Coronavirus Insights – December 15, 2020
The world watched this week as the fast-tracked Covid vaccine’s first dose outside of a trial in the US was given to an ICU nurse in New York. Despite the excited publicity behind it, mixed feelings linger in the eye of public perception. For some, the vaccine is a magic bullet, but for others, many questions remain around the safety of the vaccine.
Are those concerns valid? Mainstream headlines and well-known doctors are largely leading us to believe the vaccine is absolutely safe and effective. However, given this vaccine was developed at an unprecedented speed, some doctors and scientists are also sharing that there are caveats to the safety and effectiveness when you read past the headlines and dive into the fine print. Of concern, there are many outstanding questions that can’t be answered right now, like:
Does the vaccine prevent the spread of Covid, or simply reduce the severity of the illness? How severe are the side effects post-injection? How is the chain of command behind held accountable to keeping the vaccine stored at -94 degrees? What’s being done to monitor long-term side effects, especially given the never-been-used-before mRNA technology? And since vaccines are never tested or monitored in regard to long-term issues like cancer, infertility, autoimmune disorders or genotoxicity, how can we be sure that these aren’t real risks? If the virus is mutating, how will these vaccines stay up to date with the current virus? If I have a reaction to the vaccine and am irreparably harmed, who is going to pay my medical bills if I can’t sue the vaccine manufacturers for product liability because they are immune from liability?
Some might wonder: what is the alternative — live at the mercy of this virus? Not at all! If you have been following our newsletters, then you will know you have safe and effective options when it comes to both preventing and treating Covid. We have shared heaps of studies on therapeutics like Vitamin D, Zinc, Vitamin C, and melatonin, and if you watch Dr. Pierre Kory’s Senate testimony, you may be surprised to learn about the positive impacts of the repurposed drug Ivermectin.
Bottom line: to vaccinate or not is not so black and white. Stay informed so that you can make the best choice for you and your family.
Coronavirus Therapeutics
Via Orthomolecular Medicine News Service
Vitamin C Cuts COVID Deaths by Two-Thirds
"The world’s first randomized placebo controlled trial designed to test high dose intravenous vitamin C for treatment of COVID-19 has reduced mortality in the most critically ill patients by two thirds. The study, headed by Professor Zhiyong Peng at Wuhan’s Zhongnan University Hospital, started in February and gave every other critically ill COVID-19 patient on ventilators either 12,000 milligrams (mg) of vitamin C twice daily or sterile water in their drip. Neither the patient nor the doctors knew who was getting vitamin C or placebo so the trial was “double blind.” This is the ‘gold standard’ of research design."
Via Dr.Mercola
Simple Strategies That Will Improve Your Immunity
“'Many who end up with severe COVID-19 have reduced adaptive immune function. As a result, they don't clear the virus quickly and end up having to rely on a more proinflammatory killing of the virus inside their cells instead, which damages healthy cells as well. Reduced T cell function appears to be a primary cause of severe COVID-19. Diet and nutritional supplementation are two key strategies that can help support your immune function. Topping the list of nutrients required are vitamin D, magnesium, zinc and selenium. Melatonin is also important. It has the ability to freely pass into any cell where it upregulates Nrf2 transcription, thereby boosting endogenous antioxidant production. Other strategies that help support your immunity through a variety of means include time-restricted eating, exercise and sauna.''
Via NewsNow from Fox on YouTube
Senate Hearings on Treatment Approaches
Hear the first-person testimony of Dr. Pierre Kory. Also, see last week’s newsletter for studies on Ivermectin that support Dr. Kory’s testimony.
Vaccine Concerns
Via NY Times
Pfizer Pays $2.3 Billion to Settle Marketing Case (2009)
“The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain.
While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.
Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement, a companywide promise to behave.”
Via CNN
Pfizer and Moderna could score $32 billion in Covid-19 vaccine sales -- in 2021 alone
These are staggering sums -- especially for Moderna, a company that generated just $60 million in sales in 2019 and has never previously licensed a product.
Via Stat News
A guide to who can safely get the Pfizer/BioNTech Covid-19 vaccine
There are lots of inconclusive guidelines...for now, the CDC’s assessment is that pregnant people should be offered a chance to get the vaccine, but should be informed it hasn’t yet been tested in the population. (Britain’s Joint Committee on Vaccination and Immunization took a different approach, advising against giving the vaccine to pregnant people.) To date, the vaccine’s safety in those who are lactating hasn’t been studied -- so there is no data on which to advise whether they should be vaccinated.
Via FDA
Vaccines and Related Biological Products Advisory Committee Meeting | Dec. 10, 2020 | FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine
"Unsolicited (non-serious) AEs
A higher frequency of unsolicited, non-serious adverse events was reported in the vaccine group compared to placebo group and was primarily attributed to local reactions and systemic adverse events in subjects not in the reactogenicity subset and are consistent with solicited reactions/events reported by reactogenicity subset participants during the first 7 days following vaccination. Table 19 below presents unsolicited adverse events reported by at least 1% of participants in any treatment group for the phase 2/3 safety population.
