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Delaying second COVID-19 vaccine doses will make supplies last longer but comes with risks

With vaccine shortages looming, experts are debating whether it is important to receive two doses or whether it’s better to give one dose to more people and give a second when the supply is better.

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Health care workers wait in line for vaccinations at a site in Los Angeles. Xinhua News Agency via Getty Images

Drugmakers are facing challenges in manufacturing vaccines and building supply chains to meet the demand for COVID-19 vaccines. Pfizer has even lowered production targets. Scarcity of vaccines has prompted calls for a Band-Aid-like strategy to stretch the precarious supply.

To protect as many people as possible from COVID-19, the U.K.‘s medical officers have chosen to prioritize distribution of a first vaccine dose to as many people as possible – by delaying the second doses of the Pfizer/BioNTech COVID vaccine up to 12 weeks from the recommended 3-4. President-elect Biden wants to release all vaccine doses to speed up the vaccination program – but the risk is that vaccine makers won’t be able to replenish the supply to make sure that the second dose is delivered on time.

These decisions have opened up a rift between experts because some support giving a single vaccine dose to as many people as possible, while others want to vaccinate according to the protocol used during the clinical trials. In the U.S. only around a 10th of the 300 million doses promised by January under Operation Warp Speed are actually available. Nevertheless, the Food and Drug Administration has reminded the medical community of the importance of receiving both doses of COVID-19 vaccines in line with the way they were tested in clinical trials. The FDA says there is no data that demonstrates vaccine efficacy if the second dose is delayed.

I’m interested in this debate because I coordinate an international registry of patients with cancer who have been diagnosed with COVID-19. Patients with current or prior cancers are twice as likely to die from COVID-19 than those without cancer. The Centers for Disease Control and Prevention has not included current or surviving cancer patients for inclusion in the first group of COVID-19 vaccine recipents. Altering vaccine doses seems an easy fix to stretch limited supplies and provide vaccines for more vulnerable populations. But is it the right thing to do?

What is a vaccine?

A vaccine gives the human body a glimpse of the disease-causing virus. This preview trains the immune system for exposure to the real virus. Early vaccines, like the oral poliovirus vaccines, contained live but weakened viruses. These provide robust immunity but carry a small risk of illness because even a weakened virus can become active and cause disease in rare cases.

Modern vaccines are safer because they increasingly rely on only parts of the virus, called antigens. In the case of COVID-19, the antigen is the spike protein that enables the SARS-CoV-2 virus to enter cells. Various COVID-19 vaccines under development are based on a synthetic spike protein or its genetic code.

The FDA has so far given emergency use authorization to two mRNA-based COVID-19 vaccines; from Moderna and Pfizer-BioNTech. In the U.K., a DNA vaccine created by AstraZeneca is also authorized. These three vaccines supply the genetic material that encodes the viral spike protein. After injection in the upper arm, the muscle cells read the genetic instructions and use them to make the viral spike protein directly in the body.

The downside to these safer, newer vaccines is that a single dose triggers a less effective immune response than a weakened virus vaccine and often requires repeated vaccinations to get more complete immunity. Many current human vaccines, such as against tetanus, hepatitis B, measles, polio and HPV, require two doses: the first to prime the immune system and the second to boost the immune response.

Efficacy of all three authorized COVID-19 vaccines was studied in the two-dose regimens. For the Pfizer-BioNTech COVID-19 vaccine, the studied and approved interval is 21 days between the first and second dose. For the Moderna COVID-19 vaccine, the interval is 28 days. For the AstraZeneca vaccine, the trial is for two doses 28 days apart.

In clinical trials, the two doses of the Pfizer/BioNTech vaccine were taken three weeks apart. This led to 95% efficacy against the COVID-19 virus. iStock/Getty Images Plus

What happens after vaccination?

An effective vaccine should produce immunological memory similar to or better than what is acquired by exposure to the natural disease – but without causing the disease. To do so, after the first exposure, from a vaccine or a natural infection, a class of white blood cells called the naïve B cells produce antibodies as the first line of defense against infection.

