Friday, October 14, 2022

Not up to snuff: AstraZeneca's nasal spray Covid vaccine FAILS to protect against virus

AstraZeneca's leading Covid nasal spray vaccine does not protect well against the virus, a study has shown — dashing hopes it could replace traditional jabs.

The University of Oxford — which is developing and running trials of the vaccine — said only a minority of patients mounted an immune response.

Even those who did react to the jab had lower antibody levels than someone given a shot-in-the-arm vaccination.

It is another blow for AstraZeneca which has so far failed to break the US vaccine market — after concerns about its original jab's link to blood clots.

Researchers across the world have placed high hopes on nasal spray vaccines because they may have the potential to stop Covid infections entirely.

It was thought that prompting an immune response directly in the airways would be able to shut the virus down before it spreads to the rest of the body.

But Dr Sandy Douglas, who ran the UK-based AstraZeneca trial, said the spray did not perform 'as well as we had hoped'.

China and India have already approved nasal spray Covid jabs, although there is no public data on how well they work.

The US has spent billions purchasing more than 800million doses of Covid vaccines, but a third of Americans are still yet to get their first shots.

It was hoped that nasal vaccines could offer an alternative inoculation because they are easy to administer and don't cause pain. Scientists also believed they might 'enhance' protection because they target the lining of the nose, where the virus infects first.

But today's results — thought to be the first on a nasal spray for Covid — suggest more research is needed.

What is the advantage of nasal sprays for Covid vaccines?

Scientists have been chasing a nasal spray Covid vaccine as an alternative to the needle-based method. They hope that it could 'enhance' immune responses because it is administered to the lining of the nose, the first place the virus infects.

Experts also say it can help people with a fear of jabs get the vaccine. The fear — known as trypanophobia — affects about 10 per cent of adults.

There is still little evidence that they are as good as standard jabs, however. Oxford University found they only sparked immunity in a minority of participants.

The sprays have been approved for use in China and India. But studies on this are yet to be released.

In the Phase I clinical trial scientists recruited 30 healthy volunteers who had not previously been vaccinated. The purpose of the study was to perfect the dosage size and timing.

All received a first dose of the AstraZeneca vaccine as a nasal spray, and half also got a second dose. These were given as low, medium or high doses.

Blood tests and swabs showed 'little evidence' all those who got one dose had an immune response.

After the second spray just four participants — or 30 per cent of the total — had evidence of an immune response.

But this was much weaker than that triggered by standard vaccines.

In a second arm of the trial, 15 double-vaccinated people were given the nasal spray as a booster dose.

But again this did not appear to trigger an immune response — with antibody levels remaining 'indistinguishable' from the unvaccinated individuals.

No adverse safety effects were spotted during the trial.

The results were published today in the journal eBioMedicine.

Dr Douglas, from Oxford University's Jenner Institute, said: 'The nasal spray did not perform as well in this study as we had hoped.

'One possibility is simply that the majority of the nasal spray vaccine ends up being swallowed and destroyed in the stomach – delivery to the lungs could avoid that.

'A further challenge is that researchers don’t fully understand the relationships between the strength and types of immune responses within the airways and protection against infection.'

She called for more research into these vaccines, to determine whether another method could help develop a nasal version.

'[Our results] were quite different from recent data from China, which has suggested good results can be achieved by delivery of a similar vaccine,' she said.

'A nasal spray vaccine has recently been approved for intranasal use in India and we are looking forward to the peer-reviewed publication of the clinical trial data used to support that.'

China gave emergency approval for a nasal spray Covid vaccine — from CanSino Biologics Inc — last month.

CanSino said studies indicated that its vaccine induced a strong immune response, although trial data is yet to be released.

Unlike AstraZeneca's it is given via a nebuliser device, a machine that turns a liquid into a fine mist that is then breathed in.

India's health ministry also approved a nasal spray Covid vaccine last month by Bharat Biotech.


Dangerous vaccines

More on the great unravelling of the Covid vaccine story

It’s Dreamtime down under as Australian politicians and the media, led by their health authorities, sleepwalk through 2022.

Last Saturday, Florida’s surgeon general, Joseph Ladapo, released analysis showing that Covid-19 mRNA vaccines increased the risk of cardiac-related death by a staggering 84 per cent among men aged 18 to 39 within 28 days of injection. Ladapo had already recommended against Covid vaccination in children aged 5 to 17 in March. Now he has added children aged less than five and men aged 18 to 39, tweeting, ‘Florida will not be silent on the truth’.

Ladapo is not alone. In mid-September Denmark recommended against Covid shots for any healthy person under 50 years. A fortnight later, Norway recommended against the jabs for healthy people aged under 65. In the UK healthy children who turned five on or after 1 September will not be vaccinated until they turn 12 unless they live with someone with a weakened immune system.

Esteemed UK cardiologist Dr Aseem Malhotra, an erstwhile TV talking head in support of Covid vaccines has gone further. His peer-reviewed paper published a fortnight ago calls for their immediate suspension. ‘Until all the raw data on the mRNA Covid-19 vaccines have been independently analysed, any claims purporting that they confer a net benefit to humankind cannot be considered to be evidence based,’ he says.

On 16 September, an international group of scientists and doctors, led by French scientist Alexandra Henrion-Caude and American doctor Sally Priester issued a declaration of an international medical crisis due to diseases and death related to Covid vaccination. They pointed to high excess mortality in countries with high vaccination rates, ‘the large number of sudden deaths in previously healthy young people’, ‘the high incidence of miscarriages and perinatal deaths’, and the ‘large number of adverse side effects, including hospitalisations, permanent disabilitie, and deaths’.

