Chief Stipe

Breaking: FDA Panel Endorses Pfizer Shots for 5- to 11-Year-Olds, Experts Say Vaccine for Kids Is ‘Unnecessary, Premature and Will Do More Harm Than Good’ The U.S. Food and Drug Administration’s advisory panel today voted to recommend the agency allow Pfizer to amend its Emergency Use Authorization for its COVID vaccine for children 5 through 11 years old, despite a host of objections from scientists and physicians. By Megan Redshaw The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It's free. The U.S. Food and Drug Administration’s (FDA) advisory committee today endorsed Pfizer’s COVID vaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians. The vote passed with 17 supporting it and one abstention. Before the shots can be rolled out, the FDA will have to formally authorize the vaccine, and the Centers for Disease Control and Prevention (CDC) must also weigh in with its own recommendations — but the Biden administration’s announcement last week that it has already ordered 68 million doses of the pediatric vaccine suggests Pfizer’s request will sail through. During today’s meeting, the Vaccines and Related Biological Products Committee (VRBPAC) heard evidence from Pfizer and regulators, and listened to concerns from numerous experts. According to the FDA website, as of Oct. 25, the agency had received 139,470 comments from the public prior to today’s meeting — a number federal officials described as strikingly high. As he opened the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said, “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization. Marks stressed the only question before the experts was whether shots should be allowed, not whether to mandate them, the New York Times reported. The dose for younger children would be one-third the strength given to people 12 and older, with two shots given three weeks apart. Based on CDC data presented during the meeting, among children 5 to <12 years of age, there have been approximately 1.8 million confirmed and reported COVID cases since the beginning of the pandemic, and only 143 COVID-related deaths in the U.S. through Oct. 14. In this same age group, there were 8,622 COVID-related hospitalizations through Sept 18. “This translates to cumulative incidence rates of approximately 6,000 and 30 per 100,000 for confirmed COVID cases and COVID-related hospitalizations, respectively, among children 5 to <12 years of age,” Pfizer’s application said. Children with underlying medical conditions, such as asthma, diabetes and obesity, made up two-thirds of severe COVID cases. Pfizer provided safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed only for about two months, the second for only two-and-a-half weeks. The two-month cohort included 2,268 children ages 5 to 11. Of the 2,268 children, 1,518 received the vaccine and 750 received a placebo. Each received two shots spaced three weeks apart. Pfizer’s study found its vaccine was about 91% effective against symptomatic COVID in children, based on 16 cases of COVID in the placebo group and three cases in the vaccinated group over the brief follow-up period. Most side effects occurred within a couple of days and included pain at the injection site, fatigue, headache, muscle pains and chills, Pfizer said. According to Pfizer, the number of participants in the current clinical development program was “too small to detect any potential risks of myocarditis associated with vaccination.” Long-term safety of Pfizer’s COVID-19 vaccine “to evaluate long-term sequelae of post-vaccination myocarditis/pericarditis” in participants 5 to <12 years of age will not be studied until after the vaccine is authorized for children,” Pfizer’s application noted. Pfizer data insufficient, kids’ risk of vaccine injury greater than COVID risk, experts say Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System (VAERS). They also questioned the need to vaccinate children — whose risk of dying from COVID is “almost nil” — at all. According to Dr. Meryl Nass, member of the Children’s Health Defense Scientific Advisory Panel, Pfizer once again did not use all of the children who participated in the trial in their safety study. “Three thousand children received Pfizer’s COVID vaccine, but only 750 children were selectively included in the company’s safety analysis,” Nass said. “Studies in the 5-11 age group are essentially the same as the 12-15 group — in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immuno-bridging analysis is sufficient.” Nass said, “All serious adverse events were considered unrelated to the vaccine.” During the meeting and in its FDA application, Pfizer argued children should be vaccinated to prevent SARS-CoV-2 transmission, yet the company did not assess asymptomatic transmission. Dr. Ofer Levy, a VRBPAC member, asked for evidence that Pfizer’s vaccine prevents transmission. Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults. When questioned further, Gruber was unable to cite specific evidence to back his assertion. Steve Kirsch, founder of the COVID-19 Early Treatment Fund, asked the panel how they could do a risk-benefit analysis with Pfizer’s COVID vaccine if they did not know the CDC’s VAERS under-reporting factor (URF). Kirsch asked: “How can you do a risk-benefit of analysis of COVID vaccines if you don’t know the URF? This is extremely, extremely important. You have been assuming it has been one. It is not one. Using a URF of 41, which is calculated using CDC methodology, we find over 300,000 excess deaths in VAERS. If the vaccine didn’t kill these people, what did?” “How many Americans have to die before you pull the plug?” Kirsch asked. Kirsch also questioned the panel on why Maddie de Garay’s severe adverse reaction to the Pfizer vaccine, which left her paralyzed, was not reported by the company to the FDA. Dr. Jessica Rose, viral immunologist and biologist, told the panel EUA of biological agents requires the existence of an emergency and the nonexistence of alternate treatment. “There is no emergency and COVID-19 is exceedingly treatable,” Rose said. In a peer-reviewed study co-authored by Rose, myocarditis rates were significantly higher in people 13 to 23 years old within eight weeks of the COVID vaccine rollout. In 12- to15-year-olds, Rose said, reported cases of myocarditis were 19 times higher than background rates. “In an act of censorship, this paper has been temporarily removed and it has now been killed without criticism of the work,” Rose said, noting the timing of the removal was strange. Rose said tens of thousands of reports have been submitted to VAERS for children ages 0 to 18. Rose explained: “In this age group, 60 children have died — 23 of them were less than 2 years old. It is disturbing to note that “product administered to patient of inappropriate age was filed 5,510 times in this age group. Two children were inappropriately injected, presumably by a trained medical professional, and subsequently died.” Dr. Josh Guetzkow, a senior lecturer at the Hebrew University of Jerusalem, said expanding the EUA to children is unnecessary, premature and will do more harm than good. Guetzkow said there is no emergency for children, especially healthy ones whose risk of severe illness and death is “almost nil.” Guetzkow said kids with pre-existing conditions and prior COVID infections were not included in Pfizer’s study, so including them in the EUA is negligence. “Pfizer’s trial is woefully underpowered to detect specific safety concerns, such as myocarditis, just like the adolescent study was, and if they weren’t able to detect an unexpected safety concern there, they wouldn’t be able to here,” Guetzkow said. Guetzkow said: “In Pfizer’s study, only .5% of controls were dropped due to important protocol violations, versus 3% in the treatment group. The odds of that happening by chance are 1 in 10,000. This deviation is poorly explained with no ITT analysis. The study is not double-blind and may be subject to bias. Most VSD safety monitoring programs have not reported results, why not wait?” Guetzkow said, “from CDC reports, we can expect that for every 18 child hospitalizations prevented, at least 43 will end up in the hospital for all causes following vaccination,” yet, the “FDA’s risk-benefit analysis only counts myocarditis hospitalization.” “Why ignore the V-safe data, and shouldn’t FDA verify Pfizer’s efficacy and immunobridging analysis first?” he asked. Guetzkow said VAERS shows alarming safety signals, which cannot be attributed to increased vaccination, simulated reporting or COVID infections. “We calculated the ratio of adverse events reported per million Pfizer vaccinations to reports per million flu vaccinations among teenagers to see what to expect in children. Serious events are reported 51% more often for Pfizer, deaths 47 times, life-threatening conditions 49 times,” Guetzkow said. Guetzkow asked the panel to look at the data on COVID vaccines compared to flu vaccines. Pointing to the data on reproductive organs, Guetzkow asked, “why would we expect children to take these risks to protect adults?” There are more than 900 types of adverse events reported after Pfizer vaccination that have never been reported after flu vaccines, including 11 cases of multisystem-inflammatory syndrome (MS-C) that occurred without previous history of COVID infection, Guetzkow said. He added that if the panel was considering authorizing Pfizer’s COVID vaccine to prevent MS-C — as Pfizer’s application suggested as one of the reasons they should — the panel should reconsider. During another part of the meeting, Julia Barnes-Weise, director of the Global Healthcare Innovation Alliance Accelerator, said pharmaceutical companies have concerns. “One of them is, especially for a not-yet-approved vaccine, that they could be held liable for any injury that that vaccine seems to have caused,” Barnes-Weise said. In a preliminary analysis last week, FDA reviewers said protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic, PBS News Hour reported. Children’s Health Defense (CHD) said yesterday it would take legal action against the FDA if it granted EUA for the Pfizer-BioNTech vaccine for children 5- to 11- years old. In a letter signed by Robert F. Kennedy, Jr., CHD chairman and chief legal counsel, and Nass, Kennedy and Nass wrote: “CHD will seek to hold you accountable for recklessly endangering this population with a product that has little efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke, and other thrombotic events and reproductive harms.”

