Search database using this exact word string without the quotations “covid-19 vaccine”.

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As of 9/15/21, total number of records retrieved: 2,009,195.

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Roy Butler: 23-year-old Irish soccer (football) player suffers massive “brain bleed,” dead four days after experimental Johnson & Johnson viral vector DNA injection

Irish community in mourning as tributes paid to talented young sportsman after ‘untimely’ death

SCOTT GOTTLIEB, M.D.

Special Partner, New Enterprise Associations, Inc.’s healthcare investment team and Resident Fellow of the American Enterprise Institute. Dr. Gottlieb served as the 23rd Commissioner of the U.S. Food and Drug Administration (FDA) from 2017 to 2019.

Prior to serving as Commissioner, Dr. Gottlieb held several roles in the public and private sectors including serving as Managing Director, T.R. Winston & Company from 2013 to 2017. Dr. Gottlieb was previously the FDA’s Deputy Commissioner for Medical and Scientific Affairs from 2005 to 2007, as well as the senior advisor to the FDA Commissioner from 2003 to 2004. He had been a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services in 2004.

Dr. Gottlieb is a member of the National Academy of Medicine and is a Contributor to the financial news network, CNBC. Director Illumina, Inc., Director of Aetion, Inc. a private healthcare data technology company and Tempus, a private technology company. Pfizer Director since 2019. Chair of our Regulatory and Compliance Committee and Member of our Science and Technology Committee.

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February 19, 2021 5:00 AM ET by Richard Harris

Tens of thousands of people who volunteered to be in studies of the Pfizer-BioNTech and Moderna COVID-19 vaccines are still participating in follow-up research. But some key questions won’t be easily answered, because many people who had been in the placebo group have now opted to take the vaccine.

Even so, there’s valuable information to be had in the planned two-year follow-up studies. And that motivated Karen Mott, a 56-year-old job counselor who stuck with the continuing study.

“I’ve been taking prescription medicine for the last 25 years,” she says, referring to antiseizure drugs she takes. In order to show those drugs worked, people previously volunteered to take them when they were still experimental, “so I felt it was my way of giving back.”

Mott, who lives in the Overland Park, Kan., got a strong reaction to the second shot, so she correctly surmised she had received the Moderna vaccine, not the placebo. She was sad to read that one of the volunteers in the placebo group did die of COVID-19.

“I keep thinking about that. Why am I one of the lucky ones?” she says. “And I think that makes me feel like, I need to keep providing the information that we need.”

So, when the clinic called her in January and offered to reveal her actual vaccine status it was an easy call for her. She agreed to keep participating in the two-year follow-up study.

Participants provide periodic nose swabs and saliva samples, to see if they’ve been infected. They also give blood so scientists can better understand how the vaccine is providing protection.

Mott was one of about 650 volunteers who took the experimental Moderna vaccine at a company called Johnson County Clinical Trials in Lenexa, Kan. Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.

“It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots.

Dr. Steven Goodman, a clinical trials specialist at Stanford University, says losing those control groups makes it more difficult to answer some important questions about COVID-19 vaccines.

“We don’t know how long protections lasts,” he says. “We don’t know efficacy against variants — for which we definitely need a good control arm — and we also don’t know if there are any differences in any of these parameters by age or race or infirmity.”

Scientists may be able to infer some of this, for example if it becomes evident that vaccinated people commonly fall ill after exposure to virus variants. Further safety information is also being collected by the Centers for Disease Control and Prevention, as well as the FDA, based on the experience of millions of people who have now taken the shots.

But clinical trials that include a placebo group are the surest and most definitive ways to gather information about vaccine effectiveness. “I think over time we’ll get that data,” Fierro says, even without a placebo group.

Scientists have already collected data from the vaccine studies that could help them identify how individuals’ immune systems have responded to vaccination. That could eventually let them identify immune system features, called correlates of protection, that could strongly indicate vaccine effectiveness.

