Covid 19 > FDA Recognizes Heart Issues With Moderna; Fauci Slams Rand Paul; Swedish Inquiry Slams Government

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Increased risk of heart inflammation from Moderna Covid jab in

young men, US regulator says, after suspensions in Nordic nations

22 Oct, 2021 12:08

FILE PHOTO: A vial containing doses of the Moderna vaccine against the coronavirus disease (COVID-19) and syringes are pictured at Japan Airlines (JAL) facility where its staff receive the vaccines at Haneda airport in Tokyo, Japan June 14, 2021.

© Reuters / Kim Kyung-Hoon

The US Food and Drug Administration (FDA) has reiterated the risk of heart inflammation in young men following vaccination with Moderna’s Covid-19 jab after a handful of Nordic nations halted its use in this age group.

In an announcement released on Wednesday, the body shared that “ongoing analyses from the FDA and the Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis and pericarditis following vaccination with the Moderna COVID-19 vaccine.”

As per the statement, this risk has been seen particularly following the second dose, with symptoms appearing a few days after receiving the jab.

“The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than among females and older males,” the notice read.

The comments in the FDA press release echo similar concerns from Nordic nations that led to Spikevax, the marketing name for Moderna’s Covid vaccine, to be suspended in some form.

Icelandic health authorities announced on October 8 that it will no longer administer Moderna’s mRNA shot due to the risk of rare heart inflammation seen in other Nordic countries.

The director of Finland’s National Institution for Health and Welfare, Mika Salminen, said that “A Nordic study involving Finland, Sweden, Norway and Denmark found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis.”

The findings prompted Helsinki to announce that men born in 1991 and after would no longer be given the jab.

Sweden, just one day prior, froze the use of Spikevax on all of its population under 30, citing an “increased incidence” of heart inflammation diseases, myocarditis and pericarditis. Meanwhile, Norway recommends that men under the age of 30 opt for Pfizer’s jab instead.

Concerns over heart inflammation after receiving mRNA jabs from both Pfizer and Moderna, however, are not new. In June, the Advisory Committee on Immunization Practices (ACIP) to the CDC revealed a total of 323 preliminary incidents, of what met the CDC definition of myocarditis or pericarditis, were recorded in Americans under the age of 29. A total of 309 of those were hospitalized.

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Fauci slams Rand Paul’s claims US-funded bat virus research led to

Covid-19 after senator demands his firing amid longstanding row

25 Oct, 2021 13:18

Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, testifies at a Senate Health,

Education, Labor, and Pensions Committee hearing at the Dirksen Senate Office Building on July 20, 2021 in Washington, DC.

© AFP /Getty Images / Stefani Reynolds-Pool

White House Medical Advisor Dr. Anthony Fauci has lashed out at claims made by Senator Rand Paul that US-funded bat virus research in China could have spawned Covid-19, rebuffing the idea as “molecularly impossible.”

Speaking on Sunday to ABC News, Fauci blasted accusations made by Rand Paul (R-Kentucky) that the National Institutes of Health (NIH) had funded research in Wuhan which resulted in the origination of the coronavirus: “He's absolutely incorrect. Neither I nor Dr. Francis Collins, the director of the NIH, lied or misled about what we've done.”

The senator also called for Fauci to be fired by US President Joe Biden “for lack of judgement,” and said it is unlikely he will “admit that he lied” in an interview with Axios on HBO. “He's gonna continue to dissemble, and try to work around the truth, and massage the truth,” Paul remarked.

Of course, no one can ever admit doing anything close to willfully creating the CV19 virus.

The remarks come after the NIH’s principal deputy director, Lawrence Tabak, revealed last week that nonprofit EcoHealth Alliance did experiment on coronaviruses in China with the organization’s funding, but he denied this had anything to do with the virus that causes Covid-19.

Fauci also reiterated this and said that the viruses being studied “were distant enough molecularly that no matter what you did to them, they could never, ever become SARS-CoV-2.” It would be “molecularly impossible,” he insisted.

In a letter sent to Republican lawmakers, Tabak said the experiment found mice infected with one bat coronavirus “became sicker than those” given another type.

