Category: Covid-19 Vaccine

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The largest COVID vaccine study to date has identified some risks associated with the shot.

Researchers from the Global Vaccine Data Network (GVDN) in New Zealand analyzed 99 million people who received COVID vaccinations across eight countries.

They monitored for increases in 13 different medical conditions in the period after people received a COVID vaccine.

The study, which was published in the journal Vaccine last week, found that the vaccine was linked to a slight increase in neurological, blood and heart-related medical conditions, according to a press release from GVDN.

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People who received certain types of mRNA vaccines were found to have a higher risk of myocarditis, which is inflammation of the heart muscle.

Some viral-vector vaccines were linked to a higher risk of blood clots in the brain, as well as an increased likelihood of Guillain-Barre syndrome, a neurological disorder in which the immune system attacks the nerves.

Researchers from the Global Vaccine Data Network in New Zealand analyzed 99 million people who received COVID vaccinations across eight countries. (iStock)

Other potential risks included inflammation of part of the spinal cord after viral vector vaccines, and inflammation and swelling in the brain and spinal cord after viral vector and mRNA vaccines, the press release stated.

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"The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals," lead author Kristna Faksov of the Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark, said in the release.

"Single sites or regions are unlikely to have a large enough population to detect very rare signals."

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, was not involved in the research but commented on the findings.

More than 80% of the U.S. population has received at least one dose of the COVID vaccine, per the CDC. (iStock)

"The massive study and review of the data reveals some rare association of the MRNA vaccines and myocarditis, especially after the second shot, as well as an association between the Oxford Astra Zeneca adenovirus vector vaccines and Guillain Barre syndrome," he told Fox News Digital.

"But these risks are rare," he added, "and other studies show that the vaccine decreases the risk of myocarditis from COVID itself dramatically."

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Siegel noted that all vaccines have side effects.

"It always comes down to a risk/benefit analysis of what you are more afraid of the vaccine's side effects or the virus itself, which can have long-term side effects in terms of brain fog, fatigue, cough and also heart issues," he said.

"Denying or exaggerating a vaccine's side effects is not good science nor is underestimating the risks of the virus, especially in high-risk groups," Siegel added.

"It comes down to a risk/benefit analysis of what you are more afraid of the vaccine's side effects or the virus itself."

The key is for doctors and their patients to carefully weigh the risks and benefits, the doctor emphasized.

"This study does not really change anything; it just provides much further evidence of what we already know," he said.

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Dr. Jacob Glanville, CEO of Centivax, a San Francisco biotechnology company, also reacted to the studys findings.

"This study is confirming in a much larger cohort what has been previously identified in the original studies during the pandemic myocarditis and pericarditis as a rare side effect of mRNA vaccines and clots as a rare side effect of the viral vectored vaccines," he told Fox News Digital.

Finley Martin, 14, is seen getting a shot of the Pfizer COVID-19 vaccine at the First Baptist Church of Pasadena, May 14, 2021, in Pasadena, California. (AP Photo/Marcio Jose Sanchez, File)

"The odds of all of these adverse events are still much, much higher when infected with SARS-CoV-2 (COVID-19), so getting vaccinated is still by far the safer choice."

This study was part of a more widespread research initiative, the Global COVID Vaccine Safety (GCoVS) Project.

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The project is supported by Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS).

More than 80% of the U.S. population has received at least one dose of the COVID vaccine, per the CDC.

Fox News Digital reached out to Pfizer and Moderna, makers of mRNA COVID vaccines, for comment.

For more Health articles, visit http://www.foxnews.com/health.

Link:

Largest-ever COVID vaccine study links shot to small increase in heart and brain conditions - Fox News

CDC guidelines still recommend isolating for five days. People should also wear a high-quality mask if they have to be around others in their home.

PORTLAND, Ore. As the Centers for Disease Control and Prevention (CDC) eyes easing its five-day isolation policy for those who test positive for COVID-19, the Oregon Health Authority (OHA) had already adopted that practice in May 2023.

The OHA's policy is that someone with COVID-19 doesnt need to stay home for five days.