Yet, it is as if none of this happened to the somnambulists running Australia. This week, Karen Andrews, the former minister for Home Affairs who cancelled Novak Djokovic’s visa twice ranted that he must not be allowed to compete in the next Australia Open just because ‘he’s a high-ranking tennis player with many millions of dollars’. ‘It shouldn’t be just one rule for (him) and a different rule for everyone else,’ she pontificated. Yet preventing Djokovic from entering applies a harsher rule to him than anyone else, since nobody has been required to be vaccinated to enter Australia since 6 July. And if Florida and the dissenting doctors are correct, Andrews should be apologising to Djokovic for trying to coerce him to get a vaccine that could have killed him.

Equally, if the dissenting doctors and scientists are right, it is also the ongoing mass Covid vaccination campaigns that underlie Australia’s shocking excess mortality which started rising in March 2021, just when the Covid vaccines started to be rolled out and is now running at 17 per cent. This year, there had been 13,524 excess deaths by 30 June of which less than 40 per cent (5,387) were due to Covid. What caused the deaths of the other 8,137 Australians? And why is it that Australian health officers who lamented every Covid death when there were only 905 in 2020 and 1,342 in 2021, have said nothing about excess mortality in 2022 which is ten times worse than Covid mortality in 2021?

Australian Medical Association president Professor Steve Robson described Australia’s excess mortality as a ‘worrying’ trend that mirrored countries such as the UK but said he couldn’t explain it adding, ‘there needs to be some research into why this is happening’. There has been none. Why not? Instead, Australia’s health authorities still recommend repeatedly jabbing everyone from the age of six months up intoning the mantra that the vaccines are ‘safe and effective’.

Yet that’s not what the NSW data, the most complete in Australia, shows. Vaccinated people in NSW are six times more likely to get Covid than the unvaccinated, 77 times more likely to be hospitalised, ten times more likely to end up in ICU, and 1.1 times more likely to die even though the people most likely to die of Covid – people in palliative care, severe illness, the frailest elderly – are often unvaccinated because they are so close to death.

NSW does not release the data it collects on the comorbidities of those who are hospitalised or die with or of Covid. If it did we could compare like with like and establish the risk of the virus to healthy or sick people in each age group, and the risks or benefits of vaccination to those same groups. Why don’t health authorities do this? Are they just woefully obtuse or do they fear that the results would reveal that the vaccine is neither safe nor effective?

Despite the incompleteness, the NSW statistics strongly suggest that the vaccine is increasing the risk of illness and death. This was a known danger. Are Australia’s health authorities actively monitoring for it? It seems not. Yet Dr. Fauci warned in May 2020 that there was a ‘possibility of negative consequences’ because ‘certain vaccines can actually enhance the negative effect of the infection’. This was true for a vaccine developed for respiratory syncytial virus which was never approved and a measles vaccine developed in the 1960s which was withdrawn.

Why are the Covid vaccines not being withdrawn, asks Dr Malhotra. He notes the swine flu vaccine developed in 1976 was withdrawn because of a 1 in 100,000 risk of Guillain-Barré syndrome and the rotavirus vaccine was withdrawn because of a 1 in 10,000 risk of bowel obstruction. He estimates the true prevalence of serious adverse events from Covid-19 mRNA vaccines is between 1 in 800 and 1 in 1,000.

What about excess mortality? The easiest way to establish whether vaccination is contributing would be to identify the vaccine status of all those who died since Covid immunisation commenced, together with their age and comorbidities. It’s not hard.

That’s what Florida, and presumably Denmark and Norway have done. But not Australia. Its leaders slumber on at the wheel as the nation careens towards a calamitous awakening.




Wednesday, October 12, 2022

The Conspiracy To Hide The True Dangers Of The COVID-19 mRNA Vaccines

On Friday, October 7, 2022, Florida Surgeon General Dr. Joseph Ladapo released a study on the dangers of the COVID-19 mRNA Vaccines and recommended that adult men under 40 stay away from the COVID-19 mRNA vaccines.

"The Florida Department of Health (Department) conducted an analysis through a self-controlled case series, which is a technique originally developed to evaluate vaccine safety,” a news release from the Florida Department of Health states. “This analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group.”

Newsweek reported the analysis clarified that COVID-19 vaccination was associated with a "modestly increased risk for cardiac-related mortality" 28 days after receiving the vaccine.

The primary analysis was conducted on Floridians who were 18 years and older "who died within 25-weeks of COVID-19 vaccination" since the vaccines were first rolled out in December 2020.

However, noted Newsweek staff writer Fatma Khaled, the analysis excluded individuals who had a confirmed COVID-19 infection, received a booster or received their last COVID-19 vaccination after December 8, 2021. The study concluded on June 1.

"Individuals with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when considering vaccination and discuss with their health care provider," the state's health department said in the statement.

"Based on currently available data, patients should be informed of the possible cardiac complications that can arise after receiving a mRNA COVID-19 vaccine. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac related death among men in this age group," it added as new guidelines.

The analysis said that men over 60 years old had a 10 percent increased risk of cardiac-related death within 28 days of receiving vaccines that contain mRNA. It also said that vaccines without mRNA didn't have these increased risks among any population.

No sooner had Dr. Ladapo released the study, than the tweet announcing the release of the study was taken down by Twitter for "disinformation." Twitter restored the post on Sunday morning after a firestorm of criticism.

Ladapo is an outspoken skeptic of COVID-19 vaccines who has questioned both the effectiveness and safety of the vaccine. Ladapo's concerns are shared by many who point out that, while the vaccines were originally sold as a traditional preventative vaccine, now the mRNA COVID-19 vaccine narrative has shifted to claim the vaccine may prevent the disease and may lessen its symptoms.

