FDA Panel Backs Shift Toward One-Dose COVID Shot

Jan. 26, 2023 – A panel of advisers to the FDA unanimously supported an effort today to simplify COVID-19 vaccinations, with the aim of developing a one-dose approach — perhaps annually — for the general population.

The FDA is looking to give clearer direction to vaccine makers about future development of COVID-19 vaccines. The plan is to narrow down the current complex landscape of options for vaccinations, and thus help increase use of these shots. 

COVID remains a serious threat, causing about 4,000 deaths a week recently, according to the CDC. 

The 21 Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously “yes” on a single question posed by the FDA: 

“Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the U.S. to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

In other words, would it be better to have one vaccine potentially combining multiple strains of the virus, instead of multiple vaccines – such as a two-shot primary series then a booster containing different combinations of viral strains.

The FDA will consider the panel’s advice as it outlines new strategies for keeping ahead of the evolving virus.

In explaining their support for the FDA plan, panel members said they hoped that a simpler regime would aid in persuading more people to get COVID vaccines.

Pamela McInnes, DDS, MSc, noted that it’s difficult to explain to many people that the vaccine worked to protect them from more severe illness if they contract COVID after getting vaccinated. 

“That is a real challenge,” said McInness, a retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

“The message that you would have gotten more sick and landed in the hospital resonates with me, but I’m not sure if it resonates with” many people who become infected, she said.

The Plan

In the briefing document for the meeting, the FDA outlined a plan for transitioning from the current complex landscape of COVID-19 vaccines to a single vaccine- composition for the primary series and booster vaccination. 

This would require:

• Harmonizing the strain composition of all COVID-19 vaccines;

• Simplifying the immunization schedule for future vaccination campaigns to administer a two-dose series in certain young children and in older adults and persons with compromised immunity, and only one dose in all other individuals;

• Establishing a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September.

During the discussion, though, questions arose about the June target date. Given the production schedule for some vaccines, that date might need to shift, said Jerry Weir, PhD, director of the division of viral products at FDA’s Center for Biologics Evaluation and Research. 

“We’re all just going to have to maintain flexibility,” Weir said, adding that there is not yet a “good pattern” established for updating these vaccines. 

Increasing Vaccination Rates

There was broad consensus about the need to boost public support for COVID-19 vaccinations. While about 81% of the US population has had at least one dose of this vaccine, only 15.3% have had an updated bivalent booster dose, according to the CDC.

“Anything that results in better public communication would be extremely valuable,” said committee member Henry H. Bernstein, DO, MHCM, of the Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, New York.

But it’s unclear what expectations will be prioritized for the COVID vaccine program, he said. 

“Realistically, I don’t think we can have it all — less infection, less transmission, less severe disease, and less long COVID,” Bernstein said. “And that seems to be a major challenge for public messaging.” 

Panelists Press for More Data 

Other committee members also pressed for clearer targets in evaluating the goals for COVID vaccines, and for more robust data. 

Like his fellow VRBPAC members, Cody Meissner, MD, of Dartmouth’s Geisel School of Medicine, supported a move toward harmonizing the strains used in different companies’ vaccines. But he added that it wasn’t clear yet how frequently they should be administered. 

“We need to see what happens with disease burden,” Meissner said, “We may or may not need annual vaccination. It’s just awfully early, it seems to me, in this process to answer that question.”

Among those serving on VRBPAC Thursday was one of the FDA’s more vocal critics on these points, Paul A. Offit, MD, a vaccine expert from Children’s Hospital of Philadelphia. Offit, for example, joined former FDA officials in writing a November opinion article for the Washington Post, arguing that the evidence for boosters for healthy younger adults was not strong.

At Thursday’s meeting, he supported the drive toward simplification of COVID vaccine schedules, while arguing for more data about how well these products are working.

“This virus is going to be with us for years, if not decades, and there will always be vulnerable groups who are going to be hospitalized and killed by the virus,” Offit said.

