NIH orders $1.67M study on how COVID-19 vaccine impacts menstrual cycle

Authors: By Hannah Sparks September 7, 2021

The National Institutes of Health has announced a $1.67 million study to investigate reports that suggest the COVID-19 vaccine may come with an unexpected impact on reproductive health.

It’s been a little over six months since the three COVID-19 vaccines in the US — Pfizer, Moderna and Johnson & Johnson — became widely available to all adults. But even in the early days of vaccine rollout, some women were noticing irregular periods following their shots, as reported first by the Lily in April.

Shana Clauson, 45, spoke to the Washington Post’s women’s news site at the time, and again this week, about her experience after getting the jab — revealing that her period arrived earlier and heavier than what she considers normal. She was one of many who gathered on social media to share what they were seeing.

“Is this not being discussed, or is it even being looked at or researched because it’s a ‘woman’s issue?’ ” Clauson speculated to the Lily last spring.

Women, those under 40 more likely to have side effects to COVID vaccine, expert says

It would appear that the NIH heard Clauson and others’ reports, as they announced on Aug. 30 that they intended to embark on just such research — aiming to incorporate up to half a million participants, including teens and transgender and nonbinary people.

Researchers at Boston University, Harvard Medical School, Johns Hopkins University, Michigan State University and Oregon Health and Science University have been enlisted to embark on the study, commissioned by the NIH’s National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health.

The approximately yearlong study will follow initially unvaccinated participants to observe changes that occur following each dose. More specifically, some groups will exclude participants on birth control or gender-affirming hormones, which may have their own impact on periods.

“Our goal is to provide menstruating people with information, mainly as to what to expect, because I think that was the biggest issue: Nobody expected it to affect the menstrual system, because the information wasn’t being collected in the early vaccine studies,” said NICHD director Diana Bianchi in a statement to the Lily — reportedly crediting their early coverage for helping to make the NIH aware.

‘We were worried this was contributing to vaccine hesitancy in reproductive-age women.’

NICHD director Diana Bianchi

The NIH suggests that changes to the menstrual cycle could arise out of several of life’s circumstances during a pandemic — the stress of lifestyle changes or possibly contending with illness. Moreover, the immune and reproductive systems are intrinsically linked, and the notion that the immune-boosting vaccine may disrupt the typical menstrual cycle is plausible, as demonstrated by previous studies concerning vaccine uptake.

It’s also worth noting the vaccine does not cause infertility and the Centers for Disease Control and Prevention recommends the shot even for pregnant women.

As changes to the menstrual cycle are “really not a life and death issue,” explained Bianchi, the Food and Drug Administration — fast-tracking their work — prioritized only the most critical risks associated with the COVID-19 vaccine.

The NIH, too, pulled together the initiative at breakneck speed. Funding for such a study would typically take years to see approval.

“We were worried this was contributing to vaccine hesitancy in reproductive-age women,” said Bianchi.

COVID-19 live updates: Vaccine protection against hospitalization is dropping slightly, CDC says

The CDC initially said 97% of people hospitalized with COVID-19 are unvaccinated

Authors: By Julia Jacobo and Ivan Pereira Last Updated: August 30, 2021, 5:18 PM ET

The COVID-19 vaccines’ ability to keep people out of the hospital appears to be dropping slightly, particularly for those 75 and older, the Centers for Disease Control and Prevention announced Monday during an advisory panel.

The CDC has previously estimated that 97% of people in the hospital being treated for COVID-19 are unvaccinated, but that data was collected before the spread of delta, a hyper-transmissible variant that many doctors have warned appears to be making people sicker.

The latest CDC analysis estimates that the ability of the COVID vaccines to keep a person out of the hospital is now between 75% to 95%.

For people older than 75 in particular, vaccine effectiveness against hospitalization experienced the steepest decline, from more than 90% to 80% between June and July.

Health experts are also concerned that a person’s immunity could be waning over time, particularly among older people whose bodies are less likely than younger people to develop a strong immune response to the vaccines.

However, the vaccine still remain highly effective at preventing serious illness, according to the briefing.

Scientists push back on call to endorse booster shots for all

Authors: By Ariel Hart,  Helena Oliviero– The Atlanta Journal-Constitution

Responding to the resurging pandemic and breakthrough infections, President Biden and some top health officials are pushing for the U.S. to begin vaccine booster shots by Sept. 20. But the committee of scientists who officially recommend whether to take such steps met Monday and pushed back.

