Connect with us

Government

Going it Alone, FDA Authorizes Second Booster for Adults 50 Plus

Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot of the Pfizer-BioNTech…

Published

on

Going it Alone, FDA Authorizes Second Booster for Adults 50 Plus

 

Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot of the PfizerBioNTech and Moderna COVID-19 vaccines. The authorization is for everyone 50 years of age and older. 

The decision to not hold a meeting of the advisory committee is controversial. The vaccines advisory committee is already scheduled to meet on April 6 to discuss booster shots in the U.S., although they were not expected to vote on specific recommendations. 

In addition to the authorization of the fourth shot for people 50 and older, the agency authorized a second Pfizer-BioNTech shot for people 12 years and older who are immunocompromised, and Moderna’s for adults 18 and older who are immunocompromised.  

Dr. Paul Offit, M.D., director of the Vaccine Education Center, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia and member of the FDA’s Vaccines and Related Biological Products Advisory Committee, criticized the agency over the decision. 

“It’s just sort of fait accompli,” Offit said. “So is this the way it works? We talk endlessly about how we follow the science — it doesn’t seem to work out that way.” 

The decision to authorize the fourth shot is questioned by many health and vaccines experts. Generally, they agree that for the elderly or immunocompromised, it’s probably a good idea. But for people who are younger, healthy or are less susceptible to severe COVID-19, they tend to question the need. Some of that thinking relates to the goal of the vaccine. If it’s to prevent hospitalization and death, then the fourth shot is probably not necessary for most healthy people. If the idea is to completely prevent infection over concerns about Long COVID, then perhaps the fourth dose is a good idea. 

A study published in February by the U.S. Centers for Disease Control and Prevention (CDC) found that the third dose of the two vaccines resulted in emergency room visits dropping from 87% to 66% and 91% to 78% against hospitalizations four months after that third shot. 

“That gives me pause for concern that the boosters are not necessarily holding up as well as we’d like,” said Dr. Peter Hotez, a vaccine expert at Baylor College of Medicine in Houston.  

Hotez is one of those who strongly support a fourth dose, based largely on research out of Israel. A study there published last week indicated the death rate from the Omicron variant was 78% lower in people 60- to-100 years old who received a fourth shot of the Pfizer-BioNTech vaccine compared to people who only received three shots. This study has yet to be peer-reviewed. 

Alternatively, John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, questioned Moderna’s request for the fourth dose for all adults. “The old and frail person has much more need of an additional vaccine dose than a young, healthy athlete,” he noted.

A male doctor puts a band aid on a senior woman’s arm after he administered the COVID-19 vaccine injection. Close up image of elderly woman having vaccination. Coronavirus, medical exam, consultation.

The FDA’s authorization appears to be at least partly related to concerns over the Omicron subvariant, BA.2, which is about 30% more infectious than Omicron BA.1. It currently accounts for 30% to 50% of new cases in the U.S. However, it does not seem to be causing the same rise in hospitalizations seen with Omicron BA.1 and even Delta. 

In the next few days, the CDC will follow with their own use recommendation for the fourth dose. It has previously been suggested that the agency will agree that it should be made available to those 50 and up, but they may not call it a recommendation. This is dubbed a permissive recommendation, which makes the information available, but leaves it up to individuals to take into consideration their own health and risk tolerance. 

Dr. Eric Topol, a cardiologist and director of the Scripps Translational Research Institute in California, is largely in support of the fourth shot based on the Israeli data. He alsopointed out to CNN that any Americans who wanted a fourth dose could already go to a pharmacy and get it by saying they were immunocompromised. The FDA’s decision, he says, just legitimized what many were doing anyway. 

 
 
BioSpace source:
 
 

Read More

Continue Reading

Science

University of Kentucky researchers develop online portal to show how biases in RNA sequences affect gene expression

LEXINGTON, Ky. (June 29, 2022) — A recent publication from researchers at the University of Kentucky explains the importance of identifying and understanding…

Published

on

LEXINGTON, Ky. (June 29, 2022) — A recent publication from researchers at the University of Kentucky explains the importance of identifying and understanding how differences between tissues and cells alter gene expression without changing the underlying genetic code.

Credit: Pete Comparoni | University of Kentucky Photo

LEXINGTON, Ky. (June 29, 2022) — A recent publication from researchers at the University of Kentucky explains the importance of identifying and understanding how differences between tissues and cells alter gene expression without changing the underlying genetic code.

Introductory biology classes teach that DNA is transcribed into RNA, which is then translated into proteins. However, many cellular processes affect how quickly transcription and translation occur. Gene expression looks at the differences in RNA concentrations within a cell, and it can help scientists know which genes are active within that tissue or cell.

“Changes in gene expression can significantly affect various diseases and disease trajectories,” said Justin Miller, Ph.D., assistant professor in the UK College of Medicine’s Department of Pathology and Laboratory Medicine.

