FDA Approves First RSV Vaccine, But Some Experts Say Weak Safety, Efficacy Data Suggest Benefits Don’t Outweigh Risks
By Michael Nevradakis, Ph.D. | The Defender | May 4, 2023
Describing it as a “long-sought scientific achievement,” the U.S. Food and Drug Administration (FDA) on Wednesday approved Arexvy, the first vaccine for respiratory syncytial virus (RSV).
GlaxoSmithKline Biologicals (GSK) developed Arexvy under the FDA’s Priority Review designation. The FDA approved it for people ages 60 and older.
According to CNBC, the U.S. “suffered an unusually severe RSV season” this past winter. The New York Times reported on a “tripledemic” involving RSV, flu and COVID-19, “that swamped children’s hospitals and some I.C.U. wards.”
One U.S. county — Orange County, California — declared a local health emergency and issued a proclamation of local emergency in November 2022, citing rising RSV cases among children in the region.
GSK described results from clinical trials for Arexvy as “positive,” and the company said the U.S. launch of the vaccine is planned before the 2023-24 RSV season.
Other RSV vaccines, including one produced by Pfizer, are in the pipeline and expectations are that the FDA will approve them.
During clinical trials for both the GSK and Pfizer vaccines, several participants were diagnosed with rare conditions such as Guillain-Barré syndrome (GBS) and acute disseminated encephalomyelitis (ADEM). One of the individuals who developed ADEM later died, according to the FDA.
Aside from concerns over potential serious adverse events related to RSV vaccines, some experts have questioned the need for such a vaccine in the first place.
According to the journal Science, “RSV is a common respiratory infection” with symptoms “similar to a cold,” adding that “The majority of individuals recover within a few days from an uncomplicated RSV infection, although occasionally the virus can cause lower respiratory infections requiring medical attention.”
Dr. Peter McCullough, a cardiologist, told The Defender:
“Respiratory syncytial virus is a negligible threat to even the most frail elderly adults. The effort of widespread vaccination is simply not worth it. Even rare side effects will outweigh any theoretical benefit.”
And in a November 2022 episode of “RFK Jr. The Defender” podcast, several medical and public health experts expressed concerns about RSV vaccines.
“We have to stop these shots,” said Dr. Meryl Nass, an internist and biological warfare epidemiologist. “It’s just extraordinary that we’re still vaccinating people … we have a lot of work to do.”
Robert F. Kennedy Jr., then-chairman and chief litigation counsel for Children’s Health Defense (now chairman on leave), described RSV as “a vehicle for re-implementing the COVID-19 playbook all over the country and responding with vaccines.”
And according to the National Vaccine Information Center (NVIC), “Cost analysis data presented to the ACIP [Advisory Committee on Immunization Practices] did not show the RSV vaccines to be cost-effective at reducing the burden of costs associated with RSV illness.”
Nevertheless, more RSV vaccines are expected to receive FDA approval this year — including a Pfizer RSV vaccine for pregnant women that led to a high incidence of adverse events for both the women and their infants during clinical trials, as well as several deaths and stillbirths.
Arexvy approval ushers in new ‘highly competitive and lucrative vaccine market’
The RSV vaccine market is estimated to be worth up to $10 billion by 2030.
According to Endpoints News, the FDA’s approval of Arexvy ends “half a century of failed efforts against the elusive, shape-shifting virus” and “officially start[s] what analysts expect will be a highly competitive and lucrative new vaccine market.”
In getting Arexvy approved, “GSK beat a crowded field of competitors to cross the finish line first.”
Arexvy “showed strong efficacy in stopping lower-respiratory tract infections as well as more severe disease” and will be administered as a single dose, according to Endpoints News.
STAT reported that a “vaccine that was developed by Pfizer and aimed at the same demographic [adults 60 and over] is expected to be approved by the end of the month,” while other RSV vaccines and therapeutics, including some intended for children and pregnant women, are in the pipeline and also are close to receiving FDA approval.
The FDA’s approval of Arexvy came after an FDA advisory panel reviewed data from GSK’s and Pfizer’s clinical trials on March 1. The panel unanimously agreed that GSK’s vaccine is effective and, in a 10-2 vote, deemed it “safe,” according to The Washington Post.
The same panel also approved Pfizer’s candidate vaccine, Abrysvo, but with a 7-4 vote.
On June 21 or 22, ACIP, which advises the Centers for Disease Control and Prevention (CDC), will convene to “make recommendations on the appropriate use of the vaccine in the U.S.,” according to GSK’s announcement. The ACIP must recommend the vaccines before they are marketed.
