Pfizer said that data from the U.S. and Israel suggest that the efficacy of its COVID-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants. “Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier,” Pfizer said in its presentation, which was posted on the FDA website. The drug giant is partnering with Germany’s BioNTech SE to make the shots. The decrease in effectiveness is “primarily due to waning of vaccine immune responses over time,” rather than the delta variant, Pfizer researchers said in the presentation. FDA staff also posted its report for the panel’s consideration Wednesday, summarizing much of the same data that Pfizer presented earlier. Like Pfizer,

the FDA staff found that a booster shot of the Pfizer vaccine was safe and raised antibody levels. Still, the staff said it hasn’t yet independently reviewed or verified the underlying data or conclusions of some relevant studies, such as the Israel study, which will be summarized in Friday’s meeting.

The staff’s 23-page briefing paper noted that the likely benefit of a booster shot would depend on how much the third shot reduces disease relative to the first two. If the first two shots are still highly effective, then the efficacy of the booster shot “is likely to be more limited,” the staff said. Overall data in the U.S. indicate that the first two shots of the vaccine still protect against severe disease and death, the staff said. The staff also noted that it is not currently clear whether there will be an increased risk of inflammation of the heart and heart lining after a booster shot, and that potential risks of a booster shot also must be considered. It didn’t offer a clear indication of which way the agency was leaning, which it often does before meetings. While its vaccine continues to provide strong protection against hospitalizations and severe disease in the U.S., Pfizer said in its report, the data from Israel and elsewhere suggest that a reduction in efficacy against infection may be followed by reduced effectiveness against severe disease, especially among vulnerable elderly people.Early unpublished data from an Israeli health maintenance organization suggest that a third booster dose is highly effective in areas where the delta variant is dominant, according to the Pfizer document. Giving a third dose to people more than 60 years old was associated with 86% effectiveness against testing positive for COVID starting at least a week after the booster, Pfizer said. Pfizer also detailed immune response results from a final-stage trial of booster shots in over 300 people, showing that a third dose bolstered blood antibody levels. One month after the third dose, levels of the protective antibodies were more than triple what they had been a month after the second shot. No new unexpected side effects were identified from safety data associated with boosters in the final-stage study, according to the Pfizer report. Consideration of a booster dose six months after a second dose of its shot is warranted, based on similarities between the outbreaks in Israel and the U.S., Pfizer said. Nick Note: unless your a special case I urge you to get the third dose. Talk to your medical professional, if you need more convincing get your antibodies tested. And make sure they aspirate the syringe to make SURE they are not injecting the vaccine into a vein…… So my other stories on this subject

(Reuters) – A panel of expert outside advisers to the U.S. Food and Drug Administration voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.

Accidental intravenous injections of BioNTech jabs may cause heart muscle inflammation, research conducted by the University of Hong Kong has found. The team advised that those who administer jabs briefly withdraw the syringe plunger to exclude blood aspiration to ensure that the needle is not accidentally in a vein before the injection is given. According to global statistics, 50 per million doses of mRNA vaccine including BioNTech ones could trigger myocarditis or pericarditis – inflammation of the heart muscles and tissues surrounding the heart. The 12 to 29 age group is more prone to the condition, especially after the second dose. But most patients rapidly recovered from this potentially life threatening side effect, and mRNA vaccines are deemed safe, with the risks markedly outweighing the side effects. But research led by Dr. Can Li, Dr. Anna Zhang and Professor Yuen Kwok-Yung pointed that accidental intravenous injection could trigger heart conditions. In the study, researchers injected the mRNA vaccine into the thigh muscles of mice via the standard intramuscular routes and compared the outcomes with those of mice injected with the intravenous route. “We found that the heart of those mice receiving intravenous vaccine developed obvious myocarditis and pericarditis within 24 to 48 hours. This heart damage is greater even after a second dose of vaccination 14 days later,” according to the team. The hearts of mice which received intramuscular injections saw no such damage, leading the team to believe that accidental intravenous injections may cause the heart conditions. “As health authorities have previously advised that there is no need to aspirate a needle before injection, there is a risk that in rare circumstances, the injection may inadvertently be injected intravenously,” the team said. “We therefore advise that the practice of intramuscular injection should revert to the conventional way. That means a brief withdrawal of syringe plunger to exclude blood aspiration to ensure that the needle is not accidentally located in a vein before the injection is given.” Another possible method to reduce risk is to change the injection site from the shoulder muscle to the lateral side of thigh muscle, they added.  Nick Note: Mystery solved. When they inject all the cooties into your arm including the nanobots, if they are injected into a vain it may be  what is causing the blood clots and other heart side effects. To give the vaccine correctly the syrinage must be aspirated…. That is where the plunger is pulled back a little bit. If their is blood then your medical professional hit a vein. The recommended procedure is to pull out the needle and pick another injection sight……