POLITICO reported that Dr. Ladapo has previously recommended that young children should not receive the Covid-19 vaccine. The Florida Department of Health over the summer did not pre-order vaccines for children aged 5 and under even though 49 other states did in the lead-up to the Food and Drug Administration issuing emergency authorization for young kids to receive the Pfizer and Moderna shots.

Bryan Griffin, press secretary for Florida Gov. Ron DeSantis, called Twitter’s actions “an unacceptable and Orwellian move for narrative over fact.”

Critics of the study and Dr. Ladapo’s conclusions from it have objected that it has yet to be peer reviewed and have questioned its methodology.

However, those same critics were nowhere to be found when flawed, and even fraudulent, studies and projections of COVID mortality were released at the beginning of the pandemic (or as we prefer to call it, the Chinese Communist biological weapons attack).

On Monday, Ladapo created a new thread on Twitter discussing the study’s results and process, saying he loved the “discussion that we’ve stimulated” and praising discussing science “transparently instead of trying to cancel one another.” In the thread, Ladapo responds to three critiques of the study.

The critiques, and responses:

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The coordination between Big Government, Big Tech and Big Pharma to suppress any scientific inquiry into the origin of the COVID virus, how it spread from Communist China to the rest of the world and the side effects and efficacy of the mRNA vaccines appears to us to be a conspiracy to enforce a political narrative, rather than what a democratically elected government should do – which is foster open and transparent scientific inquiry conducted in the public interest.

Our view is that studying the COVID virus and vaccines should proceed along the same scientific method path of inquiry that scientists and physicians have used since the Italian physicist Galileo Galilee began the modern age of scientific inquiry over 400-years ago. If the monumental work of Sir Isaac Newton and Albert Einstein can be continually tested, questioned, and refined, surely the pronouncements of a second-rate bureaucrat like Anthony Fauci and the profit-driven results of companies like Pfizer-BioNTech or Moderna can and should be subjected to continued scientific inquiry.


'Covid is NOT over': White House's top doctor undermines Biden and urges Americans to get their booster shot before Halloween

The White House's lead Covid chief said that the pandemic is not over, contradicting statements made by President Joe Biden last month. Dr Ashish Jha, the White House's COVID-19 response coordinator responded to faltering booster uptick rate by warning Americans that the pandemic is ongoing.

His words counter that of President Biden, who told 60 Minutes last month that it had ended - though he would walk back his comments in the following days.

This is not the first time leading US officials have flip-flopped on the pandemic. Earlier this year, Dr Anthony Fauci told PBS Newshour the pandemic was over before going back on his words days later.

The rollout of the bivalent booster shots has largely been a failure to this point.

Most recent data from the Centers for Disease Control and Prevention (CDC) show that only 11 million Americans have receive the jab so far.

The lack of booster uptake seems to have had little affect on the spread of cases, though. Covid cases have plummeted over the past two months - a period where the opposite trend would have been expected. On August 3, America was recording 118,000 cases per day. That figure has dropped to 40,000 as of October 11.

An expected BA.5-variant fueled surge over summer did not materialize either.

Despite this, Dr Jha is pushing for Americans to receive the new Covid jab before Halloween at the end of the month.

'The President was very clear. Covid is not over, there is a lot of work to do,' Dr Jha said at a White House press briefing Tuesday. 'We still have 300 to 400 Americans dying every day, tens of thousands of people getting infected every day, there is a lot of work to do.

'What we know is that if we want to keep people safe and protect them from serious illness, which is obviously priority number one, the number one thing that people need to do is get vaccinated.'

Jha urged Americans to get the additional shot before Halloween so it would be fully effective in their body for Thanksgiving gatherings.

This contradicts statements by President Biden last month, who told CBS' 60 minutes: 'The pandemic is over.

'We still have a problem with COVID. We're still doing a lot of work on it. But the pandemic is over. 'If you notice, no one's wearing masks. Everybody seems to be in pretty good shape, and so I think it's changing.'

Dr Jha used the briefing to urge Americans to receive the bivalent booster shot - which the White House touted throughout the summer.

Latest official data shows there were more than 1,000 patients with flu in the week ending October 1 — up 303 per cent compared to the first week of August. This is a vast underestimate because the US does not routinely test for influenza in the same way as Covid.

Test positivity — the share of swabs for the virus that are coming back positive — has risen from 0.49 per cent to 2.5 per cent in the same time.

Dr Fauci said Monday that the nation should keep its guard up in the coming months as cases of both the flu and Covid are expected to rise. Cases and hospitalization for the flu and related illnesses often surge in cold weather months were people spend more time indoors - which makes it easier for viruses to spread.

But Covid cases are currently plummeting in the US. The nation is averaging 42,000 daily cases, dropping more than 60 per cent from the 100,000 per day average in early August.

The flu largely vanished in recent years as viral interference from Covid and pandemic-related restrictions and mask orders stopped its spread.

America's overall vaccination rate is relatively high, with 80 per cent of the overall population and 90 per cent of adults having received at least one shot.

The additional booster doses have never proved to have appeal among the American population, though. The third doses were rolled out the public just over a year ago, yet still only 50 per cent of the population has gotten the shots.

A large portion of those who did receive the third jab did so not when they first were made available during fall either, instead waiting till the end-of-the-year Omicron surge where it appeared the shot was necessary.

Rollout of the the fourth doses, targeted towards Americans 50 and older, has been abysmal as well. The CDC reports that only 38 per cent of eligible Americans have received the second booster.

Despite this, the impact the virus has had on the life of Americans has faltered throughout the year. After the Omicron-fueled surge began to recede in March, case figures have steadied.