According to STAT, there is a likelihood that ACIP may not approve Arexvy for its intended age group, stating:
“Though Arexvy’s approval is for adults 60 and older, it remains to be seen if the CDC will recommend it for that entire group.
“At an advisory committee meeting in February, members of a work group studying the adult vaccines that will soon come before ACIP indicated that at present, they don’t believe the vaccine would be cost-effective in people aged 60 to 64 and they would not recommend to the wider committee that it include people 60 to 64 in its recommendation for the use of the vaccine. (The group held the same position for the Pfizer RSV vaccine.)”
In April, the European Medicines Agency (EMA) issued its own recommendation for Arexvy, for adults 60 and over, according to the Times. However, a final EMA regulatory decision is anticipated later this year. GSK is also awaiting licensure for Arexvy in Australia, China, Japan and other countries, STAT reported.
In an earnings presentation April 26, GSK said it has “millions of doses” of Arexvy “ready to be shipped.”
“GSK’s RSV vaccine works by using a small piece of the virus: a protein that sticks out on its surface called the fusion, or F, protein, which helps the virus glom onto and infect cells in the body’s upper airways. The protein pieces in the vaccine are made in a lab, using cells specially programmed to manufacture them.”
CNN noted that the vaccine “builds on a pivotal discovery made a decade ago” by National Institutes of Health researchers, “including some of the same scientists who helped make the COVID-19 vaccines.” Specifically, the researchers figured out how to freeze the otherwise “wiggly” F protein, “in the shape it takes before it fuses onto a cell.”
STAT, quoting Phil Dormitzer, GSK senior vice president and global head of vaccines research and development, reported that although Arexvy “contains only one of the two RSV subtypes, RSV A,” studies showed that it is “virtually equally protective against both RSV A and RSV B” as the F protein on both subtypes is similar.
Dormitzer acknowledged natural immunity, telling STAT, “because older adults have all had RSV probably multiple times by the time they get [the vaccine], they’re primed against both A and B. So you’re able to get very solid boosting against both subtypes with a single adjuvanted F antigen.”
According to GSK, the Arexvy vaccine does not use mRNA technology, but “contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.”
GSK, FDA claim Arexvy clinical trial data show vaccine is ‘safe and effective’ but annual shot may be needed
The FDA announcement stated:
“The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older.”
According to the FDA, “approximately 12,500 participants … received Arexvy and 12,500 participants … received a placebo. Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD [lower respiratory tract disease] by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.”
LRTD was “defined as two or more symptoms including shortness of breath, wheezing, cough, increased mucus production, crackles, low oxygen saturation, or need for oxygen supplementation,” according to CNBC, while according to CNN, “People were considered to have severe disease if they needed supplemental oxygen or needed mechanical help to breathe, like a ventilator.”
According to the FDA, half of the 25,000 participants received Arexvy, while the other half received a placebo.
The results of GSK’s clinical trials for Arexvy were published in the New England Journal of Medicine on Feb. 16.
FDA and GSK officials provided glowing reviews of the new vaccine. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement:
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”
Tony Wood, GSK’s chief scientific officer, described Arexvy’s approval as “a turning point in our effort to reduce the significant burden of RSV,” adding that “Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries.”
In turn, Dormitzer said, “There’s just the broad excitement of finally, after all these years, having good options emerging for RSV,” describing this as a “triumph of the basic science.”
While GSK is first out of the gate in the RSV vaccine race with Arexvy, Pfizer’s candidate vaccine has also completed clinical trials, which found it to be “nearly 67 percent effective in preventing R.S.V. – related illness,” according to the Times.
The FDA and GSK announcements did not mention the vaccines’ waning effectiveness. An analysis by the NVIC found that the effectiveness of the GSK vaccine peaked after two months and offered no protection after one year. This may result in recommendations for adults to receive annual doses of the vaccine.
Trial participant died from a rare inflammatory condition, others developed GBS
Despite positive comments from FDA and GSK officials, clinical trial data for Arexvy revealed instances of GBS and other rare conditions.
In its announcement Wednesday, GSK claimed:
“The vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient.”
The announcement did not mention GBS.
According to the FDA announcement Wednesday:
“The most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain.
“Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants who received Arexvy and 4 participants who received placebo.”
However, the FDA noted that in two other Arexvy studies involving approximately 2,500 participants 60 and over, “two participants developed acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that affects the brain and spinal cord, seven and 22 days, respectively, after receiving Arexvy and the influenza vaccine.”