These early antibodies reach peak levels usually four weeks after the first immunization but decline significantly thereafter. Fewer antibodies means it’s more likely that invading virus particles can escape destruction. So the protective immunity from the first or prime vaccination dose is generally not very effective or durable.

After the first exposure, some B cells and another type of white blood cell called T cells become “memory” cells that remember the antigen – in this case the spike protein. On second and subsequent booster exposures, these memory cells quickly reactivate to produce more potent antibodies that are able to recognize and bind to the target virus tightly. The antibodies produced by memory cells after the booster dose rise rapidly at tens to hundreds-fold higher protective levels and persist longer.

Why is the timing of the second dose important?

Both mRNA vaccines, even after the first dose, offer protection well above the 50% minimum threshold set for emergency use authorization criteria for COVID-19 vaccines based on the clinical trials. But the efficacy of these vaccines was tested in a two-dose regimen.

Gloved hand holding two syringes.
In clinical trials the volunteers received two doses of the vaccine 3-4 weeks apart. Will immunity be complete if the second dose is delayed? Jose A. Bernat Bacete/Moment/Getty Images

During Pfizer-BioNTech’s vaccine trial, one vaccinated participant and nine who received a placebo developed a severe case of COVID-19 after the first dose. This suggests that participants developed partial protection as early as 12 days after the first dose. However, all vaccine recipients eventually received their second dose just nine days later, so the data does not exist for how long the protection from the single dose would have lasted.

Similarly, for Moderna’s vaccine trial, there appeared to be some protection against COVID-19 following one dose; but the limited data does not provide sufficient information about longer-term protection beyond 28 days after the single dose.

In the absence of supporting evidence, nothing definitive can be concluded about the depth or duration of protection after just a single dose of currently authorized vaccines, or choosing between the studied and longer gaps between doses.

While the efficacy of the mRNA COVID-19 vaccines against symptomatic COVID-19 has exceeded expectations, researchers still do not know how long that protection lasts. In the follow-up of the phase 1 trial of Moderna’s vaccine during the 119 days after the first dose, the antibodies declined in all participants and the neutralizing antibodies – which not only bind the virus but also block infection – fell 50% to 75% in the people older than 56.

What can happen if vaccination is incomplete?

Viruses naturally mutate because of copying errors in their genetic code as they multiply in the host’s body, or due to swapping of genetic codes between different viruses co-infecting the same host.

But they also evolve to evade the immunity of the host, specially if competing against weak but sustained immune response. SARS-CoV-2 can already lie low in infected individuals, and approximately 40% to 45% of those infected display no symptoms at all. In an immunocompromised patient – using therapies to fight autoimmune disease or cancer – the virus has been found to be present for up to 154 days. In such situations there are increased odds that a virus variant can emerge that can escape the immune response and spread fast. Indeed, it is suspected that the new highly infectious U.K. variant, which is also spreading in the U.S., could have originated in a chronically infected individual.

Although evolution of vaccine resistance is considered very rare because of effective and rigorously developed vaccines, mathematical modeling suggests that a resistant virus can readily arise if immune response is too weak to destroy all the viruses in the host.

Rushed and ineffective vaccines can produce antibodies that fail to recognize and bind viruses poorly, which can do more harm than good.

Changing the dosing to overcome supply shortages is a contentious and ongoing debate. However, making wrong decisions without adequate scientific evidence could be counterproductive.

Sanjay Mishra receives funding from the National Cancer Institute (NCI) and has previously received support from the National Institutes of Health (NIH).

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Supreme Court Rules Public Officials May Block Their Constituents On Social Media

Supreme Court Rules Public Officials May Block Their Constituents On Social Media

Authored by Matthew Vadum via The Epoch Times (emphasis…

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Supreme Court Rules Public Officials May Block Their Constituents On Social Media

Authored by Matthew Vadum via The Epoch Times (emphasis ours),

Public officials may block people on social media in certain situations, the Supreme Court ruled unanimously on March 15.