"Were seeing a lot less severe disease than we had early on in the pandemic, given the amount of people who are vaccinated already, have recovered from COVID-19 or both and had some level of immunity," said Dr. Dean Sidelinger, Oregon's state epidemiologist. "So that is what contributed to our decision back in May."

OHA recommends people now look at symptoms to determine when it is time to stop isolating. With the new approach, the agency said people don't need to stay home if they are fever-free for 24 hours without medication and have mild or improving symptoms.

"COVID can be unpredictable, but so far, we are seeing a slow steady decline," Sidelinger said. "Our vaccines work to protect people from the variants that have emerged over the past couple of years. COVID is coming down, influenza is coming down and RSV is coming down."

As of February, emergency room visits, hospitalizations and deaths from COVID-19 are down, according to the latest CDC data.

To keep this immunity up, OHA said it is important for people to stay up to date on vaccinations, especially when it comes to kids in school.

On Saturday, Multnomah County held a free catch-up clinic for children still needing their immunizations at David Douglas High School. If they dont meet this requirement by Feb. 21, they will be turned away from all schools or daycares.

"We want to make sure that our communities are protected," said Richard Bruno, the Multnomah County Public Health Officer. "We want to have very low-barrier access to vaccines that are needed. We dont check for insurance and have a great supply of vaccines available for anybody who needs it."

For parents who missed Saturday's clinic, they still have another chance to get their children up to date on vaccines. On Feb. 21, Multnomah County will hold its final immunization clinic with CareOregon Boys & Girls Club in Rockwood from 8:30 a.m. to noon.

Meanwhile, the CDC is still recommending that people who test positive for COVID-19 stay home for at least five days and isolate themselves from others in their home. People should also wear a high-quality mask if they have to be around others in their home during the isolation period, according to current guidelines.

See the article here:

Oregon Health Authority on isolating for 5 days with COVID-19 - KGW.com

The COVID-19 vaccine is still relatively new, and researchers are still interested in studying how to maximize its effectiveness.

Typically, people receive the COVID-19 vaccine in the upper arm, which has multidose options. Multidose vaccines can be received in the same or different injection site for each dose. Other examples of multidose vaccines include those for measles mumps and rubella (MMR) and shingles.

A recent study published in The Journal of Clinical Investigation examined whether switching arms for two doses of the Pfizer BioNTech COVID-19 vaccine increased effectiveness.

Participants who switched arms for vaccine doses experienced a higher antibody response than those who received doses in the same arm.

The results showed this response increased over time in the subsequent follow-up visits.

These results point to a simple way to increase vaccine effectiveness. Future research could explore whether switching injection sites for other multidose vaccines could help improve immunity.

COVID-19 vaccination has effectively slowed infection rates and helped reduced severe illness.

The two main COVID-19 vaccines are both mRNA vaccines produced by Pfizer and Moderna.

Current recommendations from the Centers for Disease Control and Prevention (CDC) involve single doses of the Moderna or Pfizer-BioNTech vaccines for people who are not immunocompromised. However, multiple doses are still recommended for people who are immunocompromised.

Previously, other individuals received two doses of the Pfizer-BioNTech vaccine. Researchers of the current study wanted to see if the immune response produced by the Pfizer-BioNTech vaccine differed based on whether or not participants received doses in the same arm or the opposite arm from their initial dose. Study authors note there hasnt been a lot of research conducted in this area.

Researchers included participants from the OHSU COVID-19 Serology study, including almost 950 adults in their analysis. A total of 507 participants received at least two doses in the same arm, and 440 received at least two doses in opposite arms.

Researchers also looked at antibody response in a subgroup of matched pairs, with each pair having similar age, gender, vaccination, and time intervals between blood sample testing.

They were able to follow up on immune response among participants for up to 14 months after boosting.

Overall, researchers found that the group receiving vaccination doses one and two in opposite arms had a better immune response than those receiving doses in the same arm.

They saw higher levels of SARS-CoV-2 specific serum antibodies. They observed this difference more with later immunity testing than with earlier testing.