The CDC needs to provide more information about the characteristics of people being hospitalized with COVID infections, including their ages and comorbidities as well as details about their vaccine history, he said. In addition, academic researchers should provide a clearer picture of what immunological predictors are at play in increasing people’s risk from COVID.

“Then and only then can we really best make the decision about who gets vaccinated with what and when,” Offit said. 

VRBPAC member Ofer Levy, MD, PhD, also urged the FDA to press for a collection of more robust and detailed information about the immune response to COVID-19 vaccinations, such as a deeper look at what’s happening with antibodies.

“I hope FDA will continue to reflect on how to best take this information forward, and encourage –or require —sponsors to gather more information in a standardized way across these different arms of the human immune system,” Levy said. “So we keep learning and keep doing this better.”

In recapping the panel’s suggestions at the end of the meeting, Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research, addressed the requests made during the day’s meeting about better data on how the vaccines work.

“We heard loud and clear that we need to use a data-driven approach to get to the simplest possible scheme that we can for vaccination,” Marks said. “And it should be as simple as possible but not over simplified, a little bit like they say about Mozart’s music.”

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Robby Soave drops Facebook Files, detailing federal gov’t ‘jawboning’ to censor inconvenient content

Chances are pretty good that by this point, you’ve read through at least a couple of the extensive threads and articles known as The Twitter Files, and you’ve seen the disturbing lengths to which Democrats and the federal government have gone — with varying degrees of cooperation from Twitter execs and middle management — to suppress information and push false narratives and silence debate.

And you may have gotten the sneaking suspicion that, given just how damning and disturbing these revelations were, it was entirely possible that the suppression of information and pushing of false narratives and silencing of debate weren’t just issues at Twitter. And you’d evidently be right.

Today, Reason’s Robby Soave has a new exposé to share, and this one is all about censorship at Facebook and Instagram, carried out at the behest of the federal government, including the Centers for Disease Control. And, as was the case with The Twitter Files, you’ll want to take the time to read this one:

Good Lord.

And it gets messier still:

And there we have it. How many Twitter users were laughed at or denounced as conspiracy theorists for suspecting that censorship was at play? They turned out to be right. And now we have compelling evidence that Facebook did the exact same thing. It’s not a conspiracy theory; it’s reality.

Anyone else get the feeling that all the revelations are just barely scratching the surface of what went on between the Biden administration and Twitter and Facebook?

***

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Michael Shellenberger’s thread on WEF, Davos, and Schwab DAMNING enough to give Elon Musk ‘the willies’

Ok you guys, this World Economic Forum (WEF) stuff is freakin’ scary.

Honestly, looking at Michael Shellenberger’s thread about the WEF, Schwab, and Davos it’s like a dystopian novel that is coming to fruition. But of course, if you believe any of this you’re a total nutball conspiracy theorist, white supremacist Nazi or something so DON’T BELIEVE YOU’RE LYING EYES.

Our lying eyes are open … especially after reading this:

Even his name sounds like a villain.

Klaus Schwab.

Keep going.

… culled from the Internet by an anonymous anti-semitic account on 4chan.

Right.

What do you know?

They were lying.

WE’RE SHOCKED.

The elitist of the elite.

Again, all of this reads like some really bad sci-fi movie.

Blackrock.

Yeah, that’s not good.

How convenient.

Sure it does.

And if you dare question them you’re an anti-Semite.

AL GORE.

HA HA HA HA HA HA HA HA HA

Man, this just get worse and worse.

He makes our skin crawl.

Whatever they’re up to, it doesn’t sound like it’s good.

It even gave Elon Musk ‘the willies’.

Yeah, totally fine.

Wow.

But there’s no way they’re trying to cull the herd and stuff. Nope.

*cough cough*

Sure, nothing to see there.

Meep.

***

Related:

Sheila Jackson Lee wants to make criticizing non-white people ILLEGAL in new ‘white supremacy’ bill

Chuck Todd comes unglued defending Hunter Biden while interviewing Ron Johnson and YIKES (watch)

Matt Taibbi DROPS Lefties accusing him of pushing ‘right-wing’ trope by exposing #RussiaGate LIE

BUSTED! Andy Ngô BLASTS Adam Schiff for trying to exploit Keenan Anderson video to rile up anti-police rhetoric

***

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The world hitting ‘peak baby’ and other stories you might have missed this year

From Russia’s invasion of Ukraine, to the death of Queen Elizabeth II, 2022 was full of big stories.

