Study participants and design
This prospective cohort study enrolled adult patients in Korea with polymerase chain reaction-confirmed COVID-19 infection between February 17, 2020, and March 24, 2020, and data were collected between August 31, 2020, and March 29, 2022. Initially, 5,252 adult patients with COVID-19 infection were identified from the Daegu Center for Infectious Disease Control and Prevention registry in Daegu and contacted individually by mobile phone. After excluding deceased patients, we included those who agreed to participate and were able to visit the study hospital. Patients were recruited to be evenly distributed by age to reduce age-related bias.
Participants visited Kyungpook National University Hospital four times in the 24months following the onset or diagnosis of COVID-19. Enrolled patients were those who consented to participate and completed all four hospital visits. A survey was conducted using a modified version of the International Severe Acute Respiratory and Emerging Infection Consortium protocol, translated into Korean22 (Supplementary Table S1). Long COVID was defined by 38 symptoms: fever, chills, myalgia, arthralgia, fatigue, cough, sore throat, rhinorrhea, sputum production, dyspnea, palpitations, arrhythmia, chest discomfort, headache, dizziness, cognitive dysfunction, difficulty concentrating, amnesia, abnormal directional sensibility, seizure, paresthesia, globus pharyngeus, hallucination, insomnia, social phobia, depression, anxiety, obsessive thinking, anorexia, diarrhea, nausea or vomiting, anosmia, ageusia, tinnitus, alopecia, skin rashes, pruritis, and COVID toes.
The survey included questions on the following: sex, birth date, COVID-19 diagnosis date, COVID-19 symptom onset date, height, weight, smoking history, quarantine site during acute COVID-19 infection, oxygen treatment history including ventilator usage, extracorporeal membrane oxygenation (ECMO), dialysis at the time of hospitalization, intensive care unit admission history, COVID-19 vaccination history, underlying diseases, symptoms or diseases newly identified after COVID-19 infection, hospitalization history after acute COVID-19 infection, and COVID-19 reinfection history. Disease severity during acute COVID-19 infection was classified into five categories ranging from asymptomatic to critical illness. Clinical data, including symptoms and disease severity during acute COVID-19 infection, was confirmed using the Daegu Center for Infectious Disease Control and Prevention registry.
Long COVID was defined as having at least one newly identified intermittent or continuous symptom 3months after the initial SARS-CoV-2 infection, lasting for at least 2months, with no other explanation23. Vaccination was considered complete in patients after at least (a) 2weeks after receiving the second dose in a two-dose COVID-19 vaccine series or (b) 2weeks after receiving a single dose COVID-19 vaccine.
The study investigated the clinical characteristics of long COVID and the impact of vaccination on long COVID symptoms, focusing on quality of life and mental health using several scales. These included the EuroQol 5-dimension 5-level (EQ5D) tool, Korean version of the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) scale, and the Post-Traumatic Stress Disorder (PTSD) Checklist-5-Korean version (PCL-5-K) scores. The EQ5D score comprises five categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each category has five levels to indicate the severity of problems (none, slight, moderate, severe, and extreme). Respondents indicated their health status by selecting the most appropriate statement for each category. The scores for the five categories were then combined to form a five-digit number representing the respondents health status24. PHQ-9 is an instrument for screening, diagnosing, monitoring, and measuring the severity of depression. PHQ-9 scores were rated using a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Total score can range from 0 to 27, with high scores indicating more severe depression. Based on the original validation studies, the total score is then interpreted to represent no (04), mild (59), moderate (1014), moderately severe (1519), or severe (2027) depression. A cutoff score of 10 suggests a possible diagnosis of depressive disorder25. The GAD-7 is a seven-item self-reported instrument with each item scored on a four-point Likert scale indicating symptom frequency, ranging from 0 (not at all) to 3 (nearly every day). Total scores represent none/minimal (05), mild (610), moderate (1115), and severe (>16) anxiety symptoms. The GAD-7 score can range from 0 to 21, with a score10 indicative of generalized anxiety disorder25. The PCL-5-K consists of five, single-factor items scored dichotomously as either yes (1 point) or no (0 points). Higher scores indicate more severe symptoms, and 3 is the cutoff score for significant PTSD26. In addition to using these standardized scales, we also evaluated other changes in lifestyle habits potentially related to long COVID.
