and no funding or organizational bodies were involved in the writing or content of this article.

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Government

The Grinch Who Stole Freedom

The Grinch Who Stole Freedom

Authored by Jeffrey A. Tucker via The Epoch Times (emphasis ours),

Before President Joe Biden’s State of the…

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The Grinch Who Stole Freedom

Authored by Jeffrey A. Tucker via The Epoch Times (emphasis ours),

Before President Joe Biden’s State of the Union address, the pundit class was predicting that he would deliver a message of unity and calm, if only to attract undecided voters to his side.

President Joe Biden delivers the State of the Union address in the House Chamber of the U.S. Capitol in Washington, D.C., on March 7, 2024. (Mandel Ngan/AFP/Getty Images)

He did the opposite. The speech revealed a loud, cranky, angry, bitter side of the man that people don’t usually see. It seemed like the real Joe Biden I remember from the old days, full of venom, sarcasm, disdain, threats, and extreme partisanship.

The base might have loved it except that he made reference to an “illegal” alien, which is apparently a trigger word for the left. He failed their purity test.

The speech was stunning in its bile and bitterness. It’s beyond belief that he began with a pitch for more funds for the Ukraine war, which has killed 10,000 civilians and some 200,000 troops on both sides. It’s a bloody mess that could have been resolved early on but for U.S. tax funding of the conflict.

Despite the push from the higher ends of conservative commentary, average Republicans have turned hard against this war. The United States is in a fiscal crisis and every manner of domestic crisis, and the U.S. president opens his speech with a pitch to protect the border in Ukraine? It was completely bizarre, and lent some weight to the darkest conspiracies about why the Biden administration cares so much about this issue.

From there, he pivoted to wildly overblown rhetoric about the most hysterically exaggerated event of our times: the legendary Jan. 6 protests on Capitol Hill. Arrests for daring to protest the government on that day are growing.

The media and the Biden administration continue to describe it as the worst crisis since the War of the Roses, or something. It’s all a wild stretch, but it set the tone of the whole speech, complete with unrelenting attacks on former President Donald Trump. He would use the speech not to unite or make a pitch that he is president of the entire country but rather intensify his fundamental attack on everything America is supposed to be.

Hard to isolate the most alarming part, but one aspect really stood out to me. He glared directly at the Supreme Court Justices sitting there and threatened them with political power. He said that they were awful for getting rid of nationwide abortion rights and returning the issue to the states where it belongs, very obviously. But President Biden whipped up his base to exact some kind of retribution against the court.

Looking this up, we have a few historical examples of presidents criticizing the court but none to their faces in a State of the Union address. This comes two weeks after President Biden directly bragged about defying the Supreme Court over the issue of student loan forgiveness. The court said he could not do this on his own, but President Biden did it anyway.

Here we have an issue of civic decorum that you cannot legislate or legally codify. Essentially, under the U.S. system, the president has to agree to defer to the highest court in its rulings even if he doesn’t like them. President Biden is now aggressively defying the court and adding direct threats on top of that. In other words, this president is plunging us straight into lawlessness and dictatorship.

In the background here, you must understand, is the most important free speech case in U.S. history. The Supreme Court on March 18 will hear arguments over an injunction against President Biden’s administrative agencies as issued by the Fifth Circuit. The injunction would forbid government agencies from imposing themselves on media and social media companies to curate content and censor contrary opinions, either directly or indirectly through so-called “switchboarding.”

A ruling for the plaintiffs in the case would force the dismantling of a growing and massive industry that has come to be called the censorship-industrial complex. It involves dozens or even more than 100 government agencies, including quasi-intelligence agencies such as the Cybersecurity and Infrastructure Security Agency (CISA), which was set up only in 2018 but managed information flow, labor force designations, and absentee voting during the COVID-19 response.

A good ruling here will protect free speech or at least intend to. But, of course, the Biden administration could directly defy it. That seems to be where this administration is headed. It’s extremely dangerous.

A ruling for the defense and against the injunction would be a catastrophe. It would invite every government agency to exercise direct control over all media and social media in the country, effectively abolishing the First Amendment.

Close watchers of the court have no clear idea of how this will turn out. But watching President Biden glare at court members at the address, one does wonder. Did they sense the threats he was making against them? Will they stand up for the independence of the judicial branch?

Maybe his intimidation tactics will end up backfiring. After all, does the Supreme Court really think it is wise to license this administration with the power to control all information flows in the United States?

The deeper issue here is a pressing battle that is roiling American life today. It concerns the future and power of the administrative state versus the elected one. The Constitution contains no reference to a fourth branch of government, but that is what has been allowed to form and entrench itself, in complete violation of the Founders’ intentions. Only the Supreme Court can stop it, if they are brave enough to take it on.

If you haven’t figured it out yet, and surely you have, President Biden is nothing but a marionette of deep-state interests. He is there to pretend to be the people’s representative, but everything that he does is about entrenching the fourth branch of government, the permanent bureaucracy that goes on its merry way without any real civilian oversight.

We know this for a fact by virtue of one of his first acts as president, to repeal an executive order by President Trump that would have reclassified some (or many) federal employees as directly under the control of the elected president rather than have independent power. The elites in Washington absolutely panicked about President Trump’s executive order. They plotted to make sure that he didn’t get a second term, and quickly scratched that brilliant act by President Trump from the historical record.

This epic battle is the subtext behind nearly everything taking place in Washington today.

Aside from the vicious moment of directly attacking the Supreme Court, President Biden set himself up as some kind of economic central planner, promising to abolish hidden fees and bags of chips that weren’t full enough, as if he has the power to do this, which he does not. He was up there just muttering gibberish. If he is serious, he believes that the U.S. president has the power to dictate the prices of every candy bar and hotel room in the United States—an absolutely terrifying exercise of power that compares only to Stalin and Mao. And yet there he was promising to do just that.

Aside from demonizing the opposition, wildly exaggerating about Jan. 6, whipping up war frenzy, swearing to end climate change, which will make the “green energy” industry rich, threatening more taxes on business enterprise, promising to cure cancer (again!), and parading as the master of candy bar prices, what else did he do? Well, he took credit for the supposedly growing economy even as a vast number of Americans are deeply suffering from his awful policies.

It’s hard to imagine that this speech could be considered a success. The optics alone made him look like the Grinch who stole freedom, except the Grinch was far more articulate and clever. He’s a mean one, Mr. Biden.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Mon, 03/11/2024 - 12:00

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