Despite there being a 96-97% similarity between SARS-CoV-2 and the RaTG13 and BANAL-52 bat coronaviruses, Tabak insisted “the bat coronaviruses studied under the EcoHealth Alliance grant could not have been the source of … the COVID-19 pandemic.”

The World Health Organization announced a renewed probe to determine the origins of the coronavirus earlier this month. Chinese Foreign Ministry Spokesperson Zhao Lijian promised that Beijing would continue to support and participate in finding out where the virus came from, but said it will “firmly oppose any form of political manipulation.”

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Government response to Covid-19 was too slow and insufficient

to stop spread, Swedish commission finds

29 Oct, 2021 12:37

People enjoy the sun at an outdoor restaurant during first wave of Covid-19 in Stockholm, Sweden

(FILE PHOTO) © TT News Agency/Janerik Henriksson via REUTERS

A commission appointed by the government has said that Sweden’s interventions at the start of the Covid-19 pandemic were insufficient to prevent the spread of the virus, and the state’s preparedness was substandard.

The commission investigating the government’s management of the Covid-19 pandemic has issued a scathing interim report, accusing the state of introducing measures too late to prevent the spread of the deadly virus. 

“Sweden’s handling of the pandemic has been marked by a slowness of response,” the commission stated, adding that “the initial disease prevention and control measures were insufficient to stop or even substantially limit the spread of the virus in the country.” 

The commission also contended that it had taken “far too long” to build sufficient testing capacity as, at first, only targeted groups, such as healthcare staff, were able to get tested.

Sweden embarked on a no-lockdown strategy with tighter restrictions added during later waves of the pandemic. The country had recorded around 15,000 deaths from the virus, substantially more than its Nordic neighbors who locked down quickly. 

The strategy, largely reflecting the now-defunct Great Barrington Declaration, was controversial at home and abroad as preventative measures were dropped in favor of asking the public to make their own decisions.

The move was praised by some who saw the model as more business friendly, and some predicted naturally developing herd immunity would eventually slow the spread of the virus.

The commission will deliver its final findings in a 2022 report, although the interim reports have been highly critical of the government. Beyond making its findings public, the commission has no legal power.

Nearly all Covid-19 measures have now been removed in Sweden.

Covid 19 > Nordic Countries Stop Moderna for Some; 4 & 5 y/o USA Kids Get Covid Vax in Error; GBS Very Rare Side Effect from AZ Vax;

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Nordic Countries halt Moderna vaccinations for young men

over heart inflammation concerns

7 Oct, 2021 10:45

Vials of the Moderna vaccine against the Covid-19 coronavirus July 18, 2021. © Reuters / Munir Uz zaman

Finland has decided it will pause rolling out Moderna’s Covid-19 vaccine to men born in 1991 and later due to concerns about the rare side effect of heart inflammation post-inoculation, following Nordic nations Sweden and Denmark.

Speaking at a news conference on Thursday, the director of Finland’s National Institute for Health and Welfare, Mika Salminen, announced Helsinki’s halt on offering Moderna’s Spikevax jab to its younger male population. 

“A Nordic study involving Finland, Sweden, Norway and Denmark found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis,” he explained. 

Salminen said that while the heart inflammation often went away on its own in a few days, he recommended instead that this demographic be inoculated with Pfizer-BioNTech’s vaccine, marketed as Comirnaty. 

The director also said young male Finns who have had their first dose of Spikevax would receive Comirnaty for their second. He insisted it was still important to get the second dose to get maximum protection against the virus. 

Finland’s decision comes a day after neighboring Sweden suspended the use of Spikevax on all of its population born in 1991 and later after an “increased incidence” of heart inflammation diseases myocarditis and pericarditis following inoculation, especially after the second dose. 

Nordic nation Denmark also paused the use of Spikevax on the same day on similar grounds, although only for minors under age 18.

Geir Bukholm, head of infection control at the Norwegian Institute of Public Health, said on Wednesday that “men under the age of 30 should also consider choosing Comirnaty when they get vaccinated,” as Oslo already recommends Pfizer’s jab for its minors. 

