Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19

Authors: Stephanie Seneff1and Greg Nigh21Computer Science and Artificial Intelligence Laboratory, MIT, Cambridge MA, 02139, USA, E-mail: seneff@csail.mit.edu

ABSTRACT

Operation Warp Speed brought to market in the United States two mRNA vaccines, produced by Pfizer and Moderna. Interim data suggested high efficacy for both of these vaccines, which helped legitimize Emergency Use Authorization (EUA) by the FDA. However, the exceptionally rapid movement of these vaccines through controlled trials and into mass deployment raises multiple safety concerns. In this review we first describe the technology underlying these vaccines in detail. We then review both components of and the intended biological response to these vaccines, including production of the spike protein itself, and their potential relationship to a wide range of both acute and long-term induced pathologies, such as blood disorders, neurodegenerative diseases and autoimmune diseases. Among these potential induced pathologies, we discuss the relevance of prion-protein-related amino acid sequences within the spike protein. We also present a brief review of studies supporting the potential for spike protein “shedding”, transmission of the protein from a vaccinated to an unvaccinated person, resulting in symptoms induced in the latter. We finish by addressing a common point of debate, namely, whether or not these vaccines could modify the DNA of those receiving the vaccination. While there are no studies demonstrating definitively that this is happening, we provide a plausible scenario, supported by previously established pathways for transformation and transport of genetic material, whereby injected mRNA could ultimately be incorporated into germ cell DNA for transgenerational transmission. We conclude with our recommendations regarding surveillance that will help to clarify the long-term effects of these experimental drugs and allow us to better assess the true risk/benefit ratio of these novel technologies.

For More Information: https://ijvtpr.com/index.php/IJVTPR/article/view/23/51

Do Masks Work?

A review of the evidence

Authors: Jeffrey H. AndersonAugust 11, 2021 Covid-19Health CarePolitics and law

Seriously people—STOP BUYING MASKS!” So tweeted then–surgeon general Jerome Adams on February 29, 2020, adding, “They are NOT effective in preventing general public from catching #Coronavirus.” Two days later, Adams said, “Folks who don’t know how to wear them properly tend to touch their faces a lot and actually can increase the spread of coronavirus.” Less than a week earlier, on February 25, public-health authorities in the United Kingdom had published guidance that masks were unnecessary even for those providing community or residential care: “During normal day-to-day activities facemasks do not provide protection from respiratory viruses, such as COVID-19 and do not need to be worn by staff.” About a month later, on March 30, World Health Organization (WHO) Health Emergencies Program executive director Mike Ryan said that “there is no specific evidence to suggest that the wearing of masks by the mass population has any particular benefit.” He added, “In fact there’s some evidence to suggest the opposite” because of the possibility of not “wearing a mask properly or fitting it properly” and of “taking it off and all the other risks that are otherwise associated with that.”

Surgical masks were designed to keep medical personnel from inadvertently infecting patients’ wounds, not to prevent the spread of viruses. Public-health officials’ advice in the early days of Covid-19 was consistent with that understanding. Then, on April 3, 2020, Adams announced that the CDC was changing its guidance and that the general public should hereafter wear masks whenever sufficient social distancing could not be maintained.

Fast-forward 15 months. Rand Paul has been suspended from YouTube for a week for saying, “Most of the masks you get over the counter don’t work.” Many cities across the country, following new CDC guidance handed down amid a spike in cases nationally caused by the Delta variant, are once again mandating indoor mask-wearing for everyone, regardless of inoculation status. The CDC further recommends that all schoolchildren and teachers, even those who have had Covid-19 or have been vaccinated, should wear masks.

The CDC asserts this even though its own statistics show that Covid-19 is not much of a threat to schoolchildren. Its numbers show that more people under the age of 18 died of influenza during the 2018–19 flu season—a season of “moderate severity” that lasted eight months—than have died of Covid-19 across more than 18 months. What’s more, the CDC says that out of every 1,738 Covid-19-related deaths in the U.S. in 2020 and 2021, just one has involved someone under 18 years of age; and out of every 150 deaths of someone under 18 years of age, just one has been Covid-related. Yet the CDC declares that schoolchildren, who learn in part from communication conveyed through facial expressions, should nevertheless hide their faces—and so should their teachers.

How did mask guidance change so profoundly? Did the medical research on the effectiveness of masks change—and in a remarkably short period of time—or just the guidance on wearing them?

Since we are constantly told that the CDC and other public-health entities are basing their recommendations on science, it’s crucial to know what, specifically, has been found in various medical studies. Significant choices about how our republic should function cannot be made on the basis of science alone—they require judgment and the weighing of countless considerations—but they must be informed by knowledge of it.