“One of the participants who developed ADEM died,” according to the FDA.
In another Arexvy study conducted by GSK, “one participant developed Guillain-Barré syndrome (a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) nine days after receiving Arexvy,” the FDA stated.
According to an FDA briefing document cited by CNBC:
“A 78-year-old woman in Japan was diagnosed with Guillain-Barré syndrome nine days after receiving GSK’s vaccine … She was hospitalized for six months before being released.”
CNBC reported that GSK claimed in February “There is insufficient evidence to confirm the woman got Guillain-Barre as a result of GSK’s shot.” However, the FDA “considers the case to be related to GSK’s vaccine.”
According to the FDA’s announcement:
“The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. In addition, although not an FDA requirement, the company has committed to assess atrial fibrillation in the postmarketing study.”
According to the Times, “Once the shots become available to the public, the agency said it would require GSK to monitor the incidence of Guillain-Barré and another rare condition that was possibly related to the shot.”
The FDA similarly flagged GSK “as a potential safety issue with Pfizer’s RSV vaccine for older adults,” CNBC reported after two clinical trial participants developed GBS. According to the Post, both participants — one man and one woman — were 66 years old.
CNBC in February reported that Pfizer “will conduct a safety study to further address Guillain-Barré syndrome if the FDA approves its vaccine.”
GSK’s chief commercial officer, Luke Miels, said the vaccine would cost upwards of $120 a dose, according to the Post, which also reported that private insurers may cover “many costs” associated with the vaccine, while Medicare patients with Part D coverage “won’t pay anything out of pocket” for the vaccine.
“Shares of GSK rose nearly 2% Wednesday following the approval,” CNBC reported.
GSK is also pressing forward with “A clinical trial that aims to expand the population who may benefit from RSV vaccination into adults aged 50-59, including participants with underlying comorbidities,” according to the company’s Wednesday announcement, with results “expected in 2023.”
Is there a need for an RSV vaccine?
According to the FDA:
“RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter.
“In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs).”
The FDA cited CDC figures claiming each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.”
STAT reported that “RSV season has been unpredictable in the wake of the COVID-19 pandemic, though some experts believe RSV activity is moving back toward the seasonality seen in the pre-COVID days,” noting that “there was little transmission in 2020, when people were wearing masks and social distancing.”
But RSV “returned abnormally early in 2021,” STAT reported, but without an explanation for why this occurred, despite widespread masking and social distancing that year, too.
In the U.S., pediatric deaths from RSV are not common but the infection is the No. 1 cause of hospitalizations for children under the age of 1, STAT reported. Globally, however, it is the second leading cause of death in children under 1, after malaria.
According to STAT, “All but the youngest of children have had RSV multiple times, but few of us would know with any certainty that this bad cold was caused by that bad virus.”
Nevertheless, Pfizer is proceeding with the development of an RSV for infants as young as 6 months — “the age group at highest risk of being hospitalized with RSV,” STAT reported, noting that the vaccine for this age group is expected to gain FDA approval later this year and will be administered to pregnant women “to generate antibodies that protect both the pregnant person and their newborn.”
Data reported by Pfizer to the CDC indicated that 14% of pregnant women who participated in Pfizer’s trial sustained an adverse event, with 4.2% sustaining a “serious” adverse event, 1.7% experiencing a “severe” adverse event and 0.5% suffering a “life-threatening” adverse event.
Similarly, the same data showed that 37.1% of infants whose mothers received the experimental Pfizer vaccine experienced adverse events within one month of birth — with 15.5% classified as “serious,” 4.5% as “severe” and 1% as “life-threatening,” while efficacy waned within months of vaccination.
According to the NVIC, “The RSV clinical trial data also included the death of one pregnant woman, 18 still births (10 in vaccinated pregnant women and 8 in unvaccinated pregnant women), and 17 infant deaths (five from the vaccinated pregnancy group and 12 in unvaccinated pregnancy group).”
In its report to the CDC, Pfizer claimed the deaths were unrelated to the vaccine.
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet virtually on May 18 to discuss approval of this vaccine. The meeting is open to the public, and a public comment period is open until May 17. A final FDA decision is expected in August.
According to the Times, “Moderna is also developing an RSV vaccine for adults 60 and over, with authorization expected in the first half of this year. The Times referenced clinical trial data released by Moderna claiming 82% efficacy, with “no safety concerns identified.”