But because the best evidence comes from a controlled study, Goodman is thinking about how those could be conducted ethically, now that there are effective vaccines available.

One option is to identify people who are in groups that are not currently eligible for a vaccine, as is happening now with children. Another option is to conduct studies in other parts of the world, where vaccines simply aren’t available. But that raises ethical issues, as well: Why not provide those countries vaccine, rather than recruiting them for a study?

“But the fact is we do have an unfair world and there are inequities in global health and financing,” Goodman says. So, offering people a chance to participate in a study could be ethical. “The countries themselves may demand it,” he says, as they work to understand the risks that virus variants pose to their populations.

Another option is to run a study in which all participants get vaccinated, but not right away. After two months, for example, people would get a second treatment – either the real vaccine if they originally got the placebo, or vice versa. One key here, Goodman says, is that nobody should know which was which. That way people wouldn’t change their behavior, which itself could influence the outcome of a trial because people who know they are vaccinated might take greater risks.

The appearance of virus variants “may really scramble things up because there may be certain variants where the efficacy of all vaccines might be so low that we’re basically back to zero,” Goodman says. “We might have to go back to placebo-controlled trials. It’s hard to know.”

That’s the worse-case scenario. The vaccines currently in use in the United States seem to work well against the variant first seen in the United Kingdom and appear to offer at least partial protection from the variant identified first in South Africa, but more evasive new variants could emerge in the months and years to come.

Fierro sees another possibility. Perhaps in a year or two the existing vaccines will have proven so effective that COVID-19 becomes not much more than a nuisance. Under those circumstances, the risk of participating in a study that has a placebo option would be low enough to be acceptable, say, for young people who have not yet been vaccinated.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.

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OUR NEGATIVE REACTIONS
NEED POSITIVE ACTIONS.

“WHO WE ARE:

• We are a large and ever growing group of Americans who were previously healthy and have been seriously injured by the COVID vaccines (Pfizer, Moderna, J&J as well as Astra Zeneca in the clinical trial stage in the United States).

• We are pro-vaccine, pro-science and were excited for the opportunity to be vaccinated and to do our part in helping to end the pandemic.

• We are completely independent of any other organization.”

Full Article

By Meredith Wadman Aug. 16, 2021 , 6:55 PM

…

“His message was meant for his fellow Israelis, but it is a warning to the world. Israel has among the world’s highest levels of vaccination for COVID-19, with 78% of those 12 and older fully vaccinated, the vast majority with the Pfizer vaccine. Yet the country is now logging one of the world’s highest infection rates, with nearly 650 new cases daily per million people. More than half are in fully vaccinated people, underscoring the extraordinary transmissibility of the Delta variant and stoking concerns that the benefits of vaccination ebb over time.”

…

“What is clear is that “breakthrough” cases are not the rare events the term implies. As of 15 August, 514 Israelis were hospitalized with severe or critical COVID-19, a 31% increase from just 4 days earlier. Of the 514, 59% were fully vaccinated. Of the vaccinated, 87% were 60 or older. “There are so many breakthrough infections that they dominate and most of the hospitalized patients are actually vaccinated,” says Uri Shalit, a bioinformatician at the Israel Institute of Technology (Technion) who has consulted on COVID-19 for the government. “One of the big stories from Israel [is]: ‘Vaccines work, but not well enough.’”

Aran’s message for the United States and other wealthier nations considering boosters is stark: “Do not think that the boosters are the solution.”

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PUBLISHED TUE, JUL 6 202112:16 PM EDTUPDATED TUE, JUL 6 20211:30 PM EDT
Greg Iacurci

KEY POINTS

• The Federal Emergency Management Agency loosened rules for a program that reimburses funeral costs of up to $9,000 per death linked to Covid-19. 
• Early in the pandemic, death certificates may not have listed the coronavirus as a cause of death due to limited availability of testing and less knowledge about the virus.
• FEMA’s tweak offers funds to families in some cases without having a death certificate amended.

The Biden administration made it easier for many families to qualify for aid toward funeral costs after loosening rules for a Covid-era program.