The world has got completely insane! Your browser does not support the audio tag. 20211027-183802-Molloy.mp3

Geez if they keep chipping away they'll only have enough room to race miniature ponies!! That aside doesn't show much hope for expansion in the future.

Victorian Race Club bans daring outfit in spring carnival crackdown The singer attended an official Melbourne Cup event today in an outfit officials have banned from the racecourse in a dress code crackdown. Rebekah Scanlan @rebekahscanlan less than 2 min read October 27, 2021 - 2:19PM Take a look at some of the fashion from this year's Ladies Oaks Day! More From Celebrity VIP attendees of the prestigious Melbourne Cup will be subjected to a strict new dress code as spring racing officials continue to crack down on racy outfits. Just two weeks after the Australian Turf Club (ATC) stated trendy “cut out” dresses were now “unacceptable” race day attire, the Victorian Race Club (VRC) has issued the same strict guidelines to its members. The club’s members enclosure has warned it will be “strictly enforcing” the ladies dress regulations throughout the Melbourne Cup Carnival, which begins Saturday October 30 and ends on November 6. Race day fashion has always come with a strict guide book, but it seems organisers are doubling down after rules continuoually fail to act as a deterrant to famous attendees in the past. Flashing the flesh at the Melbourne Cup has always been frowned upon, but now officials have issued strict guidelines enforcing no midriffs. Picture: Media Mode Delta Goodrem attended the Lexus Melbourne Cup Media Event in Sydney on Wednesday wearing a dress with cut-outs. Picture: Media Mode Outfits worn to the Lexus Melbourne Cup event held in Sydney today to celebrate the “race that stops the nation” on Tuesday November 2 shows the memo doesn’t appear to have sunk in just yet. Singer Delta Goodrem arrived in a gorgeous green floral dress that featured sheer puff sleeves and ran down to her shins. However the floaty number also had cut-outs on her hips, showing off her midriff. The 36-year-old finished her look with pale pink accessories, including a pink clutch, fascinator and strappy heels while her blonde hair was tied back with curled strands framing her face. Other garments deemed “not acceptable” at Flemington include jeans, shorts and leggings as well as “ripped” clothing and bulky jackets like parkas and duffel coats. Australian Turf Club recently ruled cut-out dresses were ‘not acceptable’. Picture: Mackenzie Sweetnam/Getty Images The embattled former WAG wore the controversial outfit at Derby Day in 2019. Picture: James Gourley/Getty Images In the past, the no skin rule has failed to stop other attendees, including embattled former WAG Nadia Bartel who controversially a wore white Dion Lee dress to Derby Day in 2019 that featured cut outs on the hip. The cut-out trend has become a celebrity favourite in the last few years, regularly worn by influencers and A-listers. Kim Kardashian was one of the first to go full throttle with the risque design, wearing a vintage Thierry Mugler gown in 2019 that sparked the trend. Since then it has been seen on countless red carpets for movie premieres as well as altering fashion and swimwear trends.

I realise that. Just thought I throw up the latest overall numbers.

Notice the population in surrounding suburbs? 2018 Census - Kumara 285 pop. I suspect they counted a few possums in that number though.

Betting Profit is tracking pretty well but Gaming Profit is taking a hit due no doubt to people being locked out of Pokie rooms. The Pokie's have long been a strategic weakness with $21m of net Profit contingent on them performing.

September Operational Performance Reported Profit for the month was $13.8m, which was $1.6m above Budget. Operating Expenses were $9.1m for the month, which was $0.8m below Budget. Year To Date (1 Aug 2021 to 30 Sep 2021) Reported Profit was $22.5m which was $1.4m below Budget and $5.1m below last year. Year To Date ((1 Aug 2021 to 30 Sep 2021) Operating Expenses were $18.2M, which was $1.4m below Budget and $0.1m below last year. --------------------- September Distributions Racing Codes were paid $12.6m in distributions and other payments for September, versus $12.6m budgeted. This consisted of TAB NZ Betting Profit (listed as Fixed Distribution in the table below), Offshore Bookmaker Commission Fees, which are based on actual turnover (termed Betting Information Use Charges (BIUC) in the table below), and Betting Duty/Levy repeal. Top 10 Racing events by turnover Date Venue Race No. Race description Turnover 18-Sep Hastings R9 Tarzino Trophy (G1) $653K 18-Sep Caulfield R8 Sir Rupert Clarke Stakes (G1) $508K 4-Sep Te Rapa R9 War Decree 1200 $439K 18-Sep Hastings R7 Hawke's Bay Breeders' Gold Trail Stakes (G3) $412K 25-Sep Rosehill R7 Keeneland Golden Pendant (G2) $390K 11-Sep Flemington R8 PFD Food Services Makybe Diva Stakes (G1) $376K 18-Sep Randwick R7 Fujitsu General George Main Stakes (G1) $355K 11-Sep Flemington R6 Furphy Let's Elope Stakes (G2) $352K 18-Sep Hastings R10 Brew's & 'Que's Tickets On Sale Now $351K 25-Sep Rosehill R8 XXXX Golden Rose Stakes (G1) $335K