Study author Dr. Marcel E. Curlin, associate professor of medicine in the division of infectious diseases at the Oregon Health and Sciences University and the medical director for occupational health at OHSU, noted the following to Medical News Today:

In the context of first-time receipt of a 2-dose vaccine regimen, antigenspecific antibody levels resulting from vaccination are higher when giving the second dose in the contralateral arm relative to the first dose. This effect is durable, lasting more than a year after boosting. Contralateral vaccination also results in a broader immune response to challenges slightly different from the original vaccine (for example, to a variant of the original virus). We do not yet understand why this happens, but it is likely related to formation of memory and multiple rather than individual lymphoid centers.

Non-study author Dr. Arturo Casadevall, PhD, a microbiology and immunology expert with Johns Hopkins Medicine, told MNT the study data are strong.

The finding that contralateral arm vaccination results in higher antibody responses suggests that the simple intervention of switching arms during initial vaccination and boosting could produce stronger immunity and perhaps longer lasting protection, he shared.

This is an example of simple medical research with potentially high benefits for the individual and for public health.

Despite the promising implications the new research does have certain limitations.

First, researchers acknowledge the potential bias that could have occurred, though they believe this cannot account for all the results seen. Second, this study looked at a specific type of vaccination among adults and did not examine alternative immunization routes, so the results may not apply or be significant for other areas.

Researchers also did not look at cellular immunity when looking at potential protection from severe illness.

In addition, the cohort was comprised of healthcare workers, a specific population, so more research could also include more individuals in other fields.

Only 23% of participants were male, so its also possible for future research to include more gender balance. There was also a limitation based on how many participants completed all follow-up appointments.

Non-study author Jessica Smith Schwind, PhD, MPH, director at the Institute for Health Logistics & Analytics and associate professor of Epidemiology, Georgia Southern University, said from an epidemiologic perspective, the study has the potential to influence standard practice, but shared a word of caution:

However, a randomized study will be the gold standard to determine if a contralateral administration of the vaccine series would be most beneficial (and to what extent) for mRNA COVID-19 vaccinations. Also, it is important to keep in mind that immunologic response is a multi-faceted, complex process that can be measured in different ways. This study only measured antibody titers, which is only one component that influences a persons overall immune response to a pathogen.

Future research could focus on verifying these initial findings and expanding the data collection, such as looking at additional time points after vaccination.

At a basic science level the observation raises new questions for immunological research since it is difficult to explain how this effect occurs based on current understanding of how immune responses develop, Dr. Casadevall said.

I think the next step would be to carry out a prospective randomized controlled trial to determine if the effect holds. If the findings are replicated, I can imagine that this could lead to changes in clinical practice for how vaccines are administered and would stimulate new basic science research to understand the immunological mechanisms involved, Dr. Casadevall noted.

This research opens the door for future research into maximizing vaccine effectiveness.

We can probably derive greater levels of protection elicited by vaccines, based on the way we provide vaccination, Prof. Curlin noted.

Improved protection would likely be in the form of some degree of decrease in disease severity, particularly those with comorbid illness who are likely susceptible to severe disease.

One area for future research is looking into how switching vaccination sites may apply to other multidose vaccines. For example, the boost in immunity seen in this study may hold true for other multidose vaccines and increase their overall effectiveness.

Researchers note that future research can include pediatric data, as many of these multidose vaccines are usually part of child vaccination regimens.

Professor Curlin noted the potential benefits of this line of research in the future:

This effect, if generalized, could change the way we administer certain vaccine regimens, particularly in children. This effect could [also] have an impact on vaccines in development, particularly those with efficacy near threshold cutoffs for viable vaccine products. [However], it is important to remember that this issue requires additional study to help us better understand the mechanism for this effect and its generalizability to other vaccines.

See more here:

Could alternating arms for multidose vaccines boost your immunity? - Medical News Today

A new COVID-19 vaccine study published last week linked the vaccine with an increased risk of heart, brain, and blood-related medical disorders.

The new study, which is the largest COVID-19 vaccine study to date, was conducted by the Global Vaccine Data Network (GVDN) in New Zealand and analyzed 99 million individuals who received COVID-19 vaccinations in eight different countries. The study monitored 13 different potential medical conditions in the individuals after they received a COVID-19 vaccination.