A high point was reached over summer at around 140,000 cases per day - a figure dwarfed by the over 800,000 case-per-day mark reached in January.

Deaths never reached the same devastating totals they had reached in previous surges as well, lingering between 300 to 500 cases per day throughout summer.

This spurred many to put the pandemic behind them - even some of the nation's leading health officials.

Dr Fauci, the nation's leading infectious disease expert, said in April to PBS Newshour that: We are certainly right now in this country out of the pandemic phase.

'Namely, we don't have 900,000 new infections a day and tens and tens and tens of thousands of hospitalizations and thousands of deaths. We are at a low level right now.

'So, if you're saying, are we out of the pandemic phase in this country, we are. What we hope to do, I don't believe — and I have spoken about this widely — we're not going to eradicate this virus.'

He would walk the comments back after backlash from others in the field.




Tuesday, October 11, 2022

Independent task-force releases new report into origins of COVID-19

A new report by a team of independent global scientists has found it “highly likely” the origins of Covid-19 was bats who passed the virus to animal hosts and then to people working in the wildlife trade at a seafood market in China.

The report, published Tuesday by the Independent Task Force on Covid-19 in the Proceedings of the National Academy of Sciences (PNAS) concluded that based on the available evidence it was highly unlikely the virus was created in or released from a laboratory.

The team of 12 internationally renowned experts from a diverse range of disciplines included Dr Danielle Anderson from Victoria.

The team found the evidence strongly indicated that Covid-19 originated via a pathway similar to SARS-CoV, involving a spillover from bats to animals to people leading to the first known cluster of Covid-19 at the Huanan Seafood Market in Wuhan in China in December 2019.

Dr Anderson, from the Royal Melbourne Hospital and a research scientist at the Victorian Infectious Diseases Reference Laboratory (VIDRL) at the Doherty Institute, said the team looked at hundreds of research papers and preprints – papers yet to be peer-reviewed and published – and interviewed those who had an opinion on the pandemic.

Dr Anderson, an expert on bat-borne viruses who also worked at the Wuhan Institute of Virology prior to the outbreak, said based on the evidence the team reviewed, there were no big surprises.

“We did this to understand some of the information people were referencing,” she said.


Are COVID Jabs Causing Leukemia? A Preliminary Analysis of Adverse Event Cases

On November 23, 2021, former South Korean President Chun Doo-hwan died at the age of 90. According to South Korea’s JTBC TV, a former Cheong Wa Dae (South Korean presidential palace) secretary revealed that Chun had not eaten properly for 10 consecutive days since he received the Pfizer COVID-19 vaccine. His health deteriorated rapidly and he lost 20 pounds. And he was diagnosed with leukemia and was hospitalized for 12 days. One of his former aides suspected that his leukemia was related to the side effects of the vaccine.

Moreover, an open letter from a group of Mainland Chinese leukemia patients was circulating on Chinese social media platforms in early May 2022, but it was quickly taken down. In the letter, the patients, aged 3 to 70 years old and from more than 30 provinces and central government directly controlled municipalities across China, stated that they had developed leukemia after receiving COVID-19 vaccines and suspected that their disease was a severe vaccination adverse event. And they hoped that the government would investigate the matter.

So, is it possible that vaccination can cause leukemia? What are the possible causes of the disease, and how can we prevent it?

Principles of Pharmacovigilance

Dr. Yuhong Dong, virologist and infectious disease doctor, has also worked in pharmacovigilance department for cancer drugs at a major international pharmaceutical company.

According to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E2A (Page 4): “An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.” (pdf)

In the pharmacovigilance industry, there is a generally accepted principle: “It is better to make 3,000 misjudgments rather than to miss one case.”

Regardless of the source of the adverse event report and whether the report was made by a professional or not, every piece of information regarding a potential adverse experience of a new drug or vaccine must be properly taken as an AE. And it has to be included in the vaccine adverse event report database for medical analysis. The purpose is to collect as much information as possible to find patterns in these cases and monitor any potential serious adverse events proactively.

According to international good practice principles in the pharmaceutical industry in monitoring vaccine adverse events, an adverse drug or vaccine event is considered eligible to be reported if the piece of information meets the following four conditions:

There is an identifiable patient;

There is an identifiable reporter;

There is exposure to a drug or vaccine;

There is an adverse experience (symptoms or signs or lab test, etc), regardless of whether a causality relationship with the drug or vaccine has been established or not

The key rationale is that after the new vaccine or drug is applied in a large population, the top priority would be safety rather than efficacy. There are many examples of pharmaceuticals or vaccines that have been recalled or even withdrawn from the market due to safety issues. So if there is a safety concern, it must be addressed immediately and proper actions shall be taken in order to protect humanity’s safety.

Case Study: Almost 1,000 People Suspected of Developing Leukemia after Vaccination

A veteran journalist has provided Dr. Dong with two large excel sheets of adverse leukemia events made collectively by mainland Chinese-manufactured vaccine recipients. These data sheets contain adverse events reported by nearly 1,000 patients as of June 4, 2022, at 10 p.m. EST. The adverse events are mentioned in great detail, and the reports’ contents are alarming.

Due to time constraints, we have so far conducted a preliminary analysis of 235 valid cases, accounting for approximately 20 percent of the total.

What we presented here in this paper is the preliminary data analysis, but a more complete analysis will be performed during the coming weeks.

In terms of gender, the victims in 56 percent of these 235 cases were male; 2 percent were female; and 42 percent of the cases didn’t specify gender information. There is currently a lot of missing information, and the gender ratio is predicted to be around 1:1 in the complete data, with the number of men possibly slightly larger.

Their age range was 3 to 79 years old, with an average age of 30 years old.