 

 

Respondents to a New York FED urvey see inflation at 5.2% a year from now and 4% in three years; expected income also rises Americans are expecting a record surge in inflation over the next few years, according to a new report from the Federal Reserve Bank of New York. In its August Survey of Consumer Expectations, the bank said Monday that respondents see inflation a year from now at 5.2%, up from 4.9% the prior month. Three years from now, it is expected to be at 4%, up from 3.7% in July. Both readings mark record-high readings for data that goes back to 2013.

The report also found projections of big increases in some of the most important costs Americans face on a regular basis. Food prices are seen rising by 7.9% a year from now, rent by 10% and medical care costs by 9.7%.

Lessening the blow of the expected leap in price pressures is respondents’ sanguine outlook for their personal finances. The survey found that the median expected growth in household income a year from now hit a series high of 3%. Survey respondents also expect home-price growth to slow. The New York Fed survey arrives at a time of flux for the U.S. economy. So far, the recovery process from the depths of the coronavirus pandemic’s impact has been swift, but that rebound has been accompanied by much higher than expected levels of inflation, Fed officials have acknowledged. Nick Bit: The spin is: The jump in price pressures has been driven largely by supply disruptions tied to the reopening process. Fed officials have repeatedly flagged that most of the biggest gains in inflation have happened in parts of the economy most affected by the pandemic.

Nick Bite: if price stability is their goal i would submit to you record inflation and embedded inflation and record breaking inflationary expectations means their policy is a dismal failure. The inflation is their fuck up. Interest rates to low for to long and 200 billion a month in Fed money pumped into the system has set forces in motion that will cause a full blown depression…...Central bankers, who have maintaining price stability as an official goal, still largely say they believe that price pressures will moderate over time as imbalances get resolved. HA HA HA HA HA “It’s going to take some time,” but the disruption causing the inflation jump should abate and “that’ll help the inflation measures move back down,” Cleveland Fed leader Loretta Mester told reporters on Friday. Fed officials also base their confidence that inflation will moderate on what many of them see as relatively stable long-term inflation expectations. In an interview last week, Federal Reserve Bank of Atlanta President Raphael Bostic said he’s looking to see if “businesses and families are starting to make decisions, taking on board these higher levels of inflation as something that is potentially more permanent. If those sorts of behavioral changes start to play out, then that’s something I’ll have to take on board” when thinking about where monetary policy needs to be set. “Fortunately we have not seen that in terms of long run inflation expectations-—there’s been a little movement in the short run side, but since that hasn’t necessarily, or to this date, bled into the longer run, I’m, I’m inclined to mainly look through it,” and retain confidence price pressures will moderate over time, Mr. Bostic said.

That said, the New York Fed data show inflation expectations are blasting through the Fed’s 2% inflation target, while actual inflation also exceeds that goal. The personal consumption expenditures price index, the central bank’s preferred inflation barometer, showed prices rose by 4.2% year-over-year in July.

Nick Note: Talk about denial. Inflation is out of control. Do not confuse this with hyper inflation. This will turn into stagflation. A recessionary economy and inflation soaring. Kicking and screaming the FED will raise rates significant and they will not only stop adding money to the system but they will forced to drain funds. I see a potiential for a 400 to 500 bases point rise is rates!

