Category: Covid-19 Vaccine

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Revisiting tips to prevent COVID-19 infection as Long Island cases rise – Newsday

July 24, 2024

When the virus that causes COVID-19emerged in 2019, no one had protectiveimmunity. Nearly five years later, most of the United States population has some immunity, either because ofvaccination,infectionor both.Inmost cases, COVID-19illnesses now are less severe than in the early days of the pandemic.

But the coronavirus remains a public health threat, according to the Centers for Disease Control and Prevention. And on Long Island and statewide,positive tests for COVID-19 have been on the rise since late spring.

The CDC's recommendations from how to prevent getting infected orpassing the viruson to someone else, to symptoms and therapeutic treatments remain largely the same.

The coronavirus that causes COVID-19 isstill transmitted by airborne particles and droplets, according to the CDC. The risk of infection increases with close or prolonged contact with an infected person, especially in indoor or crowded settings.

The CDC has long recommended vaccination against the virusas the best way to prevent serious illness from COVID-19. Vaccination also provides some protection from initial infection.Avoiding close contact with others if infected, masking in crowded indoor spaces and hand washing can also prevent infection, the CDC says.

In most cases, yes, experts say.CDC recommendations call foreveryone 6 months and older to get an updated 2024-2025 COVID-19vaccine to protect against potentially serious complications of the diseasethis fall and winter. Getting an updated version of the vaccine is important because it will be better able to protect against new variants of the virus that causes COVID-19. Also, the protection from a vaccine declines over time. The updated COVID-19 vaccines will be available later this year from Moderna, Novavax, and Pfizer, most likely in September or October.

Dr. Bruce Farber, chief of epidemiology and public health with Northwell Health, recommended taking the vaccine as soon as its available.

"Its a long time since weve had a vaccine for many of us, its going to be a year," he said. Because Long Islanders and Americans in general have done a "remarkably poor" job keeping up with vaccinations in recent years, he recommended signing up to take the flu vaccine at the same time as the one against COVID-19.

People with COVID-19 can be infectious from 1 to 2 days before and up to 8 to 10 days after symptoms begin, according to the CDC. The majority of transmission appears to occur during the early periods of infection, particularly in the 1 to 2 days before symptoms start and within the first few days of their onset.

Yes. Symptoms include fever, chills, cough, shortness of breath, fatigue, muscle aches, headache, loss of taste or smell, sore throat, nasal congestion or rhinorrhea, vomiting, diarrhea and skin rashes. However, not everyone infected experiences these symptoms.

Anyone with symptoms who is planningtoattenda gathering or visitsomeoneespecially vulnerable to illness, like anelderly person or the very young or immunosuppressed, should take a COVID-19 test, experts said.

But test wisely, Farber said. "The rapid tests that we now rely on are no longer particularly good at diagnosing COVID, with these newer variants that are circulating," he said. A positive result still likely means infection, but false negatives are possible with rapid tests, also known as antigen tests. For that reason, especially if you have symptoms but negative results, "if you want to test reliably, you need to do a PCR." The PCR testsare generally administered by a health care professional and results take longer, but they offer what the CDC calls the "gold standard" of accuracy.

Not necessarily. If you have COVID-19 symptoms, you should stay home until they improve, according to the CDC. But since March, the agency has advised that people can return to work and regular activities if their symptoms are mild and improving and its been at least a day since theyve had a fever. "If you go out, think about wearing a mask," said Dr. Sharon Nachman, division chief of pediatric infectious disease at Stony Brook Children's Hospital.

Dr. Aaron Glatt, chair of the Department of Medicine and chief of infectious diseases at Mount Sinai South Nassau hospital, said "youre probably contagious" if you test positive, even if you feel fine. At a minimum, Glatt said, consider the risk profile of the people you might be around and tell them youve been sick. Consider that "Most people wont want to be around you" if theres a chance you can get them sick too, he said.

Start by exercising common sense, said Nachman. "If you have a fever, you should be home drinking fluids and taking it easy." If you have no fever, see how your body responds to walking up the stairs: "if you are air hungry or getting short of breath then no exercise."

Antiviral treatments like Paxlovid have been shown to reduce hospitalizations and deaths among older people and people with underlying health conditions when taken soon after COVID-19 symptoms start. But "for people who are under 60 and healthy, theres no evidence" to indicate their use, said Glatt.