Miller, who is also affiliated with the Sanders-Brown Center on Aging and Biomedical Informatics, says he and his colleagues previously developed the first algorithm to identify ramp sequences from a single gene sequence. Through their recent work, Miller and fellow UK co-authors Mark Ebbert, Ph.D., and Matthew Hodgman created an online version of that algorithm and showed that ramp sequences change between tissues and cells without changing the RNA sequence.

A ramp sequence is part of the RNA sequence that slows translation at the beginning of the gene by using codons (sequences of three DNA or RNA nucleotides) that are not easily translated. Ramp sequences counterintuitively increase overall gene expression by evenly spacing the translational machinery and preventing collisions later in translation.

In their recent publication in NAR Genomics and Bioinformatics, the researchers present the first comprehensive analysis of tissue- and cell type-specific ramp sequences and report more than 3,000 genes with ramp sequences that change between tissues and cell types, which correspond with increased gene expression within those tissues and cells.

“This research is the first time that variable ramp sequences have been described. Our comprehensive web interface allows other researchers to creatively explore ramp sequences and gene expression,” said Miller.

The research team says this work is important because while there are multiple ways for our RNA to encode the same proteins, the specific RNA sequence is important to regulate protein and RNA levels.

“Essentially, a ramp sequence works like an on-ramp to a freeway so that ribosomes do not crash into each other, but the length and speed limit of that onramp can change depending on the cell and the available resources within that cell,” Miller explained.

He says he enjoyed working on this project not only with his colleagues at UK but as well as his former colleagues at Brigham Young University and his brother, Kyle Miller, at Utah Valley University. Together, the group created a web interface for people to see how ramp sequences correspond with human and COVID-19 gene expression in different tissues and cells.

Miller says he believes this work will eventually impact patient care. “We created an online interface for researchers to query all human genes and see if a specific gene has a ramp sequence in a given tissue and how that gene is expressed within that tissue,” said Miller. “We also show that various COVID-19 genes and human entry factors for COVID-19 have ramp sequences that change between different tissues. Ramp sequences are much more likely to occur in tissues where the virus is known to proliferate.”

So, the researchers believe that COVID-19 genes have genetic biases (ramp sequences) that allow them to use the available cellular machinery to increase their expression. “Our research may help us better predict which tissues and cells new viruses will infect and also provides a potential therapeutic target to regulate tissue-specific gene expression without changing the translated protein,” said Miller.

Research reported in this publication was supported by the National Institute on Aging of the National Institutes of Health under Award Numbers P30AG072946 and R01AG068331, and the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R35GM138636. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

This work was also funded by the BrightFocus Foundation, under awards A2020118F and A2020161S, and the Alzheimer’s Association, under award 2019-AARG-644082.

The University of Kentucky is increasingly the first choice for students, faculty and staff to pursue their passions and their professional goals. In the last two years, Forbes has named UK among the best employers for diversity, and INSIGHT into Diversity recognized us as a Diversity Champion four years running. UK is ranked among the top 30 campuses in the nation for LGBTQ* inclusion and safety. UK has been judged a “Great College to Work for” three years in a row, and UK is among only 22 universities in the country on Forbes’ list of “America’s Best Employers.”  We are ranked among the top 10 percent of public institutions for research expenditures — a tangible symbol of our breadth and depth as a university focused on discovery that changes lives and communities. And our patients know and appreciate the fact that UK HealthCare has been named the state’s top hospital for five straight years. Accolades and honors are great. But they are more important for what they represent: the idea that creating a community of belonging and commitment to excellence is how we honor our mission to be not simply the University of Kentucky, but the University for Kentucky.


Read More

Continue Reading

Government

White House Is Quietly Modeling For $200 Oil “Shock”

White House Is Quietly Modeling For $200 Oil "Shock"

While the Biden administration is hoping and praying that someone – anyone – will watch…

Published

on

White House Is Quietly Modeling For $200 Oil "Shock"

While the Biden administration is hoping and praying that someone - anyone - will watch the comical "Jan 6" kangaroo hearsay court taking place in Congress and meant to somehow block Trump from running for president in 2024 while also making hundreds of millions of Americans forget that the current administration could very well be the worst in US history, it is quietly preparing for the worst.

As none other than pro-Biden propaganda spinmaster CNN reports, when it comes to what really matters (at least according to Gallup), namely the economy, and specifically galloping gasoline prices, the White House is in a historic shambles.

For an administration that ended last year forecasting a leveling off of 40-year high inflation and eager to tout a historically rapid recovery from the pandemic-driven economic crisis, there is a level of frustration that comes with an acutely perilous moment. Asked by CNN about progress on a seemingly intractable challenge, another senior White House official responded flatly: "Which one?"

The suspects behind the historic implosion are well known: "soaring prices, teetering poll numbers and congressional majorities that appear to be on the brink have created no shortage of reasons for unease. Gas prices are hovering at or around $5 per gallon, plastered on signs and billboards across the country as a symbolic daily reminder of the reality -- one in which White House officials are extremely aware -- that the country's view of the economy is growing darker and taking Biden's political future with it."