Descriptive statistics were used to assess demographic differences. Other categorical and noncategorical variables were compared using Fishers exact test, chi-square test, Students t-test, or MannWhitney U test as appropriate. Clinical characteristics were compared between the symptomatic group and asymptomatic group at 24months following acute COVID-19 infection to identify the factors affecting thedevelopment of long COVID. The frequency of each long COVID symptom was calculated at 6, 12, 18, and 24months following acute COVID-19 infection and shown as a percentage of the respondents. In addition, we conducted univariate analysis to identify the impact of vaccination on long COVID symptoms. The score distributions from PHQ-9, GAD-7, and PCL-5-K scales were compared between 12-month and 24-month timepoints after acute infection to identify the long-term impact of COVID-19 on psychiatric symptoms. The PHQ, GAD-7, and PCL-5-K scores at 12, 18, and 24months after acute COVID-19 infection were analyzed with respect to disease severity, using violin plots to show the distribution and peak of the scores from each scale. Furthermore, Sankey flow diagrams were generated to identify changes in the distribution and interaction of major long COVID symptoms over time. For all tests, differences were considered statistically significant at P<0.05. R Statistics version 4.0.2 was used for all statistical analyses (The R Foundation; https://www.r-project.org).
This study was reviewed and approved by the Institutional Review Board of Kyungpook National University Hospital (approval no.: 202102-003). All methods were performed in accordance with the relevant guidelines and regulations by including a statement in the methods section. All respondents provided digital informed consent before the questionnaire was administered.
PHILADELPHIA Children and adolescents who received one of the main COVID-19 vaccines were significantly protected from the illness and showed no increased signs of cardiac complications compared to young people who were not vaccinated, according to a new real-world study led by researchers from the Perelman School of Medicine at the University of Pennsylvania and Childrens Hospital of Philadelphia (CHOP). When the Delta variant rose to prominence, the study showed that vaccinated young people were 98 percent less likely to be infected than their unvaccinated peers, and data indicated that the vaccines effectiveness decline slightly when the Omicron variant became dominant. The paper was published today in Annals of Internal Medicine.
In their analysis of 250,000 patients, with around half of them received at least one dose of the BNT162b2 vaccine (the vaccine produced by a collaboration between Pfizer and BioNTech), the researchersled by Yong Chen, PhD, and Jeffrey Morris, PhD, both professors of Biostatistics at the Perelman School of Medicine, and Christopher Forrest, MD, PhD, a professor of Pediatrics at CHOP and Penncovered the periods in which the Delta and Omicron variants became dominant, in mid-2021 and 2022, respectively.
While previous clinical trials established that the vaccines provided strong protection against infection for children and adolescents, limited evidence of the vaccines performance existed beyond controlled settings. So, the researchers conducted one of the largest "real-world" COVID-19 vaccine studies of children and adolescents in the United States with the assistance of data from electronic health records gleaned from a national network of pediatric medical centers, known as PEDSnet.In so doing, the study provides a picture of the vaccine's effectiveness outside of controlled trial conditions, in the "real world" of visits to pediatricians, family medicine doctors, emergency departments, and more.
Our study has longer follow-up than any previous study, which enabled us to evaluate the real-world, long-term durability of vaccine protection against Delta and Omicron variants, said Chen. Further, it covered a diverse representation of U.S. pediatric populations from primary care, specialty care, emergency department, testing centers, and inpatient settings.
One of the main ideas behind the work, as stated by the studys first authorsQiong Wu, PhD, a postdoctoral research fellow at Penn Medicine and Jiayi Tong, a PhD candidate in Biostatistics at Pennwas to help address under-reporting in vaccine status to give a clearer picture of its effects.
Yet, infection prevention wasnt the studys only area of focus. The researchers also explored potential effects on risk of heart conditions.
We found no indication of increased cardiac risks during either variant phase, said Morris.
During the period of time in which the Delta variant of the SARS-CoV-2 virus emerged and became dominant, the researchers found that adolescents (defined as patients who were 12-to 20-years old) who received the vaccine were approximately 98 percent less likely to be infected or have severe disease compared to those who did not receive it, with no evidence of increased cardiac complications or significant waning infection protection over the subsequent four months.