The experts say yes. New York State testing data shows that positive tests have been on the rise statewide and Long Islandwide since late spring, though the latest Long Island rate of 16.9 cases per 100,000 people is well below the January high of 72.3. Whats going on? "We are seeing new variants, and its possible that our current variant is more infectious than the prior one," Nachman said. Also, she said, "People have lost some immunity to COVID over the last year, so perhaps theyre a little more susceptible than last year." Changes in behavior like more socializing could also play a role, she said. However, "hospitalization rates and death rates are not up significantly," Farber said. "Most people are recovering very well."

Nicholas Spangler is a general assignment reporter and has worked at Newsday since 2010.

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Revisiting tips to prevent COVID-19 infection as Long Island cases rise - Newsday

Long-term risk of autoimmune diseases after mRNA-based SARS-CoV2 vaccination in a Korean, nationwide, population-based cohort study – Nature.com

July 24, 2024

Study population

The primary cohort was established by combining the National Health Insurance Service (NHIS) and Korea Disease Control and Prevention Agency (KDCA) databases, which comprised the healthcare data of >99% of the entire Korean population and their COVID-19 diagnosis and vaccination profiles. In total, 9,258,803 individuals who had received at least one dose of the mRNA-based COVID-19 vaccine were included (Fig.1). As COVID-19 vaccines have been administered nationwide in South Korea, the proportion of unvaccinated individuals was minimal13. Therefore, the use of unvaccinated individuals as comparators could have resulted in improper cohort selection and potential selection bias. We consequently established a historical control cohort within mRNA-vaccinated individuals, but the observational period was shifted back 2 years from the date of the first dose of mRNA vaccination of the historical control cohort. In total, 4,445,333 and 4,444,932 patients were included in the vaccination and historical control cohorts, respectively, and all were observed for 1 year. The baseline demographic and general health characteristics of each cohort are summarised in Table1. The covariates were well-balanced after the inverse probability of treatment weighting (IPTW). The COVID-19 vaccination profiles, such as the type of mRNA vaccine or history of non-mRNA vaccination, are summarised in Supplementary Table1. The mean follow-up times for the vaccination and historical control cohorts were 471.2466.16 days and 471.2866.15 days, respectively.

This nationwide population-based cohort study combined data from the Korea Disease Control and Prevention Agency (KDCA) and the COVID-19 National Health Insurance Service (NHIS) cohort (K-COV-N cohort). The study included approximately 20% of the total South Korean population. This primary cohort comprised all individuals vaccinated with at least one dose of the mRNA-based COVID-19 vaccine (BNT162b2, Pfizer-BioNTech; mRNA-1273, Moderna) until 31 December 2022. Subsequently, half of the primary cohort was extracted to establish the vaccination cohort, and the study index was defined as the date of the first dose of the mRNA-based COVID-19 vaccine. A historical control cohort was established by extracting the other half of the primary cohort as the control, and its study index was assigned as the date of the first dose of the mRNA-based COVID-19 vaccine minus 2 years. A total of 4,445,333 vaccination and 4,444,932 control cohorts were selected and observed until 31 December 2022 and 31 December 2020, respectively. Abbreviations: COVID-19, Coronavirus 2019 disease.

Cumulative incidence plots for the AI-CTDs are shown in Fig.2, with Supplementary Fig.1 providing additional details, including cumulative incidence for positive and negative control outcomes, as well as the cumulative number of events for each time point. The risks of developing incident AI-CTDs in the vaccination and historical control cohorts are shown in Fig.3. To mitigate the risk of type I error induced by multiple comparisons, we employed a Bonferroni correction for 27 predefined outcomes and used an adjusted 99.81% confidence interval (99% CI) to determine statistical significance. Individuals who had the mRNA COVID-19 vaccine did not incur higher risks of developing most AI-CTDs such as alopecia areata (adjusted hazard ratio [aHR], 1.00; 99% CI, 0.961.04), alopecia totalis (aHR, 0.79; 99% CI, 0.680.93), psoriasis (aHR, 0.80; 99% CI, 0.770.84), vitiligo (aHR, 0.95; 99% CI, 0.881.02), anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (aHR, 1.09; 99% CI, 0.721.66), sarcoidosis (aHR, 1.06; 99% CI, 0.781.44), Behcet disease (aHR, 0.69; 99% CI, 0.580.82), Crohns disease (aHR, 0.92; 99% CI, 0.771.09), ulcerative colitis (aHR, 0.97; 99% CI, 0.871.08), rheumatoid arthritis (aHR, 0.86; 99% CI, 0.840.89), systemic sclerosis (aHR, 1.01; 99% CI, 0.731.38), Sjogrens syndrome (aHR, 1.07; 99% CI, 0.961.18), ankylosing spondylitis (aHR, 0.95; 99% CI, 0.871.04), dermato/polymyositis (aHR, 1.02; 99% CI, 0.771.35), and bullous pemphigoid (BP) (aHR, 1.53; 99% CI, 0.902.60). However, individuals in the mRNA vaccination cohort were at considerably higher risk of developing systemic lupus erythematosus (SLE) (aHR, 1.16; 99% CI, 1.021.32) than those in the historical control cohort.