Vaccines are mainly from Sinovac Life Sciences Co., Ltd, but some are produced by Beijing Institute of Biological Products Co., Ltd., Wuhan Institute of Biological Products Co., Ltd., and several others.

Among the vaccine related adverse events concerning leukemia, the most common is acute myeloid leukemia (49 percent of the cases). It is followed by acute lymphoblastic leukemia (34 percent), aplastic anemia (9 percent), and several other hematological malignancies such as lymphoma.

In 44 percent of the cases, symptoms or diagnoses of these adverse events were reported to occur on average 84 days after the second dose.

In 16 percent of the cases, these leukemia-like events were reported to occur on average 52 days after the third dose. This is a reasonable time frame, as leukemia involves genetic mutations, and there would be a pathological process, which is a chronic adverse reaction. It does not occur in a short period of one or two weeks like the acute side effects of myocarditis or blood clots.

In 16 percent of the patients, the symptoms appeared on average 40 days after the first dose of the vaccine. During this time period, many people might have already received a second dose. So it is likely that they are still classified as having received a second dose, as the patients’ reporting habits vary.

Most of these patients are currently undergoing treatment, with some requiring organ transplantation and/or chemotherapy, and there hasn’t been any case of recovery so far. ?


‘Not having a big impact’: COVID drug fails to beat placebo in major trial

A COVID-19 medication that was thought to strongly reduce the risk of the illness becoming life-threatening and was bought in bulk by the federal government works no better than a placebo, preliminary findings from a major new study suggest.

Molnupiravir, sold in Australia under the brand name Lagevrio, disrupts the coronavirus’ ability to copy itself and was the first COVID-19 antiviral to win government subsidy here.

The medication is intended for people at high risk of serious illness – those aged over 50 who have risk factors, and the immunocompromised – after they test positive to COVID-19 but before they are sick enough to need a hospital. Australia was one of the most aggressive movers in securing access to molnupiravir, buying 300,000 courses in late 2021, before it was approved by medical regulator the Therapeutic Goods Administration (TGA).

But some scientists have long been suspicious of strange results in the drug’s early trials. Data from the new trial has hardened their scepticism.

The University of Oxford’s PANORAMIC trial enrolled 25,783 people with COVID-19, half of whom got molnupiravir. After 28 days, 103 people given molnupiravir had died, compared with 96 in the second group.

“Clearly, it isn’t having a big impact,” said Professor Peter Wark, an expert on antivirals at the University of Newcastle. “I think we’d have to look very critically as to the cost-effectiveness of continuing in this sort of way.”

Governments keen to end COVID restrictions had leant on antivirals as a way out of the pandemic, Wark said. “A slower relaxation of restrictions probably would have had a bigger impact than relying heavily on these antivirals.”

Dr Kyle Sheldrick – a University of NSW researcher who co-authored a paper earlier this year on molnupiravir’s problems – is critical of the TGA’s approach. “I did not think it should have been approved before PANORAMIC,” he said “I certainly don’t think it should be now.”

The Health Department did not answer questions on how much it had spent on the drug, but the US paid about $US700 ($1099) a dose at the same time.

Australia’s National COVID-19 Clinical Evidence Taskforce said it was reviewing the study and would probably soon update its recommendations, which endorse molnupiravir.

A spokesman for the drug’s sponsor Merck said PANORAMIC had focused on a low-risk group, and pointed to other studies showing the treatment was effective.

In April Merck predicted it would make $US5 billion to $US5.5 billion selling the drug this financial year.

In an effort to get more people using the drug, the Australian government widened eligibility in July and Merck launched an advertising campaign.

Due to uncertainties about the clinical trial evidence, molnupiravir remains unapproved by the European Union; France cancelled its order in December.

Merck’s spokesman argued the patients in PANORAMIC were relatively healthy, whereas in Australia, the drug is reserved for people with major risk factors. “Other recent real-world studies, including the Clalit study from Israel, have indicated that [molnupiravir] was associated with a significant reduction in hospitalisations and mortality due to COVID-19 in patients 65 years and above,” he said.

Initial uncertainties about molnupiravir stemmed from strange results in the original Merck trial that got the drug approved.

Merck’s trial recruited about 1500 patients and gave half the drug. Early results from the first half of patients tested were so positive – a halving of the chance of death – that the trial was stopped early so everyone could get the apparently life-saving treatment.

But when data from the remaining half of patients in the trial was published a month later, it told a different story. The second group had done far worse than the first. In fact, the data suggested molnupiravir did not improve their outcomes. Combined, the full trial suggested molnupiravir may not cut the risk of death.

“We think this is unprecedented. None of us had ever seen anything like this before,” said Sheldrick.

The strange results may have been caused by a new coronavirus variant emerging mid-trial, he said. Merck disputes that, and claims the early results were the key ones.

Wark said it was possible the drug was of less use in a highly vaccinated population faced with a milder variant such as Omicron.

Sheldrick said the PANORAMIC results suggested governments need to think differently about rushing to approve drugs with limited evidence – even in the middle of a pandemic.

A spokeswoman for the TGA said the drug remained provisionally approved for use. “It is noted that while, in the PANORAMIC trial, hospitalisation and death was not reduced by molnupiravir for adults under 65 years, the time to first self-reported recovery was six days shorter.”




Monday, October 10, 2022

Mother, 32, fears condition that almost killed her during pregnancy was sparked by COVID - after studies linked the virus with stillbirths and other dangerous complications

A Brooklyn mother has issued an alarming warning about the risk catching the coronavirus can have on giving birth. Lauren Phillips told how she suffered from preeclampsia after having her baby and linked it to going down with the virus earlier in her pregnancy.

