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Pfizer Announces Plans To Apply For FDA EUA for COVID-19 Vaccine in the 3rd Week Of November

Pfizer Plans To Apply For FDA’s Emergency-Use Approval During Third Week Of November, CEO Says

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This article was originally published by ZerroHedge.

Pfizer Plans To Apply For FDA's Emergency-Use Approval During Third Week Of November, CEO Says Tyler Durden Fri, 10/16/2020 - 07:07
Marking a return to market-pumping vaccine headlines after a string of halts involving trials for COVID-19 vaccines and therapeutics, Pfizer CEO Albert Bourla confirmed on Friday that the company plans to apply for an emergency use dispensation from the FDA as soon as a "safety milestone" has been achieved, which is expected to be achieved during the third week of November, according to Reuters. The main purpose of the letter, it seems, was to dispel claims that vaccine makers were being pressured by President Trump to apply for the EUA before election day, regardless of the research warranted it or not. In an earlier announcement, Bourla said the company should know whether the vaccine works or not before the end of October, leaving open the possibility - however remote - that the vaccine candidate Pfizer is working on along with Germany's BioNTech might have earned the EUA before election day. According to the NYT, Friday's statement marked a "shift in tone" for the company and its leaders, who had previously emphasized the month of October during interviews. One scientist told the NYT that Bourla's latest letter helped give him peace of mind about alleged political meddling within the FDA. "This is good, really good," said Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego, adding that the letter on Friday shows the company is "not being part of any political machinations." In September, Pfizer was the driving force behind a pledge by nine vaccine companies to “stand with science” and not put forward anything that had not been properly vetted. Stock futures rallied on the news, affirming just how important the issue of vaccine 'credibility' has become to investors, following surveys showing public confidence in the rushed process was seriously lacking. During an appearance on CNBC Friday morning, former FDA head Dr. Scott Gottlieb said Pfizer's plans to apply for the EUA fit all of the FDA's guidelines, including collecting more than 2 months of data, the subject of a reported dispute between the administration and the agency, as well as other requirements. Read the full letter below: As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine. There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards. To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas. As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates. As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial. Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us. A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use. The second requirement is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high. In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years. And finally, if we achieve a positive efficacy readout and a robust safety profile, the last requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced. Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached. So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency. The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine. In the meantime, I hope you and your loved ones are staying safe and well.

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America’s Top Graduates Don’t Want Jobs On Wall Street

America’s Top Graduates Don’t Want Jobs On Wall Street

Even after trading Midtown and Wall Street skyscrapers for the familiarity of their parent’s basement, the army of junior investment banking analysts employed at Goldman Sachs and the…

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America's Top Graduates Don't Want Jobs On Wall Street

Even after trading Midtown and Wall Street skyscrapers for the familiarity of their parent's basement, the army of junior investment banking analysts employed at Goldman Sachs and the other major investment banks quickly found that there was no way to avoid the punishing 90+ hour weeks that are a hallmark of the investment-banking analyst programs across Wall Street. However, with the explosion of deals during the pandemic, a cadre of Goldman junior analysts decided to go public with their complaints about the hopelessly skewed work-life balance.

That sparked a conversation about whether investment banking analyst slots, once seen as a virtually guaranteed path to success in one of the world's most lucrative industries, were still worth the tremendous effort required to succeed. While the jobs typically offer six-figure compensation packages, competition from the world of tech - not to mention the buy side, where both work-life balance and compensation are more desirable - has stunted their allure.

And as bankers rebel against management's demands that they return to offices full-time, the NYT has just published a story proclaiming that "the lure of investment banking is fading" for the youngest members of the workforce.

To try and give their reporting an empirical basis, the NYT cited data from top MBA programs showing fewer graduates are finding jobs on Wall Street.

The number of applicants to banking analyst programs is hard to track, but business school data, which captures a slightly older cohort of potential financiers, shows a broad decline in interest in investment banking. Last year, the five top-ranked U.S. business schools sent, on average, 7 percent of graduates from their master’s of business administration programs into full-time investment banking roles, down from 9 percent in 2016. The decline was pronounced at the University of Pennsylvania’s Wharton School, where bankers were 12 percent of the M.B.A. cohort in 2020, compared with more than a fifth of the class a decade earlier. Harvard sent just 3 percent of its 2020 class.

After the data, the reporters included a comment from an Accenture consultant who specializes in recruiting.

"The industry is not as attractive" as it once was, said Rob Dicks, a consultant at Accenture who specializes in recruiting in financial services. "Employees want a hybrid model, and the banks are saying no," he said, referring to a combination of in-person and remote work. "The message is: 'The bank knows best, we have a model for doing this, and you will conform to that model.'"

But perhaps the most tantalizing detail included in the story was an interview with Jamie Lee, the son of legendary JPM banker Jimmy Lee. Apparently, before his death, Jimmy Lee advised his son not to accept an offer for an analyst position.

"The technology sector has just completely changed the game," said Jamie Lee, 37, who worked in banking before starting a venture-capital firm this year. "The opportunity cost is simply too high to be sticking around in a job where you’re not getting the treatment that you want."