After two years dominated by COVID-19, these headlines took attention away from a pandemic that stubbornly rages on.

We’ve compiled a list of your 15 most-read for the year.

Anthony Albanese led Labor back from the political wilderness in 2022. (AP: Rick Rycroft)

After almost a decade in the political wilderness, Australian voters returned Labor to office in 2022, led by Anthony Albanese.

While self-described “bulldozer” Scott Morrison had made a last-ditch pitch to voters to keep him in power, his unpopularity would play a key role in a raft of Coalition seat losses.

Former treasurer Josh Frydenberg was just one of those high-profile candidates sent packing, amidst a so-called “teal” (independent) wave.

A disgruntled-looking Novak Djokovic spreads his arms wide as he looks down at the court  after a point during a match.
The federal government spectacularly deported Novak Djokovic ahead of the Australian Open. (AP: Kamran Jebreili)

Confusion reigned in January when nine-time Australian Open champion Novak Djokovic was granted an exemption to travel to Australia without being vaccinated against COVID-19.

With Melburnians having spent more than 260 days in lockdown, there was also a fair share of public anger at the seeming double standard.

The federal government subsequently stepped in, announcing that it would deport the 34-year-old, with Djokovic spending the night in immigration detention as his lawyers appealed.

The fiasco made headlines around the world, with the world number one eventually deported on the eve of the tournament.

A man in a suit stands in front of a red backdrop.
At least 6,702 civilians have died since Russia invaded Ukraine. (AP: Sergei Bobylev/Sputnik/Kremlin Pool Photo)

News first broke in February that Russian President Vladimir Putin had authorised a military operation in the Eastern European country.

As of December, war still rages in Ukraine, with scores of civilians dead and millions displaced.

A recent UN report, released on December 4, estimated that 6,702 civilians had died, with Russian forces killing at least 441 in the first weeks of the invasion.

All is not going to plan for Putin, however, with discussion recently turning to the possibility of Ukraine recapturing all of its southern territory — even liberating Crimea.

A huge grey cloud rises from a submarine volcano, as a forked bolt of lightnight hits the left side of the rising ash plume.
The Hunga Tonga-Hunga Ha’apai erupted off Tonga in January, causing widespead chaos.(Reuters: Tonga Geological Services)

The Hunga Tonga-Hunga Ha’apai volcanic eruption came to a powerful climax in the middle of January, causing tsunamis locally as well as in New Zealand, Japan, the US, Russia and Peru, to name a few.

Australia’s east coast and islands were also issued tsunami alerts, while at least six people were reported dead.

NASA later declared that the Tongan tsunami was hundreds of times more powerful than the atomic bomb the US dropped on Hiroshima during World War II.

Constables Rachel McCrow and Matthew Arnold smiles with the police badge behind them.
Constables Rachel McCrow and Matthew Arnold were killed in a deadly siege in rural Queensland in December.(ABC News: Lewi Hirvela/Supplied: Queensland Police Service)

Two police officers and a member of the public lost their lives in horrific circumstances in December, after police were called out to a property in Wieambilla, west of Brisbane, searching for a missing Dubbo man.

Queensland Police Union president Ian Leavers said Constable Rachel McCrow (29), Constable Matthew Arnold (26) and neighbour Alan Dare (58) were killed in a “ruthless, calculated and targeted execution”.

“Just such a tragedy, this should never happen,” Leavers said.

“They’re both under 30, they’ve hardly lived life and their lives have been cut short.”

Rapid antigen test kits for detecting COVID-19
Should you be asking for an antibody test to see if you’ve been infected with COVID-19?(ABC News: Tara Cassidy)

This article starts with a scene from the start of the year that could well describe the situation today.

