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Moderna, BioNtech Plunge As FDA ‘Booster’ Debate Raises Questions About Vaccine Efficacy, Side-Effects

Moderna, BioNtech Plunge As FDA ‘Booster’ Debate Raises Questions About Vaccine Efficacy, Side-Effects

Update (1255ET): As The FDA Panel hears from various health officials during the public comment section on the pros and cons of a booster..

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Moderna, BioNtech Plunge As FDA 'Booster' Debate Raises Questions About Vaccine Efficacy, Side-Effects

Update (1255ET): As The FDA Panel hears from various health officials during the public comment section on the pros and cons of a booster shot, some very uncomfortable facts are coming out about vaccine efficacy and vaccine side effects - facts that anywhere else would immediately be deplatformed and banned from discourse.

Perhaps this is why two top FDA officials just resigned.

“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” FDA scientists Marion Gruber and Phil Krause wrote.

“If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the scientists said.

And then there was this slide...

Pfizer shares are sliding but Moderna and BioNtech stock prices are plunging as Evercore ISI analyst Umer Raffat predicts that the panel of advisers won’t recommend booster shots (with the vote due later today)...

Raffat in a midday note Friday says voting members on the advisory committee “are already leaning against boosters” and the “FDA does not sound convinced by balance of evidence to date”

The CDC advisory group now says it will take up the need for booster shots at a meeting now scheduled for Sept 22nd and Sept 23rd. That makes it all but certain no booster rollout will happen Monday as the President gave as a date to possibly get boosters.

*  *  *

The big day has finally arrived.

On Friday, a group of key FDA advisors - the Advisory Committee on Immunization Practices - is meeting to debate and vote on Pfizer's request for approval of a third COVID booster shot of its "Comirnaty" vaccine for all Americans age 16 and older. The two big questions they must answer are: is there enough evidence to suggest that booster shots are safe and should be made available to everyone, or should they be limited to a smaller group of older and immunocompromised Americans?

On the agenda are presentations from Pfizer, FDA staff, CDC staff,  Israeli researchers, and others. At the end of the virtual meeting, which began at 0830ET Eastern, members will be asked to vote yes or no. That vote isn't expected until later in the afternoon after a long day of debate.

Interested parties can watch the debate streaming live via YouTube:

After the White House waffled on whether the shot could be delivered five or eight months after the second dose, Pfizer has requested approval for the booster dose about six months after the second shot after submitting data showing efficacy wanes over time. And while Moderna has made a similar request and submitted similar data, it's vaccine isn't being considered on Friday. A committee of advisors from the CDC will meet next week to develop booster shots. Despite the drug companies' best efforts, the FDA has seemingly remained unconvinced about the necessity of booster jabs.

In recent weeks, scientists have become increasingly vocal about their opposition for the US pushing ahead with booster jabs so soon. Most argue that these jabs would be better utilized in the developing world, where vaccination rates are lower, and the risk of a deadly new variant arising are higher. One exasperated scientist lamented that the scientific process was being "short circuited" by politics, a reference to President Biden's push to start doling out booster jabs in the face of the delta driven wave that surged over the summer and - in the US, at least - appears to have finally peaked (with deaths hopefully soon to follow). The WHO has also urged President Biden to hold off on the booster jabs, arguing that there's greater need elsewhere.

University of Florida biostatistician Ira Longini (a co-author on the Lancet paper we will mention below) said it would be "immoral" to begin widespread boosters before the rest of the world has been vaccinated, per CNN.

On the data front, new data published this week out of Israel offer a "compelling" case for a booster to be administered at some point as vaccines-induced efficacy wanes. But the data is based on a sample of just 300 patients.

Meanwhile, on Monday, an international group of scientists led by Dr. Philip Krause, deputy chief of the FDA's vaccine regulation office, and his boss, Dr. Marion Gruber - both of whom are leaving the FDA, apparently in protest, published an essay in The Lancet that questioned the need for widespread booster shots right now. Gruber, who has decided to remain at the agency until later this fall, is listed as a participant in Friday's meeting, .

In a nutshell, the Lancet paper argues that vaccine-based protection against severe Covid is still strong, while evidence is lacking that booster shots will be safe and effective.

