FDA Advisors Meet To Decide On Booster Jabs As "The Science" Remains Uncertain
  [Source: http://www.zerohedge.com/fullrss2.xml 2021/09/17-22:12]

FDA Advisors Meet To Decide On Booster Jabs As "The Science" Remains Uncertain

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.

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 - 10:12
Democrats Spark Disappointing Sentiment Survey In Early September, Buying Conditions Crash
  [Source: http://www.zerohedge.com/fullrss2.xml 2021/09/17-22:10]

Democrats Spark Disappointing Sentiment Survey In Early September, Buying Conditions Crash

Following August's unexpected collapse in confidence, analysts expected a modest rebound in headline sentiment from the University of Michigan survey, and they were barely right. UMich rose from 70.3 in August (10 year lows) to 71.0 in preliminary September data (but that was below expectations of a jump to 72.0).

Current Conditions actually fell further in early Sept data, from 78.5 to 77.0; as Expectations rose modestly from 65.1 to 67.1.

Source: Bloomberg

Interestingly, it was only Democrats that saw sentiment fall in early September, as Independents and Republicans rebounded...

Source: Bloomberg

Buying Conditions crashed even further in early Sept data...

Source: Bloomberg

The report said the declines were due to complaints about high prices.

Source: Bloomberg

Finally we note that 1-year inflation-expectations legged higher (from +4.6% to +4.7%)...

Source: Bloomberg

The delta variant of the coronavirus has damped consumer sentiment and led economists to downgrade their forecasts for third-quarter growth as economic activity slows. Concerns about rising prices have also led to a deterioration in confidence in recent months.

“Although declining living standards were still more frequently cited by older, poorer, and less educated households, over the past few months, complaints about rising prices have increased among younger, richer, and more educated households,” Richard Curtin, director of the survey, said in a statement.

Consumers’ longer-term outlook for the economy declined to a decade low, the report showed.

Tyler Durden Fri, 09/17/2021 - 10:10
Iron Ore Futures Stumble In Worst Week Ever Amid Evergrande Meltdown
  [Source: http://www.zerohedge.com/fullrss2.xml 2021/09/17-21:57]

Iron Ore Futures Stumble In Worst Week Ever Amid Evergrande Meltdown

Iron ore prices have plunged under $100 per ton (its worst week ever) as anxiety over China's Lehman moment: the collapse of Evergrande, a Chinese real estate company with $300 billion of debt, is weighing on some base metal prices. 

Iron ore futures on the Singapore Exchange plummeted 21% this week as the Evergrande meltdown has hurt China's residential property market outlook. Evergrande's 2023 bonds overlaid on iron ore futures suggest metal traders are concerned the massive real estate company might fold, and the stoppage of new residential buildings could hamper future demand. 

Beijing has also pushed to reign in the country's massive steel industry by forcibly shutting down smelters to reduce carbon emissions ahead of next year's Winter Olympics. 

This week's slump makes iron ore the worst-performing major commodities and an outlier as aluminum soars to a 13-year high, coal futures surge, natural gas prices are on a tear, and power prices are off the charts in some parts of the world. 

Iron ore prices slumping below $100 is a sign of relief for steel producers but inversely impact the world's top miners, many of whom are based in Australia, have handsomely reaped the profits of the key steel-making ingredient, more than doubling in price since the pandemic low of around $80. 

If Evergrande is "too big to fail," then one would suspect a government bailout to ensure the property market doesn't stumble is imminent, which would help stabilize the metals market. 

New data from the People’s Bank of China shows Beijing has blinked. On Friday, the central bank added $14 billion in liquidity injections, the most significant one-day injection since February. It suggests the one-time liquidity boost could be tied to measures to prevent a system-wide unraveling as Evergrande faces insolvency. 

The one thing Beijing cannot let happen is to allow depression in the second-largest economy. As the country's credit impulse has bottomed, a new wave of credit creation could be ahead to save it from financial turmoil. 

Tyler Durden Fri, 09/17/2021 - 09:57