The cumulative incidence plot shows the cumulative incidences of autoimmune connective tissue diseases in mRNA-based COVID-19 vaccination cohort and historical control cohort. The shaded area shows a 95% confidence interval for the cumulative incidences. Additional information, including cumulative incidence for positive and negative control outcomes, as well as the cumulative number of events for each time point, was presented in Supplementary Fig.1. Abbreviation: ANCA, anti-neutrophil cytoplasmic antibody; COVID-19, coronavirus disease 2019.

To minimise the differences in baseline characteristics between the vaccination and historical control cohorts, predefined covariates, including demographics, socioeconomic status, and comorbidities, were balanced using inverse probability of treatment weighting. Subsequently, the incidence in the vaccination cohort compared to that in the historical control cohort was estimated using multivariable Cox proportional hazards analysis after adjusting for all predefined covariates. The forest plot depicts adjusted hazard ratios (aHRs) in individuals with mRNA-based COVID-19 vaccination compared with historical controls, with the confidence interval (CI) adjusted to 99.81% for Bonferroni correction but presented as 99% CI for simplicity. The point estimate (centre) represents the aHR, and the horizontal line (error bar) shows the range of the 99% CI. The incidence rate was calculated as the number of events divided by 10,000 person-years, with the population at risk also presented. Abbreviations: aHR, adjusted hazard ratio; ANCA, antineutrophil cytoplasmic antibody; CI, confidence interval; COVID-19, coronavirus disease 2019; HR, hazard ratio.

To validate these findings, we evaluated the risks of positive and negative control outcomes associated with mRNA vaccination. For the positive control outcomes, the risk of myocarditis (aHR, 7.20; 99% CI, 4.3711.86), pericarditis (aHR, 2.75; 99% CI, 1.953.88), and GuillainBarre syndrome (aHR, 1.62; 99% CI, 1.162.25) were considerably higher in the vaccination cohort than in the historical control cohort (Fig.3). Conversely, the risk of having negative control outcomes was not considerably higher in the vaccination cohort than in the historical control cohort (benign skin tumour (aHR, 1.02; 99% CI, 1.001.05), melanoma in situ (aHR, 1.21; 99% CI, 0.642.29), and tympanic membrane perforation (aHR, 0.84; 99% CI, 0.770.91)).

In subgroup analyses, we compared the vaccination and historical control cohorts stratified by sex, age (<40 vs. 40), type of mRNA-based COVID-19 vaccine (BNT162b2, PfizerBioNTech vs. mRNA-1273, Moderna), cross-vaccination status with any history of non-mRNA COVID vaccination (ChAdOx1 nCoV-19 [AZD1222], OxfordAstraZeneca or Ad26.COV2.S, JanssenJohnson & Johnson, or others) prior to mRNA vaccination, and any history of COVID-19 diagnosis. In general, there were no significant differences between the two cohorts in the subgroup analyses for most outcomes (Figs.45), with Supplementary Figs.211 providing additional details for each stratified analysis. However, women who had received the mRNA vaccine had a significantly higher risk of developing BP (aHR, 2.67; 99% CI, 1.116.42) (Fig.4a, b). In addition, aged 40 years who had undergone mRNA vaccination tended to have a higher risk of developing BP (aHR, 1.53; 99% CI, 0.902.61) (Fig.4c, d). In the stratified analysis based on the type of mRNA vaccine received, individuals who received the BNT162b2 vaccine had a significantly higher risk of developing SLE (aHR, 1.18; 99% CI, 1.021.36) (Fig.5a, b). In addition, cross-vaccination with non-mRNA vaccines did not independently affect the incident risk of any AI-CTDs (Fig.5c, d). In analyses according to the status of COVID-19 diagnosis, the incidence was not higher for almost all AI-CTDs, except SLE in individuals with COVID-19 diagnosis (aHR, 1.23; 99% CI, 1.051.44) (Supplementary Figs.6 and 7).