People leave the U.S. Supreme Court in Washington on Feb. 21, 2024. (Kevin Dietsch/Getty Images)

At the same time, the court held that public officials who post about topics pertaining to their work on their personal social media accounts are acting on behalf of the government. But such officials can be found liable for violating the First Amendment only when they have been properly authorized by the government to communicate on its behalf.

The case is important because nowadays public officials routinely reach out to voters through social media on the same pages where they discuss personal matters unrelated to government business.

When a government official posts about job-related topics on social media, it can be difficult to tell whether the speech is official or private,” Justice Amy Coney Barrett wrote for the nation’s highest court.

The case is separate from but brings to mind a lawsuit that several individuals previously filed against former President Donald Trump after he blocked them from accessing his social media account on Twitter, which was later renamed X. The Supreme Court dismissed that case, Biden v. Knight First Amendment Institute, in April 2021 as moot because President Trump had already left office.

At the time of the ruling, the then-Twitter had banned President Trump. When Elon Musk took over the company he reversed that policy.

The new decision in Lindke v. Freed was written by Justice Amy Coney Barrett.

Respondent James Freed, the city manager of Port Huron, Michigan, used a public Facebook account to communicate with his constituents. Petitioner Kevin Lindke, a resident of Port Huron, criticized the municipality’s response to the COVID-19 pandemic, including accusations of hypocrisy by local officials.

Mr. Freed blocked Mr. Lindke and others and removed their comments, according to Mr. Lindke’s petition.

The U.S. Court of Appeals for the 6th Circuit ruled for Mr. Freed, finding that he was acting only in a personal capacity and that his activities did not constitute governmental action.

Mr. Freed’s attorney, Victoria Ferres, said during oral arguments before the Supreme Court on Oct. 31, 2023, that her client didn’t give up his rights when using social media.

This country’s 21 million government employees should have the right to talk publicly about their jobs on personal social media accounts like their private-sector counterparts.”

The position advocated by the other side would unfairly punish government officials, and “will result in uncertainty and self-censorship for this country’s government employees despite this Court repeatedly finding that government employees do not lose their rights merely by virtue of public employment,” she said.

In Lindke v. Freed, the Supreme Court found that a public official who prevents a person from comments on the official’s social media pages engages in governmental action under Section 1983 only if the official had “actual authority” to speak on the government’s behalf on a specific matter and if the official claimed to exercise that authority when speaking in the relevant social media posts.

Section 1983 refers to Title 42, U.S. Code, Section 1983, which allows people to sue government actors for deprivation of civil rights.

Justice Barrett wrote that according to the so-called state action doctrine, the test for “actual authority” must be “rooted in written law or longstanding custom to speak for the State.”

“That authority must extend to speech of the sort that caused the alleged rights deprivation. If the plaintiff cannot make this threshold showing of authority, he cannot establish state action.”

“For social-media activity to constitute state action, an official must not only have state authority—he must also purport to use it,” the justice continued.

State officials have a choice about the capacity in which they choose to speak.

Citing previous precedent, Justice Barrett wrote that generally a public employee claiming to speak on behalf of the government acts with state authority when he speaks “in his official capacity or” when he uses his speech to carry out “his responsibilities pursuant to state law.”

“If the public employee does not use his speech in furtherance of his official responsibilities, he is speaking in his own voice.”

The Supreme Court remanded the case to the 6th Circuit with instructions to vacate its judgment and ordered it to conduct “further proceedings consistent with this opinion.”

Also on March 15, the Supreme Court ruled on O’Connor-Ratcliff v. Garnier, a related case. The court’s sparse, unanimous opinion was unsigned.

Petitioners Michelle O’Connor-Ratcliff and T.J. Zane were two elected members of the Poway Unified School District Board of Trustees in California who used their personal Facebook and Twitter accounts to communicate with the public.

Respondents Christopher Garnier and Kimberly Garnier, parents of local students, “spammed Petitioners’ posts and tweets with repetitive comments and replies” so the school board members blocked the respondents from the accounts, according to the petition filed by Ms. O’Connor-Ratcliff and Mr. Zane.

