FDA advisory committee votes unanimously in favor of a one-shot COVID-19 vaccine approach

What the proposed changes to vaccine policy mean?

Matthew Woodruff

The FDA advisory committee discussed vaccine safety,
effectiveness of the current shots, potential seasonality of
COVID-19 and more. wildpixel/iStock via Getty Images Plus

The U.S. Food and Drug Administration’s key science advisory panel, the Vaccines and Related Biological Products Advisory Committee, met on Jan. 26, 2023, to chart a path forward for COVID-19 vaccine policy. During the all-day meeting, the 21-member committee discussed an array of weighty issues including the efficacy of existing vaccines, the composition of future vaccine strains and the need to match them to the circulating variants of SARS-CoV-2, the possibility of moving to an annual-shot model, the potential seasonality of the virus and much more.

But the key question at hand, and the only formal question that was voted on, following a proposal from the FDA earlier in the week, had to do with how to simplify the path to getting people vaccinated.

The Conversation asked immunologist Matthew Woodruff, who has been on the front lines of studying immune responses to COVID-19 since the early days of the pandemic, to walk us through the big questions of the day and what they mean for future COVID-19 vaccine strategies.

What exactly did the advisory committee vote on?

The question put before the committee for a vote was whether to move to one COVID-19 vaccine consisting of a single composition for all people – whether currently vaccinated or not – and away from the current model that includes one formulation given as a primary series and a separate formulation administered as a booster. Importantly, approved formulations could come from any number of vaccine manufacturers, not just those that have currently authorized vaccines.

The U.S. Centers for Disease Control and Prevention currently requires that the primary series of shots, or the first two doses of the vaccine that a patient receives, consist of the first generation of vaccine against the original strain of SARS-CoV-2, known as the “Wuhan” strain of the virus. 

These shots are given weeks apart, followed months later by a booster shot that was updated in August 2022 to contain a bivalent formulation of vaccine that targets both the original viral strain and newer subvariants of omicron.

The committee’s endorsement simplifies those recommendations. In a 21-to-0 vote, the advisory board recommended fully replacing, or “harmonizing,” the original formulation of the vaccine with a single shot that would consist of – at least for now – the current bivalent vaccine.

In doing so, it has signaled its belief that these new second-generation vaccines are an upgrade over their predecessors in protecting from infection and severe illness at this point in the pandemic.

Do boycotts work?

Impact? A New Study Sheds Light

By INSTITUTE FOR OPERATIONS RESEARCH AND THE MANAGEMENT SCIENCES 

ACLU

A boycott is a form of protest in which individuals or groups refuse to buy or use a particular product or service in order to show their opposition to a company or entity.

 Boycotts are often organized as a way to apply pressure on companies or governments to change their policies or practices. They can be motivated by a wide range of issues, such as human rights violations, environmental concerns, or political beliefs.

The political controversy surrounding Goya CEO’s political statements in 2020 has shed light on the question.

The CEO of Goya, a well-known Latin food brand, publicly endorsed then-president Donald Trump during a campaign event in the 2020 US presidential election. This sparked a boycott and a counter “buycott” movement in support of the brand. 

Do such boycotts or “buycotts” have any impact on brand sales? 

Not all insurrections are equal

For enslaved Americans, it was the only option

Deion Scott Hawkins, Emerson College

Donald Trump supporters take over the steps of the
U.S. Capitol on Jan. 6, 2021. 
Bill Clark/CQ-Roll Call, Inc via Getty Images

For most Americans, Jan. 6 was once an ordinary, ho-hum day.

That changed in 2021 when millions of television viewers watched thousands of Trump supporters assault the U.S. Capitol in their violent attempt to stop Joe Biden’s presidential victory.

Legislators fled for their lives as the mob shattered windows and vandalized congressional offices.

While those images and subsequent congressional investigation and report are part of the collective memory, a debate still rages over what exactly to call what happened that day.

Was it a rally comprising American patriots, or, as many Republicans refer to the day’s events, “legitimate political discourse”?

Or was it an insurrection, as most observers have called the Jan. 6 attack?

House Speaker selection set to music

 

Here's what's up

 

Bumblebee Study Helps Scientists Track Habitats, Species Decline

Volunteers sought for 2023 study beginning in April

By Emily Olsen / ecoRI News contributor

The brilliant blue morning sky was made more vibrant by the contrasting field of goldenrod in the Great Swamp Management Area where Katie Burns stood. Alone in the cacophony of insect song, she quietly let her eyes adjust to the unique movements of the different pollinators around her before spotting a particular flight pattern. She swept her net through a swath of goldenrod, catching a bumblebee, and crooned to the insect as if it were a puppy as she coaxed it into a specimen jar and pointed out its identifying characteristics.