The Federal Emergency Management Agency, which administers the program, changed its funeral-assistance policy related to deaths that occurred in the early months of the pandemic.

Applicants for funeral assistance — up to $9,000 per deceased person and $35,500 per application — initially had to provide a death certificate listing Covid-19 as the cause of death.

But early on, death certificates may not have cited the virus. Testing wasn’t as widespread and the coronavirus wasn’t as well understood by the medical community, for example. Many families may have been denied as a result.

FEMA’s tweak offers reimbursement if applicants submit a statement or letter from the death certificate’s certifying official, medical examiner, or coroner that attributes the death to Covid-19, according to the agency.

The change applies to deaths between Jan. 20 and May 16 last year.

The new policy offers flexibility to attribute a death to Covid without amending the death certificate, according to FEMA. It also covers the period before the Centers for Disease Control and Prevention published death-certificate guidance in the spring of 2020, the agency said.

Individuals must still submit a death certificate linking the fatality to Covid-19 for deaths occurring after May 16.

Program funds can reimburse costs associated with funeral services, cremation, a casket or urn, burial plot, marker or headstone, and transportation for up to two people to identify the deceased individual, for example.

The program has $2 billion of total funding and opened to applicants in April.

Since then, more than 78,000 applicants have received $525 million in assistance, according to FEMA. More than 605,000 people have died from Covid-19, according to Johns Hopkins University data.

Scammers targeted the program early on, when there was a high volume of applicants. Criminals posed as government agents who offered to register applicants for assistance, but instead tried to steal money or sensitive personal information, according to the Federal Trade Commission.

Video below not a part of original original article.

Hujoel PP, Bollen AM, Noonan CJ, del Aguila MA. Antepartum dental radiography and infant low birth weight. JAMA. 2004 Apr 28;291(16):1987-93. doi: 10.1001/jama.291.16.1987. PMID: 15113817.

Context: Both high- and low-dose radiation exposures in women have been associated with low-birth-weight offspring. It is unclear if radiation affects the hypothalamus-pituitary-thyroid axis and thereby indirectly birth weight, or if the radiation directly affects the reproductive organs.

Objective: To investigate whether antepartum dental radiography is associated with low-birth-weight offspring.

Design: A population-based case-control study.

Participants and setting: Enrollees of a dental insurance plan with live singleton births in Washington State between January 1993 and December 2000. Cases were 1117 women with low-birth-weight infants (<2500 g), of whom 336 were term low-birth-weight infants (1501-2499 g and gestation > or =37 weeks). Four control pregnancies resulting in normal-birth-weight infants (> or =2500 g) were randomly selected for each case (n = 4468).

Main outcome measures: Odds of low birth weight and term low birth weight by dental radiographic dose during gestation.

Results: An exposure higher than 0.4 milligray (mGy) during gestation occurred in 21 (1.9%) mothers of low-birth-weight infants and, when compared with women who had no known dental radiography, was associated with an adjusted odds ratio (OR) for a low-birth-weight infant of 2.27 (95% confidence interval [CI], 1.11-4.66, P =.03). Exposure higher than 0.4 mGy occurred in 10 (3%) term low-birth-weight pregnancies and was associated with an adjusted OR for a term low-birth-weight infant of 3.61 (95% CI, 1.46-8.92, P =.005).

Conclusion: Dental radiography during pregnancy is associated with low birth weight, specifically with term low birth weight.

Hwang SY, Choi ES, Kim YS, Gim BE, Ha M, Kim HY. Health effects from exposure to dental diagnostic X-ray. Environ Health Toxicol. 2018 Dec;33(4):e2018017. doi: 10.5620/eht.e2018017. Epub 2018 Nov 21. PMID: 30661338; PMCID: PMC6341170.