The forest plot depicts adjusted hazard ratios (aHRs) and 99% confidence intervals (CIs) in individuals with mRNA-based COVID-19 vaccination compared with historical controls. The point estimate (centre) represents the aHR, and the horizontal line (error bar) shows the range of the 99% CI. The incident risks of autoimmune disorder outcomes were stratified by sex ((a) Male or (b) Female) and age ((c) <40 years or (d) 40 years). Additional details, including unadjusted HRs and population at risk, were provided in Supplementary Figures.; Male subgroup (Supplementary Fig.2), female subgroup (Supplementary Fig.3), subgroup aged <40 years (Supplementary Fig.4), and subgroup aged 40 years (Supplementary Fig.5). Abbreviations: aHR, adjusted hazard ratio; ANCA, antineutrophil cytoplasmic antibody; CI, confidence interval; COVID-19, coronavirus disease 2019.

The forest plot depicts adjusted hazard ratios (aHRs) and 99% confidence intervals (CIs) in individuals with mRNA-based COVID-19 vaccination compared with historical controls. The point estimate (centre) represents the aHR, and the horizontal line (error bar) shows the range of the 99% CI. The incident risks of autoimmune disorder outcomes were stratified by the type of mRNA vaccine ((a) BNT162b2 or (b) mRNA-1273) and the history of cross-vaccination ((c) Only mRNA vaccination or (d) Cross-vaccination with non-mRNA vaccination (AZD12222 or Ad26.COV2.S)). Additional details, including unadjusted HRs and population at risk, were provided in Supplementary Figures.; Subgroup who received the BNT162b2 vaccine (Supplementary Fig.8), subgroup who received the mRNA-1273 vaccine (Supplementary Fig.9), subgroup who received only mRNA-based vaccines (Supplementary Fig.10), and subgroup who had a history of cross-vaccination with any non-mRNA vaccines (Supplementary Fig.11). Abbreviations: aHR, adjusted hazard ratio; ANCA, antineutrophil cytoplasmic antibody; CI, confidence interval; COVID-19, coronavirus disease 2019.

In total, 2,284,342 individuals had the booster mRNA vaccination (3rd dose of mRNA vaccination) among the vaccination cohort. In extended Cox proportional hazard analyses treating booster vaccination as time-varying covariate, the risk of alopecia areata (aHR, 1.12; 99% CI, 1.051.19), psoriasis (aHR, 1.16; 99% CI, 1.061.27), and rheumatoid arthritis (aHR, 1.14; 99% CI, 1.081.21) were greater in individuals who had booster vaccination compared to those who had not (Fig.6).

The forest plot depicts adjusted hazard ratios (aHRs) with 99% confidence intervals (CIs) in individuals within the vaccination cohort according to prior history of booster vaccination, defined by the administration of 3rd additional dose of the mRNA-based COVID-19 vaccine following the completion of the two-dose primary series of the same mRNA-based COVID-19 vaccine. The point estimate (centre) represents the aHR, and the horizontal line (error bar) shows the range of the 99% CI. Among the vaccination cohort, 2,284,342 individuals were vaccinated with a booster dose and the extended Cox proportional hazard analyses treating booster vaccination as a time-varying covariate were conducted for the variability of vaccination status during the observation period. The numbers of events of autoimmune disorder outcomes and population at risk were presented for each group divided based on booster vaccination status, with the number of events specifically shown before and after the booster vaccination in the individuals with booster vaccination group. Abbreviations: aHR, adjusted hazard ratio; ANCA, antineutrophil cytoplasmic antibody; CI, confidence interval; COVID-19, coronavirus disease 2019; HR, hazard ratio.