Reports of lymphadenopathy were imbalanced with notably more cases in the vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Bell’s palsy was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination. One case (onset at 3 days postvaccination) was reported as resolved with sequelae within three days after onset, and the other three were reported as continuing or resolving as of the November 14, 2020 data cut-off with ongoing durations of 10, 15, and 21 days, respectively. The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time, but FDA will recommend surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations. There were no other notable patterns or numerical imbalances between treatment groups for specific categories (system organ class or preferred term) of non-serious adverse events, including other neurologic, neuro-inflammatory, and thrombotic events, that would suggest a causal relationship to BNT162b2 vaccine."
Via BBC
Covid: Australian vaccine abandoned after false HIV response
"The vaccine had been in stage one of trials, and proving to be effective in making antibodies. But it also generated HIV antibodies in some recipients - which meant it showed false positives for HIV. Further testing proved the HIV wasn't there."
Via Reuters
UK issues warning on Pfizer vaccine after adverse reactions
"Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol. However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG*, which helps stabilise the shot and is not in other types of vaccines."
*Note that PEG components are hotly debated in the beauty industry because contamination of carcinogenic materials is often present during manufacturing
Via CBS News
UK issues warning after 2 allergic reactions to vaccine
In addition to the warning against giving the Pfizer shot to people with a history of significant allergic reactions, the British regulatory agency also said the drug should only be administered "in facilities where resuscitation measures are available."
Via FDA
FDA Safety Surveillance of COVID-19 Vaccines: DRAFT Working list of possible adverse event outcomes
Via Vanity Fair
The Covid Vaccines are Approaching. Is the FDA Ready to Inspect the Plants Where They're Made?
"But perhaps even more troubling, the document included an 11-page letter that the informant had first sent to the FDA in January 2016, which did not seem to have been forwarded to investigators. That letter included similar allegations: Fecal matter had been found on sterile garments and on the floor of controlled areas; a urine-filled glove had been tied up and placed in a trash container in a critical production area; technicians had been caught on video dancing in clean room suites, thus sending potentially dangerous particulates into the air. The allegations suggested a manufacturing plant that was out of control, and that prioritized production at the expense of patient safety.
The informant wrote in the 2018 letter, “How is it that a company that is so heavily regulated due to the criticality of what we manufacture, these VIOLATIONS are allowed to take place year-after-year-after-year.” Until the plant’s managers started firing employees, the letter went on, “this facility will never change. Hopefully, it will change before the death of a child or adult from one of our vaccines.”
Vanity Fair confirmed this account of Menachem’s Merck inspection, and events inside Team Biologics, through interviews with four current or former FDA employees, including Menachem, a detailed review of documents, and an analysis of Team Biologics inspection data. One person with knowledge of the Merck investigation described it as “malfeasance” by the FDA.
**In November 2018, one month after the Merck inspection, he filed a complaint with the U.S. Office of Special Counsel, an independent federal agency that protects government whistleblowers. Claiming that the FDA was failing to properly regulate vaccine- and biologics-manufacturing plants, Menachem alleged that after inspections at Merck, and three other manufacturing plants, his supervisor and other FDA compliance officials improperly downgraded his findings and allowed the facilities to escape regulatory enforcement.
As for any drug, the safety and efficacy of vaccines lie not just in their development, but in how they’re manufactured. But as the FDA’s impending vaccine-approval decisions have dominated public discussion, the unprecedented effort to actually make the more than 300 million doses that a successful national vaccination effort will require has gotten less attention. Vital questions about the FDA’s inspections of vaccine plants have slipped under the radar. “Oversight of the manufacturing process is a very important part of what the FDA does,” said Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health. While expressing confidence in FDA oversight, he added, “There is not a lot of room for error on a COVID vaccine.”
Menachem’s experience inside Team Biologics is critical now because it raises questions about the FDA’s oversight of the manufacturing plants that will be producing COVID-19 vaccines. Because such facilities face financial and production pressures that are often at odds with safety, regulatory oversight is essential. As well, shifting any drug in development from a controlled laboratory setting to the manufacturing floor, and scaling up production from thousands to millions of doses, can present a minefield of hazards, leading drugs to become unstable or impure.
Even before a COVID-19 vaccine has been approved, manufacturing plants are already churning them out in advance, to be ready if and when the FDA grants emergency approval. But so far those plants are not undergoing full FDA inspections, which the agency often performs before approving a new drug, one person familiar with the process told Vanity Fair. Instead, this person said, Team Biologics investigators are making site visits and submitting their findings in internal memos, rather than typical public inspection reports. “They won’t be publicly released, which is the reason they’re doing it,” the person told Vanity Fair. “It’s not really a good process. It seems like a lot of people are trying to dilute any findings, if there are some.”