Vaccination proved strongly protective against the Omicron wave, albeit at a lower magnitude than during Delta. Among adolescents, those who were vaccinated were roughly 86 percent less likely to be infected compared to unvaccinated peers, and their protection against severe illness and ICU admission was similarly high, being approximately 85 and 91 percent less likely, respectively, than the unvaccinated.
Among children, (those who were 5-to-11 years old at the time of vaccination during Omicron), the protection against infection was 74 percent better than unvaccinated peers. Their comparative protection against severe illness and ICU admission stood at 76 and 85 percent, respectively.
During the Omicron wave, the data showed some reduction in effectiveness in the four months following vaccination, while the vaccinated actually had a lower risk of cardiac complications during this time period.
In a follow-up study, the researchers are conducting further work to characterize the direct and indirect impacts of vaccination on outcomes tied to Long COVID, the phenomenon in which symptoms related to the illness linger for months or even years.
Additionally, the researchers believe even longer-term work is needed to better understand how well the vaccines continue to protect their recipients.
Children and adolescents were the last age group to be enrolled in COVID-19 vaccine clinical trials. Although the pandemic has been declared over, the risk of COVID-19 is present throughout U.S. communities, Forrest said. Thus, more information is needed on effectiveness of vaccination delivered to children and adolescents during more recent time periods.
This research was funded, in part, by the National Institutes of Health (OT2HL161847-01, 1R01LM012607, 1R01AI130460, 1R01AG073435, 1R56AG074604, 1R01LM013519, 1R56AG069880, 1R01AG077820, 1U01TR003709) and the Patient-Centered Outcomes Research Institutes Project Program Awards (ME-2019C3-18315 and ME-2018C3-14899).
Penn Medicineis one of the worlds leading academic medical centers, dedicated to the related missions of medical education, biomedical research, excellence in patient care, and community service. The organization consists of theUniversity of Pennsylvania Health System and PennsRaymond and Ruth Perelman School of Medicine, founded in 1765 as the nations first medical school.
The Perelman School of Medicine is consistently among the nation's top recipients of funding from the National Institutes of Health, with $550 million awarded in the 2022 fiscal year. Home to a proud history of firsts in medicine, Penn Medicine teams have pioneered discoveries and innovations that have shaped modern medicine, including recent breakthroughs such as CAR T cell therapy for cancer and the mRNA technology used in COVID-19 vaccines.
The University of Pennsylvania Health Systems patient care facilities stretch from the Susquehanna River in Pennsylvania to the New Jersey shore. These include the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Chester County Hospital, Lancaster General Health, Penn Medicine Princeton Health, and Pennsylvania Hospitalthe nations first hospital, founded in 1751. Additional facilities and enterprises include Good Shepherd Penn Partners, Penn Medicine at Home, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.
Penn Medicine is an $11.1 billion enterprise powered by more than 49,000 talented faculty and staff.
Moderna on Monday said 2023 product sales hit $6.7 billion, slightly above the companys latest guidance for at least $6 billion, down 63.6% from 2022. Sales for 2023 also beat the consensus estimate for $6.3 billion, according to FactSet.
The announcement, which came ahead of a presentation by Moderna executives at J.P. Morgans annual healthcare conference scheduled for Monday afternoon, largely repeated guidance that the company laid out in early November.
Moderna said its Covid-19 vaccine sales were $6.1 billion for the year. The balance of the product sales consisted of about $600 million the company said it received as deferred revenue related to its supply agreements with GAVI, The Vaccine Alliance, an international nongovernmental organization that provided Covid-19 vaccines to low- and middle-income countries.
Moderna said it had cash, cash equivalents, and investments of more than $13 billion at the end of 2023, up from $12.8 billion as of Sept. 30, 2023.
The company also said its Covid-19 vaccine has had 48% of the U.S. market share in the current winter season so far, up from 37% in 2022, a sign of commercial success in a shrinking market competitor Pfizer .
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Moderna stock jumped 1.2% on Monday. Moderna shares have suffered a steep selloff since mid-2021, amid declining investor expectations around the long-term value of its Covid-19 vaccine, but the stock has been climbing in recent months, and is up 49.1% since the start of November.
Moderna said again on Monday that it expects revenue to drop again to just $4 billion in 2024, for sales to begin to grow again in 2025, and for the company to break even in 2026.
