“Mysterious Chinese Pneumonia” spreads as Drug shortage expands


Important Takeaways:

  • ‘WHITE LUNG’ Comes to America as Drug Shortages Grow
  • A “mysterious Chinese pneumonia,” termed “White Lung” by the clever pundits on the evening news, is making headlines as it rolls through schools and homes across the United States.
  • As the fear-mongering escalates, many Americans recall a lesson from the last pandemic: the FDA demonized and blocked access to important medications like Ivermectin.
  • Pharmaceutical shortages and bans are real. And it’s happening again.
  • The cures for sicknesses like this new pneumonia are nothing revolutionary. The only thing standing between many Americans and health could be our own government.
  • That’s why it pays to be prepared ahead of time.
  • Drew Pinsky, world-renowned doctor at The Wellness Company, explains: “White Lung” is a sensational name for these pneumonia infections seen this winter in the United States. This outbreak seems to be the result of RSV, Influenza, and most likely common Mycoplasma. The first line of Mycoplasma treatment for adults is Azithromycin (Z-pak) — a core life-saving medicine found in our Medical Emergency Kits. Having a kit on hand is an ideal way to be prepared for the first sign of a Mycoplasma [pneumonia] infection.
  • Don’t rely on Joe Biden’s healthcare system to have your back.
  • Whether the crisis comes in the form of a new pneumonia or something more mundane like a tick bite – you and your family need to be prepared.

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FDA advisers consider what human trials of ‘artificial womb’ could look like for human infants


Important Takeaways:

  • FDA advisers discuss future of ‘artificial womb’ for human infants
  • Independent advisers to the U.S. Food and Drug Administration are meeting this week to discuss the regulations, ethics and possibilities of creating an artificial womb to increase the chances that extremely premature babies would survive — and without long-term health problems.
  • Although no such device has been tested in humans, similar ones have been used in a handful of cases to successfully develop animals
  • An artificial womb is not designed to replace a pregnant person; it could not be used from conception until birth. Rather, it could be used to help a small number of infants born before 28 weeks of pregnancy, which is considered extreme prematurity.
  • “We believe that our preclinical data supports feasibility and safety and that it’s adequate for consideration of a carefully designed clinical study of artificial womb technology,” Flake told the committee.

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Bombshell Report: CDC study confirms risk of heart disease skyrockets among those who were vaccinated

Luke 21:11 There will be great earthquakes, and in various places famines and pestilences. And there will be terrors and great signs from heaven.

Important Takeaways:

  • CDC confirms heart disease risk soars 13,200 percent among vaccinated
  • A bombshell study from the U.S. Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) has confirmed that the risk of autoimmune heart disease is 13,200% higher in people who are vaccinated for Covid.
  • The study found that the risk of myocarditis following mRNA Covid vaccination is around 133x greater than the background risk in the population.
  • The study’s authors used data obtained from the CDC’s VAERS reporting system.
  • The data was then cross-checked to ensure the results complied with the CDC’s definition of myocarditis.
  • The researchers also noted that given the passive nature of the VAERS system, the number of reported incidents is likely to be an underestimate of the extent of the phenomenon.
  • 1626 cases of myocarditis were studied.
  • The results showed that the Pfizer-BioNTech product was most associated with higher risk.
  • The Pfizer jabs caused 105.9 cases per million doses after the second vaccine shot in the 16 to 17 age group for males.
  • In the 12 to 15 age group for males, 70.7 cases per million doses were recorded after the second shot.
  • The 18 to 24 male age group also saw significantly higher rates of myocarditis for both Pfizer’s (52.4 cases per million) and Moderna’s (56.3 cases per million) products.
  • Researchers also noted that 82 percent of cases were in males, consistent with previous studies.
  • The risk was highest after the second vaccination dose in adolescent males and young men.

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Warning shortage of Amoxicillin FDA blames surge on respiratory illness

Revelations 18:23:’For the merchants were the great men of the earth; for by thy sorceries were all nations deceived.’

Important Takeaways:

  • U.S. is running out of common children’s antibiotic amoxicillin – forcing parents to shop around multiple pharmacies
  • Four Drugmakers behind nearly the entire country’s supply are facing a shortage
  • The liquid form of the medication is in short supply, they said
  • Officials made aware last month when patients struggled to fill prescriptions
  • The Food and Drug Association (FDA) blamed a surge in demand for the shortage — with respiratory illnesses at unseasonably high levels.
  • Amoxicillin is a common antibiotic prescribed to children to treat ear and sinus infections.

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Israeli based company hopes to fill the void on Baby Formula. Waiting on FDA

Rev 6:6 NAS “And I heard something like a voice in the center of the four living creatures saying, “A quart of wheat for a denarius, and three quarts of barley for a denarius; and do not damage the oil and the wine.”

Important Takeaways:

  • An Israeli-based company hopes to fill the void
  • Three weeks ago, the U.S. Food and Drug Administration issued emergency guidance enabling the import of infant formulas produced abroad.
  • Tel Aviv-based MyOr—an Israeli health-tech company—is among companies seeking FDA approval as its Mexican subsidiary, AlphaCare, produces and markets MyOr formulas from a plant in north-central Mexico.
  • “We have 200,000 cans of formula ready to be shipped right now, with a capacity to produce another 250,000 a month,” said MyOr co-founder and chief technology officer Michael Brandwein.
  • Founded in 2018, MyOr provides preventive health-care solutions for infants at-risk with a specific focus on food allergies and nutritional sufficiency.