But the Garniers said they were acting in good faith.

“The Garniers left comments exposing financial mismanagement by the former superintendent as well as incidents of racism,” the couple said in a brief.

The U.S. Court of Appeals for the 9th Circuit found in favor of the Garniers, holding that elected officials using social media accounts were participating in a public forum.

The Supreme Court ruled in a three-page opinion that because the 9th Circuit deviated from the standard the high court articulated in Lindke v. Freed, the 9th Circuit’s decision must be vacated.

The case was remanded to the 9th Circuit “for further proceedings consistent with our opinion” in the Lindke case, the Supreme Court stated.

Tyler Durden Sun, 03/17/2024 - 22:10

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Home buyers must now navigate higher mortgage rates and prices

Rates under 4% came and went during the Covid pandemic, but home prices soared. Here’s what buyers and sellers face as the housing season ramps up.

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Springtime is spreading across the country. You can see it as daffodil, camellia, tulip and other blossoms start to emerge. 

You can also see it in the increasing number of for sale signs popping up in front of homes, along with the painting, gardening and general sprucing up as buyers get ready to sell. 

Which leads to two questions: 

  • How is the real estate market this spring? 
  • Where are mortgage rates? 

What buyers and sellers face

The housing market is bedeviled with supply shortages, high prices and slow sales.

Mortgage rates are still high and may limit what a buyer can offer and a seller can expect.  

Related: Analyst warns that a TikTok ban could lead to major trouble for Apple, Big Tech

And there's a factor not expected that may affect the sales process. Fixed commission rates on home sales are going away in July.

Reports this week and in a week will make the situation clearer for buyers and sellers. 

The reports are:

  • Housing starts from the U.S. Commerce Department due Tuesday. The consensus estimate is for a seasonally adjusted rate of about 1.4 million homes. These would include apartments, both rentals and condominiums. 
  • Existing home sales, due Thursday from the National Association of Realtors. The consensus estimate is for a seasonally adjusted sales rate of about 4 million homes. In 2023, some 4.1 million homes were sold, the worst sales rate since 1995. 
  • New-home sales and prices, due Monday from the Commerce Department. Analysts are expecting a sales rate of 661,000 homes (including condos), up 1.5% from a year ago.

Here is what buyers and sellers need to know about the situation. 

Mortgage rates will stay above 5% 

That's what most analysts believe. Right now, the rate on a 30-year mortgage is between 6.7% and 7%. 

Rates peaked at 8% in October after the Federal Reserve signaled it was done raising interest rates.

The Freddie Mac Primary Mortgage Market Survey of March 14 was at 6.74%. 

Freddie Mac buys mortgages from lenders and sells securities to investors. The effect is to replenish lenders' cash levels to make more loans. 

A hotter-than-expected Producer Price Index released that day has pushed quotes to 7% or higher, according to data from Mortgage News Daily, which tracks mortgage markets.

Home buyers must navigate higher mortgage rates and prices this spring.

TheStreet

On a median-priced home (price: $380,000) and a 20% down payment, that means a principal and interest rate payment of $2,022. The payment  does not include taxes and insurance.

Last fall when the 30-year rate hit 8%, the payment would have been $2,230. 

In 2021, the average rate was 2.96%, which translated into a payment of $1,275. 

Short of a depression, that's a rate that won't happen in most of our lifetimes. 

Most economists believe current rates will fall to around 6.3% by the end of the year, maybe lower, depending on how many times the Federal Reserve cuts rates this year. 

If 6%, the payment on our median-priced home is $1,823.

But under 5%, absent a nasty recession, fuhgettaboutit.

Supply will be tight, keeping prices up

Two factors are affecting the supply of homes for sale in just about every market.

First: Homeowners who had been able to land a mortgage at 2.96% are very reluctant to sell because they would then have to find a home they could afford with, probably, a higher-cost mortgage.

More economic news:

Second, the combination of high prices and high mortgage rates are freezing out thousands of potential buyers, especially those looking for homes in lower price ranges.