The 32-year-old attorney said she was rushed back into hospital with dangerously high blood pressure just days after having her son.

She urged would-be parents to avoid coronavirus during pregnancy and seek immediate medical advice because she says it saved her life.

It comes as experts fear catching Covid could cause deadly complications with childbirth and even lead to stillbirths.

A swathe of studies during the pandemic found women had a 60 percent greater risk of having preeclampsia if they had suffered from the virus.

Phillips sailed through an easy pregnancy aside from becoming infected with COVID in her second trimester, which she described in her blog as a 'mild cold.'

But a few days after her baby son Arthur was born in April, the Brooklyn-based attorney was rushed to the emergency room as her blood pressure hit 160/116.

Phillips, who was up to date with her vaccinations and was careful with masking, found she had preeclampsia doctors believe was linked to a February Omicron infection.

She wrote: 'In the last hours of labor before the c section my blood pressure started to rise, but after delivery it came down enough that I was discharged on day 3 post delivery.

'On day 5, I experienced a severe dizzy spell. I was sitting down at the time. It felt like a sudden pulse or pressure wave, making the room spin. I'd never experienced anything like it, it felt bizarre, and it frightened me. 'I called my doctor and she told me to call back if it happened again. A few hours later, it did.

'My husband ran out to Rite Aid and bought a blood pressure cuff, which indicated my pressure was up to 140/90.

'I also noticed that my ankles were starting to swell and had become much more swollen than they had even been during pregnancy. I called the doctor and she had me come to the emergency room.

'I was brought back to the labor and delivery ward for observation, where over the course of a few hours my pressure spiked to 160/116. 'Once it hit that level, the medical team started me on a magnesium drip and admitted me for severe preeclampsia. 'I stayed in the hospital for two days before the doctors had me stable on blood pressure-reducing medication (nifidipene).

'Happily, my hospital allowed my spouse and son to stay in the hospital with me for those two days, so I could give him a steady supply of milk and hold or breastfeed him when I was stable enough to do so.'

She added: 'After discharge with instructions to take my pressure 4 times per day at home, my pressure spiked again less than 24 hours later, necessitating a return to the hospital. 'There they gave me a high dose of blood pressure medication (labetelol) intravenously.

'I was able to return home the same day on two drugs which kept my pressure out of the danger zone.

'About 5 weeks later, after steady drops in my pressure week by week, I was able to come off both drugs. 'Now 3 months postpartum, my blood pressure has returned to the healthy levels I had pre-labor.'

Preeclampsia is a complication of pregnancy that results in 70,000 maternal and 500,000 fetal deaths worldwide each year, the Seattle Times reported, and the number of cases jumped during the pandemic.

The illness is just one part of a slew of information scientists are studying to learn more about how Covid affects pregnancy.

Experts say women who contracted Covid-19 during their pregnancy also face an elevated risk of stillbirths.

But they believe vaccination can help prevent these cases, with statistics showing unvaccinated women at higher risk of complications.

Earlier on in the pandemic, many thought the coronavirus didn't affect unborn fetuses because few babies were born with the infection.

But in the American Journal of Obstetrics & Gynecology study published in September, it was revealed that the infection damages the placenta's immune response to further infections.

'What we're seeing now is that the placenta is vulnerable to COVID-19, and the infection changes the way the placenta works, and that in turn is likely to impact the development of the fetus,' Dr. Kristina Adams Waldorf said.

Scientists also believed Covid to be a virus that mainly affected the respiratory system - but it has now been proven to wreak havoc with the circulatory system too.

Doctors also fear a Covid infection may 'unmask' health conditions that a pregnant woman's immune system would otherwise be able to shield her from.

The placenta, an organ that attaches to the womb during pregnancy, connects with the umbilical cord and provides oxygen and nourishment from the mother's bloodstream to the baby.

In the fall and winter of 2021, Amy Heerema McKenney, a Cleveland Clinic pathologist whose job involves figuring out why some babies die, began receiving eerily similar reports of stillbirths, The Times reported. She recalled feeling 'pretty panicked' as she began to look into the cases, which happened in quick succession.

While a normal placenta is spongy and dark reddish hue, which shows the nourishing blood flowing through it, the ones she was studying from mothers who lost their babies were like nothing she'd ever seen.

They were firm, discolored, scarred, and more of a tan color. 'The degree of devastation was unique,' she said.


Florida warns young men on Covid boosters

Florida, the third most populous US state, has warned young men they face a greater risk of dying after receiving Covid-19 vaccines manufactured by Pfizer and Moderna, as the US government forks out billions of dollars on a new (third) round of Covid-19 boosters.

The Florida health department on Friday (Saturday AEDT) specifically warned 18 to 39 year old men against seeking Covid-19 vaccinations that use mRNA technology, citing new research that found this group had an 84 per cent higher chance of cardiac-related death within 28 days of vaccination.

“With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group,” the state’s health department said in a statement.

However the baseline chance of a heart attack among young adults was miniscule according to a 2020 Norwegian study of around 33,000 people: 2.1 per 100,000 people for those aged 20-29 and 16.9 for those aged between 30 and 39.

The warning comes amid growing debate in the US over the wisdom of mandating Covid-19 vaccines — which critics say failed to prevent transmission, illness or death — and waning interest among parents in vaccinating their children.

“Studying the safety and efficacy of any medications, including vaccines, is an important component of public health,” said Florida’s Surgeon General Dr Joseph Ladapo.

“Far less attention has been paid to safety and the concerns of many individuals have been dismissed – these are important findings that should be communicated to Floridians.”

Separate figures from the US Centre for Disease Control, released a day earlier, indicated 11.5m Americans had received one of the new ‘bivalent’ boosters so far, or around 5.3 per cent of the 212 million Americans who were eligible to receive the shots.