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FDA issues list of drug shortages


Rev 6:6 NAS And I heard something like a voice in the center of the four living creatures saying, “A quart of wheat for a denarius, and three quarts of barley for a denarius; and do not damage the oil and the wine.”

Important Takeaways:

  • 114 drugs currently in shortage, per FDA
  • Nationwide, more than 100 drugs are in short supply, including antibiotics, diuretics, opioids and heart failure medications, FDA data shows.
  • The most recent drug added to the FDA’s shortage list was heparin sodium and sodium chloride 0.9 percent injection, an anticoagulant, on Jan. 7. Dexmedetomidine injection, a sedative used for patients on ventilators, was added Dec. 27, 2021.
  • View the entire list here https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

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Study shows America is too dependent on China for Pharmaceuticals

Rev 6:6 NAS And I heard something like a voice in the center of the four living creatures saying, “A quart of wheat for a denarius, and three quarts of barley for a denarius; and do not damage the oil and the wine.”

Important Takeaways:

  • Gary Cohn, then chief economic advisor to President Trump, argued against a trade war with China by invoking a Department of Commerce study that found that 97 percent of all antibiotics in the United States came from China. “If you’re the Chinese and you want to really just destroy us, just stop sending us antibiotics,” he said.
  • If we are dependent on China for thousands of ingredients and raw materials to make our medicine, China could use this dependence as a weapon against us.

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Ellume’s COVID-19 home test recall most serious, FDA says

(Reuters) – The U.S. Food and Drug Administration classified the recall of Ellume’s over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month.

Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall.

A ‘false positive’ indicates that a person has the virus when they actually do not.

The antigen test, which detects proteins from the SARS-CoV-2 virus from a nasal sample, is available without a prescription for use by people above two years of age with or without COVID-19 symptoms.

The agency said on Wednesday there have been 35 complaints of the antigen test giving false positive results, but no death had been reported related to the test.

Ellume has so far recalled 2,212,335 tests in the United States.

(Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli)

U.S. CDC advisers recommend COVID-19 vaccine for young children

By Michael Erman

(Reuters) -Advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday unanimously supported broad use of Pfizer and BioNTech’s COVID-19 vaccine in children ages 5 to 11, with shots potentially going into young arms as soon as Wednesday.

They said the benefits of vaccination outweigh the risks of the vaccine. Much of their discussion stemmed from rare cases of heart inflammation that have been linked to the vaccine, particularly young men.

CDC Director Rochelle Walensky must sign off on recommendations before the United States can begin administering the vaccine to children in the age group. The U.S. Food and Drug Administration granted emergency use authorization of the vaccine in 5-11 year old’s on Friday.

The FDA authorized a 10-microgram dose of Pfizer’s vaccine in young children. The original shot given to those age 12 and older is 30 micrograms.

At the outset of the meeting Walensky said that pediatric hospitalizations had surged during the recent wave driven by the Delta variant of the coronavirus.

The risk from COVID-19 “is too high and too devastating to our children and far higher than for many other diseases for which we vaccinate children,” she said.

Walensky said school closures have had detrimental social and mental health impacts on children.

“Pediatric vaccination has the power to help us change all of that,” she said.

The U.S. government and Pfizer have already begun distributing the vaccine in preparation for a widespread rollout for children, many of whom are back in school for in-person learning.

Earlier this week, the White House said the United States has enough supply of the Pfizer/BioNTech vaccine for all 28 million children aged 5 to 11. While some children may be able to get their first shots as soon as Wednesday, the plans is for the U.S. pediatric vaccine program to be running at full strength by next week, a Biden administration official said.

Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.

(Reporting by Michael Erman in New Jersey, Julie Steenhuysen in Chicago and Manas Mishra, Manojna Maddipatla in Bengaluru; Editing by Bill Berkrot)

U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

By Manas Mishra and Michael Erman

(Reuters) -An expert panel will weigh authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for U.S. children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the federal Food and Drug Administration.

An authorization is an important regulatory step toward reaching about 28 million children of these ages, most of them back in school for in-person learning.

The FDA need not follow the advice of its outside experts, but usually does.

While children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.

The age group is “far from being spared from the harm of COVID-19,” with the virus now one of the top 10 causes of deaths in American children, FDA official Peter Marks told the panel. He said there had been close to 100 deaths in that age group so far, and 1.9 million infections.

“In addition, infections have caused many school closures and disrupted the education and socialization of children,” he said.

FDA staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.

Only a few other countries, including China, Cuba and the United Arab Emirates, have cleared COVID-19 vaccines for children in this age group and younger.

Since May, the World Health Organization has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX scheme for poorer countries.

The advisers are expected to pay close attention to the rate of the rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

After the FDA, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.

Top U.S. infectious disease expert Anthony Fauci said on Sunday that it was likely the vaccine will be available to children in the first week or two of November.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

“No matter what size of the safety database, there will always be uncertainties regarding benefits and risks, including for example, the risk of vaccine-associated myocarditis,” said Doran Fink, the FDA’s deputy director for vaccine development.

These uncertainties have to be addressed in surveillance data and studies following authorization, Fink told the panel.

Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Caroline Humer, Richard Chang and Jonathan Oatis)