September Operational Performance Reported Profit for the month was $13.8m, which was $1.6m above Budget. Operating Expenses were $9.1m for the month, which was $0.8m below Budget. Year To Date (1 Aug 2021 to 30 Sep 2021) Reported Profit was $22.5m which was $1.4m below Budget and $5.1m below last year. Year To Date ((1 Aug 2021 to 30 Sep 2021) Operating Expenses were $18.2M, which was $1.4m below Budget and $0.1m below last year. --------------------- September Distributions Racing Codes were paid $12.6m in distributions and other payments for September, versus $12.6m budgeted. This consisted of TAB NZ Betting Profit (listed as Fixed Distribution in the table below), Offshore Bookmaker Commission Fees, which are based on actual turnover (termed Betting Information Use Charges (BIUC) in the table below), and Betting Duty/Levy repeal. Top 10 Racing events by turnover Date Venue Race No. Race description Turnover 18-Sep Hastings R9 Tarzino Trophy (G1) $653K 18-Sep Caulfield R8 Sir Rupert Clarke Stakes (G1) $508K 4-Sep Te Rapa R9 War Decree 1200 $439K 18-Sep Hastings R7 Hawke's Bay Breeders' Gold Trail Stakes (G3) $412K 25-Sep Rosehill R7 Keeneland Golden Pendant (G2) $390K 11-Sep Flemington R8 PFD Food Services Makybe Diva Stakes (G1) $376K 18-Sep Randwick R7 Fujitsu General George Main Stakes (G1) $355K 11-Sep Flemington R6 Furphy Let's Elope Stakes (G2) $352K 18-Sep Hastings R10 Brew's & 'Que's Tickets On Sale Now $351K 25-Sep Rosehill R8 XXXX Golden Rose Stakes (G1) $335K

FFS God give me strength!!!! Page 19 - a bloody Breeders Championship!!!!!! A $1m race for mares to support breeders! I thought they already had a subsidised day for them - it's called the Karaka Millions Day!

I hear you. I'm up to page 19 and I just can't seem to get rid of this feeling of deja vu! None of it so far focuses on developing quality product or generating revenue!

WTF! I've been reading this Directions paper in between doing other stuff and just got to page 18. Aotearoa Champions Day with 10 x $200,000 races! FFS as that famous Ozzie kid Jonsey once said - "Your dreamin - mate!" Anyway I thought we already had a day like that that doesn't pay its way - it's called Karaka Millions Day!

Pay is not enough plus going on what @Freda has written he would fail in terms of PC. You can't tear someone a new arsehole nowadays even if they are in the process of killing or injuring themselves!

Like what? It used to be farming. The core business is wagering from racing. If you fail at that or even fail to recognise that then you are doomed to fail.

I have noticed that there is a bit of the squeaky wheel in some of the decisions so some credit to @Reefton. The most disturbing aspect is that much of the decisions are driven by the need to feed the AWT's not what is BEST for RACING. My prediction is that will get worse primarily because of the switch from a low cost delivery model to a high cost one without any obvious revenue generation breakthroughs. I just can't seen how the dominance of our racing by dirt tracks will appeal to the Ozzie and NZ punter.

Well do we have enough as it is for both Islands?

What are you suggesting?

Make that 11 suspended. 10 injured. 3 MIA.

GOJ why this fixation on bagging some very successful Trainers and Breeders?

Not surprising when it bled! The horse was previously with Roger James who had a high opinion of it until it broke down. There's plenty of material to bag Molloy on but his efforts as an Owner, Jockey and Trainer don't provide much.

So your good memory enables you to remember a horses stable name but not its race name even after it ran in a Railway Handicap? Are you thinking of Celeris? If you are she never ran in a Railway but she did win the Levin Stakes and started in the Telegraph finishing last. She bled in that race. I remember it well because I talked to the distraught trainer down at the stables after the race. Also remember and average ride from Mark Du Plesis on our horse to run third that day. James McDonald rode that day. Another vivid memory at the end of the day was seeing Rosie Myers, Kelly Myers, Sam Spratt and Michelle Spratt in the Owners/Trainers bar after the last race all dressed up for town.

It's got worse or harder depending on your perspective as the quality of our racing has declined. A stable like Te Akau can compensate because they have a big stable and can mix and match to push their horses to a different level. Murray Baker has it down to an art form with a smaller stable however I understand his attrition rate is up there with Gai Waterhouse. Now that doesn't work for many owners with many getting the stitch quickly when they fork out big dosh for yearlings and training fees only to see their horses never getting to the races!