The scientists said they still had fundamental questions to answer, such as whether the increase in COVID-19 infections after vaccination, so-called breakthrough cases, was related at all to waning effectiveness of the vaccines.

When the Sept. 20 date was announced “it led everyone—it led physicians, it led the public—to believe that they had access to information about these vaccines and the need for boosters that had not yet been publicly released,” said Dr. Sandra Fryhofer of Atlanta, a nonvoting member of the committee. “And to me, that kind of opened the door to a lot of confusion.”

The group, the Advisory Committee on Immunization Practices, advises the Centers for Disease Control and Prevention on whether scientific data merit approval or warnings on vaccines. From the moment its chairwoman opened Monday’s meeting, members made blunt statements that they would follow scientific data and processes on booster shots, regardless.

Other scientists were glad to hear it.

“There is a process that is being undermined by ‘science by leak,’” said Dr. Felipe Lobelo of Emory University, an epidemiologist and associate professor told the AJC. “We don’t really have strong data on when the waning starts; on whether the increased rates of infection and so called breakthrough infections…are occurring because of this waning effect— or is it because delta is more transmissible? Or is it because people are changing behaviors?”

Dr. Carlos del Rio, professor of medicine at Emory University, agreed. “The problem is by focusing on boosters we’re distracting from the biggest problem, which is all the unvaccinated people,” he said.

Without calling them “booster shots,” the FDA has authorized an extra shot for certain people with compromised immune systems, like organ transplant recipients, after they have completed their original coronavirus vaccine regimen. But no decisions have been made for other vulnerable groups, much less the general public.

That leaves Georgians who are now eager for a booster shot not knowing what comes next.

In Avondale Estates, Carolyn Chandler, 80, has marked her calendar for Oct. 16, the day she should get a booster if they’re recommended eight months from initial vaccination, as federal officials have touted.

Ever since Chandler started to see reports showing waning immunity from the vaccines, there was no question for her that she would get a booster.

“I just would like to stick around for a while,” Chandler said.

Israeli experts analyze mRNA COVID vaccines long-term effects

Experts believe there will be no long-term side effects to the mRNA vaccines.

Authors: By MAAYAN JAFFE-HOFFMAN   AUGUST 30, 2021 22:34

As thousands of Israelis rush back to their health funds in search of a third COVID-19 vaccine shot and a Green Pass from isolation after traveling abroad, others are asking if another injection of messenger RNA is safe.The American Food and Drug Administration provided full approval of the Pfizer coronavirus vaccine last week, but noted in its press release that “information is not yet available about potential long-term health outcomes.”However, Tal Brosh, head of the Infectious Disease Unit at Samson Assuta Ashdod University Hospital, told The Jerusalem Post that while he cannot claim to know what is going to happen in 10 years, “there is no true reason to think there are any significant long-term effects” of the vaccine.He explained that there is no other vaccine that was evaluated for a decade before approval and that there is not an example of another vaccine – although no other vaccine is an mRNA vaccine – that has been linked to any significant long-term effects.“There is no evidence of something happening unless it happened in the first two hours, two weeks or two months,” said Michal Linial, a professor of biological chemistry at the Hebrew University of Jerusalem. “We do not know of any other examples in which the immune system decided to suddenly react to a vaccine that was given 15 years prior.”THERE ARE also few examples of people being nervous about taking a booster shot of an already approved vaccine.If a person were to get cut by rusted metal and go to a doctor, the health professional would probably tell that individual to get a tetanus booster shot. It is unlikely this person would ask the doctor if the booster was safe or if it could prevent her from getting pregnant or him from making babies.“This is the same thing,” Linial said. “I can understand in the beginning that this was a breakthrough and people were shocked, like it is some kind of satellite to the Moon and they don’t want to be the first on the satellite. But now we know: This is nothing like that.”Rather, more than two billion people worldwide have been inoculated against COVID-19 with more than five billion doses. Around 210 million Pfizer mRNA doses have been distributed in America, for example. In Israel, more than 8.5 million doses have been administered. While traditional vaccines generally put a weakened or inactivated germ into our bodies, according to the Centers for Disease Control and Prevention, mRNA vaccines “teach our cells how to make a protein – or even just a piece of a protein – that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.”Brosh said that this does not mean that the vaccine changes people’s genetic code. Rather, he said the mRNA is more like a USB device that is inserted into a computer: It does not impact the hard drive of the computer but runs a certain program.“ Messenger RNA is a very fragile molecule, meaning it can be destroyed very easily,” Linial explained. “If you put mRNA on the table, for example, in a minute there will not be any mRNA left. This is as opposed to DNA, which is as stable as you get. ”She said that this fragility is true of the mRNA of any living thing, whether it belongs to a plant, bacteria,