GVDN researchers concluded that the COVID-19 vaccine was linked to a small increase in heart, blood, and brain disorders. For example, some of the individuals who received mRNA vaccines had an increased risk of myocarditis, which is an inflammation of the heart muscle, while some individuals who received viral-vector vaccines had an increased risk of blood clots in the brain and an increased risk of Guillain-Barre syndrome, which is a brain disorder that causes the immune system to attack the bodys nerves.

The GVDN study also linked increased risks of spinal cord inflammation to viral vector vaccines and increased risks of swelling and inflammation in both the brain and spinal cord to mRNA and viral vector vaccines.

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According to the Centers for Disease Control and Prevention, 81.4% of the U.S. population has had at least one COVID-19 vaccine. Unlike other vaccine studies, the GVDN study was able to identify potential vaccine safety signals due to the large sample size of the data.

The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals, said Kristna Faksov of the Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark, the lead author of the report. Single sites or regions are unlikely to have a large enough population to detect very rare signals.

Following the publication of the link between COVID-19 vaccines and heart, brain, and blood disorders, Dr. Marc Siegel, an NYU Langone Medical Center clinical professor of medicine, emphasized to Fox News that all vaccines have the potential for side effects.

It always comes down to a risk/benefit analysis of what you are more afraid of the vaccines side effects or the virus itself, which can have long-term side effects in terms of brain fog, fatigue, cough and alsoheart issues, he said.

Link:

Covid vaccine linked to heart and brain disorders, study shows - American Military News

Trust in public health agencies declined during the COVID-19 pandemic, as misinformation about vaccines and the virus proliferated on social media. But did the public health agencies themselves also play a role in the decline of their credibility?

Paul Offit had a front-row seat to federal public health agencies pandemic response. A pediatrician and vaccine developer from the Childrens Hospital of Philadelphia, Offit is a member of the FDAs vaccine advisory committee, which played a critical role in reviewing COVID vaccine research and advising the FDA on vaccine safety.

READ MORE: Paul Offit, Phillys most vocal vaccine advocate, on science, truth, and why hes not a fan of the latest COVID boosters

In his new book, Tell Me When Its Over: An Insiders Guide to Deciphering Covid Myths and Navigating Our Post-Pandemic World, Offit chronicles the first years of the pandemic, explains the science of COVID, and traces the rise of anti-vaccine movement and misinformation. He also blames those charged with protecting the nations health of taking action against evidence and in doing so undermining public trust.

He says public health agencies made mistakes in key moments, such as when the FDA fast tracked in 2020 the authorization of an antimalaria drug with risk of fatal heart side effects that didnt work against COVID. At the time, President Donald Trump called the medication a game changer and promoted it as a COVID treatment. The FDA revoked the authorization a few months later.

People lost faith in the FDA, Offit said. People saw that you could twist the FDAs arm.

The Inquirer spoke to Offit about his new book, and what steps public health agencies can take to reclaim the publics trust.

The pandemic saw significant scientific advancement. Scientists were able to produce a safe and effective vaccine to protect against a new virus within a year a feat that can take more than 10 years. Offit called the vaccine the greatest medical achievement in his lifetime.

At the same time, more people grew suspicious of vaccines, and their mistrust continued to grow through last fall, according to surveys by the Annenberg Public Policy Center at the University of Pennsylvania. In the centers most recent survey, 71% agreed that vaccines approved in the U.S. are safe, down from 77% in April 2021.

The way public health agencies and elected officials communicated also contributed to the publics loss of faith, Offit said.

He criticized the response to a July 4, 2021, celebration in Provincetown, Mass. After thousands of people attended the event, nearly 350 fully vaccinated men were among those who developed COVID. Only four of those vaccinated were hospitalized, and the rest developed mild or no symptoms.

Offit saw a success: the vaccines were working.

But the Centers for Disease Control and Prevention used the term breakthrough infection to describe the incident, a phrasing choice that Offit said implied failure to offer protection.

READ MORE: Pandemic-era misinformation erodes confidence in all vaccines, Penn researchers find in new survey

Another mixed message came in August 2021: President Joe Biden promoted booster shots for American adults even though boosters had not been approved by the FDA yet.

A month later, the FDA advisory committee overwhelmingly voted against the recommendation to offer boosters to people under age 65, because there wasnt enough evidence at the time that an extra dose would improve protection to people of all ages.