The company continues to expect regulatory approvals for its respiratory syncytial virus vaccine for older adults to begin in the first half of this year. That shot will compete with similar products from GSK and Pfizer , though Moderna says that it believes its shot will be more convenient for providers.
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Moderna also expects data from a Phase 3 study of a new refrigerator-stable Covid-19 vaccine in the first half of the year, and data from a Phase 3 study of a vaccine that protects against both flu and Covid-19.
We are preparing for the launch of Modernas second product, our RSV vaccine. 2024 is going to be an exciting year for the Company with multiple milestones across our nine late-stage programs, Moderna CEO Stphane Bancel said in a statement. Through these product launches, we are focused on returning to sales growth in 2025.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
Health
Boston wastewater data reveals that theres been a concerning spike in COVID-19 cases and medical professionals are urging Bostonians to get vaccinated.
The weekly average of COVID-19 found in wastewater south of Boston was 2,110 copies per milliliter whereas north of Boston was looking at 2,084 copies in the most recent data update. While this isnt a whole lot compared to numbers seen in early 2021, there still is a marked increase from the early November data.
The Department of Public Health reported there were 5,955 confirmed cases of COVID-19 last week, a marked increase from the 2,121 new cases in a week in early November.
The physicians of the Massachusetts Medical Society are seeing a concerning and marked rise in cases of influenza and COVID-19 among out patients, said Barbara Spivak, the president of the Massachusetts Medical Society to The Boston Herald. It is not too late in the season to get vaccinated against the flu and to get the most updated COVID-19 vaccines, and we urge people to contact their health care provider to schedule an appointment to do so as soon as possible.
According to the website COVID Act Now, the Boston area has a medium level of COVID threat with an increase in cases and people admitted to the hospital, according to the websites data.
Transmissible diseases may be a nuisance over the course of a few days and not trigger serious symptoms in most healthy people, but it is critically important to take every available measure to protect those among us who are most vulnerable, said Spivak.
Masks are being urged by local businesses and community hubs, with Boston hospitals renewing their mask policy before the end of 2023.
A location to find a COVID-19 booster or vaccination can be searched here.
According to USAFacts, 95% of Bostons population has received at least one dose of the COVID-19 vaccine. 84% are fully vaccinated as of May 2023 and 44% have received the full dosage of the vaccine and a booster.
Stay up to date on all the latest news from Boston.com
Moderna's announcement, which came ahead of its presentation at the annual JPMorgan Healthcare Conference, shows the steep drop in demand for Covid products last year as cases and public concern about the virus dwindled from their pandemic peaks. Weakening demand for the company's shot, its only commercially available product, led shares of Moderna to fall nearly 45% last year.
Roughly $6.1 billion of Moderna's revenue related to the shot came from sales of the vaccine. Another $600 million was deferred revenue related to the company's work with Gavi, a nongovernmental global vaccine organization that coordinated a global shot distribution program, Moderna said in a release.
Moderna, during its third-quarter earnings report in November, forecast at least $6 billion in full-year Covid vaccine sales, but did not provide a range for that guidance. Notably, that forecast did not include contributions from Gavi, Moderna CFO Jamey Mock told CNBC during an interview.
In August, before the rollout of its latest version of the jab, the company said it expected the shot to rake in between $6 billion and $8 billion in revenue.
The company noted that the vaccine won 48% of the U.S. Covid vaccine market share last year. That's up from the 37% market it captured in 2022.
The size of the U.S. market for Covid shots in 2023 is likely around 40 million and 60 million doses during the fall and winter season, which is consistent with what the nation saw in 2022, according to Mock.
But the biotech company expects sales from the shot to drop even further in 2024. It reiterated its companywide full-year sales guidance of roughly $4 billion on Monday. Notably, that forecast includes revenue from its vaccine against respiratory syncytial virus, or RSV, which could win U.S. Food and Drug Administration approval in April.
Moderna said it expects to return to sales growth in 2025 with the launch of new products. The company currently has 45 products in development, nine of which are in late-stage trials. They include Moderna's combination shot targeting Covid and the flu, which could win approval as early as 2025.
Mock said combination vaccines should be "very helpful" in terms of providing more convenience to patients and health-care providers and reducing the costs of goods sold, among other factors, which might have a positive impact on Covid vaccination rates overall.
The company said it expects to "break even" by 2026.
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Two hurdles mRNA drugs face are a short half-life and impurities that trigger immune responses. BlackJack3D/iStock via Getty Images Plus
Vaccines have been reliably and affordably protecting people from diseases worldwide for centuries. Until the COVID-19 pandemic, however, vaccine development was still a long and idiosyncratic process. Traditionally, researchers had to tailor manufacturing processes and facilities for each vaccine candidate, and the scientific knowledge gained from one vaccine was often not directly transferable to another.
But the COVID-19 mRNA vaccines brought a new approach to vaccine development that has far-reaching implications for how researchers make drugs to treat many other diseases.
I am a biochemist, and my lab at UMass Chan Medical School focuses on developing better ways to use mRNA as a drug. Although there are many possibilities for what researchers can use mRNA to treat, some important limitations remain. Better understanding how mRNA-based drugs interact with the immune system and how they are degraded in human cells can help lead to safe, durable and effective treatments for a wide range of diseases.
Messenger RNA, or mRNA, is made of four building blocks denoted by the letters A, C, G and U. The sequence of letters in an mRNA molecule conveys genetic information that directs how a protein is made.
An mRNA drug comprises two essential components: mRNA molecules, which code for desired proteins, and the lipid molecules such as phospholipids and cholesterol that encapsulate them. These mRNA-lipid nanoparticles, or LNPs, are tiny spheres about 100 nanometers in diameter that protect mRNA from degradation and facilitate its delivery into target cells.
Once inside cells, mRNA molecules instruct the cells machinery to produce the target protein required for a desired therapeutic effect. For example, the mRNA in the Pfizer-BioNTech and Moderna COVID-19 vaccines directs cells to produce a harmless version of the virus spike protein that trains the immune system to recognize and better prepare for potential infection.
From a drug development perspective, mRNA drugs offer significant advantages over traditional drugs because they are easily programmable. Hundreds of pounds of mRNA can be made from readily available DNA templates, such that producing a different mRNA drug is as simple as changing the corresponding DNA templates.
More importantly, different mRNA drugs produced by the same set of methods will have similar properties. They will be delivered to the same tissues, trigger similar levels of immune responses and degrade in similar ways. This predictability significantly reduces the development risks and financial costs of developing mRNA drugs.
In addition to being easy to program, mRNA drugs have several other unique properties. For example, just like the mRNAs your body naturally produces, therapeutic mRNAs have a short half-life in cells: about one day. As a result, current mRNA technology is ideal for treatments that arent meant to last long in the body.
This is why vaccines are popular candidates for mRNA technology: They provide long-term protection against disease after brief exposure to the drug with few side effects. There are currently more than 30 mRNA vaccine candidates, not including vaccines for COVID-19, in clinical trials.
Another critical feature of mRNA drugs is their intrinsic ability to stimulate the immune system. This may sound paradoxical after all, your cells already contain large amounts of mRNAs. Why would other mRNAs activate your immune system? How does your immune system distinguish between self and nonself mRNAs?
The first reason involves location. Therapeutic mRNAs enter cells using endosomes sacs made of the cells membrane that take in materials from the cells environment. Your immune system can detect mRNA in endosomes because this is usually a sign of an RNA virus infection cellular mRNAs normally dont enter endosomes. When your immune system labels therapeutic mRNAs as viral material, it triggers a strong inflammatory response that can lead to severe side effects.
One solution to this problem is to modify mRNAs building blocks specifically, changing the U, or uridine, to its chemical cousins, pseudouridine and N1-methylpseudouridine. This subtle chemical change prevents the unwanted immune response while allowing the therapeutic mRNA to direct the cell to make the protein it encodes. The 2023 Nobel Prize in physiology or medicine was awarded to the scientists who made this breakthrough discovery. Both the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines use this technique.
The second source of unwanted immune response is impurities from mRNA production. To prepare mRNA from a DNA template, scientists use a protein called RNA polymerase that tends to make a small amount of side product called double-stranded RNA. Unlike mRNA, which is single-stranded, double-stranded RNA has two chains that form a double helix. RNA viruses also form double-stranded RNA when they replicate, and exposing cells to double-stranded RNA can lead to a strong immune response.
Removing double-stranded RNA is challenging, especially at the industrial scale. Fortuitously, for mRNA vaccines, the residual amount of double-stranded RNA can stimulate the immune system to enhance antibody responses. However, for applications other than vaccines, a cleaner RNA product is necessary to reduce side effects.
Although mRNA has the potential to transform drug development for various medical purposes, careful consideration is required to identify targets that align with the technologys strengths.
For example, because there is currently a limit to how long mRNA can last in the body, treatments that need a protein to be present for only a short period of time to achieve a lasting therapeutic effect are ideal. One promising example in development is using mRNA that encodes CRISPR-Cas9 gene-editing proteins to knock out genes that cause specific diseases.
Researchers are exploring this strategy to develop a single-dose treatment for hereditary transthyretin amyloidosis, a rare genetic disease caused by the accumulation of misfolded proteins in the heart and nerves. This disease is an ideal target for mRNA-based CRISPR gene therapy because the target protein is produced by the liver. Because most drugs pass through the liver, this makes it easier to deliver CRISPR-Cas9 mRNA to its target. In the next few years, a new generation of more precise mRNA-based genome editing therapies will enter clinical trials.
For treatments that need a specific protein to be present in the body for long periods of time or need to prompt little to no immune reaction, further advancements in mRNA technology are necessary to extend mRNAs half-life and eliminate immune-triggering contaminants. Notable new developments in these areas include using computational algorithms to optimize mRNA sequences in ways that enhance their stability and engineering RNA polymerases that introduce fewer side products that may cause an immune response.
Further advancements have the potential to enable a new generation of safe, durable and effective mRNA therapeutics for applications beyond vaccines.
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Florida’s surgeon general on Wednesday officially called for a halt “to the use of mRNA COVID-19 vaccines,” citing a discredited theory that has been debunked by federal and global health officials.
In a statement released by the Florida Department of Health, Surgeon General Joseph Ladapo said he previously raised questions about the safety of the COVID-19 vaccines with the Food and Drug Administration (FDA), but the agency provided “no evidence” to refute his claims.
Last month, Ladapo wrote to the FDA and the Centers for Disease Control and Prevention (CDC) alleging that DNA fragments from the Pfizer and Moderna mRNA vaccines could “integrate” with the DNA of the person they’re injected into, causing a host of harmful side effects.
“DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome,” Ladapo said, alleging the FDA did not adequately assess those risks.
“If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings. … It is my hope that, in regard to COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome,” Ladapo said.
In a letter responding to Ladapo, the FDA refuted each of his assertions and noted that there have been over one billion shots administered worldwide, and no safety concerns related to residual DNA have been identified.
Peter Marks, director of FDA’s Center for Drug Evaluation and Research, essentially accused Ladapo of spreading misinformation.
“On first principle, it is quite implausible” that the vaccines could contaminate someone’s DNA, Marks wrote. “Perpetuating references to this information about residual DNA without placing it within the context of the manufacturing process is misleading.”
Marks said the FDA stands by the safety and efficacy of the vaccines, and there is substantial evidence they reduce severe disease and death. He warned that false and misleading information leads to low uptake.
“The challenge we continue to face is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake,” Marks wrote. “Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19.”
Ladapo was appointed by Gov. Ron DeSantis (R) in 2021 and has been vocal about his opposition to federal health policies. He has previously cast doubt on the safety and efficacy of COVID-19 shots.
This is also not the first time he has clashed with federal health officials.
In 2022, Ladapo recommend against healthy children receiving the COVID-19 vaccines. Last year he recommended against anyone younger than 65 getting new COVID-19 vaccine boosters. In response, the CDC and FDA warned Lapado that he was fueling vaccine hesitancy and harming Florida’s seniors.
DeSantis is running for president and has made a name for himself on the national stage by publicly feuding with the Biden administration’s top health officials over COVID-19 policy.
Significance of Vaccination in Mitigating COVID-19 Severity in Young People
A recent study has underscored the importance of COVID-19 vaccination in reducing the severity of the disease in children and teens. The research found that those who received the vaccine demonstrated high protection against moderate and severe COVID-19 cases throughout the duration of the pandemic. This proves the efficacy of the vaccines in curbing not only the spread but also the severity of the disease among the younger population.
Notably, the research also revealed a reduced risk of cardiac complications in the vaccinated group, particularly in the context of the Omicron variant. This is a crucial finding that further underscores the benefits of vaccination, as it suggests that vaccines can help to prevent potential heart issues that could arise as a result of a COVID-19 infection.
Many parents and guardians have questions and concerns about the impacts of the COVID-19 vaccine on their children. However, health experts emphasize the necessity of vaccination in young children to prevent severe disease. The COVID-19 vaccines currently available in the U.S. have undergone rigorous testing and have been found to be safe and effective for use in children.
While vaccination significantly reduces the risk of severe disease, some children may be more prone to severe COVID-19 infection due to certain risk factors. A study in Germany identified obesity, Trisomy 21, being between five and 11 years of age, neurological neuromuscular diseases, and coinfections as factors that increased the risk of severe infection in children and adolescents. The study noted a decrease in hospitalization and ICU admission rates during the Omicron variant circulation, which was attributed to reduced virulence and higher vaccination coverage.
Despite the increased transmissibility of newer variants such as the JN1, infections have generally been causing less severe disease than earlier in the pandemic. However, the threat of long COVID remains significant, with some recovering patients experiencing persistent symptoms months after their initial infection. This further emphasizes the importance of vaccination to guard against severe disease and potential long-term health complications.
In the United States, the National Vaccine Injury Compensation Program (VICP) provides liability protections to vaccine manufacturers and administrators under the National Childhood Vaccine Injury Act of 1986. However, COVID-19 vaccines are covered under the Countermeasures Injury Compensation Program (CICP), not the VICP. The CICP provides benefits to individuals who sustain a covered serious physical injury as a direct result of the administration or use of covered countermeasures.
In conclusion, with the available data, it is clear that vaccination plays a pivotal role in mitigating the impact of COVID-19, especially in children and teenagers. It not only aids in reducing the severity of the disease but also lowers the risk of cardiac complications. Hence, vaccination should be considered a crucial part of the global strategy against COVID-19.
Unveiling the Effectiveness of COVID-19 Vaccines for Young People
As the world continues to grapple with the ongoing pandemic, the role of COVID-19 vaccines in safeguarding our children and adolescents has been a topic of much discussion and study. A real-world study spearheaded by researchers from the Perelman School of Medicine at the University of Pennsylvania and Childrens Hospital of Philadelphia has shed significant light on this crucial issue. The study, which examined the effects of the COVID-19 vaccines on children and adolescents, found that these vaccines provide significant protection against the illness and do not increase the risk of cardiac complications in these young recipients.
The study spanned the periods when the delta and omicron variants were dominant and encompassed a sample of 250,000 patients, about half of whom had received at least one dose of the BNT162b2 vaccine. The results were rather encouraging. Vaccinated young people were found to be 98% less likely to contract the delta variant and 86% less likely to be infected with the omicron variant. Furthermore, there was no indication of increased cardiac risks during either variant phase, countering some of the concerns raised about potential cardiac complications from the vaccines.
While the vaccines effectiveness did decline slightly against the omicron variant, it still offered substantial protection. Even amidst the rise of the omicron variant, vaccinated individuals maintained a lower risk of cardiac complications. This highlights the vaccines continued relevance and necessity, despite the emergence of new variants.
The study underlines the critical role that vaccinating children and adolescents plays in controlling the viruss spread and safeguarding public health. Besides providing direct protection to the vaccinated individuals, it also contributes to building the community-wide immunity necessary to curb the pandemic.
The researchers are not stopping here. They are carrying out additional work to assess the direct and indirect impacts of vaccination on outcomes tied to long COVID, a condition where COVID-19 symptoms persist for weeks or even months after the acute illness has resolved. Also, they believe that further research is necessary to understand how well the vaccines continue to protect their recipients, especially considering the newer variants. As our knowledge about the virus and its variants continues to evolve, so will our strategies to combat it. Vaccination remains a potent tool in our arsenal, and studies like this underscore its effectiveness and importance in our fight against this global health crisis.
Cases of three major respiratory viruses — the flu, COVID-19 and RSV — are surging in the U.S., pushing the country toward a feared “tripledemic” during its first post-pandemic respiratory viral season.
Optimism was high this autumn as the U.S. headed into the viral season. The national arsenal against these viruses had vaccines against RSV for the first time, newly updated COVID-19 vaccines, and the flu “immunity debt” that plagued children in 2022 was history.