"You don't have to be a very sophisticated person to know how lines of presidential approval and gas prices go historically in the United States," a senior White House official told CNN.

A CNN Poll of Polls average of ratings for Biden's handling of the presidency finds that 39% of Americans approve of the job he's doing. His numbers on the economy, gas prices and inflation specifically are even worse in recent polls. What CNN won't tell you is that Biden is now polling well below Trump at this time in his tenure.

The CNN article then goes into a lengthy analysis of what is behind the current gasoline crisis (those with lots of time to kill can read it here) and also tries to explains, without actually saying it, that the only thing that can fix the problem is more supply, but - as we first explained - this can't and won't happen because green fanatics and socialist environmentalists will never agree to boosting output.

Which brings us to the punchline: as CNN's Phil Mattingly writes, "instead of managing an economy in the midst of a natural rotation away from recovery and into a stable period of growth, economic officials are analyzing and modeling worst-case scenarios like what the shock of gas prices hitting $200 per barrel may mean for the economy."

Well, in an article titled "Give us a plan or give us someone to blame", this seems like both a plan, and someone to blame.

But unfortunately for Biden - and CNN which is hoping to reset expectations - it's only going to get worse, because as we noted moments ago, while nobody was paying attention, Cushing inventories dropped to just 1 million away from operational bottoms at roughly 20MM barrels. This means that the US is officially looking at tank bottoms.

But wait, there's more... or rather, it's even worse, because as even Bloomberg's chief energy guru Javier Blas notes, over the last 2 weeks, the US gov has drained 13.7 million barrels from the SPR, "and yet, commercial oil stockpiles still fell 3 million barrels over the period."

Just imagine, Blas asks rhetorically, "if the SPR wasn't there. Or what would happen post-Oct when sales end."

And here is the punchline: at the current record pace of SPR drainage, one way or another the Biden admin will have to end its artificial attempts to keep the price of oil lower some time in October (or risk entering a war with China over Taiwan with virtually no oil reserve). This means that unless Putin ends his war some time in the next 5 months, there is a non-trivial chance that oil will hit a record price around $200 - precisely the price the White House is bracing for - a few days before the midterms. While translates into $10+ gasoline.

And while one can speculate how much longer Democrats can continue the "Jan 6" dog and pony show as the entire economy implodes around them, how America will vote in November when gas is double digits should not be a mystery to anyone.

Tyler Durden Wed, 06/29/2022 - 13:05

Read More

Continue Reading

Science

European Commission says it doesn’t have texts between president Ursula von der Leyen and Pfizer CEO Albert Bourla

Under fire from the European ombudsman, the Commission said on Wednesday that it hasn’t found any text messages between president Ursula von der Leyen…

Published

on

Under fire from the European ombudsman, the Commission said on Wednesday that it hasn’t found any text messages between president Ursula von der Leyen and Pfizer chief Albert Bourla regarding the purchase of Covid-19 vaccines.

The messages became of interest last April, when the New York Times reported that a series of texts and calls between von der Leyen and Bourla led to Pfizer’s largest vaccine deal — 900 million doses of the current vaccine and a vaccine adapted to variants, with the option to purchase an additional 900 million doses through 2023.

Emily O’Reilly

Upon a public access request made by a journalist, the EC responded that it had no record of them. However, it was later revealed by ombudsman Emily O’Reilly, the EU’s internal watchdog, that the EC never explicitly asked the cabinet to look for the texts.

Instead, the EC requested other documents that fall under its internal criteria for recording, which doesn’t include text messages.

O’Reilly accused the Commission of “maladministration,” and urged the administration to conduct a more thorough search.

“When it comes to the right of public access to EU documents, it is the content of the document that matters and not the device or form,” she said in a statement back in January. “If text messages concern EU policies and decisions, they should be treated as EU documents.”

On Wednesday, the EC claimed to side with O’Reilly: “The Commission and the Ombudsman agree that what matters is the content of a document,” a spokesperson said in an email to Endpoints News. 

However, the Commission maintained that the texts were not registered as documents “due to their short-lived and ephemeral nature.”

“Text and instant messages in general do not contain important information relating to policies, activities and decisions of the Commission, nor are they in the possession of the institution,” the EC shared in a letter.

The administration added that it intends to issue further guidance on the use of “modern communication tools” such as text and instant messages to clear up any confusion.

“The Ombudsman could equally be invited to participate in those discussions, if she wishes to do so,” the statement said.

Pfizer declined to comment on the content of the text messages.

Stella Kyriakides

The EC struck its third vaccine deal with Pfizer and BioNTech last May, after its other major supplier AstraZeneca ran into production issues and announced it would significantly reduce deliveries.

The contract, which called for up to 1.8 billion doses through 2023, also reserved the EU right to resell or donate doses to countries in need.

“We need to be one step ahead of the virus. This means having access to adapted vaccines to protect us against the threat of variants, booster vaccines to prolong immunity, as well as protecting our younger population,” commissioner for health and food safety Stella Kyriakides said at the time.

Read More

Continue Reading

Trending