The conflicting messages added to public distrust, Offit said.

The FDA began expanding the eligibility for boosters in Nov. 2021, and currently recommends that everyone over age 6 months receive an extra shoot.

Neither the FDA nor the CDC responded to request for comment about Offits criticism. A spokesperson for the FDA shared a statement saying the agency stands by the safety and effectiveness of the COVID vaccines.

Rebuilding trust in public health agencies wont be easy, Offit said. But he has some ideas for how to move forward.

Science and knowledge are always evolving, which means the best advice experts can offer may change. Public health agencies shouldnt shy away from that fact and should do more to explain the scientific process, Offit said.

READ MORE: How many workers in Philadelphia-area hospitals are unvaccinated against COVID-19 or flu? Check your local hospital.

You have to trust the American public to at least tell them the truth, he said. Its OK to make your best guess and get it wrong, but say that.

Offit also wants to see public health agencies more aggressively responding to anti-vaccination claims and other misinformation. When misinformation is spread, public health agencies should spend resources on campaigns disputing the claims with science.

People who advocate against vaccines harm children, he said, pointing to the recent measles outbreaks in the U.S, and he wants public health agencies to portray them as such.

Hammer back, Offit said.

Link:

Paul Offit looks back on COVID-19, misinformation, and how public health lost the public's trust in new book - The Philadelphia Inquirer

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COVID-19: Eased isolation periods, free vaccinations and tests and more - The News Journal

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Assessment of Female Hormonal Influence on COVID-19 Vaccine Response: A Prospective Cohort Study - Cureus

Babies born to women who received a course of mRNA-based COVID-19 vaccinations or a booster dose during pregnancy are protected against symptomatic COVID-19 infection for at least six months, data suggests.

COVID-19 is especially dangerous for newborns and young infants, yet they are unable to be vaccinated until they are at least six months old. While previous research had suggested that protective antibodies could transfer across the placenta in women who had been vaccinated, it was unclear how strong and long the protection they afforded might last in their infants, and what the impact of a booster dose might be.

To investigate, Cristina V. Cardemil at the National Institute of Allergy and Infectious Diseases in Rockville, US, and colleagues followed 271 infants born to mothers who received two doses of a messenger RNA (mRNA) COVID-19 vaccine during pregnancy, and 204 further infants whose mothers received these, plus a third booster dose.

As well as analysing samples of the babies' cord blood at birth, the researchers evaluated the infants during at least one follow-up visit during their first six months of life. Their parents also reported whether they had become infected with COVID-19 or exhibited any symptoms.

The research, published in Pediatrics, found that newborns with high antibody levels at birth also had greater protection against COVID-19 infection during their first six months. And while the infants of mothers who received two vaccine doses had strong antibody responses at birth, those whose mothers had received an additional booster dose during pregnancy had both higher levels of antibodies at birth and greater protection from COVID-19 infection at their follow-up visits.

The study reinforces the importance of receiving both a COVID-19 vaccine and booster during pregnancy for both mothers and their babies. It follows separate evidence published earlier this month confirming that babies whose mothers were vaccinated against COVID-19 during pregnancy are at no greater risk of adverse events and may be at lower risk of death and severe complications during birth.

In contrast to the first two years of the pandemic when the burden of disease was highest in adults, hospitalisation rates in infants under six months of age have surged during the Omicron period and are currently on par with those of adults aged 65 to 74, Cardemil said.

"Among infants who are hospitalised with COVID-19, more than half are previously healthy without underlying comorbidities," she added.

"Maternal booster vaccination during pregnancy is an effective strategy that provides [antibodies] that protect effectively against infection during early infancy."

Read more here:

COVID-19 vaccination in pregnancy protects newborns for up to six months - Gavi, the Vaccine Alliance

WASHINGTON The Select Subcommittee on the Coronavirus Pandemic held a hearing titled Assessing Americas Vaccine Safety Systems, Part 1 to examine the effectiveness of vaccine safety reporting and injury compensation systems following the rollout of the COVID-19 vaccine. Biden Administration officials from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Health Resources and Services Administration (HRSA) all testified that Americas vaccine injury and compensation systems have serious deficiencies related to inadequate staffing, lackluster surveillance, and overlapping programs. Select Subcommittee Members pointed out the false narrative about the efficacy of the COVID-19 vaccine and pressed witnesses to explain potentially politically motivated decision making during the pandemic. This hearing served as part one of a two-part series. The second hearing will emphasize the importance of the doctor-patient relationship in order to obtain public trust in vaccines during a future public health crisis.