But now, confidence is waning. Accessing the vaccine for RSV, or respiratory syncytial virus, has been a struggle for many, and enthusiasm for the new COVID-19 vaccines turned out to be abysmal. COVID-19 hospital admissions have been rising since November and wastewater detection indicates most sites — 69 percent — are seeing large increases in virus levels.
Flu activity across the country is currently “elevated and continues to increase in most parts of the country,” according to the latest update from the Centers for Disease Control and Prevention (CDC). And vaccine uptake for the flu seems to be lagging, with the CDC saying nearly 8 million fewer people got the shot by mid-December compared to the same period in 2022.
During the first couple of years of the pandemic, flu activity remained low, attributed to the precautionary measures that communities took to mitigate the viral spread of COVID. The 2022-23 flu season appeared to mark a return to normal flu levels.
Only about a fifth of U.S. adults say they’ve received the newest COVID-19 shot, according to polling from KFF. Uptake for the previous bivalent shots was similarly low and many Americans likely haven’t been immunized since receiving their first doses in 2020 or 2021.
“We’re definitely seeing an increase in the number of flu cases, COVID-19. They’re both surging right now,” said Luis Ostrosky, chief of infectious diseases and epidemiology with UTHealth Houston and Memorial Hermann.
Speaking on the RSV cases he’s seen in the Houston area, Ostrosky said infections appeared to surge earlier in December, though he is still seeing a “steady” number.
“This is so alarming that it prompted CDC to send out a health alert towards the end of December reminding all clinicians to really work on getting patients vaccinated and, when they have symptoms, tested so that they can access therapy if they need it,” Ostrosky noted.
Available RSV data from the CDC does seem to suggest test positivity peaked toward the end of November, with the positivity rates for antigen and PCR tests just beginning to drop in recent weeks.
Hopes were high that the approval of two RSV vaccines for seniors and a preventive monoclonal antibody for infants would help keep cases low this season.
But Sanofi, the maker of the monoclonal antibody Beyfortus, said in October that “unprecedented demand” had led to short supply, leading the CDC to advise doctors to reserve doses for their highest-risk patients.
And RSV vaccine uptake among seniors appears rather lackluster, with CDC data suggesting only about 10 percent of nursing home residents had gotten immunized against the virus by mid-December.
“The numbers are not looking good,” said Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, of the three circulating viruses.
“I think when we get some new numbers for the last week, it’s going to be sort of continued trends in the same direction and increased activity across all of those conditions,” added Plescia.
A holiday “bump” in cases is to be expected following weeks of year-end travel. AAA estimated in December that more than 115 million people in the U.S. would be traveling 50 miles or more from home during the festivities.
Amid all the travel, Plescia lamented that social norms which he hoped became commonplace following the pandemic appeared to have been largely abandoned.
“I think we’re kind of going back to, you know, the old approach of people don’t stay home when they’re sick,” said Plescia. “And they think it’s sort of a minor thing and the thought that they might infect somebody else just doesn’t really occur to them.”
Masking has also become rare once again, though Plescia noted many hospital systems are bringing back mask requirements amid the rise in respiratory viruses. These hospital-enacted requirements may be more easily accepted by communities than those issued by the government, and Plescia expects to see more like them in the future.
While cases are rising, Plescia said his organization hasn’t yet heard of any health systems around the country being unduly stressed by the respiratory viral situation.
“That is sort of the first concern with some kind of ‘tripledemic’ is that we would have so many people getting sick that hospitals would become overwhelmed either because they didn’t have enough beds or they didn’t have enough staff to care for that number of people. We’re not hearing that we’re approaching that, but that is the thing that we’re most concerned about,” he said.
Ostrosky is optimistic case rates will begin to go down soon after a potential holiday bump, with past winter peaks indicating a drop sometime in early January. He emphasized it is still worthwhile to get tested if you experience symptoms because there is now a plethora of therapeutics available for treating these infections.
Going forward, Plescia also recommended that more focus be placed on vaccinations among health care workers.
“That’s important not just because we don’t want health care workers to get sick and give it to their patients but also, you know, when you have a lot of health care workers getting sick, this whole capacity thing becomes problematic,” Plescia said.
“Because what we’re hearing now is that hospitals are less concerned about not having enough beds. They’re more concerned about having enough health care workers to staff those beds.”