The European Medicines Agency in July published findings urging heart conditions myocarditis and pericarditis to be added to the list of potential rare side effects of mRNA Covid-19 vaccines manufactured by Pfizer-BioNTech and Moderna after reviewing over 300 incidences across the European Economic Area. According to the medicinal regulatory body, these cases represent only a minute number, however.

On Oct 8th, Iceland stopped using Moderna for all age groups.

Indiana family says their 4 & 5yo children received Covid

vaccines by mistake, after flu shot mix-up at Walgreens

12 Oct, 2021 04:17

FILE PHOTO: Walgreens workers exchange doses of coronavirus vaccines at an immunization site in Evanston, Illinois. ©  Reuters / Kamil Krzaczynski

A family of four in Indiana claims they were given Covid-19 vaccinations in error after showing up at a Walgreens location for flu shots – not the first time such a mix-up has been reported at the pharmacy chain.

Alexandra and Joshua Price of Evansville, Indiana told local media that they and their two young children were scheduled for flu shots at a local Walgreens on October 4, but were instead administered coronavirus shots by mistake. Though no Covid vaccine is approved for children younger than the age of 12, the Price family says their four- and five-year-old were given full adult doses of the Pfizer shot.

The family’s lawyer, Daniel Tuley, provided vaccination cards to local media, which he says were given to the Price family after the mix-up was discovered. The cards show the names and dates of birth for each family member – including the two children, born in 2016 and 2017 – and noted that they were given the Pfizer formulation at a Walgreens vaccination site. 

The Prices say they initially left the appointment believing that they had, in fact, received flu shots, but were informed by a Walgreens employee that there was an error a short time later. 

“Walgreens called me to say there was a mix-up, we did not receive the flu shot,” Alexandra told a local NBC affiliate. “And I’m like ‘Well what did we get?’ And he was like we got the Covid-19 shot, And instantly I was like, ‘Well what does this mean for my kids?’”

The concerned mom then brought the children to a pediatrician, she says, and was told some irregularities were detected. “[The cardiologist] said our daughter was having higher blood pressure than she would like,” Alexandra said, adding that “our son was having tachycardia,” referring to an abnormally fast heart rate. 

It is unclear whether the symptoms had any link to the vaccines, though health officials have raised concerns about the increased risk of heart issues, particularly for younger recipients of the Covid immunizations. Reports of adverse reactions remain rare, however. 

Responding to repeated requests for comment by the NBC affiliate, Walgreens issued a statement on Monday which declined to confirm the Price family’s charges, though nonetheless said it takes any such cases “very seriously.”

“Due to privacy laws, we cannot comment on specific patient events. However, in general, such instances are rare and Walgreens takes these matters very seriously,” the company said, adding: “In the event of any error, our first concern is always our patients’ wellbeing,” and that Walgreens implements “several safety checks to minimize the chance of human error.”

As of Monday night, the Price family had not filed a lawsuit over the incident, and it remains unclear whether they intend to bring the matter to the courts despite their lawyer’s involvement. 

The apparent mix-up would not be the first of its kind. Late last month, a Baltimore family expecting flu shots were shocked to find their four-year-old daughter had been jabbed with the Covid immunization by mistake. That error also took place at a Walgreens location, and, like the two Price children, the four-year-old received Pfizer’s formulation. Fortunately, the little girl did not experience any adverse symptoms in that case.

Nerve disorder Guillain-Barre syndrome added as very rare

side effect for AstraZeneca Covid-19 vaccine in UK

21 Oct, 2021 17:48

©  REUTERS/Dado Ruvic/Illustration

The Medicines and Healthcare products Regulatory Agency has added a serious nerve disorder as a possible side effect to the AstraZeneca Covid-19 vaccine after a handful of cases were linked to the jab.

Guillain-Barre syndrome (GBS) itself is a rare nerve disorder that can cause paralysis, but recent data has shown the likelihood “of a possible association” to the vaccine “has strengthened,” according to the regulatory agency.