Key Takeaways

The Biden Administration mandated the COVID-19 vaccine without a sufficient system in place to compensate individuals injured by the policy.

HRSA Director at the Division of Injury Compensation Programs CDR George Reed Grimes: At the beginning of the COVID 19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff.

The FDA accelerated the COVID-19 vaccine approval process to seemingly meet arbitrary mandate timelines set by the Biden Administration.

Executive branch officials from the CDC and FDA agree that the federal government can never guarantee a vaccine is 100% safe.

Chairman Wenstrup: Is any pharmaceutical 100% safe?

FDA Director at the Center for Biologics Evaluation and Research, Dr. Peter Marks: No pharmaceutical is 100% safe.

CDC Director at the National Center for Emerging and Zoonotic Infectious Diseases, Dr. Daniel Jernigan: No medical intervention is risk-free.

CDR Grimes: Theres a reason we have a compensation program, and were dedicated to diligently carrying that out. I cant say it any better than my colleagues sitting next to me have.

Vaccine injury reporting and compensation systems were not prepared to handle the avalanche of injury claims caused by the COVID-19 vaccine.

Dr. Peter Marks: We tried to be prepared for that, but the avalanche of reports was tremendous. It, again, required re-tasking people on the flyWe had to usually staff up and had many meetings working to increase our ability to go through these reports.

Shortcomings in vaccine injury reporting and vaccine compensation systems, as well as ineffective government messaging during the pandemic, deteriorated public trust in vaccine safety.

Dr. Peter Marks: We probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus whats in VAERS.

Member Highlights

Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-Ohio), D.P.M, argued that advancing an accurate narrative about the COVID-19 vaccine through doctor-patient relationships during the pandemic would have decreased misinformation and disinformation.

Chairman Wenstrup: I want everyone to understand, especially those serving on the government side that the public perception becomes reality. And because of that, words matter. Words matter that are coming out, you know. For those of us as Members of Congress or as physicians at home, were face to face with people. We are sitting face to face with somebody. Were not just looking at data on a sheet and making decisions. It needs to be done, what youre doing, but theres a difference and thats why I say words matter. Let me give you an example. When you say safe and effective, thats relative in your mind. Its relative in your mind, but its not to the person at home. They hear 100% safe and 100% effective. Thats what they hear. This is why words matter. Dr. Fauci, in his testimony, even said, you can never say that any treatment is 100% safe. Yet, in essence, thats what people heard and are still hearing today. Weve got to change that because the doctor on the ground or the Member of Congress on the ground is one on one with somebody and explains that to them.

Let me tell you, Im grateful we live in a country that has these systems (vaccine injury reporting and compensation systems) in place because theyre there to protect the American people and to provide for better health in America. But theres ways we can do better.

Committee on Oversight and Accountability Chairman James Comer (R-Ky.) pressed FDA Director Dr. Peter Marks to admit he ignored warnings from his colleagues about the dangers of accelerating the COVID-19 vaccine approval process. Chairman Comer further noted that the timing of the Biden Administrations vaccine mandate and the FDAs rushed approval of the vaccine appear to correlate.

Chairman Comer: Why were you pressuring the doctors and then removing them from the approval process when they disagreed?

Dr. Marks: The approval process was one that needed to move as rapidly as possible.

Chairman Comer: Do you recall any conversations regarding the need to approve the vaccines in order for it to then be mandated?

Dr. Marks: There was an acknowledgment that an approval could allow vaccine mandates to occur.

Chairman Comer: So, Dr. Gruber wrote that you and Dr. Woodcock expressed your opinion that absent a license, states cannot require mandatory vaccination. Do you recall this conversation?

Dr. Marks: I dont know what youre what youre referring to, but theres probably, its just a statement of fact that once you have a license, vaccine and mandate could be placed.