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Long-term risk of autoimmune diseases after mRNA-based SARS-CoV2 vaccination in a Korean, nationwide, population-based cohort study - Nature.com

Teen disputes federal immunity in forced COVID vaccination lawsuit – Carolina Journal

July 24, 2024

A Guilford County teenager and his mother challenge the argument that a federal law blocks their lawsuit over the teens forced COVID vaccination. They filed a new brief Tuesday with the North Carolina Supreme Court, which agreed in May to hear the case.

Mother Emily Happel and son Tanner Smith sued the Guilford County school board and Old North State Medical Society over the forced vaccination in 2021.

Lower courts have ruled against Happel and Smith. Those courts have determined that the federal Public Readiness and Emergency Preparedness Act offered immunity to the school board and medical society.

In the instant case, the particular facts and circumstances do not give rise to the types of liability for which Congress was attempting to provide immunity, wrote David Steven Walker, the mother and teens lawyer. The PREP Acts purpose was to provide for quick action when all the answers may not be readily apparent during a time of emergency. It was to promote that by providing immunity for negligent acts, for unknown side-effects, and for other matters directly related to the countermeasures (such as breakdowns in crowd control).

However, in this case, defendants assert immunity for a willful act the administration of a medical procedure without the required consent of the patient or the patients parent, Walker added. This was not the type of act for which Congress was seeking to provide immunity, and this Court should find that immunity does not exist.

Congress made this clear in the Emergency Use Authorization Act, when it required as a condition for authorization of an unapproved product [a]ppropriate conditions designed to ensure that individuals to whom the product is administered are informed of the option to accept or refuse administration of the product, he wrote.

Happel and Smiths brief also highlighted state law.

Just as Congress envisioned individuals to be able to refuse administration of a EUA vaccine, the General Assembly made it crystal clear that parents could also make that decision for their children, Walker wrote. At the time of the vaccine administration to Tanner, the law of the land of North Carolina required parental consent.

Defendants view of the PREP Act is so sweeping that it would sweep this important act of the General Assembly into the dustbin as a statute that states nothing more than an aspirational goal, rather than a concrete and enforceable mandate, Walker added.

The intent of Congress, when reading the Act as a whole, was to limit the liability for adverse effects and promote the quick development and deployment of the countermeasure, not to give carte blanche to medical providers to perform medical procedures without consent, Walker wrote. To hold otherwise would violate the canon against absurdities.

A May 23 order confirmed that the state Supreme Court would take up the case from Happel and Smith, who was 14 when he faced the forced vaccination. Justices signaled that they would consider a single issue: Whether the trial court and the Court of Appeals erred when they determined that the PREP Act provided immunity to the defendants for constitutional violations and pre-empted all state law claims.

The case has attracted attention from eight Republican members of North Carolinas House of Representatives. They filed a brief on April 12 urging the high court to take the case.

They have a special interest in protecting the fundamental rights of the parents they represent and for whom the General Assembly has recently enacted legislation on the very subject embraced by this appeal, wrote Tyler Brooks of the Thomas More Society, who represents the eight legislators.

As members of the General Assembly, they have a unique role in ensuring that local governmental bodies, particularly those charged with public education or who otherwise interact with children, abide by and are governed according to North Carolina state law, Brooks added. In this same vein, they further have a strong interest in ensuring that the enactments of the General Assembly are upheld against erroneous findings of federal preemption, as occurred in the instant case.

The Guilford school board and Old North State Medical Society filed separate documents asking North Carolinas highest court not to take the case.

The school boards court filing asked the court to reject claims from Happel and Smith on the grounds that the alleged constitutional questions are not real and substantial and that the subject matter of this case does not involve legal principles of major significance to the jurisprudence of this State or raise issues of significant public interest.

[T]he direct issue before the Court of Appeals is not a substantial constitutional question rather, it is a straightforward application of federal statutory immunity, which applies to the same degree to state law claims and state constitutional claims, and which is not at all an issue of first impression, the Guilford schools lawyers wrote. In fact, the idea of federal law overriding contrary state constitutional provisions appears in the U.S. Constitution itself, which expressly states that federal law supersedes both contrary state laws and state constitutions.

Even the specific idea of the PREP Act immunizing against constitutional claims is not a new one, the court filing added. