Newly Obtained Emails Shed More Light on CDC’s False Vaccine Safety Monitoring Statements

 Newly obtained emails show the Centers for Disease Control and Prevention (CDC) made a false statement on COVID-19 vaccine safety monitoring in 2021, months before agency officials gave false statements on the matter to The Epoch Times.

The emails also show top officials in the agency discussing performing safety monitoring on a key database for myocarditis, a form of heart inflammation that has been linked to the vaccines from Pfizer and Moderna.

The CDC promised in 2021 in a set of operating procedures to perform a type of analysis called Proportional Reporting Ratio (PRR) on reports of adverse reactions following COVID-19 vaccination. The reports are submitted to the Vaccine Adverse Event Reporting System (VAERS), which officials have described as “the nation’s early warning system” for post-vaccination adverse events. The CDC also said in an updated set of operating procedures in 2022 that it would perform the analysis.

But the CDC has made false statements three times this year on PRRs, initially saying such analysis was outside the agency’s purview, then saying the analysis was performed starting in 2021, then saying the analysis did not begin until 2022. The newly obtained emails show that an official falsely said the CDC does not perform PRR analysis to an editor in 2021.

John Gregory, a health editor at NewsGuard, wrote to the CDC on Oct. 19, 2021, asking for a comment regarding a claim that the CDC’s PRR analysis cannot accurately identify when a vaccine causes adverse events, one of the emails shows. Martha Sharan, a CDC spokeswoman, sent the query to Dr. John Su, who leads the CDC’s VAERS team, and Dr. Tom Shimabukuro, who also works on vaccine safety.

Their responses were redacted apart from a comment on NewsGuard. Sharan then wrote that she’d spoken to Gregory.

“I spoke to the reporter and explained that CDC does not do PPR analysis. The reporter is not going to pursue this any further!” she wrote, adding later that she meant PRR.

That contradicts the operating procedures, which state that the CDC “will perform Proportional Reporting Ratio (PRR) analysis” on VAERS reports.

“We let our published content speak for itself,” Gregory told The Epoch Times in an email when notified that the CDC does actually perform PRRs.

Nora Burlingame, 3, sits on the lap of her mother, Dina Burlingame, and gets a fist bump from nurse Luann Majeed after receiving her first dose of the Pfizer COVID-19 vaccination at UW Medical Center-Roosevelt in Seattle, Wash., on June 21, 2022. (David Ryder/Getty Images)

‘That’s a New One to Me’

In June 2022, the CDC falsely told Children’s Health Defense, a nonprofit, that PRR analysis is “outside of th[e] agency’s purview.” An Associated Press reporter, Angelo Fichera, flagged a Children’s Health Defense article on the statement to the CDC, asking whether the CDC had ever performed the analysis, according to the newly obtained emails.

Kristen Nordlund, another CDC spokeswoman, forwarded the query to Sharan. “Martha—thoughts on this one?” she asked.

“That’s a new one on me—proportional reporting ratios’—I need to send this one to John,” Sharan responded.

Sharan later sent a statement about PRRs to The Associated Press and the Washington Examiner.

The Associated Press and NewsGuard never published stories on the topic. After The Epoch Times reported on contradictory statements from the CDC, the Examiner published an article about the developments.

Fichera, Sharan, and Su did not respond to requests for comment for this article.

The emails were obtained by The Epoch Times and an independent researcher through FOIA requests.

“The CDC claims to be vigilantly and transparently monitoring the safety of COVID-19 vaccines, but when it comes to Proportional Reporting Ratio (PRR) analysis, the CDC’s broken promises, inconsistent statements, stonewalling, and double standards tell a different story,” Mary Holland, president and general counsel of Children’s Health Defense, told The Epoch Times via email.

“When asked about PRR analysis in connection with COVID vaccines—through FOIA, media, and congressional requests—CDC has made conflicting statements, some of them false. When confronted about the statements, the CDC claimed, essentially, that PRR analysis is not worth doing.  And for the few months of PRR the CDC now says it has completed, the CDC has failed to make the results public, despite requests from multiple sources.”

“Children’s Health Defense calls on the CDC to do the right thing: do the analysis, and make the results available,” she added.

Timeline of CDC emails and statements. Some are being reported for the first time in this story, which continues below.