Of the millions who have received the AstraZeneca vaccine, there were 432 reports of GBS possibly stemming from the vaccine. There were 50 similar cases reported for the Pfizer vaccine. 

In response, the agency has updated their information on AstraZeneca’s jab to include GBS as a rare, but possible, side effect. 

The decision follows the European Medicines Agency adding the nerve disorder as a potential side effect for the vaccine last month. 

The EMA’s decision was based on hundreds of reports of GBS possibly linked to the vaccine, which is branded as Vaxzevria. The side effect, however, is still classified as very rare. 

In the US, the Food and Drug Administration (FDA) previously listed GBS as a very rare side effect for the one-shot Johnson & Johnson vaccine.

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Corruption is Everywhere - Apparently, All Over EU in Amazon; Big Pharma in Mexico; Pfizer, Moderna, Hike Prices; Complicated Corruption in Russian Investment Market

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Amazon hit with whopping $887 million fine by

European privacy regulators

30 Jul, 2021 13:57

The Amazon app is seen on a smartphone in this illustration taken July 13, 2021 © Reuters / Dado Ruvic

Amazon has been handed an $888 million fine by European Union regulators for breaching the bloc’s data protection laws. The fine is the largest issued by the EU, but is still less than one percent of the firm’s annual revenue.

The Luxembourg National Commission for Data Protection (CNPD) issued the fine earlier this month, and Amazon reported it on Friday in a filing to the US Securities and Exchange Commission (SEC).

The CNPD issued the fine claiming that Amazon had processed customer data in violation of the EU’s General Data Protection Regulation (GDPR), a tough privacy law that took effect in 2018. Amazon disputed the fine, calling it “without merit,” and stating that the firm would “defend ourselves vigorously in this matter.”

“There has been no data breach, and no customer data has been exposed to any third party,” Amazon added in a statement. “These facts are undisputed. We strongly disagree with the CNPD’s ruling.”

The fine is the largest penalty to date issued for a GDPR violation. The largest fine issued beforehand was a $57 million ruling against Google by French regulators in 2018. Nevertheless, while $887 million would be a staggering amount of money for most companies, for Amazon it represents a tiny slice of the firm’s annual takings. With sales buoyed by the closure of brick and mortar outlets during the coronavirus pandemic, Amazon recorded more than $383 billion in sales last year, enough to pay the EU fine 431 times over.

Under the GDPR, watchdogs like the CNPD can fine companies up to 4% of their annual global sales.

Amazon will appeal the fine, but even if the company loses, it can afford to shrug off nearly a billion dollars. However, the EU is also investigating Amazon for potentially breaking antitrust rules over its alleged use of data from third-party sellers to more strategically price its own products. Similar probes have been brought by Germany and the UK, and in the US, lawmakers from both parties have proposed using antitrust legislation to break up tech monopolies like Amazon and Google.

Mexico won’t be ‘hostage’ to Big Pharma, president says, as internet

predicts trouble after country rejects Covid jabs for kids

31 Jul, 2021 10:46

FILE PHOTO: Mexico's President Andres Manuel Lopez Obrador ©  REUTERS/Edgard Garrido

Social media users have theorized that President Andres Manuel López Obrador could face severe repercussions after he refused to purchase Covid vaccines for children, vowing that Mexico wouldn’t bow to pressure from drugs firms.

In remarks made earlier this week, the Mexican leader said his government was still waiting for the scientific community to demonstrate the benefits of vaccinating minors. Until conclusive evidence was provided, Mexico would refuse to purchase jabs for children, Obrador announced, adding that...

pharmaceutical firms seemed to be focused more on making profits than on

ensuring medical necessity as they rake in record sales from Covid-19 vaccines.

Mexico will not be held hostage by pharmaceutical companies that only want to do business and scare children with the idea that it is necessary to vaccinate against Covid-19.

He was similarly critical of plans by drugs companies to introduce third- or even fourth-dose booster shots, opining that the jabs could be “superfluous.”

Speaking on the same topic, Undersecretary for Health Hugo López-Gatell claimed there was “no scientific evidence” showing the jab was “essential” for minors, given the high rate of inoculation among the adult population, Excélsior, Mexico City’s second-oldest daily, reported. 