The US government in July contracted to pay Pfizer and Moderna around US$4.9bn for 171 million bivalent booster shots.

Jennifer Nuzzo, a professor of epidemiology at Brown University, said complaints that the new shots, which are meant to protect against all the Sars-Cov2 variants including Omicron, weren’t working were misleading.

“We‘ll likely see more of these. It doesn’t mean vaccines failed. The primary goal of vaccination – to reduce severity of illness – has not changed,” she said on social media on Friday.

Florida’s move to restrict Covid-19 vaccine coverage came after similar moves by jurisdictions in Europe, where Covid-19 boosters are no longer offered to healthy individuals under 65 and 50 in Norway and Denmark, respectively.

In the US, the CDC recommends a primary series of Covid-19 vaccination for everyone aged six months and up, boosters for those aged 12 and over.

Before the bivalent booster rollout began on 4th September, after the two shots received “emergency use authorisation” from the Food and Drug Administration, fewer than half of eligible Americans had received their first booster.

The Supreme Court in January overturned a Biden administration directive to compel all workers to receive the Covid-19 vaccines, reflecting efforts throughout the world to link Covid-19 vaccination to employment, education, in-person commerce, and freedom of movement.

Elite US universities, including Harvard and Stanford, and some healthcare settings have kept booster mandates for students, including the latest bivalent booster, a source of ongoing legal action and debate.

“Hey university presidents and trustees — how many cardiac deaths are acceptable as collateral damage?”, asked Todd Zywicki, as law professor at George Mason university, on social media soon after the Florida research was released.

Florida, which has a population around 21.5 million, stood out among US states in its response to Covid-19, ending lockdowns and mandates in early 2020, and last year banning ‘vaccine passports’, which were widely used across the US, throughout the state, to protect the unvaccinated against discrimination.

A federal appeals court upheld the state’s vaccine passport ban on Friday after a challenge by Norwegian cruise lines, based in Miami, which had sought to enforce vaccination among passengers.




Sunday, October 09, 2022

The Right Response to Covid Mandates, Propaganda and Censorship

JOSEPH MERCOLA interviews Dr. Meryl Nass who shares astonishing figures on the blatant PCR testing and case count frauds that occurred during the pandemic.


Dr. Meryl Nass shares astonishing figures on the blatant PCR testing and case count frauds that occurred during the pandemic

The FDA has given emergency use authorization to 281 tests for COVID-19 but not one has received approval; this means their manufacturers have zero liability if the tests don’t work

The number of people who actually had and/or died from COVID in the beginning of the pandemic is unknown, because everybody who died “with COVID” was labeled a “COVID-caused” death

Hospitals were financially incentivized to increase the number of COVID cases because they got paid more if their patients had a COVID-19 diagnosis

Nass has created a pledge to provide a way to speak out against the injustice of vaccine mandates, propaganda and censorship that’s run rampant since March 2020

The manipulation of data and testing during the COVID-19 pandemic was done intentionally to create fear in the population, driving them to accept the experimental COVID-19 jabs that we’re now learning are both dangerous and ineffective at stopping transmission.

The platforms behind COVID-19 shots were already in the works well before the pandemic. They were just waiting for the opportunity to go mainstream. COVID provided that, Nass said:2

“The powers that be, and I can’t identify who they are, but powers in Washington — this is probably some combination of federal, regulatory and research agencies like Tony Fauci and Francis Collins and officials at the FDA and CDC — they have been looking for new, what they call, platforms of vaccines.

They don’t want to make vaccines with eggs; it takes a long time, it’s expensive, they want something faster, and messenger RNA or DNA vaccines is another platform …

For some reason the mRNA platform was extremely delicious for our regulators and for industry. So there were many startups, Moderna being one of them. Moderna’s whole reason for being is to develop messenger RNA gene therapy products either for cancer or for genetic diseases or, later, when those didn’t work out for them, they turned to vaccines.

And these companies — BioNTech is another one — have gotten huge grants from governments as well as entities like the Bill and Melinda Gates Foundation. So the Gates Foundation in 2019, the year before the pandemic, invested $50 million in BioNTech. And Tony Fauci has been working with the Moderna company on messenger RNA vaccines for quite a while. So these were platforms waiting for an excuse to make a product.”

Moderna, together with the National Institute of Allergy and Infectious Diseases (NIAID), sent mRNA coronavirus vaccine candidates to the University of North Carolina at Chapel Hill on December 12, 2019, before the pandemic — raising significant red flags.3

December 18, 2020 — about one year after the material transfer agreement was signed — the FDA issued emergency use authorization for Moderna’s COVID-19 vaccine for use in individuals 18 years of age and older.4

The PCR Testing Fiasco

Problems with testing began almost immediately after the pandemic began. In the beginning, only tests from the U.S. Centers for Disease Control and Prevention were allowed, and the tests were virtually meaningless, as asymptomatic people were plagued by false positives. Host Dr. Paul Thomas described it as an epidemic of positive test results that got translated into an epidemic of the infection.5 According to Nass:6

“For the first two months of the pandemic, the CDC only offered its own test, and it knew very early on that its test didn’t work … so the SARS-CoV-2 infection spread throughout the U.S. during January, February and early March of 2020, when CDC only allowed a few hundred people, maybe 1,000 people during that period of time, to be tested with their tests. And they all had to have a clinical picture that almost proved they had COVID.

After the whole country was really frustrated with this, FDA did two remarkable things … in the beginning of March, Stephen Hahn, the [now former] FDA commissioner, said OK, we’re going to now allow other entities — universities, labs, anybody who has developed or can develop a test for COVID — to do so, and send us the paperwork and we’ll work really fast to get it done and allow your tests to get out there.”