• “I spoke to the reporter and explained that CDC does not do PPR analysis. The reporter is not going to pursue this any further!” – Martha Sharan to CDC colleagues, Oct. 19, 2021. (source: FOIA response to independent researcher)
• “Correction – that should say PRR.” – Martha Sharan to CDC colleagues, Oct. 19, 2021. (FOIA response to independent researcher)
• “[P]rogram staff within the Immunization and Safety Office inform me that no PRRs were conducted by CDC. Furthermore, data mining is outside of th[e] agency’s purview.” – Roger Andoh, June 16, 2022. (letter to Children’s Health Defense)
• “That’s a new one on me – proportional reporting ratios’ – I need to send this one to John.” – Martha Sharan to CDC colleagues, June 22, 2022 (FOIA response to The Epoch Times)
• “[P]rogram staff within the Immunization and Safety Office inform me that no PRRs were conducted by CDC. Furthermore, data mining is outside of the agency’s purview.” – Bruno Viana to Roger Andoh, June 30, 2022 (FOIA response to The Epoch Times)
• “CDC has been performing PRRs since Feb 2021, and continues to do so to date.” – Dr. John Su, July 18, 2022 (statement to The Epoch Times)
• “CDC has revisited several FOIA requests and as a result of its review CDC is issuing corrections. … In reference to Proportional Reporting Ratios (PRRs) – CDC performed PRRs from March 25, 2022 through July 31, 2022.” – Martha Sharan, Aug. 8, 2022. (statement to The Epoch Times)
• “CDC performed PRR analysis between March 25, 2022, through July 31, 2022. CDC also recently addressed a previous statement made to the Epoch Times to clarify PRR were not run between February 26, 2021, to September 30, 2021.” – Dr. Rochelle Walensky, Sept. 12, 2022 (letter to Sen. Ron Johnson (R-Wis.))

A member of the U.S. military receives the Moderna COVID-19 vaccine at Camp Foster in Ginowan, Japan, on April 28, 2021. (Carl Court/Getty Images)

Other Emails

Several other messages add to the timeline of the CDC’s internal and external statements regarding PRR.

Two weeks after Andoh falsely told Children’s Health Defense that data mining is outside of the CDC’s purview, Bruno Viana, a CDC records employee, sent emails to Andoh about the response.

Viana quoted word-for-word portions of the letter that Andoh sent to the group.

The context of the emails is unclear.

An email to Viana requesting more information returned an away message. The CDC records office declined to comment, saying a new FOIA request would be necessary to obtain the information.

Another set of internal emails showed Su and Shimabukuro involved in responding to The Associated Press and the Washington Examiner.

“With the above background, I might suggest the following response,” Su said in one heavily redacted email.

“John’s edits look fine to me. Thanks,” Shimabukuro later wrote.

And other emails featured Su and Sharan talking to and about The Epoch Times’ queries, including a followup query noting that an initial response did not make clear whether the CDC had, in fact, performed PRRs.

Su was attributed with the false statement that the CDC had started PRRs in February 2021. One of the missives indicates the statement did come from him. That portion of the email is redacted, but the length of the text aligns with the actual response.

Analysis on Myocarditis

Clinical trials for the vaccines turned up no evidence of myocarditis, a form of heart inflammation, or a related condition called pericarditis. But real-world evidence of the conditions began emerging in early 2021.

After the Department of Defense in the spring of 2021 said it identified myocarditis as a possible side effect of the vaccines, Dr. Rochelle Walensky, the CDC’s director, claimed that the CDC saw no signal for myocarditis after looking at its vaccine safety data.

“After hearing about these reports, we, again, looked back in our vaccine safety data, and we have not seen any reports of those. Those have since been reported to us, and so those investigations are ongoing,” she said during a press briefing, adding later, “We have not seen a signal, and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given.”

The CDC has declined to make public the results of that review. It’s not clear what systems the CDC reviewed.

“At the time of the director’s press conference, CDC did not have sufficient evidence to conclude there was a safety signal for myocarditis following mRNA COVID-19 vaccination. Continued surveillance subsequently detected a safety signal, and further assessment verified that signal,” Sharan told The Epoch Times in a recent email. The Pfizer and Moderna vaccines are both built on messenger RNA (mRNA) technology.

An exchange just two weeks later included in the newly released emails showed that CDC officials discussed myocarditis monitoring.

Shimabukuro wrote on May 13, 2021, to Su and Paige Marquez, another CDC official, with the subject line “PRR for myocarditis.” That email was entirely redacted.

“Are you saying…” Marquez responded. The rest of her email was redacted.

Shimabukuro’s next email was completely redacted, as was an email from Su apart from his signature.

“No Janssen,” Shimabukuro wrote next.

“Okay, thanks for clarifying!” Su wrote.

The exchange ended there.

https://www.theepochtimes.com/exclusive-newly-obtained-emails-shed-more-light-on-cdcs-false-vaccine-safety-monitoring-statements_4768562.html

How CDC’s communication failures during Covid tarnished agency

 In the early days of Covid, staffers at the Centers for Disease Control and Prevention sought to give Americans guidance about maintaining some semblance of normalcy during a once-in-a-century pandemic that had upended daily life.

One recommendation? Play basketball with your friends — online.

There was one big problem: The nation’s top public health professionals failed to consult their very colleagues who’d be responsible for communicating this advice to the public.

“We have to have a seat at the table sooner, so we can raise our hand and say, ‘Hey guys, I’m sorry, but playing basketball virtually with your friends is probably not a great recommendation,’” a CDC staffer told NBC News before adding: “That’s pretty stupid.”

Another staffer echoed the frustration. “There were a number of people inside the agency that were sometimes perplexed at whether what we were recommending was really practical.”

Communication failures like that, along with much more consequential errors, would continue throughout the pandemic, deeply tarnishing the agency — long considered the gold standard of public health institutions. The blunders have left career scientists and other longtime employees worried that the wounds can’t be healed. 

All culminated in what would become a series of unsettlingly defining moments for CDC employees who say the agency was unable to move fast enough for the public with science solid enough to meet their own expectations. 

This account is based on interviews with seven CDC employees who spoke to NBC News about their experiences during the pandemic on the condition of anonymity to discuss matters freely. All but one have been with the agency for at least 14 years, and three are nearing or have exceeded their third decade of service. 

While some employees say they are optimistic that the agency can improve its public health responses, blunders during the Covid response still haunt those who have dedicated their lives to public health.  

“When people ask, ‘where do you work?’ I used to say that ‘I work at CDC’ with pride,” a staffer said. “Now I just tell people that I work in public health and not exactly where I work, because it’s just going to become a discussion of our failures.”

“People’s lives were changing based on our decisions,” said a senior scientist within the agency. “The fear, the anxiety, the stress …” the person said, trailing off. “If only we could have stopped time.”

“There are going to be headlines that praise you and headlines that slam you,” the CDC’s director, Dr. Rochelle Walensky told NBC News. “It was going to be hard for the agency however it shook out. I can tell you numerous times where I’ve had these big decisions... many nights I’ve lost sleep.”

Six of the CDC employees who spoke to NBC News were either interviewed for or were otherwise heavily involved in a highly publicized review of the agency this year. The review was requested by Walensky and led by Jim Macrae, a longtime official within the Department of Health and Human Services. 

“In our big moment, our performance did not reliably meet expectations,” Walensky said in a statement in August, when the review was completed. Macrae’s report on the agency’s pandemic response, published Sept. 1, echoed the need for the CDC to move more quickly and reliably. 

Not all employees were happy with the proposed changes. “I certainly have talked to staff who are very distressed by it and feel very concerned,” a senior staffer said.

Another was more blunt: “It’s gonna piss off a lot of people, and people are going to leave.”

But others said they were relieved to see their frustrations outlined in Macrae’s final report, and ultimately, all agreed that the agency must make drastic changes before the next public health emergency.

‘Do what you think is best’

It was clear to CDC staffers early on in the pandemic that things were going awry. The first Covid tests to roll out in January 2020, made in a CDC lab, proved to be faulty. 

By February, staffers said, CDC scientists were unable to give clear, commonsense advice to other public health officials. 

In one case, the agency sent teams from its headquarters in Atlanta to areas of the country where the earliest cases had been reported. One team was sent to Chicago, the city that reported the first documented human-to-human transmission of the coronavirus in the U.S.

There, CDC officials met with local and state health officials to help facilitate early guidance, even though little was known about the new virus at the time. The team got on a conference call with CDC scientists in Atlanta to ask how they might best stop further spread of the virus.

“If someone sneezes on a table, how long will the virus live on the table?” they asked, according to a staffer familiar with the conversation. “What kind of precautions should they take? What kind of cleaning should be done?”

“Rather than saying, ‘We don’t know; we’re going to have to look into this,’” the person said, the CDC scientists said they didn’t see a need for any special decontamination, because there was no science at the time to back it up.

When local health officials on the call questioned the advice, the response from the CDC was “do what you think is best.”

“There was a lot of weird looking around the room, like, ‘What do I do with that?’” the person said.

Problems communicating guidance continued. The agency later flip-flopped on critical advice for the public, such as when people should wear masks, who should be tested after a Covid exposure and how the virus spreads.

All are examples, CDC employees said, of the agency’s inability to pivot from its reliance on a deliberate, tried-and-true way of gathering scientific data to an uneasy space where decisions must be made quickly, even when there’s insufficient evidence. 

The “root cause” of that unease, said Dr. Tom Frieden, the president of the global public health initiative Resolve to Save Lives, is that “too few people in Atlanta have worked at the local level and understood the need for communicating in real time.” Frieden was the CDC’s director from 2009 to 2017.

A ‘holy crap’ moment

Scientists at the CDC, the country’s foremost public health institution, have long prided themselves on thorough research to support its guidance and recommendations. 

But such research moves slowly, often including data gathered over months and years, followed by careful analysis and review. Completed reports are published in the CDC’s Mortality and Morbidity Weekly Report or in prestigious medical journals, where the work is reviewed by outside experts. 

The long-held reliance on published data is what caught so many CDC scientists off-guard when the public demanded information about what was occurring in real time, before data could be collected and assessed.

“We had to change and be more comfortable making decisions on data that was much less baked” than previous research, a staffer said.

It also proved difficult when recommendations changed — even if those changes were based on new evidence.

“There was a lot of dogma that went into the initial round of pronouncements and recommendations without preparing people for the fact that we have a lot to learn about this, and we learn as we go,” said Dr. Julie Gerberding, who was the CDC’s director from 2002 to 2009. Gerberding is now the CEO of the Foundation for the National Institutes of Health. 

In May 2021, Walensky announced that vaccinated people no longer needed to wear masks. The shift, she said, was due to several studies that suggested vaccinated people couldn’t transmit the then-dominant alpha variant to others. “We felt like we were on solid ground, scientifically.” 

But an outbreak among vaccinated people over the July 4th weekend in Provincetown, Massachusetts, changed everything. It showed that the more contagious delta variant could be spread among vaccinated people.

A senior-level CDC official said it was a “holy crap” moment. “I was like, oh my God, we have to put masks back on,” the person said.

The perceived flip-flop was another blow to the agency’s credibility.

“The traditional way that we have done public health was not meeting the needs of the American public in a pandemic,” a senior staffer said. “There are times when we can take longer and do our due diligence and do studies over multiple years, but when we’re in a pandemic, we have to learn how to share what we know when we know it.”

Communicating quickly versus communicating clearly

Before the pandemic, public health recommendations from the CDC were generated thusly: CDC scientists would write up massive guidance documents for every scenario they could think of to inform clinicians and public health partners. The information was then simplified into digestible bites that the public could understand. 

Once Covid hit, agency scientists still wrote up those documents, but instead of breaking them down into easy-to-understand guidance, the agency’s communications specialists simply posted them online — regardless of length.  

It was an approach, several employees said, that was completely unworkable.

“You can’t put 17 pages of a guidance document on a website designed for the American consumer and say, ‘Consume this,’ right?” a person said. “The idea of communicating clearly was quickly abandoned to communicating quickly with whatever you had.”

Adding to the problems, the CDC hadn’t had an official head of communications for four years when Walensky signed on as director in January 2021. 

“I suppose that’s manageable when you’re dealing with a food-borne outbreak or when you’re dealing with something relatively small,” Walensky said. “You can imagine trying to navigate a pandemic without a standing director of communications.”

This June, the CDC hired Kevin Griffis for the job. He’d worked in communications at the Department of Health and Human Services during outbreaks of Ebola and Zika. 

Separating public health from politics

Making matters more difficult was the role the White House played, opting to involve itself in briefings under both President Donald Trump and President Joe Biden. The Trump administration abruptly put an end to CDC-controlled media briefings in February 2020 after Dr. Nancy Messonnier, then a top CDC official, warned the public that, because of Covid, “disruption to everyday life might be severe.”

“We were in a period where we were driving the message,” said a staffer with close knowledge of the situation. “That’s probably what got us into trouble” early on.

While the Biden administration has allowed the CDC to participate more freely in Covid briefings, it has continued to lead most of them, frustrating some CDC staffers. 

“That carries a certain political connotation and tone to it that you can’t get away from,” an employee said. “That had people on both sides of the aisle not trusting the CDC at one time or another.”

Frieden agreed. “There’s an advantage to being in Atlanta,” where the CDC is headquartered, he said. “They need to be briefing from Atlanta. They need to distinguish themselves from the White House.”

Still, the CDC director is a position appointed by the president. Until that changes, “I don’t think we’re ever going to get to where we have the trust of the American people as a whole,” one staffer said.

For all the confusion and misunderstood messaging over the past two years, Walensky says she still supports the decisions the agency has made during her tenure.

They include controversial ones, including the initial decision in May 2021 to tell vaccinated people that they no longer needed to wear masks. 

Looking back, Walensky said she stands by that recommendation based on the science available at the time.

Would she do it again? 

Yes, with the addition of two small words: “for now.”

https://www.nbcnews.com/health/health-news/cdcs-communication-failures-covid-tarnished-agency-rcna46425

Is the Pandemic Over? Fauci Weighs In

 Is the COVID-19 pandemic really over? Could the "lab leak" theory be true? Is President Biden's chief medical advisor and the man who helped (or tried to help) America navigate and contain a deadly global outbreak now eating indoors?

Anthony Fauci, MD, also the long-time director of the National Institute of Allergy and Infectious Diseases (NIAID), answered these and other questions during an online interview with the University of Southern California's Center for Health Journalism on Tuesday.

In August, Fauci, who is both beloved and hated by certain groups of Americans, mostly on the basis of political ideologies, announced that he would be stepping down from his position in December.

The Big Question

Asked whether the pandemic is truly over, Fauci replied, "I don't think we can say 'the end' being no more COVID is in sight."

"We have had multiple waves, we've had valleys and peaks in the evolution of the outbreak as new variants came along. Right now it's all relative," he said.

While cases, hospitalizations, and deaths are "much, much lower" than they were several months ago, "it is still at a level that I have been very public about saying that I'm not comfortable with -- having 300 to 400 deaths per day," he noted.

Fauci also pointed out that winter is approaching and "there's always the risk of an uptick in respiratory diseases." Furthermore, while BA.5 remains dominant, other sublineages like BA.4.6 are "creeping up."

"We don't have much of BA2.75.2 yet, but there are other countries that do have that. So although we can feel good that we're going in the right direction, we can't let our guard down," he stressed.

Fauci also said that he remains concerned about the possibility of a new variant that could escape the immune protection Americans have built up as a result of SARS-CoV-2 infections or vaccinations.

"I hope we don't get that ... but we should not be surprised if we do," he added.

Asked about masking over the upcoming holidays, Fauci said that he hopes it won't be necessary, but that "CDC guidelines will still hold true" -- in other words, masks would be optional but recommended in areas with low transmission, and recommended in areas with high transmission, in indoor congregate settings.

As for his own masking habits, Fauci said, "It's not like I always wear one or I never wear one."

He said that he continues to avoid indoor dining, but he has attended receptions, mostly outdoors, unmasked. "But if I'm in an indoor [public] setting for a considerable period of time, I would keep the mask on."

The 'Lab Leak' Theory

Switching gears to the origins of the virus and the criticism around his agency, Fauci said he was part of the group that called on evolutionary virologists to study the "lab leak" theory. This group of experts looked at the data carefully and concluded that SARS-CoV-2's origins were "likely a natural occurrence."

While there's strong evidence to support that theory "and zero evidence to indicate that it's a lab leak," he said he continues to "keep an open mind," adding "to nail it down, we'd need more cooperation" from China.

When Fauci was asked if he believes he said or did anything wrong in the messaging to the public, he recalled "famous quotes" that his critics like to pin on him. For example, when there were about five known COVID cases in the country, he told Americans they didn't need to do anything differently.

"It was semicolon, 'however,' comma, 'this could change rapidly, and we need to be prepared,'" he explained. However, that part isn't remembered, he added.

Asked whether public health experts have broadly been too reticent to communicate "hard truths" -- for example, that gay men were contracting monkeypox through anonymous sex -- Fauci said "true honesty" and "true transparency" would be easier to achieve when not garbled by social media misinformation and disinformation.

Fauci was also asked about the criticism he received related to NIH's funding of EcoHealth Alliance, a group that conducted "gain-of-function" research. He pointed out that the group conducts other research as well, and that all grants go through a formal process of peer review. When groups are highly recommended, they can't "arbitrarily" be denied, he said.

Looking Ahead

The NIAID director also highlighted the ongoing pandemic-related challenges, including long COVID. "That's something we absolutely have to get our arms around, find out what the pathogenic mechanism of it is, and then hopefully do something about it," he noted.

He also called out the health disparities that the pandemic has cast light on as a "big problem" that emerges every time there's a major health event. These health inequities stem from "very subtle social determinants of health" that can lead to increases in conditions like diabetes, hypertension, obesity, chronic liver disease, and chronic kidney disease.

"Those are not racially determined. Those are due to social determinants of health. We need a decade's long commitment to overcome that," Fauci said.