The purpose of this review is to summarize the results of studies on of the association between exposure to dental X-rays and health risk. To perform the systematic review, We searched the PUBMED, EMBASE, and MEDLINE databases for papers published before December 15, 2016. A total of 2 158 studies, excluding duplicate studies, were found. Two reviewers independently evaluated the eligibility of each study. The final 21 studies were selected after application of exclusion criteria. In terms of health outcomes, there were 10 studies about brain tumors, 5 about thyroid cancer, 3 about tumors of head and neck areas, and 3 related to systemic health. In brain tumor studies, the association between dental X-ray exposure and meningioma was statistically significant in 5 of the 7 studies. In 4 of the 5 thyroid-related studies, there was a significant correlation with dental diagnostic X-rays. In studies on head and neck areas, tumors included laryngeal, parotid gland, and salivary gland cancers. There was also a statistically significant correlation between full-mouth X-rays and salivary gland cancer, but not parotid gland cancer. Health outcomes such as leukemia, low birth weight, cataracts, and thumb carcinomas were also reported. In a few studies examining health effects related to dental X-ray exposure, possibly increased risks of meningioma and thyroid cancer were suggested. More studies with a large population and prospective design are needed to elaborate these associations further.

Preston-Martin S, Thomas DC, White SC, Cohen D. Prior exposure to medical and dental x-rays related to tumors of the parotid gland. J Natl Cancer Inst. 1988 Aug 17;80(12):943-9. doi: 10.1093/jnci/80.12.943. PMID: 3398070.

Findings from this population-based study in Los Angeles County suggest, for the first time, that tumors of the parotid gland are related to prior exposure to diagnostic medical and dental radiography. Responses to interviews with 408 patients with a parotid tumor (269 benign tumors and 139 malignant tumors) were compared to responses of 408 neighborhood controls. Cumulative exposure of the parotid gland from diagnostic radiography was associated with a dose-related increase in risk of malignant tumors (P for trend less than .05; relative risk for exposure to greater than or equal to 50 rad = 3.4; 95% confidence interval = 1.02-11.46). Benign tumors showed a weaker positive association, and exposure before age 20 to a major diagnostic examination (full-mouth or panoramic dental radiography or medical radiography to the head) increased risk (relative risk = 1.8; confidence interval = 1.13-2.91). This study also confirmed the association of malignant tumors with prior radiation treatment to the head or neck; 28% of these tumors are attributable to exposure of the parotid gland from diagnostic and therapeutic radiation.

Memon A, Godward S, Williams D, Siddique I, Al-Saleh K. Dental x-rays and the risk of thyroid cancer: a case-control study. Acta Oncol. 2010 May;49(4):447-53. doi: 10.3109/02841861003705778. PMID: 20397774.

The thyroid gland is highly susceptible to radiation carcinogenesis and exposure to high-dose ionising radiation is the only established cause of thyroid cancer. Dental radiography, a common source of low-dose diagnostic radiation exposure in the general population, is often overlooked as a radiation hazard to the gland and may be associated with the risk of thyroid cancer. An increased risk of thyroid cancer has been reported in dentists, dental assistants, and x-ray workers; and exposure to dental x-rays has been associated with an increased risk of meningiomas and salivary tumours.

Methods: To examine whether exposure to dental x-rays was associated with the risk of thyroid cancer, we conducted a population-based case-control interview study among 313 patients with thyroid cancer and a similar number of individually matched (year of birth +/- three years, gender, nationality, district of residence) control subjects in Kuwait.

Results: Conditional logistic regression analysis, adjusted for other upper-body x-rays, showed that exposure to dental x-rays was significantly associated with an increased risk of thyroid cancer (odds ratio = 2.1, 95% confidence interval: 1.4, 3.1) (p=0.001) with a dose-response pattern (p for trend <0.0001). The association did not vary appreciably by age, gender, nationality, level of education, or parity.

Discussion: These findings, based on self-report by cases/controls, provide some support to the hypothesis that exposure to dental x-rays, particularly multiple exposures, may be associated with an increased risk of thyroid cancer; and warrant further study in settings where historical dental x-ray records may be available.