Bavarian Nordic, known for its development of a vaccine in response to last year’s monkeypox outbreak, is also developing an RSV vaccine for adults 60 and over,” expecting to release Phase 3 clinical trial data by midyear, according to the Post and CNN.
AstraZeneca and Sanofi also are seeking FDA approval, but for nirsevimab, a monoclonal antibody treatment for RSV that would be administered to infants and toddlers up to age 2, according to the Times, which referenced clinical trial results claiming a reduction of illness of up to 75%.
According to the Post, nirsevimab “is already approved in Europe, the United Kingdom and Canada.”
However, the NVIC reported that the effectiveness of nirsevimab “is not known beyond 150 days” and it is unclear if the drug prevents ICU stays or deaths. It is being reviewed by ACIP, which according to the NVIC, is “a federal advisory committee charged with making vaccine use recommendations.”
“It is unclear why the ACIP … has chosen to go beyond its charge of making vaccine use recommendations,” NVIC states.
Safety concerns related to RSV vaccines nevertheless linger. According to CNN, an RSV vaccine developed in the 1960s for children initially delivered promising results during trials in children and animals.
However, once administered to children in the general population, “many of the children who were vaccinated required hospitalization and got more severe RSV disease than what would have normally occurred” — and two of the initial trial participants died.
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
After years of mandates, German Health Ministry admit they have no idea whether or to what degree masks work at all
Pandemic mythology continues its slow decay
eugyppius: a plague chronicle | May 3, 2023
As on several prior occasions, liberal Bundestag vice-president Wolfgang Kubicki has used his parliamentary prerogatives to put a question to the German Health Ministry, and compel an answer. He asked what study results the Ministry could cite to demonstrate the efficacy of face masks. Lauterbach’s crack team of virus understanders responded that, uh, it is a very complicated problem, and, in truth, well, actually, nobody really knows what effect masks really have. This is because “the effectiveness of individual measures … cannot be examined in isolation, but only in conjunction with the other measures in place at any given time.”
In other words: they got nothing. After years of making kids mask for hours on end in school, and imposing arbitrary but quite obnoxious mandates on airplanes and public transit and clinics, they have no idea whether it did anything, and no plans even to find out whether it did anything. Suddenly all that manic masking enthusiasm has just evaporated.
The response comes several weeks after Anthony Fauci’s statement to the New York Times that “at the population level, masks work at the margins, maybe 10 percent.” This is itself a baseless claim, but it’s another important walk-back of the insane doctrines that medical bureaucrats have been spinning about masks since 2020.
You have to think of propaganda like a big machine. Somebody has to plug it in and it draws a lot of electricity, but with the right inputs it can dazzle a lot of people. The problem is that sooner or later the deception isn’t worth anybody’s time or energy anymore, and so somebody must also shut it off. It looks like nobody bothered with any kind of messaging exit strategy, and so we’ve entered a very weird period, wherein the public health leviathan has ceased rehearsing its crazy pandemic myths, leaving the ever-shrinking minority of deranged Covidians to their own devices.
Now and again the fact-checkers still throw them a bone, so there’s that.
Ireland wanted public input on proposed censorship bill… Until the majority said they actually prefer free speech
Pushing ahead with censorship
By Cindy Harper | Reclaim The Net | May 4, 2023
The Irish government has decided to move forward with the Criminal Justice (Incitement to Violence or Hatred and Hate Offenses) Bill 2022, despite the fact that a majority of public consultation responses were against the proposal. The bill, which was initiated in October 2022, aims to address “hate speech” in the country.
The public consultation, held in 2019, offered individuals the chance to express their views on the matter through either letter submissions or survey responses. Gript, a news outlet, conducted an analysis of the 3,597 submissions received during the consultation process. The results indicated that 73% of the respondents opposed the implementation of a hate speech law in Ireland.
Many respondents felt that free speech should only be restricted in cases involving incitement to violence or credible threats. One individual commented, “I’m offended by the government quite often – but they are entitled to their opinion like I am.” Another stressed the importance of free expression over safeguarding the feelings of sensitive individuals.
Despite the clear opposition, the Irish government chose to proceed with the bill, citing the sheer number of responses as justification for moving forward. The Justice Department stated, “Hate Speech can lead to hate crime,” and announced the development of new hate crime laws in Ireland, following the release of the consultation findings.
This week, the bill received a significant majority of support in the lower house, with 110 votes in favor and only 14 against. The decision to move forward with the legislation, despite widespread public disapproval, raises questions about the effectiveness of public consultation and the government’s commitment to addressing the concerns of its citizens.