In truth, the CDC’s, U.K.’s, and WHO’s earlier guidance was much more consistent with the best medical research on masks’ effectiveness in preventing the spread of viruses. That research suggests that Americans’ many months of mask-wearing has likely provided little to no health benefit and might even have been counterproductive in preventing the spread of the novel coronavirus.

For More Information: https://www.city-journal.org/do-masks-work-a-review-of-the-evidence

How Likely Are Vaccinated People To Get Meaningfully Sick From Delta?

Authors: DYLAN HOUSMAN

The reality that breakthrough cases exist and being vaccinated doesn’t guarantee protection from COVID-19 has raised a new question in the minds of many Americans: just how likely is it that someone will get seriously ill from the delta variant of COVID-19 if they are vaccinated?

Some clinical data suggests that vaccine efficacy may be slightly lower against the delta variant than previous iterations of the virus, but the overall numbers are still promising. A July study by Public Health England found that the Pfizer vaccine is still 88% effective at preventing symptomatic disease from the delta variant, only about 6% lower than against the alpha variant. A Canadian study found the Moderna jab to be 72% effective against Delta after just one dose, but more data is needed to determine how much more protection the second dose provides. The Moderna shots have shown to be around 93% effective after six months without accounting for the Delta variant.

The Centers for Disease Control and Prevention (CDC) reported 6,915 hospitalizations related to COVID-19 in vaccinated people as of Aug. 2, but the answer to how risky COVID-19 is for the vaccinated isn’t as simple as a single stat. Anecdotal accounts and a deep dive into the data indicates that a wide variety of experiences are possible when vaccinated and infected.

The CDC doesn’t track or publicly release nationwide breakthrough case data. For that reason, it’s impossible to know exactly how frequent breakthrough cases are, how many of them are asymptomatic or how many result in just mild symptoms. It’s also less likely that asymptomatic or mildly sick individuals will think to get tested for COVID-19, especially if they are vaccinated.

For More Information: https://dailycaller.com/2021/08/10/delta-variant-how-sick-vaccinated-covid-coronavirus/

Anti-maskers hurl abuse, threats after Tennessee school board reinstates mandate

Authors: By Yaron Steinbuch

Wild video captured a group of irate people in Tennessee hurling threats at health care professionals and school board members after a mask mandate was reinstated — with one man threatening, “We know who you are! You can leave freely, but we will find you!”

The chaos erupted Tuesday night in Franklin, just south of Nashville, where the Williamson County Board of Education approved the mask requirement for elementary schools as protesters gathered outside, according to News Channel 5.

During the heated debate before the measure was passed, a parent who identified himself as former Marine Daniel Jordan told the board, “Actions have consequences. If you vote for this, we will come for you, in a non-violent way,” CNN reported.

He added: “In the past, you dealt with sheep, now prepare yourself to deal with lions.”

Dr. Jennifer King, a parent and physician, told the board, “As a pediatric ICU physician, we are seeing more younger previously healthy children admitted with respiratory failure and acute respiratory distress syndrome than we have in prior strains, as cases in children are on the rise.

“This trend will only worsen if we don’t act now,” she said during the raucous meeting, where attendees cheered, clapped and booed. Police escorted some disruptive people out of the room, footage shared on Twitter shows.

For More Information: https://nypost.com/2021/08/12/anti-maskers-hurl-threats-after-school-board-reinstates-mandate/

Fauci Confirms “Likely, Inevitable” Everyone Will Need COVID Vaccine Booster Shot

Authors: BY TYLER DURDEN

Within the space of a few days, the narrative has shifted from “if” booster shots are even necessary, to “only for immunocompromised“, to “only for those who got vaccinations early on, due to fading efficacy“, and now today, His Omniscience Anthony Fauci told ‘CBS This Morning’ that while it is imminent that immune compromised people will get Covid-19 vaccine booster shots, it is likely that at some point in the future everyone will need one.

“It’s likely that that will happen at some time in the future,” Fauci said, when asked if everyone will need a booster shot at some point.

Fauci noted that this is data is being followed in real time, “literally on a weekly and monthly basis,” with cohorts of all different populations to determine if the level of protection is starting to attenuate.

“When it does get to a certain level, we will be prepared to give boosters to those people, but from what you just said a moment ago, it is imminent that we will be giving it to immune compromised,” he said.

As a reminder, the FDA is reportedly expected to announce soon that it will authorize COVID-19 vaccine booster shots for immunocompromised Americans. 

For More Information: https://www.zerohedge.com/covid-19/fauci-confirms-likely-inevitable-everyone-will-need-covid-vaccine-booster-shot

Israel, 80% Vaccinated, Suffers Another Covid-19 Surge

Country delivers more booster shots, restores mask and quarantine mandates as Delta variant drives up hospitalizations

Authors: Dov Lieber

TEL AVIV—After becoming one of the first countries to open up thanks to a widespread Covid-19 vaccination campaign, Israel is again on guard, this time against the spread of the Delta variant of the coronavirus.