Chairman Comer: Do you recall seeing safety signals regarding myocarditis in young men during this time?

Dr. Marks: There were yes. There were safety signals known and they were placed on the label.

Chairman Comer: Did you express your desire to approve the vaccine by August 20th?

Dr. Marks: I did.

Chairman Comer: And it was ultimately approved on August 23rd. Correct?

Dr. Marks: Correct.

Chairman Comer: And just for the record, the military mandate was issued on the 24th. And that is interesting timing.

Rep. Rich McCormick (R-Ga.), M.D., argued that the federal government wrongly inserted itself in the doctor patient relationship during the COVID-19 pandemic. This created a lack of trust between Americans and their public health system.

Rep. McCormick: When you insert yourself between a doctor and a patient, and some doctors contradict you and you censor them, even when youre not a doctor treating patients, people are going to say, why does the government have authority to do that, to censor my doctor? And then secondly, when you start requiring people to do something instead of encouraging the natural resistance of a freedom-loving people that were founded on those principles, will be to resist what youre requiring. So, it shouldnt be any surprise to us when the people say, Im not going to do what youre telling me I have to do when my doctor may agree with me and not you. Youre the government. Why do they insert themselves in inappropriate ways?

And really, when we talk about the evolution of science, when you have immunity and youre still requiring a vaccination that can cause a hyper-immune response, which were all scientists, we can admit to, theres risk versus benefit on every decision. When the government says were going to make a carte blanche requirement without taking science into account, its no wonder people are mistrustful of our recommendations.

Rep. Debbie Lesko (R-Ariz.) demanded FDA Director Dr. Peter Marks explain why the publicly reported data on vaccine injuries differs significantly from the confirmed death and injury count available to FDA officials.

Rep. Lesko: We spoke over the phone back on August 10th of 2021, and I was asking about VAERS because I had lots of constituents reaching out to me saying there were tons of adverse effects, there were thousands of deaths, etc., and they were very concerned. And I asked how many were confirmed. And at that time, you said four. There were four cases that you confirmed deaths that were caused by the vaccine. I suggested, at that time, that the CDC and FDA do a better job of telling the public not just how many cases were reported, but how many were actually confirmed. And just if I heard you right, just recently, you said, well, we dont want to give out too much information because of privacy rights. But certainly, we could put out how many were confirmed deaths, couldnt we?

Dr. Marks: I fully agree with you that we probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus whats in VAERS. In fact, we just nearly fell prey to it here at this hearing.

Rep. Lesko: It seems very logical to me that if youre saying the public shouldnt count on VAERS because anybody can report to that, which they can, why wouldnt you as actively report to the public well, we confirmed this really low number of cases that actually were caused by vaccines. I mean, its been years now. Why? Why havent you done it?

Dr. Marks: We did present that in various settings, including at, I believe, at the Advisory Committee on Immunization Practices. It was mentioned at our vaccine advisory committee. It perhaps did not go as broadly.

Rep. Mariannette Miller-Meeks (R-Iowa), M.D., uncovered evidence that the COVID-19 vaccine was mandated for healthy Americans and U.S. service members without a sufficient system in place to compensate those harmed by the coercive policy.

Rep. Mariannette Miller-Meeks: I understand that theres a current backlog of claims in CICP, by about more than 10,000. Why is there a backlog of claims for the COVID 19 vaccines?

CDR Grimes: At the beginning of the COVID 19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff. When we received our first direct appropriation in fiscal year 2022, we were able to ramp up quickly and now we have over 35 staff who are assisting to adjudicate claims.

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More:

Hearing Wrap Up: Americans Deserve Improved Vaccine Injury and Compensation Systems - United States House ... - House Committee on Oversight and...

The first COVID-19 vaccine candidate was administered during a clinical trial in March 2020, a triumph shared worldwide by all those working to overcome the deadly virus. A year later, there are almost 100 vaccines being tested in human trials, including new approaches to immunization whose development has been accelerated by the pandemic. Researchers are now working not just to prevent COVID-19 infections, but to prevent reinfection and address emerging variants as well.

Below, The Scientist rounds up those vaccine candidates that have advanced to clinical trials.