Mexico has approved a range of Covid vaccines for emergency use, including shots developed by Pfizer, AstraZeneca, Johnson & Johnson, and Sinovac, as well as Russia’s Sputnik V. 

The country’s Health Ministry recently revealed that a minimum of 48% of Mexicans have received at least one vaccine dose. 

Like many other countries, Mexico rolled out its inoculation program in phases, giving high-risk groups first priority. Currently, those under 18 are not included in the vaccine drive.

Largely ignored by international media, Obrador’s provocative remarks went viral after an English-subtitled video of his speech was shared across social media. 

Several comments hailed the Mexican president’s “cajones” for calling out Big Pharma greed. Pfizer, for example, has boasted record profits and recently raised full-year sales estimates for its vaccine to $45 billion.

Others shared more conspiratorial reactions to Obrador’s comments. Numerous observers theorized that the Mexican president was exposing himself to potential harm or an “accident” by criticizing Big Pharma firms in such a blunt and direct manner. 

With 45 billion dollars a year on the line, one life lost seems like a good deal. It's just my humble opinion, but I think JFK, RFK, MLK, and Pope John Paul (In God's Name - David Yallop) were murdered for a lot less. 

While Mexico doesn’t feel comfortable administering the shot to youngsters, many other countries have begun to offer the vaccine to minors, both in clinical trials and as part of inoculation drives. According to the Mayo Clinic, around 14% of Americans under 18 have received at least one Covid shot. 

Pfizer, Moderna, hike prices for their Covid jabs by up to a quarter for the EU

1 Aug, 2021 19:04

©  REUTERS/Dado Ruvic/Illustration

Pfizer has reportedly raised the price of its Covid vaccine dose by a quarter, with Moderna also ramping up the price in its latest deal with the European Union. The two are making tens of billions of dollars in pandemic profits.

According to the Financial Times, which has seen contracts between the two pharmaceutical companies and the EU, Pfizer's latest price for one vaccine dose was €19.50, or around $23 – up by four euro from the previous unit price of €15.50 euro.

Meanwhile, Moderna's latest price is around €21.50 ($25.50) per dose, up from the previous price of €19 ($22.60). Despite this, the Moderna price is still lower than previously expected – $28.50 – because of the EU purchasing more doses.

Pfizer and Moderna – which earn a profit from the vaccines, unlike AstraZeneca, which is sold at cost – have pulled in tens of billions of dollars from the vaccines, with Pfizer forecasting $33.5 billion in revenue from its doses in this year alone. The forecast is up $7.5 billion from its previous prediction in the last quarter.

The previous story used the forecast number of $45 billion.

Moderna, though behind Pfizer in sales, is forecasting $19.2 billion in Covid-19 vaccine revenue for 2021.

Russia’s Sputnik V vaccine still hasn’t been approved by the European Medicines Agency (EMA) despite having been registered in 69 of the world's countries to date, including EU members Hungary and Slovakia.

And yet, nobody is doing double-blind studies on Ivermectin which is almost free. Why?

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How Michael Calvey went from billion-dollar Moscow investor

to facing years behind bars in a Russian jail

1 Aug, 2021 10:24

By Gabriel Gavin, in Moscow

One morning in February, back in 2019, Michael Calvey got a knock on the door of his Moscow apartment. The American financier may have been an influential poster-boy for foreign investment in Russia, but the police didn’t care.

Accused of dodgy dealing, the businessman was locked up in the notorious Matrosskaya Tishina prison, on the outskirts of the Russian capital, within days. After months of appeals he was released, first to house arrest in his upmarket residential building and, later, he was allowed to go out subject to curfew rules. Despite that, Calvey’s life has gone from business meetings and investment opportunities to legal proceedings and the ever-looming threat of jail time. Now, that two-and-a-half-year-long battle might be coming to a head, and his team expects to hear a verdict on Monday.