Mask mandates are back, including requirements to mask up for large outdoor gatherings. Many venues require people to show proof of vaccination, a negative Covid-19 test or proof of recovery from the virus. People returning from most countries have to quarantine for at least a week, even if they are fully vaccinated. Over-60s are being offered a third, booster shot of Pfizer Inc.’s vaccine, and the government is planning to offer it to younger recipients with the hopes it can suppress the rise of cases of severe illness.

Health officials are warning that Israel could face a fourth lockdown during the Jewish holiday season in September if the country doesn’t improve on its 80% adult vaccination rate and deliver more booster shots.

A little over a month ago, day-to-day life in Israel was quickly getting back to normal. People were dining indoors or attending concerts without needing the so-called green pass, a digital certificate stored on phones to show the holder is fully vaccinated. But the more contagious Delta variant is forcing a change in tack, in a test case for what could happen elsewhere, including countries with high vaccination rates.

For More Information: https://www.axios.com/vaccine-efficacy-biden-pfizer-moderna-death-infetion-4403be7b-ced7-410e-9c19-67e201f031f7.html

Biden’s big COVID challenge: Fading vaccines may demand boosters

Authors: Caitlin OwensSam Bake

The Biden administration is intensely scrutinizing coronavirus vaccines’ effectiveness over time, facing the daunting task of timing booster shots right while still convincing the unvaccinated that getting the jab is worthwhile.

The bottom line: The vaccines still work incredibly well at protecting against severe disease and death, meaning the benefits of getting vaccinated are immense. But it’s less clear how well they’re working at preventing infection, which has huge public health implications with so many Americans still unvaccinated.

“I think everybody believes this wanes over time, the question is to what extent,” a senior Biden official said. “Nobody wants to be behind the eight-ball here. We want to catch it before there’s an issue, and that’s why there is very intense scrutiny.”

  • But getting the timing right won’t be easy, especially without better data than we have now.
  • “By the time we have the data that efficacy is declining, we’re already behind,” said a person close to the administration. “A public health decision can be made on imperfect data. So are you waiting for a ton of breakthrough cases and a ton of death and disease before you boost everyone? That’s not a good idea.”

For More Information: https://www.axios.com/vaccine-efficacy-biden-pfizer-moderna-death-infetion-4403be7b-ced7-410e-9c19-67e201f031f7.html

Contributors BC, CW, and YeW had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. CW and BC decided to publish the paper. BC, CW, YeW, PWH, TJ, and FGH provided input on the trial design. BC, CW, YeW, FGH, and PWH were responsible for acquisition, analysis, and interpretation of data. YeW, FGH, PWH, and GF drafted the manuscript. BC, CW, PWH, FGH, GF, TJ, and XG critically revised the manuscript. YeW contributed to statistical analysis. GF gave valuable suggestions for data analysis. All authors contributed to conducting the trial.

Summary

Background

No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.

Methods

We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir–ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.govNCT04257656.

Findings

Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87–1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.

Interpretation

In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.

For More Information: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext

Study: Remdesivir Does Not Reduce COVID Mortality

Authors: By Ralph Ellis

October 19, 2020 — A large study sponsored by the World Health Organization found that remdesivir doesn’t help hospitalized patients with COVID-19 survive and doesn’t even shorten the recovery time of those who do survive.

These findings contradict smaller studies which found remdesivir, an antiviral drug, helped hospitalized coronavirus patients recover faster than patients who received a placebo. Those earlier studies led the FDA to grant emergency use authorization for the drug, which has been given to thousands of COVID patients in the United States, including President Donald Trump.

The WHO-sponsored study was conducted from March 22 to Oct. 4 and involved 11,330 patients from 405 hospitals in 30 countries. Patients were given remdesivir and three other drugs singly or in combination.

“These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” the study concluded.

The data was posted online in the preprint server medRxiv and has not been peer-reviewed or published in a scientific journal.

For More Information: https://www.webmd.com/lung/news/20201018/study-remdesivir-does-not-reduce-covid-mortality

NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19

Authors: NIAID Office of Communications

Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients, which began on February 21. The trial (known as the Adaptive COVID-19 Treatment Trial, or ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. 

An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team. Based upon their review of the data, they noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.   

Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).

More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report. As part of the U.S. Food and Drug Administration’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate. The trial closed to new enrollments on April 19. NIAID will also provide an update on the plans for the ACTT trial moving forward. This trial was an adaptive trial designed to incorporate additional investigative treatments.         

For More Information: https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19