Editors note: The introduction of this story was updated on April 15, 2021.

DEVELOPER(S)

VACCINE METHOD

EVIDENCE

STATUS

Finlay Vaccine Institute/Pasteur...

DEVELOPER(S)

VACCINE METHOD

EVIDENCE

STATUS

Multiple organizations

International

The Bacille Calmette-Guerin (BCG) vaccine for tuberculosis consists of live attenuated Mycobacterium bovis.

Lower rates of COVID-19related deaths in countries with mandatory BCG vaccination prompted the launch of several clinical trials to test whether the immune response triggered by the vaccine may protect against SARS-CoV-2.

Several Phase 3 and 4 trials areunderway.

Multiple organizations

International

The measles-mumps-rubella (MMR) vaccine consists of live-attenuated strains of the three viruses.

Epidemiological data have revealed that places where the MMR vaccine is given as standard medical care have lower COVID-19 death rates than areas where MMR vaccination is not standard. Additionally, sailors aboard the U.S.S. Roosevelt who tested positive for COVID-19 had mostly mild symptoms, which some researchers suspect may have been due to administration of the MMR vaccine to all US Navy recruits.

A Phase 3 trial is underway in Egypt, led by researchers at Kasr El Aini Hospital. Separately, researchers at the Washington University School of Medicine are running an international Phase 3 trial of healthcare workers in the US, Canada, Europe, and Africa.

Immunovative Therapies, Mirror Biologics

US

An off-the-shelf living immune cell

The affiliated companies are currently testing the formulation as a therapeutic vaccine for chemotherapy-refractory metastatic cancers.

A Phase 1/2 trial for healthy older adults has been approved to begin in New York.

Canadian Cancer Trials Group, others

Canada

Heat-killed Mycobacterium obuense

The vaccine is intended to stimulate nonspecific innate immunity. The company is also testing the vaccine in clinical trials for cancer.

A Phase 3 trial has been approved to begin in Canada.

Bandim Health Project

Guinea-Bissau

Oral polio vaccine, an attenuated strain of the poliovirus

Researchers argue that the vaccine is safer and available in greater quantities than the BCG vaccine against tuberculosis, which is also being tested as a possible COVID-19 preventive.

A Phase 4 trial has been approved to begin in Guinea-Bissau in West Africa.

Inmunotek, BioClever

Mexico

A mixture of inactivated bacteria

The vaccine is intended to stimulate nonspecific innate immunity.

A Phase 3 trial for healthcare workers has been approved to begin in Mexico.

Pulmotect

US

An inhaled combination of two synthetic Toll-like receptor agonists

The vaccine was originally developed as a potential therapeutic for cancer and has undergone early stage clinical testing. In mice, it provided protection against a range of respiratory pathogens, including MERS and SARS.

A Phase 2 trial for people with known SARS-CoV-2 exposure is underway in several US states.

Corrections: An earlier versions of this table stated that Janssens adenovirus-based COVID-19 vaccine candidate is administered intranasally. In fact, the vaccine is administered via intramuscular injection. /An earlier version of this table stated that the Phase 1 and Phase 2 Moderna trials were taking place in Seattle. In fact, there have been multiple locations since the Phase 1. / Aprevious update to this table implied that the adverse event that caused the Phase 3 AstraZeneca trial to be put on hold occurred in the Phase 1/2 trial in the UK. In fact, the event occurred in a participant enrolled in the Phase 3 UK study./ A previous update to this table listed Switzerland as having given emergency use approval for the Pfizer/BioNTech COVID-19 vaccine. In fact, the country granted its full approval. /A previous version of this table indicated that UAE and Bahrain had given emergency approval for the Beijing Institute of Biological Productss COVID-19 vaccine; in fact, these countries have granted full approval. / A previous version of this table stated that Altimmunesvaccine was approved for a Phase 2 trial; in fact, it is approved for Phase 1. / A previous version of this table stated that China had approved the Sinopharm vaccine developed by Wuhan Institute of Biological Products in December 2020; in fact, that approval happened in February 2021.The Scientistregrets the errors.

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Track COVID-19 Vaccines Advancing Through Clinical Trials - The Scientist