Disclosures

The online interview was sponsored by the Commonwealth Fund, the National Institute for Health Care Management Foundation, and the California Endowment.

https://www.medpagetoday.com/infectiousdisease/covid19/101071

Should Myopia Control Be Mainstream in the U.S.?

 Myopia, more commonly known as nearsightedness, is a condition due to the physical length of the eye being relatively too long for its refractive components. Despite its strong family trait, juvenile myopia has been considered as a combined product of environmental influence and genetic predisposition, with factors such as lack of outdoor exposure, active use of handheld devices, and sustained near activities playing primary role in the etiology of the condition.

To Intervene or Not to Intervene?

There's some debate as to whether myopia is a benign refractive condition or a disease that significantly benefits from early intervention.

The perception of myopia as a simple refractive error versus a disease that can lead to irreversible loss varies significantly based on the patients and parents' cultural background. In general, Asian parents view myopia as much more than just a refractive problem and instead see it as a progressive condition that can lead to vision loss. Similarly, the condition is much better recognized as a disease among eye care practitioners in Asia. This is partially attributable to the higher prevalence and severity of myopia, hence the much higher incidences of blinding retinal complications seen by the eye care practitioners.

It is important to note that even though the risks of myopia-related complications -- such as myopic maculopathy, retinal detachment, primary open angle glaucoma, or early onset cataract -- increase exponentially with the severity of myopia, lower myopes are not immune from such risks. In fact, because there are so many more lower myopes in the population, the complications in myopic eyes less than -3D contribute to more than 40% of all cases. Additionally, despite the major advancement of using anti-VEGF treatment in many types of chorioretinal neovascularization, the long-term outcome of such treatment in myopic maculopathy remains equivocal, as the complication is an end-product of excessive scleral stretching and thinning at the advanced stage of the irreversible axial elongation. Consequently, early interventions that slow the axial growth and prevent excessive stretching of the posterior sclera will likely provide the best accumulative outcome in minimizing the risk of vision loss due to myopia complications.

Recent evidence from both animal and clinical studies clearly demonstrates that myopia, as well as the associated axial elongation, is controllable, especially during the early stage of visual development. Common evidence-based treatments that offer both statistically significant and clinically meaningful efficacies include daytime multifocal soft contact lenses (MFSCL), overnight orthokeratology (ortho-k), and topical low dose atropine (LDA). Novel spectacle lenses also showed a promising myopia-inhibiting effect, albeit with limited availability in U.S. at the current moment. On average, these options slow myopia progression by 30-70% compared to conventional single vision glasses or contacts. With properly selected early interventions, not only the development of myopia stabilizes at younger ages, the endpoint of the progression is also much lower, resulting in significantly lower risk of complications. Furthermore, with lower level of myopia at stabilization, many myopic patients could be good candidates for refractive surgery with given corneal thickness.

Myopia Treatment Is Good for Individual and Public Health

Permanent vision loss related to pathological myopia accounts for up to 25% of all low vision cases. Comparing to other priority eye conditions such as age-related macular degeneration, glaucoma, cataract, and diabetic retinopathy, vision loss related to myopia complications tend to have much younger age of onset, bilateral presentation, and bias toward populations with higher educational levels. As a result, its impacts on quality of life and productivity are likely much higher. With myopia becoming the most prevalent ocular condition globally, a small reduction either in the prevalence or the severity of myopia carries a huge public health benefit.

Even for myopes without permanent vision loss, the choices of optical correction reduce significantly and the cost for spectacles and contact lenses increases dramatically with increasing level of myopia. Additionally, aesthetics, optical distortion, and the field of view from high prescription are all significantly impacted.

Integrating Myopia Control

One question that arises is whether myopia control treatments should be considered as concierge service or implemented in the form of traditional primary care. The answer is both.

Evidence-based myopia control treatments include a wide variety of options including daytime MFSCL, overnight ortho-k, LDA eyedrops, or novel glasses. Despite the differences in treatment efficacies, decisions regarding treatment are also influenced by the patients' age, cultural background, lifestyle, visual needs, and the parents' knowledge of the long-term safety of the options, among other factors. The necessity for easy accessibility to practitioners, and the flexibility of office visits is highly dependent on the particular type of treatment. For options such as LDA eyedrops or novel glasses, the treatments can be offered by eye care practitioners in all settings without the need for advanced training, and the risk of serious side effects due to the treatments is minimal. Considering the tremendous size of the target patient population (i.e. children with progressive myopia), it is critical that these treatment options are available at as many practices as possible. On the other hand, it is critical to ensure easy accessibility especially after regular clinic hours, the continuity of follow-up care, as well as frequent and flexible office visits for options involve contact lens wear in children -- especially the overnight modality of the ortho-k treatment -- to minimize the risks of serious complications related to contact lens wear.