“One of the ways I can tell this one is a male is because he has a little mustache,” she said. “See?” And he did, indeed, have a little mustache that matched the earthy yellow of his stripes. She opened the jar and he flew off to return to his breakfast, seemingly unaffected by his brief capture.

That bumblebee was an unwitting volunteer for the Rhode Island Bumblebee Survey (RIBS), a project led and developed by Burns. The atlas, backed by the Rhode Island Department of Environmental Management (DEM), Burns’ employer, will provide entomologists with baseline data. 

It will inventory the bee, butterfly, and hoverfly species that currently live in Rhode Island, assess what resources are important to them, and pinpoint their preferred habitats so that scientists can track population declines and protect pollinators’ chosen dwellings.

Water

Researchers Find Super Simple Key to Healthy Aging: Good Hydration!

By NIH/NATIONAL HEART, LUNG AND BLOOD INSTITUTE 

A study published in eBioMedicine by the National Institutes of Health found that adults who maintain proper hydration tend to be in better health, have a lower risk of developing chronic conditions like heart and lung disease, and live longer compared to those who do not consume enough fluids.

Adults who stay well-hydrated appear to be healthier, develop fewer chronic conditions, such as heart and lung disease, and live longer than those who may not get sufficient fluids, according to a National Institutes of Health (NIH) study published on January 2, 2023, in the journal eBioMedicine.

Using health data gathered from 11,255 adults over a 30-year period, researchers analyzed links between serum sodium levels – which go up when fluid intake goes down – and various indicators of health. 

Ultra-processed foods – like cookies, chips, frozen meals and fast food – may contribute to cognitive decline

Junk food can make you stupid 

Sara N. Burke, University of Florida

Surprisingly, even packaged foods that contain healthy
components can qualify as ultra-processed. 
Jamie Grill Photography/Tetra Images via Getty Images

Scientists have known for years that unhealthy diets – particularly those that are high in fat and sugar – may cause detrimental changes to the brain and lead to cognitive impairment.

Many factors that contribute to cognitive decline are out of a person’s control, such as genetics and socioeconomic factors. But ongoing research increasingly indicates that a poor diet is a risk factor for memory impairments during normal aging and increases the risk of developing Alzheimer’s disease.

But when evaluating how some diets may erode brain health as we age, research on the effects of consuming minimally processed versus ultra-processed foods has been scant – that is, until now.

Two recent large-scale studies suggest that eating ultra-processed foods may exacerbate age-related cognitive decline and increase the risk of developing dementia. In contrast, another recent study reported that ultra-processed food consumption was not associated with worse cognition in people over 60.

Although more research is needed, as a neuroscientist who researches how diet can influence cognition later in life, I find that these early studies add a new layer for considering how fundamental nutrition is to brain health.

Want a Clue on Health Care Costs in Advance?

New Tools Take a Crack at It

Julie Appleby, Kaiser Health News 

Need medical treatment this year and want to nail down your out-of-pocket costs before you walk into the doctor’s office? There’s a new tool for that, at least for insured patients.

As of Jan. 1, health insurers and employers that offer health plans must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs.

It’s the latest effort in an ongoing movement to make prices and upfront cost comparisons possible in a business known for its opaqueness.

Insurers must make the cost information available for 500 nonemergency services considered “shoppable,” meaning patients generally have time to consider their options. The federal requirement stems from the Transparency in Coverage rule finalized in 2020.

So how will it work?

The End of a Hopeless, Hapless Republican Party

Once the party of small government, the new GOP wants to impose Christian nationalism on the country

ROBERT REICH in Robertreich.Substack.Com

As House Republicans are convulsing over electing their next Speaker, the civil war in the Republican Party comes into the open. But it’s not particularly civil and it’s not exactly a war. It’s the mindless hostility of a political party that’s lost any legitimate reason for being.

For all practical purposes, the Republican Party is over.

A half century ago, the Republican Party stood for limited government. Its position was not always coherent or logical (it overlooked corporate power and resisted civil rights), but at least had a certain consistency: the GOP could always be relied on to seek lower taxes and oppose Democratic attempts to enlarge the scope of the federal power.