WHILE THE Moderna and Pfizer vaccines are based on new technologies, they are asking our bodies to do something they do every day: cells synthesizing protein. Moderna and Pfizer are simply delivering a specific mRNA sequence to our cells. Once the mRNA is in the cell, human biology takes over. Ribosomes read the code and build the protein, and the cells express the protein in the body. This is one of the main reasons to believe there will be no long-term consequences to the vaccine, said Prof. Eyal Leshem, director of Sheba Medical Center’s Center for Travel Medicine and Tropical Diseases. While the Pfizer and Moderna vaccines are the first mRNA ones to ever be brought to market for human patients, Linial said she believes the reason that no mRNA vaccine has been developed until now is because there was just no need to move this fast on a vaccine until COVID-19 came along. In fact, scientists have been experimenting with mRNA for the better part of the last three decades. Leshem said mRNA vaccines for other diseases, including cancer, have been tested in humans for around 10 years and “no long-term effects were registered” in those trials – though he admitted that these trials generally included small numbers of participants. Individuals began receiving mRNA vaccines against COVID-19 as early as July of last year, and adverse effects have been closely tracked worldwide since then. In Israel, the first vaccines were administered on December 20, 2020.“There is more data on the adverse events of these vaccines than we have ever had on any other vaccine,” Brosh said, adding that no vaccine has ever been given to so many people so quickly. Most adverse events were simple “reactogenicity” – reactions that occur soon after vaccination and that are a physical manifestation of the inflammatory response. These can include fever, muscle pain, swelling at the site of injection or swelling of the lymph nodes, for example – all symptoms that can generally be treated with paracetamol or the like. THE VACCINE was linked to one “immune-mediated phenomenon,” said Brosh, and that is myocarditis – inflammation of the heart muscle – which was the predominant serious side effect in young male adults between the ages of 16 and 25. But even then, myocarditis was rare, generally mild, and those people who developed it fully recovered, he said. Moreover, unvaccinated people who contracted COVID-19 were four times more likely to develop myocarditis than vaccinated people were, according to a new study by Clalit Health Services together with Harvard University that was published last week in the New England Journal of Medicine. The study found that there were around 2.7 cases of myocarditis per 100,000 vaccinated people infected with the virus, compared with 11 cases per 100,000 unvaccinated people who were infected. In general, the study showed that individuals who take the Pfizer coronavirus vaccine may suffer from four out of up to 25 clinically relevant side effects: myocarditis, swelling of the lymph nodes, appendicitis and herpes zoster.In contrast, high rates of multiple serious adverse events were associated with coronavirus infection among unvaccinated patients, including a greatly increased risk of developing myocarditis, pericarditis, arrhythmias, heart attacks, strokes, pulmonary embolism, deep-vein thrombosis or acute kidney damage.“So, all together we know the vaccines are safe and effective. This holds true for the initial doses and probably also for the booster doses,” Leshem said. Linial said she believes that most future vaccines will be made of mRNA because “it is an easy, great technology – no question.” She also said that vaccination is the only way to beat this pandemic. “If people want to go back to their lives,” Linial said, “the population must be vaccinated.” 

Pfizer Just Got ‘Full FDA Approval’ For Its COVID Vaccine. There’s Just One Thing…

Authors: Authored by ‘Sundance’ via TheConservativeTreehouse.com,

Pfizer got full FDA approval yesterday

“The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.”

With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

[…] “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.

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

There’s no one left within the control group, of a statistically valid value, to give an adequate comparison of outcomes for vaxxed -vs- non-vaxxed.  This is nuts. That NPR article is one to bookmark when people start claiming the vaccination is effective.

How can the vaccine not be considered effective when there is no group of non-vaccinated people to compare the results to?

Good grief, the entire healthcare system is operating on a massive hive mindset where science, and the scientific method, is thrown out the window in favor of ideological outcomes and self-fulfilling prophecies.  