Russia’s coming revenge attack on Ukraine for the attempted assassination of Putin
By Gilbert Doctorow | May 4, 2023
Yesterday The New York Times only published a tiny article on the Kremlin’s assertion that Ukraine had targeted Putin in a drone attack on the Kremlin. On the contrary, The Financial Times considered the issue to be of prime importance and gave it lead position in their online edition. And what about the Russians, how did they deal with this?
The hourly news programs were very restrained, giving the story top place but only a minute or two of attention. However, the talk shows gave it extensive attention. Sixty Minutes focused on the U.S. official reaction to the Kremlin charges, with an excerpt from the interview that Antony Blinken gave. In his remarks, Blinken first put in question the whole incident, saying dismissively that you cannot believe anything the Kremlin says. Then he went on to say that Kiev can do anything it deems necessary to repel the aggressor and recover its sovereign territory, for which it has American support. The hosts left it to the audience to interpret Blinken’s words, though none but blithering idiots would fail to understand from Blinken that the USA was in cahoots with Kiev on such an attack. Those who are politically informed about Washington would understand that Blinken is now wholly controlled by his nominal subordinate, Victoria Nuland, since what he said was exactly what she would say, meaning hawkish, anti-Russian in the extreme.
Beyond that, Sixty Minutes directed attention to Zelensky’s convenient departure for Finland shortly after the attack on the Kremlin. They also noted that his stay in Finland has been extended by a day, that he is now headed for Germany, where there was no expectation of his visit, and that he is being transported by a U.S. military plane. Here again, without saying it, the program hosts allow the audience to reach the logical conclusion that Zelensky was directly involved in the plot to assassinate Putin and that the United States was at his side all the way.
The talk show Evening with Vladimir Solovyov was less subtle. The host opened by reminding his audience of what Dmitry Medvedev, former President and head of the Russian Security Council said earlier in the day: that Ukraine is now a terrorist state, that there is no longer any justification for negotiating with Zelensky and that the Kiev regime must be destroyed.
For those who think that Solovyov and Medvedev were just sounding off and have no credibility, I point out that the Volodin, Speaker of the State Duma, yesterday also called for the destruction of the decision-making bodies in Ukraine, which means, of course, the presidential administration first of all.
While American and European newscasters opine over whether all this spells an escalation of the war, I will say with almost certainty that it does. It is hard to imagine that Vladimir Putin will be able or will even want to remain calm and restrained in the face of the latest U.S.-Kiev provocations. If his position is at risk in this war, it is from Russia’s super patriots.
The Russians have the ability to strike anywhere in Ukraine and to destroy any safe-places of the Kiev leadership including the deepest of bunkers. The question now is will they do so before Zelensky returns home, if he ever does? Will they do so during or immediately after the 9 May military parade in Moscow?
We are once again at a turning point in this war which has been provoked by Washington acting through the puppet regime in Kiev.
©Gilbert Doctorow, 2023
Top Polish general says ‘situation does not look good’ for Kiev
By Drago Bosnic | May 4, 2023
For well over a year, the mainstream propaganda machine has been trying to convince everyone that the Kiev regime forces are “massively overperforming” against Russia. However, behind all the Western disinformation clutter, NATO military commanders are extremely concerned with the fact that what would be the second most powerful military in NATO (if it were a member) is being quite literally wiped out, with the casualty ratio going as high as 10:1 or even 11:1, and not in its favor. Worse yet, the Neo-Nazi junta forces include tens of thousands of NATO mercenaries and radicalized volunteers, whose casualties are estimated to be well into five figures counting. General Rajmund Andrzejczak, Chief of General Staff of the Polish Armed Forces, recently warned about this.
“War always was, is, and there is nothing to indicate otherwise – a matter of politics, and in its determinants has a substantial number of economic factors: finance, infrastructure issues, social issues, technology, food production and a whole set of problems that must be put into this box to understand this conflict… When I look at the conflict in Ukraine, I mainly see it through these political lenses, and unfortunately it does not look good,” Andrzejczak stated in the closing days of April, during a strategic debate at the National Security Bureau, adding: “I think that there is nothing that indicates Russia would be unable to sustain its war effort, and that Western economic warfare efforts had failed to prevent this.”