Indeed, The Wall Street Journal noted that online brokerage Redfin said only about 20% of homes for sale in February were affordable for the typical household.

And here mortgage rates can play one last nasty trick. If rates fall, that means a buyer can afford to pay more. Sellers and their real-estate agents know this too, and may ask for a higher price. 

Covid's last laugh: An inflation surge

Mortgage rates jumped to 8% or higher because since 2022 the Federal Reserve has been fighting to knock inflation down to 2% a year. Raising interest rates was the ammunition to battle rising prices.

In June 2022, the consumer price index was 9.1% higher than a year earlier. 

The causes of the worst inflation since the 1970s were: 

  • Covid-19 pandemic, which caused the global economy to shut down in 2020. When Covid ebbed and people got back to living their lives, getting global supply chains back to normal operation proved difficult. 
  • Oil prices jumped to record levels because of the recovery from the pandemic recovery and Russia's invasion of Ukraine.

What the changes in commissions means

The long-standing practice of paying real-estate agents will be retired this summer, after the National Association of Realtors settled a long and bitter legal fight.

No longer will the seller necessarily pay 6% of the sale price to split between buyer and seller agents.

Both sellers and buyers will have to negotiate separately the services agents have charged for 100 years or more. These include pre-screening properties, writing sales contracts, and the like. The change will continue a trend of adding costs and complications to the process of buying or selling a home.

Already, interest rates are a complication. In addition, homeowners insurance has become very pricey, especially in communities vulnerable to hurricanes, tornadoes, and forest fires. Florida homeowners have seen premiums jump more than 102% in the last three years. A policy now costs three times more than the national average.

Related: Veteran fund manager picks favorite stocks for 2024

 

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Mistakes Were Made

Mistakes Were Made

Authored by C.J.Hopkins via The Consent Factory,

Make fun of the Germans all you want, and I’ve certainly done that…

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Mistakes Were Made

Authored by C.J.Hopkins via The Consent Factory,

Make fun of the Germans all you want, and I’ve certainly done that a bit during these past few years, but, if there’s one thing they’re exceptionally good at, it’s taking responsibility for their mistakes. Seriously, when it comes to acknowledging one’s mistakes, and not rationalizing, or minimizing, or attempting to deny them, and any discomfort they may have allegedly caused, no one does it quite like the Germans.

Take this Covid mess, for example. Just last week, the German authorities confessed that they made a few minor mistakes during their management of the “Covid pandemic.” According to Karl Lauterbach, the Minister of Health, “we were sometimes too strict with the children and probably started easing the restrictions a little too late.” Horst Seehofer, the former Interior Minister, admitted that he would no longer agree to some of the Covid restrictions today, for example, nationwide nighttime curfews. “One must be very careful with calls for compulsory vaccination,” he added. Helge Braun, Head of the Chancellery and Minister for Special Affairs under Merkel, agreed that there had been “misjudgments,” for example, “overestimating the effectiveness of the vaccines.”

This display of the German authorities’ unwavering commitment to transparency and honesty, and the principle of personal honor that guides the German authorities in all their affairs, and that is deeply ingrained in the German character, was published in a piece called “The Divisive Virus” in Der Spiegel, and immediately widely disseminated by the rest of the German state and corporate media in a totally organic manner which did not in any way resemble one enormous Goebbelsian keyboard instrument pumping out official propaganda in perfect synchronization, or anything creepy and fascistic like that.

Germany, after all, is “an extremely democratic state,” with freedom of speech and the press and all that, not some kind of totalitarian country where the masses are inundated with official propaganda and critics of the government are dragged into criminal court and prosecuted on trumped-up “hate crime” charges.

OK, sure, in a non-democratic totalitarian system, such public “admissions of mistakes” — and the synchronized dissemination thereof by the media — would just be a part of the process of whitewashing the authorities’ fascistic behavior during some particularly totalitarian phase of transforming society into whatever totalitarian dystopia they were trying to transform it into (for example, a three-year-long “state of emergency,” which they declared to keep the masses terrorized and cooperative while they stripped them of their democratic rights, i.e., the ones they hadn’t already stripped them of, and conditioned them to mindlessly follow orders, and robotically repeat nonsensical official slogans, and vent their impotent hatred and fear at the new “Untermenschen” or “counter-revolutionaries”), but that is obviously not the case here.