But the very function of vaccines–to protect healthy people–requires greater vigilance, said Dr. Peter Hotez, a vaccine researcher and dean of the National School of Tropical Medicine at the Baylor College of Medicine. “The bar for COVID vaccines is higher, because you are injecting people who are generally well to prevent them from getting sick, and the margin for error is lower,” he said. With a COVID-19 vaccine, “you are potentially infecting the entire population of the United States, and if you get it wrong, it’s amplified by 330 million.”
Via Science
Fever, aches from Pfizer, Moderna jabs aren't dangerous, but may be intense for some
"This summer, Luke Hutchison, a Massachusetts Institute of Technology–educated computational biologist, volunteered for a trial of Moderna’s COVID-19 vaccine. After he got the second injection, his arm immediately swelled up to the size of a 'goose egg,' Hutchison says. He can’t be sure he got the vaccine and not a placebo, but within a few hours, the healthy then-43-year-old was beset by bone and muscle aches and a 38.9°C fever that felt, he says, 'unbearable.' 'I started shaking. I had cold and hot rushes,' he says. 'I was sitting by the phone all night long thinking: ‘Should I call 911?’ Hutchison’s symptoms resolved after 12 hours. But, he says, 'Nobody prepared me for the severity of this.'”
Via ThePrint
Alleging serious side effects, trial participant seeks Rs 5 cr from Serum Institute
"New Delhi: A Chennai resident, who was a participant in trials for the Covid-19 vaccine being manufactured by the Pune-based Serum Institute of India, has allegedly suffered serious neurological and psychological symptoms after taking the experimental shots.”
Via Vice
World's Largest Vaccine Maker Sues Trial Volunteer who Alleged Side Effects
"The world's largest vaccine producer, Serum Institute of India, has sued a COVID-19 vaccine trial participant who alleged that the trial caused him 'serious side effects.'”
Other Concerns
Via BMJ
Covid-19: Do many people have pre-existing immunity?
"Vitamin D activates T-cells - When a T cell is exposed to a foreign pathogen, it extends a signalling device or 'antenna' known as a vitamin D receptor, with which it searches for vitamin D,", and if there is an inadequate vitamin D level, "they won't even begin to mobilize." In other words, adequate vitamin D is critically important for the activation of T-cells from their inactive naïve state. The question of whether T-cells might also need a continuing supply of vitamin D to prevent the T-cell exhaustion and apoptosis observed in some serious COVID-19 cases deserves further research. High levels of vitamin D are also critical for first line immune defences including physical mucosal defences, human antiviral production, modulating cytokines, reducing blood clotting and a whole host of other important immune system functions [10]. The obese, diabetics and people of BAME origin are far more deficient in vitamin D and men have lower levels than women.”
Via The Spectator
Following the evidence for hospital admissions
"For 20 years, 'influenza' has been blamed for putting hospitals under pressure in winter. Now, this fear has been substituted by 'Covid'. Yet both are one-track, one-pathogen scenarios, which ignores the reality that there are scores of different pathogens that cause respiratory infections across a community at different times of the year. As a consequence, cases of respiratory disease fluctuate throughout the year and so do related hospital admissions and, unfortunately, deaths.And what about Covid? There is a golden opportunity for the government to prospectively test all those who are admitted, not just for Covid, but for the other common pathogens. It is possible that searching only for one pathogen may miss the others. We know for instance that some 17 per cent of respiratory infections are caused by more than one pathogen. Testing for more than just Covid would help us to find out what is making people sick, and put the Covid admissions data into context.”
Via Wall Street Journal
Covid and the New Age of Censorship
"It doesn’t promote public health when media and tech companies stifle scientific debate.Tech companies aren’t alone in their efforts to stifle debate. Traditional news outlets, book publishers and even scientific journals are reluctant to publish information that challenges ideological orthodoxies. The Danish authors of a study on whether masks protect their wearers from coronavirus struggled for months to get it published, despite its obvious public-health importance. When they finally convinced a journal to print the paper, which showed that masks didn’t appear to protect their wearers, the journal’s editor felt compelled to write a piece defending her decision to run it.
News organizations then treated the study’s findings with a skepticism absent from the coverage of most other peer-reviewed scientific research. A New York Times headline declared: “A New Study Questions Whether Masks Protect Wearers. You Need to Wear Them Anyway.” Newspapers are now in the business of ordering their readers around.
Outlets like the Times are increasingly unwilling even to ask ideologically inconvenient questions. Few acknowledge that top biologists are calling for an independent investigation into the possibility that Sars-Cov-2 is the product of a Chinese laboratory accident."