In summary, juvenile myopia is a combined product of genetic predisposition and environmental influences. Early interventions that target not only correcting myopia but also slow the excessive axial elongation and scleral stretching are critical in minimizing the risks of complications that may lead to irreversible vision loss. Myopia control options need to be prescribed with a custom-tailored approach with some options readily available in traditional primary care settings, and others more properly offered as concierge services, depending on the level of complexity of the treatment, advanced training required, and the risks of treatment related complications.

Maria Liu, OD, PhD, MPH, MBA, is an associate professor of clinical optometry and founder and chief of the Myopia Control Clinic at University of California Berkeley Optometry.

Disclosures

Liu receives consulting fees from CooperVision and Essilor.

https://www.medpagetoday.com/opinion/second-opinions/101074

Midlife Omega-3 Levels Tied to Brain Structure, Cognition

 Omega-3 fatty acid concentrations in red blood cells were linked with brain structure and cognitive function in midlife, an exploratory cross-sectional study showed.

In about 2,200 people with an average age of 46, a higher omega-3 index was associated with a larger hippocampal volume and better abstract reasoning, according to Claudia Satizabal, PhD, of the University of Texas Health Science Center at San Antonio, and colleagues.

In addition, APOE4 carriers with a higher omega-3 index had a lower white matter hyperintensity burden, they reported in Neurology.

The omega-3 index combined docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) concentrations measured by gas chromatography.

The study is one of the first to identify relationships between omega-3 polyunsaturated fatty acids (PUFA), like DHA and EPA, and brain health in a younger population.

"The new contribution here is that, even at younger ages, if you have a diet that includes some omega-3 fatty acids, you are already protecting your brain for most of the indicators of brain aging that we see at middle age," Satizabal said in a statement.

Omega-3 fatty acids are obtained largely from dietary sources like cold-water, oily fish or omega-3 fortified foods, or through nutritional supplements. In the brain, DHA is incorporated into neuronal and glial cell membranes. Both DHA and EPA are metabolized into bioactive molecules involved in neurogenesis, neurotransmission, and inflammation resolution.

In older adults, observational studies have suggested that higher DHA and EPA intake may be protective for Alzheimer's disease. Omega-3 fatty acid levels also may protect older brains from environmental exposures like air pollution. Studies have linked pro-inflammatory diets, which are low in omega-3s, to brain volume and other markers of brain aging in older people.

"Despite the beneficial associations observed for brain outcomes in population-based and experimental studies, results from dietary intervention studies using omega-3 PUFA supplementation have been inconsistent," Satizabal and colleagues pointed out.

"These studies may be hampered in part by interventions that are deemed too late in the course of the disease, when individuals may have already experienced significant neuronal damage," they noted.

The researchers evaluated 2,183 predominantly middle-aged people in the Framingham Heart Study Third-Generation and Omni 2 cohorts who were dementia-free and stroke-free at baseline. Overall, 53% were women and 22% were APOE4 carriers.

Participants had brain MRI and cognitive function tests for episodic memory, processing speed, executive function, and abstract reasoning.

Higher levels of all omega-3 predictors -- EPA, DHA, and the omega-3 index -- were linked with larger hippocampal volumes when modeled continuously. Every standard deviation unit increase of log-transformed omega-3 index was related to 0.003 cm³ larger hippocampal volume relative to intracranial volume. Associations between higher omega-3 PUFA and larger hippocampal volumes remained significant after accounting for vascular risk factors.

All three omega-3 predictors were tied to better abstract reasoning test scores. Participants in the top three quartiles of EPA levels had better abstract reasoning performance than those in the bottom EPA quartile. Again, associations remained after adjusting for vascular risk factors.

Higher levels of all omega-3 predictors also were linked with reduced white matter hyperintensity volume in APOE4 carriers. Increasing EPA levels were tied to better performance in abstract reasoning tests in APOE4 carriers, but not in non-carriers.

The findings suggest that modest omega-3 consumption may be enough to preserve brain function, the researchers noted. "This is in line with the current American Heart Association dietary guidelines to consume at least two servings of fish per week to improve cardiovascular health," Satizabal said.

"These results need to be confirmed with additional research, but it's exciting that omega-3 levels could play a role in improving cognitive resilience, even in middle-aged people," she added.