Omicron cases are much higher than official numbers, and it’s increasingly difficult to access a PCR test to find out whether or not the scratch in your throat is COVID or hayfever.

So how do you know if you’ve actually been infected with COVID-19?

Antibody tests can answer that question (depending on the time frame in which the test is done, and whether you mounted a detectable response to infection), but experts like AMA vice-president Chris Moy say there should be a clear clinical reason for conducting them.

A good example of when an antibody test might be appropriate is if someone is experiencing symptoms consistent with long-COVID.

hundreds of little human models in a big crowd
The world is now inhabited by over 8 billion people, but there may never be more children alive than there are today.

By the time you read this paragraph, the world’s population grew by around 20 people, writes Casey Briggs.

That’s about the best way to wrap your head around what it means for the world to be inhabited by eight billion people.

But while population growth has been rapid — increasing by seven billion in the last two centuries — we are now at “peak baby”, meaning there will never again be more children alive than there are today.

That’s in part because fertility rates are plummeting across the globe, although trends differ geographically: just eight countries are projected to be responsible for more than half the world’s population increase by 2050.

a young girl smiling and holding an umbrella
Charlise Mutten, 9, was on holiday in the Blue Mountains before she was allegedly murdered by her mother’s fiancé.(Supplied)

Five days after nine-year-old Charlise Mutten was last seen in the Blue Mountains, police charged 31-year-old Justin Stein with her murder.

Police alleged Stein, who was engaged to Charlise’s mother, acted alone, after Charlise’s remains were found in a barrel in the bush near the Colo River.

A number of inconsistencies in Stein’s story raised suspicions, including his purchase of 20 kilogram sandbags from a hardware store, and fuel for his boat.

Charlise lived with her grandmother in Coolangatta in Queensland, but had been holidaying in NSW with her mother and Mr Stein.

Stan Grant speaks about not being seen as a human being image
Stan Grant wasn’t afraid to talk about the big issues facing First Nations people in the wake of Queen Elizabeth II’s death. (Four Corners )

In the wake of Queen Elizabeth II’s death, Stan Grant’s analysis focused on the stuff “we aren’t supposed to talk about”: colonisation, empire, violence, Aboriginal sovereignty and the republic.

He wrote of his anger at the ongoing suffering and injustice of First Nations people — in particular those “languishing in cells. Those who take their own lives. Those who are caught in endless cycles of despair”.

He also reflected on the inevitable online abuse he and his family would receive in the wake of his column, before resolving not to be scared into silence.

“Why? Because a voice is all we have. Because too often that voice is silenced.”

A framed photograph of Shane Warne on the cricket pitch says 'THANK YOU SHANE'.
The news that 52-year-old Shane Warne had died of a heart attack prompted a global outpouring of grief. (AAP: Joel Carrett)

For many, “Warnie” was larger than life, a once-in-a-generation cricketer famous for reinvigorating the art of leg spin, as well as his embodiment of the “Aussie larrikin” trope.

So it was with great shock that many responded to the news that he had died of a heart attack in Thailand, aged just 52, leaving behind the three children he had with his former wife Simone Callahan.

It led to an outpouring of grief around the world, with Premier Daniel Andrews offering a state funeral and the MCG rebranding the Great Southern Stand the “Shane Warne Stand” in the Victorian’s honour.

The Foo Fighters lead singer and guitarist, Dave Grohl, with drummer, Taylor Hawkins.
Taylor Hawkins (left) had been the Foo Fighters’ drummer for the last 25 years.(AP: Kevin Winter)

The announcement that Taylor Hawkins had died at age 50 came just hours before the Foo Fighters were due to take the stage at a Colombian music festival in Bogota.

Hawkins had been the band’s drummer for the last 25 years, taking over from original drummer William Goldsmith in 1997.

Apart from founder Dave Grohl (formerly of Nirvana), he was arguably the most recognisable face of the band, and is survived by his wife Alison and their three children.