So far, the real-world data is scant and inconclusive. While Israel has doled out hundreds of thousands of booster jabs to patients as young as 12, it hasn't done much to stop the latest wave of cases (like in the US, deaths and hospitalizations are much lower than their 2020 peak).

Right now, evidence suggests boosters would have the greatest benefit for patients over 65, and the immunocompromised. Already, 1.9MM Americans have received booster jabs after they were authorized by the CDC for people with compromised immune systems.

Shares of vaccine-makers including Pfizer, BioNTech, Moderna and others could be volatile Friday as advisers meet, and inevitable leaks hit the tap.

"My guess is we are going to end up with a recommendation for booster doses for a certain subpopulation, such as adults older than 65," said Bill Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health.

Before we go, let's review: The FDA (and plenty of advisers and third parties) say vaccines are largely still effective enough that there's no need for boosters. Pfizer has submitted data showing efficacy is waning, and that boosters are necessary. Dr. Fauci, and seven other top health officials including the heads of the CDC and FDA have spoken in favor of the need for booster jabs. The WHO and plenty of private scientists have insisted instead that those jabs should instead go to the emerging world where vaccination rates are much lower. For what it's worth, when confronted about natural vs. vaccine-induced immunity, Dr. Fauci said "I really don't know what to tell you."

But most importantly: the White House says 'GET YOUR BOOSTER JABS NOW!' with President Biden pushing ahead with a plan to start doling out the jabs on Monday (contingent (though that plan must receive the blessing of the FDA and CDC first).

The bottom line is this: while the White House, Dr. Fauci and every other party involved claim to be following "the science", but the reality is the science hasn't really given us a clear answer. It's clear that vaccine-induced immunity fades over time - and generally more quickly than natural immunity - but as for whether a third dose will make a material difference in preventing death and serious illness in the vast majority of patients? Scientists still haven't collected and analyzed enough data.

The bigger question: will 'Uncle Joe' and myriad state and local officials require Americans to get booster jabs like they're requiring even those with natural immunity to get vaccinated, potentially exposing these patients to rare side effects while it's unclear whether they're making a meaningful difference in immunity.

The panel is meeting between 1425 and 1625. It's likely the decision won't arrive until after the market close. We will update readers with the result once it's finally released.

Read the agenda below:

Agenda on Scribd

Tyler Durden Fri, 09/17/2021 - 12:59

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International

You can strike gold and silver investment opportunities at Costco

Costco (NDAQ:COST), known for its wide array of products, also offers a distinct opportunity for investors: gold and silver.
The post You can strike gold…

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March 18, 2024

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Costco known for its wide array of products ranging from groceries to electronics and sporting goods, also offers a distinct opportunity for investors: precious metals Costco began selling 1-ounce 24-karat gold bars, in the United States in October 2023 and sold more than US$100 million by November Investors are looking for inflation-proof opportunities and as Stockhouse’s recent Thematic Insights report details, the gold supply has remained essentially flat over time, so it is never diluted Costco Wholesale Corp. stock last traded at US$725.63 on the NASDAQ and C$34.01 per share on the NEO Exchange

With gold prices hovering around all-time highs, one of the top warehouse retailers and Canada’s favourite grocer has brought the precious metal to its consumers.

Costco (NDAQ:COST), known for its wide array of products ranging from groceries to electronics and sporting goods, also offers a distinct opportunity for investors: precious metals. While the retail giant might not be the first place that comes to mind when thinking about gold and silver investments, Costco’s offerings in Canada have caught the attention of savvy investors looking to diversify their portfolios.

Let’s delve into what Costco Canada has to offer in terms of gold and silver investments and explore the potential benefits and considerations.

Gold and silver bullion at Costco

Costco began selling 1-ounce 24-karat gold bars, in the United States in October 2023 priced around US$2,000 and sold more than US$100 million by November.

Observing Costco shoppers can provide interesting economic and cultural indicators. Just like the early days of COVID-19 in 2020 when consumers emptied pallets of toilet paper, the supplies of gold and silver at Costco might reveal how confident the public is in Canadian currency and the economy.