No, this is definitely not the German authorities staging a public “accountability” spectacle in order to memory-hole what happened during 2020-2023 and enshrine the official narrative in history. There’s going to be a formal “Inquiry Commission” — conducted by the same German authorities that managed the “crisis” — which will get to the bottom of all the regrettable but completely understandable “mistakes” that were made in the heat of the heroic battle against The Divisive Virus!

OK, calm down, all you “conspiracy theorists,” “Covid deniers,” and “anti-vaxxers.” This isn’t going to be like the Nuremberg Trials. No one is going to get taken out and hanged. It’s about identifying and acknowledging mistakes, and learning from them, so that the authorities can manage everything better during the next “pandemic,” or “climate emergency,” or “terrorist attack,” or “insurrection,” or whatever.

For example, the Inquiry Commission will want to look into how the government accidentally declared a Nationwide State of Pandemic Emergency and revised the Infection Protection Act, suspending the German constitution and granting the government the power to rule by decree, on account of a respiratory virus that clearly posed no threat to society at large, and then unleashed police goon squads on the thousands of people who gathered outside the Reichstag to protest the revocation of their constitutional rights.

Once they do, I’m sure they’ll find that that “mistake” bears absolutely no resemblance to the Enabling Act of 1933, which suspended the German constitution and granted the government the power to rule by decree, after the Nazis declared a nationwide “state of emergency.”

Another thing the Commission will probably want to look into is how the German authorities accidentally banned any further demonstrations against their arbitrary decrees, and ordered the police to brutalize anyone participating in such “illegal demonstrations.”

And, while the Commission is inquiring into the possibly slightly inappropriate behavior of their law enforcement officials, they might want to also take a look at the behavior of their unofficial goon squads, like Antifa, which they accidentally encouraged to attack the “anti-vaxxers,” the “Covid deniers,” and anyone brandishing a copy of the German constitution.

Come to think of it, the Inquiry Commission might also want to look into how the German authorities, and the overwhelming majority of the state and corporate media, accidentally systematically fomented mass hatred of anyone who dared to question the government’s arbitrary and nonsensical decrees or who refused to submit to “vaccination,” and publicly demonized us as “Corona deniers,” “conspiracy theorists,” “anti-vaxxers,” “far-right anti-Semites,” etc., to the point where mainstream German celebrities like Sarah Bosetti were literally describing us as the inessential “appendix” in the body of the nation, quoting an infamous Nazi almost verbatim.

And then there’s the whole “vaccination” business. The Commission will certainly want to inquire into that. They will probably want to start their inquiry with Karl Lauterbach, and determine exactly how he accidentally lied to the public, over and over, and over again …

And whipped people up into a mass hysteria over “KILLER VARIANTS” …

And “LONG COVID BRAIN ATTACKS” …

And how “THE UNVACCINATED ARE HOLDING THE WHOLE COUNTRY HOSTAGE, SO WE NEED TO FORCIBLY VACCINATE EVERYONE!”

And so on. I could go on with this all day, but it will be much easier to just refer you, and the Commission, to this documentary film by Aya Velázquez. Non-German readers may want to skip to the second half, unless they’re interested in the German “Corona Expert Council” …

Look, the point is, everybody makes “mistakes,” especially during a “state of emergency,” or a war, or some other type of global “crisis.” At least we can always count on the Germans to step up and take responsibility for theirs, and not claim that they didn’t know what was happening, or that they were “just following orders,” or that “the science changed.”

Plus, all this Covid stuff is ancient history, and, as Olaf, an editor at Der Spiegel, reminds us, it’s time to put the “The Divisive Pandemic” behind us …

… and click heels, and heil the New Normal Democracy!

Tyler Durden Sat, 03/16/2024 - 23:20

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