Water rises over a riverfront restaurant precinct, making the restaurants look like part of the river
South-east Queenslanders were hit with “unrelenting walls of water” in February. (Supplied: Shae Laura)

In February, south-east Queensland was battered by what Premier Anastacia Palaszcuk described as “unrelenting walls of water”.

Multiple lives were lost as thousands of homes flooded, tens of thousands were evacuated, schools were closed and businesses were left without power.

It was just the start of a series of floods that would occur in Queensland and New South Wales over the coming months, devastating communities in both states.

A woman with long brown hair and a green blouse smiles while looking at the camera.
Julia Hunt wants to destigmatise public housing in Australia.(Supplied: Julia Hunt)

Victorian Liberal MP Wendy Lovell offended many in March when she told parliament that social housing should not be placed in affluent suburbs.

This article explores the stigma of growing up in social housing, and its increasing association — from the 1970s onwards — with “crime and criminality, disorder, anti-social behaviour [and] welfare dependency”.

Author Bridget Judd explores the efforts of youth worker Julia Rudd and others to combat “postcode discrimination”, writing: “For those living in public housing, it’s not an abstract policy discussion, it’s home.”

Rain on the lense
BOM didn’t have good news for us about the long-term weather outlook. (Matt Grbin)

Natural disasters (and the ongoing effects of climate change) were in the headlines again in October, with the Bureau of Meteorology (BOM) releasing a long-range forecast — until April 2023 — for Australia’s “upcoming severe weather season”.

The state-by-state forecast warned of an increased risk of widespread flooding for eastern and northern Australia, as well as an increased risk of an above-average number of tropical cyclones and tropical lows.

None of it read like great news, as many of us are experiencing currently.

The Queen shaking hands with Liz Truss in a living room
Liz Truss was sworn in by Queen Elizabeth II just two days before the monarch died. (Reuters: Jane Barlow)

Liz Truss’ prime ministership might have lasted just 44 days, but it will be remembered for the most dramatic series of events.

Truss was famously sworn in by Queen Elizabeth II on September 6, just two days before the monarch died.

She then implemented a raft of economic measures that saw the world’s sixth-biggest economy abruptly crash, saved only by extraordinary interventions from the Bank of England.

After a series of humiliations and U-turns, the British tabloid the Daily Star then set up a live feed of an unrefrigerated iceberg lettuce, asking who would last longer, the lettuce or Truss.

The lettuce won.

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Heart Disease Deaths Spiked During COVID

Nov. 29, 2022 – Deaths from heart disease and stroke among adults living in the United States have been on the decline since 2010. But the COVID-19 pandemic reversed that downward trend in 2020, new research shows. 

It was as if COVID had wiped out 5 years of progress, pushing rates back to levels seen in 2015, the researchers say.

Non-Hispanic Black people and those who were younger than 75 were affected more than others, with the pandemic reversing 10 years of progress in those groups. 

Rebecca C. Woodruff, PhD, presented these study findings at the American Heart Association 2022 Scientific Sessions.

The rate of death from heart disease had been falling for decades in the United States due to better detection of risk factors, such as high blood pressure, and better treatments, such as statins for cholesterol, she said.

The decrease in deaths from heart disease from 1900 to 1999 “has been recognized as a top public health achievement of the twentieth  century,” said Woodruff, who is an epidemiologist for the CDC.

The reversal of this positive trend shows that it is important that people “work with a health care provider to prevent and manage existing heart disease, even in challenging conditions like the COVID-19 pandemic,” she said. 

Woodruff advised that “everyone can improve and maintain their cardiovascular health and reduce the risk of cardiovascular disease by following the American Heart Association’s Life’s Essential 8 – eating better, being more active, quitting tobacco, getting healthy sleep, managing weight, controlling cholesterol, managing blood sugar, and managing blood pressure.” 

“COVID-19 vaccines can help everyone, especially those with underlying heart disease or other health conditions, and protect people from severe COVID-19,” she stressed.

Andrew J. Einstein, MD, PhD, from Columbia University Irving Medical Center in New York City, who was not involved with this research, says the results show “very disturbing changes” to the decline in deaths from heart disease over the past decade. 