The paperwork, however, was so complicated that it took companies a week to complete it. By then it was the middle of March 2020 and there were still only a few tests available in the entire U.S.

“So then Stephen Hahn did something else. He said, OK, anyone who has a test for COVID, you start using it, you put it out there. You can start testing people, you’re allowed … you send us the paperwork in a few weeks.”7 At this point, testing basically turned into a free for all, with tests from China, Germany and other countries overseas coming in.

Nearly 300 EUA PCR Tests — Not One Approved
As of Nass’ latest count, the FDA has given emergency use authorization to 281 different PCR tests for COVID-19. Not a single one has been approved or licensed.

“This means, under emergency use authorization, you can’t sue the manufacturer if your test is no good,” Nass said. “And that means FDA doesn’t have to stand by any of those authorizations … no one’s responsible. So that’s a disaster. They’ve also authorized about 50 antibody tests and other rapid tests. So we have a testing mess, and we’ve always had a testing mess.”8

The CDC also created an “odd” set of case definitions for COVID-19, basically turning “a positive test into a positive diagnosis even if you didn’t have symptoms.” The case definitions, Nass said, were so complicated they required reading through several pages of information and included whether or not the person was in an area were COVID-19 was present, whether the person had had an exposure to a known COVID case and a list of symptoms that helped formulate the definition.

She continued, “Despite all that, a positive PCR test was labeled a probable case. That’s all you really needed. And then the CDC relabeled probable cases as cases. So as everybody else has noticed, that meant we had a case-endemic. We didn’t exactly have an epidemic.”9

Hospitals Paid to Diagnose COVID Cases
The number of people who actually had and/or died from COVID in the beginning of the pandemic is unknown, because everybody who died “with COVID” was labeled a “COVID-caused” death. Health officials could count deaths from unrelated causes — even gunshots10 and motorcycle accidents11 — as COVID-19 deaths if the person had the virus within the last 30 days. According to Nass:12

“At the beginning, the number of cases, the number of people who died with COVID … everybody who died with COVID was called a COVID-caused death, and that was again due to the CDC playing with their definitions and hand coding all of their COVID deaths and requiring doctors, even if you went into the hospital with a heart attack and then they tested you in the hospital, you wound up being labeled a COVID death.”

Hospitals had every reason to go along with the questionable labels, as they earned more money if they diagnosed COVID-19 more often. They didn’t even need a positive test to do so. The end result is that the actual number of COVID-19 cases was heavily skewed and it may be impossible to sort out the real figures at this point:13

“Hospitals were financially incentivized to up the number of COVID cases because they got paid more if their patients had a COVID diagnosis. And they were told by the CDC that they didn’t even need a positive test. If it looked like a COVID case, you could call it a COVID case and then up your reimbursement. So we were all stuck with that kind of shenanigans, and it’s hard to know now who were the COVID cases and who were the COVID deaths.”

This means all the numbers of COVID deaths you hear being bandied about by mainstream are major misinformation. They are nothing more than cleverly inflated statistics based on the major incentive to identify virtually every death they could as due to SARS-CoV-2. Best estimates are the number of deaths authentically due to COVID are at least half what they say they are.

US Life Expectancy Drops

The CDC released its provisional life expectancy estimates for 2021,14 which reveals life expectancy dropped from 77 years in 2020 to 76.1 years in 2021. “It was the first time life expectancy dropped two years in a row in 100 years,” NPR noted.15 The media is, of course, blaming the drop in life expectancy primarily on COVID-19,16 largely ignoring the increasingly clear dangers of the COVID-19 shots that were forced on many in the U.S. and throughout the world.

As mentioned in the last section, the number of COVID deaths are likely half of what the inflated numbers the mainstream claims, which makes their contribution to the decrease in life expectancy essentially irrelevant. What mainstream fails to say in their misinformation coverage is that the average age of those dying of COVID were above the average life expectancy!

According to Nass, “mRNA COVID vaccines in the U.S., after you get a shot, for about two or three weeks, your immune system is not as strong as it was, and viruses that are in your body can come out, like the chicken pox virus … you’re also more susceptible to COVID for the first couple of weeks after a shot.”17

After about six months, most of the protection you may have gained from the shot wanes, and then, as time goes on, you get “negative immunity, which means you’re more susceptible to COVID,” she continued. “Unfortunately, now we’re seeing data … that you’re more susceptible to dying from any cause. Mortality goes up in the vaccinated compared to the unvaccinated.”18

When it comes to products issued under emergency use authorization, like COVID-19 shots, there’s no liability for the manufacturers or the government officials who recommended them. “There hasn’t been a single claim that has been adjudicated regarding injuries from the COVID vaccines,” Nass said.19 This is all part of the scam they have created to protect themselves.

In the U.S., vaccine makers already enjoy full indemnity against injuries occurring from this or any other pandemic vaccine under the Public Readiness and Emergency Preparedness (PREP) Act. If you’re injured, you’d have to file a compensation claim with the Countermeasures Injury Compensation Program (CICP),20 which is funded by U.S. taxpayers via Congressional appropriation to the Department of Health and Human Services (DHHS).

While similar to the National Vaccine Injury Compensation Program (NVICP), which applies to nonpandemic vaccines, the CICP is even less generous when it comes to compensation. The maximum payout you can receive — even in cases of permanent disability or death — is $250,000 per person.

However, you’d have to exhaust your private insurance policy before the CICP gives you a dime.21 The CICP also has a one-year statute of limitations, so you have to act quickly, which is also difficult since it’s unknown if long-term effects could occur more than a year later.