A U.S. Food and Drug Administration (FDA) advisory panel voted unanimously Friday to recommend Pfizer (PFE)/BioNTech’s (BNTX) third dose for Americans 65 and older, and for those with high risk of contracting a severe case of COVID-19. The vote authorizing a booster for 65 and older was the panel’s second decision of the afternoon, following a ruling against booster doses for Americans 16 and over. The second vote also approved emergency use authorization rather than a supplemental approval of the already fully-licensed vaccine. A CDC advisory panel meeting, slated for next week, will delve further into who will qualify for the additional dose. Dr. Lena Wen, visiting professor at George Washington University Milken Institute School of Public Health, told Yahoo Finance the vote achieved a balance. The vote comes after a heated debate in recent weeks over the need for booster or additional shots, which both mRNA companies — Pfizer and Moderna (MRNA) — have advocated for. “This is a reasonable ‘middle ground’ solution and gives discretion to physicians and patients to decide who is high risk. That level of individual decision-making is key,” Wen said. “Of course, it’s true that the unvaccinated are the major problem when it comes to spread of covid, but it shouldn’t mean that those vaccinated don’t deserve to be better protected with an extra dose if they so choose,” Wen added. Dr. Peter Marks, the FDA’s leading expert on vaccines, touched on the recent controversy in his introductory remarks. “We know that there may be differing opinions of the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex, and evolving,” Marks said. He added the meeting focused on almost real-time analyses compared to what is happening in the world, and the goal remains slowing the spread of COVID-19, which is killing almost 2,000 Americans daily. The question the advisory panel was originally given to consider only used the U.S. data, a small dataset, despite the presentations including data from the U.K. and Israel. Marks instructed the panel to consider all the data, noting, “This is not a legal proceeding, this is a science proceeding, so you can take all the data into account.” The meeting precedes a September 20 start date for additional doses, announced last month by the White House COVID-19 Response Team, despite U.S. Centers for Disease Control and Prevention (CDC) data showing some Americans are already receiving third doses. Last month, the CDC recommended additional doses for immunocompromised people. A CDC advisory panel will meet next week to discuss recommendations for who should receive a booster dose. At a Response Team briefing Friday, U.S. Surgeon General Dr. Vivek Murthy said the administration is already communicating with pharmacies, nursing homes and state officials to help roll out additional doses. But whether or not the average American also needed boosters had been a growing debate for weeks. Measuring antibody levels after a vaccine, which tend to wane, versus relying on memory cells, which can recall how to fight the virus, as is typical in vaccinations, was at the heart of the debate in the science community. A Pfizer official acknowledged that “its a much more complex story” than just antibody titers — even as the company relied on that data to advocate for additional doses. Meanwhile, some who opposed third doses believed those doses could be better used in countries with low vaccination rates. Marks also addressed that at the start of the meeting Friday, noting that the committee is only supposed to weigh on the data and need for shots, and not on global vaccine equity or operational concerns in rolling out a booster campaign in the U.S. The decision Friday heavily leaned on data from Israel, as well as the U.K., which has been a point of concern. In days prior, both mRNA vaccine companies discussed and advocated for boosters.  A new report from the CDC Friday showed that Moderna’s vaccine remained stronger in protecting against hospitalization compared to Pfizer and Johnson & Johnson (JNJ). Both mRNA company CEOs have previously told Yahoo Finance that additional doses are inevitable. But when those doses will be needed — annually or sometime after a third shot — remains unknown. Moderna president Stephen Hoge said as much in a recent interview. “We don’t really know” if a third shot will be the final or if more are needed, he said. Pfizer CEO Albert Bourla penned an open letter advocating for boosters based on the company’s clinical trial data and data from Israel.  But the FDA previously cautioned that some studies from Israel, including a few published this week, have not been independently verified by the regulatory agency. Bourla also addressed the concerns about equitable distribution of vaccines globally. “I believe …that the introduction of booster doses should not change the number of doses that each country receives. No commitments already made by Pfizer to a country will change if boosters are approved,” Bourla said. Meanwhile, the U.S. is reportedly gearing up to buy an additional 500 million doses of the Pfizer vaccine for global donations, according to the Washington Post. Nick Note: I could bore you with another ten pages on this issue. Let me tell you what I know. In seeing hundreds of anybody checks REAL WORD over the past year. I can tell you for a FACT that after the 2nd vaccine we see the antibody load hit over 3000. That number slowly declines. By the time people are 6 months out that number drop to a range of 800 to 1500. The science say that immunity that low is a danger. and And AND at that critical junction where immunity falls below 1000 we see vaccinated people testing positive and getting infected…… And their hospitalization rate is half of a unvaccinated person…. A real danger. When they get their 3rd vaccine immunity goes back up to 2800 to 3500. Get this the immunity boost and levels is the highest among the group that has their third shot. Their side effects and the percentage of people reporting side effects seems to stay the same as with people who received their first and second dose. We have seen no serous side effects in our area. We are talking about  vaccines that have seen 5.79 doses administered and close to 3 billion people vaccinated. Side effects are minimal in fact minuscule. For the US government to not roll out the third vaccine to its populations is nothing source of criminal. Hundreds of thousands will become infected and thousands will die. And the hell of it is eventually they will roll out the3rd dose of the vaccine to the population. Another travesty is the delay in vaccinating the kiddies. Clinical trials are very very successful. When the history of this time is written people will be shocked by the vaccine delays and the fact that kids are being forced to go back to school when a vaccine for them is a few months away…… I have tears in my eyes.