Along with three other executives from Baring Vostok, the $3.7-billion investment firm he founded, Calvey is facing charges of embezzlement and fraud. Prosecutors claim he was at the center of a scheme to pocket 2.5 billion rubles (US$34.3 million) from Russia’s Vostochny Bank as part of a high-stakes transaction, with officials claiming Calvey and his associates had overestimated the value of an asset as part of a loan scheme. The authorities are seeking a six-year suspended prison sentence, while the businessmen insist that they are innocent and the charges have been trumped up by corporate rivals.

In his final remarks in court last month, Calvey said that “the evidence that the prosecution presented to the court and that was examined during the trial not only does not incriminate me in any crime, but confirms my innocence and the innocence of my colleagues.” According to him and his lawyers, official appraisals show that there was no fudging of the figures and that they’ve only ever been honest and transparent in their multi-billion dollar transactions. 

Honest and transparent in Moscow! Whoever heard of that?

The trouble started, they said, when their firm became embroiled in a legal dispute with Vostochny Bank, owned by high-powered businessman Artem Avetisyan. The tycoon had previously been appointed head of the new business division at the Agency for Strategic Initatives, chaired by Russian President Vladimir Putin. Baring Vostok brought the case against the investment fund in a British court, claiming hundreds of million dollars in damages over the alleged stripping of assets from a jointly-owned company. The arrests, Calvey and his fellow executives say, were designed to prevent them from effectively trying the case in London.

After a Russian court ruled in favor of Avetisyan and Vostochny Bank over a separate dispute in 2019, the firm said it would no longer be pressing criminal charges against the leadership of Baring Vostok. However, prosecutors have continued unabated and, according to Calvey’s team, have taken an apparent absence of evidence for embezzlement as a sign that there was a coverup.

What makes the case remarkable is that Calvey was a clear success story for foreign investment in Russia. Passionate about the country as a burgeoning marketplace, he largely steered clear of domestic politics in a country that was not his own and appeared frequently to tout its financial prospects at major events like the annual St Petersburg International Economic Forum (SPIEF).

In addition, under his leadership, Baring Vostok has plowed cash into Russia’s star businesses, such as tech giant Yandex. Moscow business daily Vedomosti described the financial firm as “the symbol of direct investment in Russia” and, according to the company’s figures, it has invested more than $2.5 billion in mid-sized Russian firms and startups, many of which have plans to go global if they can attract enough capital.

A number of prominent officials and business executives have since rallied around Calvey and his colleagues, while the American has sought to portray the dispute as an existential issue for investment in the country. According to Calvey, a ruling in his favor would be a sign that the country is a safe destination for business. “It would not be an exaggeration to say that such a positive decision by the court could bring Russia billions of dollars in new investments, adding thousands of jobs,” he said in a statement, and has insisted he wants to remain in Russia and continue his work after the case is settled.

While Calvey and his advisers have consistently portrayed him as an apolitical figure, solely interested in opportunities in Russia as an emerging market, the financier has also served on the Board of Directors of The Atlantic Council, viewed in Moscow as a rabidly anti-Russian, NATO-aligned lobby group. He was invited to join in 2009, when relations between Russia and the West were far better than they are today. 

In 2019, the Russian Ministry of Justice designated The Atlantic Council as an “undesirable organization,” effectively banning it from operating in the country. He has, however, reportedly had no involvement since 2016. While sources say he was intent on balancing the Atlantic Council’s strongly anti-Moscow standpoint, this would have been an ill-fated task, given the body relies on that posture for its funding.

I wonder from whom their funding comes?

For Calvey’s team, even being found criminally liable for a lesser sentence – even one without jail time – would be considered a defeat, given such a verdict would be a black mark against the names of Baring Vostok executives when it comes to corporate affairs. For the prosecutors, a long-lasting and controversial case ending without a conviction, even of an administrative offense, would draw into question the basis of the charges and the decision to pursue them. In short, there is a tough standoff that will be difficult to resolve and leave at least one side feeling poorly served by the courts.

What is clear is that, while the fate of Calvey and his colleagues hangs in the balance, far broader debates around foreign investment in Russia and the rule of law are only just beginning.