This was, and still is, the position of the establishment Republican Party of the two George Bush’s, of its wealthy libertarian funders, and of its Davos-jetting corporate executive donor base. But it has little to do with the real GOP of today.

In the 1990s, Newt Gingrich and Fox News’s Roger Ailes ushered the Republican Party into cultural conservatism -- against abortion, contraception, immigration, voting rights, gay marriage, LBGTQ rights, and, eventually, against teaching America’s history of racism, trans-gender rights, and, during the pandemic, even against masks. 

At the same time, the GOP was for police cracking down on crime (especially committed by Black people), teaching religion with public money, for retailers discriminating against LBGTQ people, and for immigration authorities hunting down and deporting undocumented residents.

Fight fascism forever

For more cartoons by Jen Sorenson, CLICK HERE

 

COVID-19 Virus Found in the Brain

Autopsies Reveal Startling New Information

By JIM WAPPES, UNIVERSITY OF MINNESOTA  

An analysis of tissue samples from the autopsies of 44 people who died with COVID-19 shows that SAR-CoV-2 virus spread throughout the body—including into the brain—and that it lingered for almost 8 months. The study was published on December 14 in the journal Nature.

Scientists from the National Institutes of Health (NIH) tested samples from autopsies that were performed from April 2020 to March 2021. They conducted extensive sampling of the nervous system, including the brain, in 11 of the patients.

RNA and viable virus in various organs

All of the patients died with COVID-19, and none were vaccinated. The blood plasma of 38 patients tested positive for SARS-CoV-2, 3 tested negative, and plasma was unavailable for the other 3.

Did You React Adversely to COVID-19 Vaccines?

That Could Actually Be a Good Sign

By DEUTSCHES AERZTEBLATT INTERNATIONAL  

COVID-19 is a highly infectious disease caused by the novel coronavirus. It was first identified in Wuhan, China in 2019 and has since spread to become a global pandemic. Symptoms of COVID-19 can range from mild to severe and include fever, cough, and difficulty breathing.

A new study has found a link between vaccine responses and higher antibody concentrations. 

In a study published in Deutsches Ärzteblatt International, researchers Lukas Perkhofer and colleagues found that after receiving two or three doses of the COVID-19 vaccine, a significant increase in antibody concentration was observed, and tolerability of the vaccine was good.

The study was conducted on a large group of healthcare workers. Previous research has shown that concerns about potential side effects and a belief that the vaccine is not effective are the main reasons why some individuals refuse to be vaccinated against COVID-19.

I'm a Professional Comedy Writer — The GOP Has a 'Punching Down' Problem

When I envision the people I want leading this country, it’s people who have a baseline for decency.

JON SAVITT For Common Dreams

By Andy Marlette

There’s one rule in comedy so universal that it connects comics of every background, genre, and skill level: never punch down.

These three simple words can be the difference between being a headliner or being hated.

“Punching down” is more than being mean, rude, or vulgar. It’s the intentional act of attacking those in powerless positions. Going after the people who are most vulnerable. A specific type of cruelty and cowardice.

I’ve been a professional comedy writer for more than a decade, writing films, TV, standup, speeches, and more. I’ve performed in small towns and big cities, in countless rooms in front of every crowd. I’ve written jokes on behalf of celebrities and politicians alike. I’ve collaborated with hundreds of comedians and writers. For many years, I lived just steps away from The White House (an experience in its own right).

I’ve seen a lot of things throughout my comedy career. Still, I’ve never seen anyone master punching down quite like the GOP.

From banning abortion to downplaying the need for gun control to championing the wealthy to ignoring climate change to dehumanizing immigrants and every issue in between, ‘cruelty’ isn’t some side plot for Republicans — it’s the star of their act. It’s what keeps them booked each night. It’s what keeps their names on the marquee.

And while Trump may have been the opener (and a cruel one), there is no shortage of other performers involved.

Take the most recent example: Greg Abbott, Republican Texas Governor. In April, Abbott began sending migrants who arrived at the Texas-Mexico border to other sanctuary cities via bus as a way to antagonize the Biden administration.

This past Christmas Eve, right on cue, Gov. Abbott sent busloads of migrants from Texas to Vice President Kamala Harris' residence in Washington, D.C., leaving them stranded on the road in freezing temperatures.

The good old days

For more cartoons by Jen Sorenson, CLICK HERE