LONDON (Reuters) – International investors that have been piling into China in recent years are now bracing for one of its great falls as the troubles of over-indebted property giant China Evergrande come to a head. The developer’s woes have been snowballing since May. Dwindling resources set against 2 trillion yuan ($305 billion) of liabilities have wiped nearly 80% off its stock and bond prices and an $80 million bond coupon payment now looms next week. What happens then is unclear. Bankers have said it will most likely miss the payment and go into a kind of suspended animation where authorities step in and sell some of its assets, but it could easily get messy. “We will have to see what happens,” said Sid Dahiya, head of EM corporate bonds at abrdn, formerly Aberdeen Standard, in London, which holds a small sliver of the bonds. “They are probably working on a deal in the background, but we don’t have any clarity and we don’t really have any precedents, so it is uncharted water.” Evergrande warned just over two weeks ago that it risked defaulting on its debt if it failed to raise cash. Since then it has said that no progress has been made with those efforts. Analysts say the bigger picture is that if Evergrande – which has more than 1,300 real estate projects in over 280 cities – does topple, it will firmly dispel the idea that some Chinese firms are too big to fail. It would probably still apply to big state-linked firms of course, but it comes too after Beijing’s clampdowns on big tech firms like Alibaba and Tencent wiped nearly a trillion dollars off its markets earlier in year. Contagion from Evergrande has largely been confined to China’s other highly-indebted “high-yield” firms which have also slumped, but Hong Kong’s heavyweight Hang Seng also hit a 10-month low on Thursday showing there is some spread.  There are big name global funds involved too. EMAXX data shows that Amundi, Europe’s largest asset manager, was the largest overall holder of Evergrande’s international bonds although it is likely to have sold at least some before things turned really ugly. The Paris-headquartered firm had just under $93 million of a $625 million bond due for repayment in June 2025 the EMAXX data shows. UBS Asset Management was the number two holder in that issue with $85 million as well as one of the bigger overall holders. Amundi’s Co-Head of EM Corporate & EM High Yield, Colm d’Rosario described the fundamental picture for many Chinese firms as intact “For now, however, we await the commencement of a restructuring process (of Evergrande) to gather more information.” “It remains to be seen the scale of loss that investors will face.”

Back in April Evergrande’s bonds were trading around 90 cents on the dollar, now they are closer to 25 cents.

“It was always priced as a risky high-yield investment but what prices are telling you today is that there was some surprise that the government would let it go fully,” said the head of emerging market debt at U.S. fund Aegon Asset Management Jeff Grills.

He added it has been a text book example where investors had been lured in by the 10% plus interest rate the bonds had provided.

According to the letter Evergrande sent to the Chinese government late last year, its liabilities involve more than 128 banks and over 120 other types of institutions. A group of Evergrande bondholders has selected investment bank Moelis & Co and law firm Kirkland & Ellis as advisers on a potential restructuring of a tranche of bonds, two sources close to the matter said.

Other funds also exposed to the bonds include the world’s biggest asset manager BlackRock, as well dozens more such as Fidelity, Goldman Sachs asset management and PIMCO.

Major U.S. financial firms including BlackRock and Goldman, and the likes of Blackstone, are due to meet with officials from China’s central bank and its banking and securities regulators later on Thursday. Debt analysts hope though the damage might not be too widespread. The holdings are tiny compared to those big investment firms’ overall size. Also only $6.75 billion of near $20 billion of Evergrande debt are included on JPMorgan’s CEMBI index which big emerging market corporate debt buyers use as a kind of shopping list. Others are still wary though of the wider signal it sends. “This is part of a self-reinforcing dynamic in which rising insolvency risk sets off financial distress costs, which in turn increase insolvency risk,” Michael Pettis, a nonresident senior fellow at the Carnegie–Tsinghua Center for Global Policy, said on twitter. “Until regulators step in and credibly address insolvency risk across the board, conditions are likely only to deteriorate.” Some veteran emerging market crisis watchers also think the troubles still have further to run. “This unwind hasn’t even really started,” said Hans Humes at EM debt-focused hedge fund Greylock Capital.  Nick Note: what did Black Rock, Fidelity and  the investment banked whores do when they realized their Chinese investments were going tapioca? What they usually do. Suck as many people in as possible. Damn near every investment house has recommendations urging investors to “diversify” into China.

SCIENTISTS have raised new concerns about the rapid spread of the Delta variant of coronavirus, warning new restrictions “may still be required” even after a successful vaccine rollout. The Covid warning comes after the Government did not rule out a “firebreak” lockdown in response to rising infections and hospitalisations with COVID-19, but only as “a last resort” measure. The Delta variant was first reported in India last year and has quickly proven to be more easily transmissible and resistant to Covid antibodies. The SARS-CoV-2 B.1.617.2 variant has since spread to more than 90 countries and has emerged as the leading cause of infections in the UK, US and Israel, among others.