The fact that the researchers and doctors, apparently under the payroll of the pharmaceutical companies that have a vested financial interest in the vaccine outcome, lost the control group on purpose is alarming.

Of course, Big Pharma will promote the vaccine as beneficial, and the controlled media will promote that message with a complete disconnect from the clinical trial details, and the FDA will grant approval on results that were intentionally constructed to produce only one outcome.

As noted by Dr. Malone, the commonsense therapeutic approach should be the primary focus, not vaccination, for ongoing healthcare systems as the COVID-19 variants will continue to evolve.  Ultimately,  the natural immunity process will be of greater overall benefit than vaccinations which will require continual boosters to deal with the ever-evolving variants (a similar approach to dealing with reoccurring and evolving flu strains).   Dr. Malone provided support for his position with concurrence from the leading U.K. Vaccinologist in Great Britain, Sir Andrew Pollard 

In essence, both Dr. Andrew Pollard (Director of the U.K. Oxford Vaccine Group), and Dr. Malone state that variants of the COVID-19 virus will continue to spread throughout the population regardless of vaccine status; and the virus will continue to evolve into more infectious but less deadly or pathogenic strains.

There simply is no way to vaccinate the population and stop the spread of COVID variants, because the vaccinated will contract and spread the virus just like the non-vaccinated.  The vaccine approach should be targeted to the elderly and those most at risk.

Specific to the position of Dr. Malone – given the untested nature of the vaccine itself; no one knows the long-term side-effects; the benefit of the vaccine should be weighed against the individual’s current health status.  Elderly populations with lower immune responses should be the target for vaccination; they are the most at risk.  However, younger -less at risk- individuals will likely benefit more from therapeutic treatment after exposure *if* they experience any symptoms at all.

The problem is…. this commonsense approach is less favorable to the interests of the pharmaceutical industry and the healthcare systems that are controlled by the financial mechanisms inside the business of healthcare.  Big Pharma would obviously make less money from a smaller target population for vaccination; ergo the therapeutic approach is a threat to the preferred approach of those who operate the business model.  This is the overarching political battle.

The influence of the massive pharmaceutical corporations, inside the institutions of government controlled healthcare on a global basis, is massive.  This outlook is the origin of the vaccinate push and vaccine narrative as the *only* and *best* solution.   Anyone who raises a point, any point, in opposition to the mandated mass vaccine approach then becomes a target to be isolated, marginalized, ridiculed and removed.

Evaluation of the safety of mRNA-Moderna in adolescents

Authors: Killian Meara

The vaccine demonstrated an acceptable safety profile in the adolescent population.

A recent study conducted by investigators from the pharmaceutical and biotechnology company, Moderna, has found that their COVID-19 vaccine, mRNA-1273, was both safe and efficacious in preventing COVID-19 in adolescents.

Results from the study were published in The New England Journal of Medicine.

The incidence of COVID-19 in adolescents between the ages of 12 and 17 years was 900 per 100,000 during the time period of April and June of 2021. The aim of the study was to evaluate the safety, efficacy and immunogenicity of the Moderna vaccine in that population.

The ongoing, phase 2-3, placebo-controlled trial randomly assigned healthy adolescents between the ages of 12 and 17 in a 2:1 ratio to receive 2 doses of the vaccine or a placebo, 28 days apart.

The trial included 3,732 participants, of which 2,489 received the therapy and 1,243 received the placebo.

The primary objective was to evaluate the safety of mRNA-1273 in adolescents as compared to that in young adults between the ages of 18 to 25 years. The secondary objectives included an evaluation of the efficacy in preventing either symptomatic or asymptomatic disease.

Findings from the study demonstrated that the most commonly reported adverse reactions in the vaccine group were injection site pain, headache and fatigue. The most commonly reported adverse reactions in the placebo group were similar and no serious adverse events were noted in either group.

Mean ratio of pseudovirus neutralizing antibody titers in the adolescents relative to the young adults was 1.08, with the absolute difference in serologic response being 0.2 percentage points.

There were no reported cases of COVID-19 with an onset of 14 days after the second injection in the vaccine group and 4 cases reported in the placebo group.

“The mRNA-1273 vaccine had an acceptable safety profile in adolescents,” the authors wrote. “The immune response was similar to that in young adults, and the vaccine was efficacious in preventing COVID-19.”

For More Information: https://www.contagionlive.com/view/how-soon-covid-19-vaccine-booster-doses-available-us