Limitations include a largely white population in the study cohort and the cross-sectional design of the study, which provided only a snapshot in time, the researchers acknowledged.

Disclosures

The study was supported by the National Heart, Lung, and Blood Institute, National Institute on Aging, and National Institute of Neurological Disorders and Stroke.

Satizabal disclosed no relationships with industry. Co-authors disclosed relationships with Novartis Pharmaceuticals, OmegaQuant Analytics, Brainspan, Eisai, and Biogen.

Primary Source

Neurology

Source Reference: Satizabal CL, et al "Association of red blood cell omega-3 fatty acids with MRI markers and cognitive function in midlife: The Framingham Heart Study" Neurology 2022; DOI: 10.1212/WNL.0000000000201296.

https://www.medpagetoday.com/neurology/dementia/101080

Breakthrough Monkeypox Cases Seen Weeks After Second Jynneos Dose

 Most cases of monkeypox post-vaccination occurred within 2 weeks of the first Jynneos dose, a single-center study found, but some breakthrough cases developed weeks after a second dose of the vaccine.

Of 90 individuals who tested positive for monkeypox after a single dose of Jynneos at a large monkeypox testing and vaccination site, 77% of the cases occurred within 14 days of the first dose and 14% within 14-28 days of the first dose, reported Aniruddha Hazra, MD, of Howard Brown Health in Chicago, and colleagues.

In the eight cases occurring 28 days after vaccine initiation, five positive tests came back following a second dose of the modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine.

"Of concern is that at least two breakthrough infections were observed in individuals at least 3 weeks after a second dose," wrote Hazra and colleagues in a JAMA research letter.

MVA-BN, the Jynneos vaccine, is approved for the prevention of monkeypox disease in adults, and individuals are considered fully vaccinated 14 days after receiving the second dose.

"Early immunogenicity data around MVA-BN shows good immune response with a single dose," Hazra told MedPage Today. "Prior to moving to intradermal dosing, the public health strategy was to maximize first doses and hold off on second doses due to limited vaccine supply. We wanted to see how this approach may translate in the real world based on our experience."

In their paper, the researchers noted that "because the incubation period for monkeypox is 3 to 17 days, some of the cases occurring between 1 and 14 days after vaccination may not represent true vaccine failure," as "patients may have sought vaccination after realizing they were exposed."

Preliminary data from the CDC reported last week suggested that at-risk individuals were 14 times less likely to be infected with monkeypox at least 2 weeks after the first dose of Jynneos when compared to individuals who were eligible but didn't receive the vaccine.

During a call with reporters last week hosted by the Infectious Diseases Society of America, members of the White House Monkeypox response team urged eligible individuals to follow up with a second dose to get maximally protected.

Borrowing from a "Star Trek" reference, the team's deputy coordinator Demetre Daskalakis, MD, MPH, asked: "Why would you have your force field at level five if you can have it at level 10 against the threat?"

Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, agreed and continued the reference.

"What we have seen in the past is that if you don't get the second shot, the force field drops to zero," said Dieffenbach. "When you get a booster, you have sustained antibody response. It's an important piece of advice; I don't want people to get complacent. We do not want people to lose their force field by skipping the second shot."

The study from Hazra's group involved 7,339 individuals who were vaccinated with Jynneos at Howard Brown Health in Chicago, with 400 testing positive for monkeypox infection. Overall, 90 cases occurred at least 1 day following vaccination (median 8.5 days), including 37 cases in the 1-7 days after the first dose, 32 cases in the 8-14 days after, 13 in the 15-28 days after, and the eight cases 28 days after the initial dose.

People with HIV comprised 37% of the cases, of whom 73% were virologically suppressed (25 of 34 individuals).

Of the eight patients testing positive for monkeypox 28 days after the first dose, four had HIV, virologically suppressed in all four cases. Most of these patients had fewer than 10 lesions, and systemic symptoms included fevers, chills, myalgia, headache, fatigue, and lymphadenopathy. Three patients also had other co-infections (rectal gonorrhea, oropharyngeal gonorrhea, and rectal chlamydia).

The researchers acknowledged various limitations to the data, including that they did not include risk factors, nor did it include information on the date of monkeypox exposure. Additionally, the data were limited by the lack of uniform post-vaccination data

.Disclosures

The researchers had nothing to disclose.

Primary Source

JAMA

Source Reference: Hazra A, et al "Human monkeypox virus infection in the immediate period after receiving modified vaccinia Ankara vaccine" JAMA 2022; DOI: 10.1001/jama.2022.18320.

https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/101081