“Those financial instruments which it had before the conflict, the dynamics of spending, the effectiveness of sanctions, and the whole complex economic situation speak to the fact that Russia will have the money for this conflict,” Andrzejczak said and then warned that Kiev doesn’t have remotely similar capabilities: “We know how much the country needs per month. We know what American assistance amounts to, that of the entire collective West amounts to. We also know what Polish assistance is in this area, because we are the second-largest donor and should probably be a major inspiration for others. The speed of attrition in the financial area is, in my opinion, unfavorable, unfortunately.”
The Polish Chief of General Staff further added: “There was little indication that millions of Ukrainians who had left the country would be ready or willing to return home to rebuild. Many Western leaders failed to realize how far Ukraine is from winning the war. The Western Bloc just doesn’t have the ammunition, industry is not ready not only to send equipment to Ukraine, but to replenish our own stocks, which are melting [away]. This awareness is not the same there as it is here on the Vistula River, and it must be communicated firmly, without an aesthetic, to everyone and in all forums, wherever possible, which is what I’m doing.”
The top Polish general’s concerns are hardly misplaced, especially considering the fact that he’s getting actual, unbiased military reports from Polish and other NATO services. Expectedly, such reports are extremely unlikely to ever be published by the mainstream propaganda machine, but General Andrzejczak’s words alone should be enough to indicate the actual state of the Kiev regime forces. Indeed, in recent days, the Russian Ministry of Defense (MoD) announced that its forces have been able to neutralize nearly 600 enemy combatants and dozens of pieces of hardware in the Donetsk area alone, along with over 200 tons of various types of NATO-supplied munitions.
Battlefield reports for May 1 indicate that the Russian military used long-range weapons to destroy at least two air defense divisions composed of S-300 SAM (surface-to-air missile) systems in a strike on depots in Pavlograd, a city in the Dnepropetrovsk oblast (region). Apparently, these systems were defending a depot in which the Neo-Nazi junta’s “Grom-2” tactical ballistic missiles were housed, which were also destroyed in one of the subsequent strikes. A third strike destroyed an ammunition depot of the 127th Mechanized Brigade based in the Kharkov oblast. Only a day prior, an entire network of munitions manufacturing facilities was also destroyed.
Perhaps the most disappointing (for both Kiev and the political West) aspect of the grossly overhyped performance of the Kiev regime forces is the recent admission that the much-touted HIMARS is nowhere near its declared capabilities. While the mainstream propaganda machine extensively reported on the alleged successes of this system, in reality, it has shown less than limited performance, as Russian air defenses have been able to intercept most HIMARS rockets, while the Russian Aerospace Forces “took care” of most launchers sent by NATO. Modernized versions of the “Buk” SAM system, particularly the M3 “Viking” variant, have proven to be extremely effective in virtually nullifying this threat.
HIMARS was portrayed as one of the Neo-Nazi junta’s “wunderwaffen”, a supposedly “decisive weapon” that could “turn the tide” against Russia. However, just like many of the actual “wunderwaffen” deployed by Nazi Germany in the closing months of the Second World War, this is proving to be futile. Poland’s top general essentially confirms this by pointing out what virtually all military commanders in NATO are perfectly aware of, but can’t disclose publicly.
Drago Bosnic is an independent geopolitical and military analyst.
My MP and an exercise in vaccine damage denial
By Nicholas Britton | TCW Defending Freedom | May 4, 2023
A few weeks ago I wrote to my MP to ask if he attended Andrew Bridgen’s debate in the House of Commons about the safety and effectiveness of the Covid vaccines. Of course, I knew he wasn’t among the handful of people who stayed in the chamber for the debate, but I wanted to convey my deep disappointment at the lack of interest by those elected by us and paid by us to represent us on such important issues.
I finally got a reply about a month later. He said he was in his constituency that day but was aware of Mr Bridgen’s speech. Below are some extracts from his letter. I have not identified him because this is not a name-and-shame exercise, but an illustration of how politicians are still in complete denial about this issue and are quite happy giving us misinformation in the form of the usual unsubstantiated slogans and tropes. I don’t know whether this MP believes any of what he wrote or whether he is just saying what he’s been told to say. I know he is a party loyalist who always falls in line with the leadership; he is not an independent thinker. Either way, I don’t like being lied to or hoodwinked.