Mr. Lee’s father, the JPMorgan banker Jimmy Lee, was for decades one of the best-known players in his field, advising companies like Facebook and General Motors before he died in 2015. But when the younger Mr. Lee was finishing college in the mid-2000s, his father urged him to avoid the analyst programs.

"He said, 'Honestly, J, the way that I’ve seen that we work these kids, I’m not sure that I want that for you,'" Mr. Lee recalled.

Even foreign students who once comprised one of the most reliable cohorts for young Wall Street recruits due to the high pay and visa help see tech companies as their No. 1 choice. If they are going into banking, most are hoping to work as an engineer, not a banking analyst.

Before graduating from Mount Holyoke College in 2016, Areeba Kamal worked for a summer as a trading intern handling complex bond products at Bank of America’s Midtown Manhattan tower. She arrived around 8:30 a.m. and often stayed until 10:30 p.m., trying to learn the intricacies of her product. She sent money to her family in Pakistan.

"If you’re an international student, early on you realize your two options are finance and tech," said Ms. Kamal, 29, noting that those fields offer the most pay and help with work visas.

But after that summer in finance, she gravitated toward tech. “I don’t want to work 14 to 15 hours a day on something I don’t care about because it pays a ridiculous amount of money,” Ms. Kamal said. She now works for Apple.

In summary, maybe Goldman CEO David Solomon shouldn't have been so dismissive of his junior employees' complaints.

Tyler Durden Fri, 07/30/2021 - 18:40

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Wrong Predictions Don’t Deter The Predictors

Wrong Predictions Don’t Deter The Predictors

Authored by Cal Thomas via The Epoch Times,

We have always had them among us: fortune tellers, diviners, readers of palms, tarot cards, tea leaves, stars, horoscopes, discerners of animal entrails

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Wrong Predictions Don't Deter The Predictors

Authored by Cal Thomas via The Epoch Times,

We have always had them among us: fortune tellers, diviners, readers of palms, tarot cards, tea leaves, stars, horoscopes, discerners of animal entrails, calling on gods of wood and stone, and all sorts of other “seers” who have attempted to convince the gullible that they have the power to predict the future.

To some, climate change proponents are little more than modern-day soothsayers that media continues to legitimize, even when their dire predictions of global catastrophe turn out to be not so dire.

The latest, but assuredly not the last, is President Biden’s climate envoy, John Kerry. Kerry, whose scientific credentials are nonexistent, recently predicted we have only “100 days” to save the planet from climate disaster. That “Chicken Little” prediction was made at the U.N. Climate Summit a few days ago, so we had better subtract the days that have followed.

Kerry said on “CBS This Morning” in February that the world has “nine years” to avert a climate catastrophe.

What happened in the last five months to advance his forecast? He doesn’t say and reporters won’t ask him.

In 1967, a Los Angeles Times story reported, “It is already too late for the world to avoid a long period of famine,” this according to Stanford University biologist Paul Ehrlich, author of the controversial book “The Population Bomb.” Ehrlich also said the U.S. population was “too big” and that involuntary birth control might have to be imposed through sterilizing agents put into staple foods and drinking water. Ehrlich added the Roman Catholic Church might have to be pressured into going along to control the population. In 2018, Ehrlich was still at it claiming that climate disruption was “killing people” and that the collapse of civilization is a “near certainty.”

America is not experiencing a famine, is it? And contrary to too large a U.S. population, the 2020 Census Bureau report showed that the U.S. population has slowed in the past 10 years to its lowest rate since the 1930s. To quote from a Stephen Sondheim musical, “I’m still here.”

In 1970, a scientist named James P. Lodge, Jr. predicted “a new ice age” by the 21st century. Here we are 21 years into the 21st century and some experts are saying the opposite. No wonder critics call it junk science.

Apologists often claim their predictions were based on information available at the time. Yet they want to make changes that would affect our lives and lifestyles, perhaps forever. It’s all about control, not individual freedom.

In 1972, two members of the Department of Geological Science at Brown University wrote President Richard Nixon following a “meeting of 42 top American and European investigators.” Their letter said, “The main conclusion of the meeting was that a global deterioration of climate, by order of magnitude larger than any hitherto experienced by civilized mankind, is a very real possibility, and indeed may be due very soon.”

Nearly 50 years later we are still waiting on the sky to fall.

There’s much more for anyone who takes time to do the research.

Today, because of fear surrounding COVID-19, we have similar apocalyptic statements emanating from politicians and scientists. Are these statements their attempt to obtain more power for themselves and rob us of our individual liberties and the right to make our own choices?

Has much changed since those ludicrous statements were made a half-century ago? Are doomsday predictions being repeated in new ways today by John Kerry and his fellow climate scare travelers?

Will we resist, or blindly follow?