The study findings underscore that “as a society, we need to take efforts to ensure that all people are engaged in the health care system, with one aim being improving heart health outcomes, which worsened significantly in 2020,” he says. 

“If you don’t actively see a primary care provider, it’s important to find one with whom you can have a good relationship and can discuss with you heart-healthy living; check your blood pressure, sugar, and cholesterol; ask you about symptoms and examine you to detect disease early; and refer you for more specialized heart care as needed,” he says. 

Some Study Findings

The researchers analyzed data from the CDC’s WONDER database.

They identified adults ages 35 and older with heart disease as cause of death.

They found that the number of people who died from heart disease in every 100,000 people (heart disease death rate) dropped each year from 2010 to 2019, but it increased in 2020, the first year of the pandemic.

This increase was seen in the total population, in men, in women, in all age groups, and in all race and Hispanic ethnicity groups.

In the total population, the heart disease death rate dropped by 9.8% from 2010 to 2019. But this rate increased by 4.1% in 2020, going back to the rate it had been in 2015.

Among non-Hispanic Black people, the heart disease death rate fell by 10.4% from 2010 to 2019, but it increased by 11.2% in 2020, going back to the rate it had been in 2010.

Similarly, among adults ages 35 to 54 and those ages 55 to 74, the rates of heart disease deaths decreased from 2010 to 2019 and increased in 2020 to rates higher than they had been in 2010.

In 2020, about 7 years of progress in declining heart death rates was lost among men and 3 years of progress was lost among women, the researchers said. 

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Anti-lockdown protests intensify in China as COVID cases hit record high


Angry crowds took to the streets in Shanghai in the early hours of November 27.
| Photo Credit: AFP

Rare public protests opposing China’s stringent Covid lockdowns intensified in the country, while coronavirus cases continue to rise sharply with close to 40,000 infections reported on Sunday.

Chinese social media and Twitter have many videos of public protests, including a mass demonstration in Shanghai where people in a rare display of anger shouted slogans against the ruling Communist Party of China (CPC) and President Xi Jinping.

Many protesters were reportedly being arrested.

There are also videos of protests from various university campuses where students came out in the open to oppose the lockdowns.

On Saturday, the government stepped back from enforcing lockdowns in Urumqi, the provincial capital of Xinjiang, where 10 people were killed and nine others injured on Thursday in a fire at an apartment block which was under COVID lockdown.

During the weekend, Urumqi witnessed a huge demonstration in which many Han Chinese nationals took part along with Uygur Muslims.

Urumqi authorities on Saturday said the city would lift coronavirus restrictions “in phases” after footage surfaced online showing rare protests against a three-month lockdown, Hong Kong-based South China Morning Post reported on Sunday.

The footage of protests, which was later censored, showed hundreds of residents in a public square outside a government office, chanting slogans “serve the people” and “end the lockdown”, and singing the national anthem.

Other clips showed scuffles between residents and people in hazmat suits in the street.

In Beijing, people from several compounds, under lockdowns for days, also staged protests, leading to officials withdrawing the curbs.

Meanwhile, the National Health Commission on Sunday said 39,501 coronavirus cases, including 35,858 asymptomatic cases, were reported in the country by the end of Saturday as mass COVID tests were carried out across China to identify new clusters of infection.

It is for the fourth consecutive day that China reported an increase in cases, the highest since it recorded a sharp spike in cases in top cities like Shanghai in April.

The capital Beijing has been reporting a sharp escalation of cases, which on Sunday climbed to over 4,700, amid growing protests and unease in the city over lockdowns of dozens of apartment buildings.

As of Sunday, the city has 9,694 cumulative confirmed cases.

The State Council’s Joint Prevention and Control Mechanism, meanwhile, has reiterated its commitment to cracking down on COVID-19 control malpractices and urged localities to rectify improper implementation of the guidelines.

The mechanism said that some local governments have been found to either roll out overt measures such as ordering widespread lockdowns or take a lax attitude toward the disease, and both tendencies are wrong, state-run China Daily reported on Sunday.



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