It’s interesting that at no point does the MP refute anything Andrew Bridgen said, nor does he provide any evidence or argument to contradict his statements. That would be a tricky one, I guess, since Mr Bridgen was quoting from official figures. It’s also troubling to see such blatant denial of what is now being revealed around the world about the vaccines and which is even starting to creep into the MSM – I’ve recently noticed a few reports concerning vaccine injuries. Still, it remains an uphill struggle to convince some people that they are being lied to by the authorities. We are not trying to prove the existence of aliens or anything equally intangible, we are just trying to get those in authority to acknowledge what is screaming at them from their own official statistics. The result, as this letter shows, is for them to behave like recalcitrant children told to tidy their bedrooms, and to stick their fingers in their ears while loudly shouting ‘conspiracy theorist’, ‘misinformation’, or ‘anti-vaxxer’.
Here are the extracts (in bold) from the letter. I’ve added my thoughts below each.
‘I would point out that extensive independent research shows that COVID-19 vaccines are extremely successful at preventing deaths. They remain our best line of defence and the most effective way to enable us to live with the virus.’
‘Extremely successful’? Where is the independent evidence for that? I’d have thought he would be able to provide one or two examples of that ‘extensive independent research’ if he believes in it so fervently.
‘All vaccines must go through a rigorous testing and development process before authorisation to ensure that they meet the strict standards of safety, quality and effectiveness set by the independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).’
The Pfizer documents which the company wanted to keep under wraps for 75 years suggest more a rigorous cover-up than rigorous testing. As to quality, why have there been different rates of adverse events amongst different vaccine batches? In Japan, two men died after receiving shots from a batch contaminated with particles of stainless steel.
‘The independent Joint Committee on Vaccination and Immunisation (JCVI) provides the latest clinical and scientific evidence on vaccine safety and efficacy. Unfortunately, misinformation about Covid-19 vaccines has spread rapidly through social media and other platforms. It is crucial that we all rely on credible sources of information when it comes to vaccines. Misinformation causes harm and costs lives, and it does an incredible disservice to frontline workers who have been at the heart of the fight against coronavirus, working day and night to protect the NHS and save lives.’
He implies that the government and its ‘experts’ are the only credible sources of information and we should be trusting them alone. When were these people anointed the high priests of truth? Who in their right mind would trust Neil Ferguson and his dodgy computer models? There is indeed a vast amount of misinformation out there, most of it coming from those with connections to a certain wealthy sociopath with financial interests in the vaccine industry.
‘I reject baseless claims, including those which suggest vaccines are harming and killing many people, and that the damage is being covered up.’
As do many of us reject the government’s baseless, unevidenced, and politically-motivated claims that they are ‘safe and effective’ and that the damage is not being covered up.
‘The MHRA operates the Yellow Card reporting scheme, which allows individuals and health professionals to report any suspected reactions or side effects, even if the reporter is not sure they were caused by the vaccine. The nature of yellow card reporting means that reported events are not always proven side effects; some events may have happened anyway, regardless of vaccination.’
Ah yes, the Medical Homicide Racketeering Agency. That body which was once a gatekeeper ensuring the safety of medical products but which now calls itself an ‘enabler’. He is correct in saying that correlation is not proof of causation. However, the government deemed that a positive PCR test within 28 days of death was proof of death caused by Covid, even if you’d actually been flattened by a bus, so it seems that correlation can mean causation when it’s politically useful. The purpose of the Yellow Card system has historically been to flag up possible problems with medicines which need to be investigated. In the case of the Covid vaccines, there have been more red flags than at a Soviet Mayday parade, yet they have been ignored.
‘Where vaccine damage does tragically occur, it is right that individuals and their families can access payments via the Vaccine Damage Payment Scheme (VDPS). The VDPS is intended to support individuals and their families who have suffered severe disablement or bereavement as a result of having a vaccine. Covid-19 was added to this scheme in December 2020 and compensation payments under the scheme began last year.’
So why have the vaccine-injured been confronted with so many bureaucratic obstacles in their pursuit not just of the miserly £120,000 compensation but also recognition of their injuries, and of their need for practical help?
‘It is important to stress just how rare adverse reactions are. As with all vaccines and medicines, however, it is right that the safety of Covid-19 vaccines is continuously monitored.’
So why has the AstraZeneca vaccine, that triumph of British biotechnology, been quietly withdrawn in the UK and most other European countries? It has just been banned in Australia too. Switzerland has just removed recommendation for all Covid vaccinations for anybody, including the vulnerable. Surely it’s nothing to do with adverse reactions? The number of recorded adverse reactions for all Covid vaccines has vastly exceeded the total number for all other vaccine injuries over the past 30 years. Other vaccines and medicines have been withdrawn after far fewer recorded (suspected) adverse reactions.