Costco Canada stocks a selection of gold and silver bullion available online at Costco.ca, providing investors with the opportunity to add physical precious metals to their investment portfolios. Gold and silver bullion are typically offered in the form of bars or coins, each carrying intrinsic value based on the metal content.

(Source: Costco.ca) Benefits of investing in gold and silver Portfolio diversification: Gold and silver have historically served as a hedge against inflation and economic uncertainty. By adding precious metals to their portfolios, investors can diversify risk and potentially protect their wealth during times of market volatility. Tangible assets: Unlike stocks or bonds, which exist only as digital entries or paper certificates, gold and silver bullion offer investors tangible assets they can hold in their hands. This physical presence can provide a sense of security and stability, especially during turbulent economic times. Liquidity: Gold and silver are globally recognized as valuable commodities, making them liquid assets. Investors can easily buy and sell gold and silver bullion in various markets around the world, providing flexibility and accessibility. Store of value: Throughout history, gold and silver have maintained their value over the long term. While fiat currencies may depreciate because of factors such as inflation, political instability or economic crises, precious metals have proven to retain their purchasing power over time. Considerations when investing in precious metals Price volatility: Like any investment, the prices of gold and silver can fluctuate based on supply and demand dynamics, geopolitical events, and macroeconomic factors. Investors should be prepared for price volatility and hold a long-term perspective. Storage and security: Owning physical precious metals requires adequate storage and security measures to protect against theft or damage. Investors might opt for secure vault storage services or invest in home safes to safeguard their bullion. Transaction costs: When buying and selling gold and silver bullion, investors might incur transaction costs such as premiums, commissions or storage fees. It’s essential to factor these expenses into investment decisions to accurately assess potential returns. Costco also marks up its precious metals at a few hundred dollars above its market value, but you will likely find it slightly cheaper than what the big Canadian banks offer, if their stock isn’t sold out. Market timing: Timing the market is notoriously difficult, and attempting to predict short-term price movements in gold and silver can be challenging. Instead, focus on the long-term fundamentals and consider dollar-cost averaging as a strategy to mitigate market timing risk. Why buy gold and silver at Costco?

Already up more than 5 per cent since the beginning of the year, the value of gold is expected to continue to climb this year. Earlier this month it hit record highs above $2,181/oz. as speculation rises around the prospects of June interest rate cuts.

… but is it a good investment?

In an interview with CBC Radio’s The Current, Will Huggins, an associate professor of finance and economics at McMaster University’s DeGroote School of Business called this a good marketing strategy by Costco, but believed that buying gold from Costco doesn’t offer any advantage compared with the big Canadian banks.

“It’s not like a herd of cattle or some land or a corporate entity that we can keep bringing new people into,” he said. “It’s just a yellow rock.”

(Source: Costco Wholesale Corp.) Final thoughts on buying gold and silver

Costco Canada’s offering of gold and silver bullion presents an intriguing opportunity for investors seeking to diversify their portfolios with tangible assets.

Investors are looking for inflation-proof opportunities and as Stockhouse’s recent Thematic Insights report details, the gold supply has remained essentially flat over time, so it is never diluted and is essentially immune to inflation.

Whether you’re a seasoned investor looking to bolster your portfolio’s resilience or a newcomer exploring alternative investment avenues, the availability of gold and silver bullion at Costco Canada may offer a convenient and accessible option to incorporate precious metals into your investment strategy.

While investing in precious metals carries certain benefits and considerations, it is important for investors to conduct due diligence, assess their risk tolerance, and consult with financial professionals before making investment decisions. As with any investment, prudent decision-making and a long-term perspective are key to navigating the complexities of the financial markets.

Costco Wholesale Corp. (NDAQ:COST) stock last traded at US$725.63 on the NASDAQ and C$34.01 per share on the NEO Exchange.

Join the discussion: Find out what everybody’s saying about this stock on the Costco Wholesale Corp. Bullboard, and check out the rest of Stockhouse’s stock forums and message boards.

The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.

The post You can strike gold and silver investment opportunities at Costco appeared first on The Market Online Canada.

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Government

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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6 hours ago

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March 17, 2024

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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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8 hours ago

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March 17, 2024

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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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