Tyler Durden Fri, 07/30/2021 - 18:20

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74% Of COVID-19 Cases From Massachusetts Outbreak Occurred In Fully Vaccinated People: CDC

74% Of COVID-19 Cases From Massachusetts Outbreak Occurred In Fully Vaccinated People: CDC

Authored by Zachary Steiber via The Epoch Times (emphasis ours),

A COVID-19 outbreak in a Massachusetts county in July primarily occurred among vaccin

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74% Of COVID-19 Cases From Massachusetts Outbreak Occurred In Fully Vaccinated People: CDC

Authored by Zachary Steiber via The Epoch Times (emphasis ours),

A COVID-19 outbreak in a Massachusetts county in July primarily occurred among vaccinated people, sparking fears that a variant of the CCP virus can impact that population more than other strains.

Of the 469 cases detected in Barnstable County, 74 percent occurred among the fully vaccinated, according to a new study published on Friday.

Genomic sequencing of 133 patients showed most of them were infected with the Delta variant of the CCP (Chinese Communist Party) virus.

The bulk of the infected people did not require hospital care, but among the five that did, four were fully vaccinated.

The study, published by the Centers for Disease Control and Prevention (CDC), helped drive agency officials to change masking guidance.

CDC officials announced Tuesday that even vaccinated persons should wear masks indoors, an abrupt shift from under three months ago.

The CDC was unable to point to any published data at the time of its announcement, though an internal document leaked Thursday pointed to some published studies, as well as what was at the time unpublished data from Massachusetts.

The agency recommended that both the vaccinated and unvaccinated should don face coverings indoors in areas with high or substantial transmission of the CCP virus. More than half the counties in America meet one of those designations.

[ZH: And as Bloomberg notes, the CDC scaled back their hunt for breakthrough cases just as Delta emerged.

While the Centers for Disease Control and Prevention stopped comprehensively tracking what are known as vaccine breakthrough cases in May, the consequences of that choice are only now beginning to show.

At the time, the agency had identified only 10,262 cases across the U.S. where a fully vaccinated person had tested positive for Covid. Most people who got infected after vaccination showed few symptoms, and appeared to be at low risk of infecting others. 

But in the months since, the number of vaccine breakthrough cases has grown, as has the risk that they present. And while the CDC has stopped tracking such cases, many states have not. Bloomberg gathered data from 35 states and identified 111,748 vaccine breakthrough cases through the end of July, more than 10 times the CDC’s end-of-April tally.]

Researchers, though, said their investigation suggests people in any area should wear masks inside.

“Findings from this investigation suggest that even jurisdictions without substantial or high COVID-19 transmission might consider expanding prevention strategies, including masking in indoor public settings regardless of vaccination status, given the potential risk of infection during attendance at large public gatherings that include travelers from many areas with differing levels of transmission,” they wrote.

Some of the researchers are CDC officials. Others are with the Massachusetts Department of Public Health, which declined to facilitate an interview on the findings.

The cases in Barnstable County stemmed from summer events and large public gatherings held between July 3 and July 17, the researchers said in the study.

A graph from a new study published by the CDC shows that many of the COVID-19 cases linked to an outbreak in Barnstable County, Massachusetts, this month were among vaccinated people. (CDC)

The events attracted thousands of tourists to the area.

The average of COVID-19 cases in the county rose sharply from July 3 to July 17.

Using travel history from the state’s COVID-19 surveillance system, officials identified a cluster of cases among Massachusetts residents. Additional cases were pinpointed by local health officials.

The cluster cases were defined by a positive COVID-19 test within 14 days of travel or residence in Barnstable County since July 3.

By July 26, 469 COVID-19 cases were identified among state residents, with dates of positive specimens ranging from July 6 to July 25.

Researchers found that the bulk were fully vaccinated, a term that refers to people who have gotten two Moderna or Pfizer COVID-19 vaccines, or the single-shot Johnson & Johnson jab.

Initial data—chain reaction cycle threshold values from some of the specimens—indicate that the viral load of the vaccinated and unvaccinated cases are similar, researchers said. However, they said microbiological studies are required to confirm those findings.

Further, the Infectious Disease Society of America and the Association for Molecular Pathology earlier this year said that such values “should not be considered quantitative measures of viral load.”

Still, the findings were among those used by the CDC to justify the sudden shift this week. Where before vaccinated people were told they did not need to wear a mask anywhere, they are now being told to don a face covering inside.

The data demonstrate “that Delta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people,” Dr. Rochelle Walensky, the CDC’s director, said in a statement on Friday.

High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus. This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The recommendation is not binding but the CDC’s advice is widely adopted by counties, states, and businesses.

The rise in cases in Provincetown, part of Barnstable County, prompted town officials earlier this week to adopt an indoor mask mandate.

The mandate will shift to an advisory when the daily positive testing rate stays below 3 percent for at least five days, according to Town Manager Alex Morse.

While vaccinated people must wear masks inside, unvaccinated people, including children under the age of 12, must wear face coverings in outdoor crowded areas as well as indoors.

As of July 29, 882 cases were linked to the Barnstable County cluster, 531 of whom are state residents. The percentage of breakthrough cases remained at 74 percent.

Follow Zachary on Twitter: @zackstieber
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Tyler Durden Fri, 07/30/2021 - 17:11

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