***
I wonder how long politicians will keep up this pretence? I suspect they have dug themselves into such a deep hole they would have great trouble climbing out of it even if they eventually accept they have been complicit in the worst medical scam in history. My guess is they will keep digging because honesty and humility do not come easily to them.
Ivermectin ban lifted: Australia
The ban on off-label prescribing of the anti-viral drug has been in place for over 18 months
By Rebekah Barnett | Dystopian Down Under | May 3, 2023
Doctors will be free to prescribe ivermectin ‘off-label’ from 01 June 2023, the Therapeutic Goods Administration (TGA) announced today.
This is a reversal of a national ban on off-label prescribing of ivermectin, which the TGA enacted on 10 September 2021, in an attempt to prevent doctors from prescribing the drug to treat Covid.
At the time, the TGA stated that the restriction was necessary because:
- People would be at risk if they took ivermectin instead of getting vaccinated
- People who took ivermectin may choose not to get tested or to seek medical care if they had symptoms
- Social media posts were promoting higher doses of ivermectin than what is normally recommended for approved uses
- There had been a 3-4 fold uptake in ivermectin and the TGA was worried about a shortage disadvantaging vulnerable people who really needed the drug
So, instead of launching a nationwide education campaign and recommending that the Australian Government throw a few million dollars at bolstering the national stockpile of ivermectin, the TGA effectively banned the drug for all but a narrow set of uses.
The TGA has now relaxed the ban because, “there is sufficient evidence that the safety risks to individuals and public health is low when prescribed by a general practitioner in the current health climate.”
It would seem, though, that there was sufficient evidence of ivermectin’s safety all along. In July 2021, Rebecca Weisser wrote in Ivermectin. It’s as Aussie as Vegemite, for Spectator Australia:
As for safety, 3.7 billion doses of ivermectin have been used since 1987 and in 30 years, only 20 deaths following its use have been reported to the UN’s Vigi-Access database. Compare that to remdesivir, which has been given emergency use authorisation to treat Covid in Australian hospitals. In 12 months, there have been 551 deaths reported. Indeed, a study published in the prestigious Journal of the American Medical Association this week found remdesivir did not increase survival, just time spent in hospital.
The TGA’s stated concerns over ivermectin’s safety back in September 2021 seem incoherent when taken alongside its authorisation of remdesivir.
An Australian doctor, who prefers to remain anonymous, was suspended by industry regulator AHPRA for prescribing ivermectin off-label during the pandemic. He says,
“I think the restriction on prescribing ivermectin off-label was disingenuous from the start. It was always about coaching people toward the option of vaccination by removing a legitimate off-label therapeutic option. The decision effectively punished Australians for being self-educated and aware of the scientific evidence supporting ivermectin.
The reversal of the ban is a good step and it appears that doctors may be restored their full rights to off-label prescribing.
But, there remains the question of whether lives have in fact been lost due to the limitation of ivermectin through this policy.”
This is the question posed by Kara Thomas, Secretary of the Australian Medical Professionals’ Society, and Andrew McIntyre, Gastroenterologist and Coordinator of the Doctors Against Mandates legal action, in an op-ed from March this year, also for Spectator Australia. The article raises more questions than answers, but serves to highlight the disparity between the safety profiles of ivermectin (better) and Covid vaccines (worse), as well as a summary of the scientific evidence for ivermectin’s effectiveness.
The effectiveness of ivermectin in treating Covid is hotly argued in all corners of the internet, but it is worth noting that internationally renowned ICU doctor Paul Marik wept when his hospital enforced a policy preventing him from using it in combination with other therapeutics. There are numerous other frontline doctors who similarly expressed dismay at being prevented from administering the drug, after seeing lives saved under their care.
Though prescribing restrictions on ivermectin are to be lifted, the TGA does not endorse off-label prescribing of ivermectin for the treatment or prevention of Covid.
”A large number of clinical studies have demonstrated ivermectin does not improve outcomes in patients with COVID-19. The National Covid Evidence Taskforce (NCET) and many similar bodies around the world, including the World Health Organization, strongly advises against the use of ivermectin for the prevention or treatment of COVID-19.”
It will now be at the discretion of Australian doctors to make their best clinical judgement on a case by case basis.
Monash University, Melbourne, is running a blinded and randomised clinical trial to test ivermectin’s efficacy for Covid prevention. The trial is led by Dr Kylie Wagstaff, whose preliminary in vitro study in collaboration with the Doherty Institute (April 2020) found that ivermectin stopped the replication of the SARS-CoV-2 virus in cell culture within 48 hours.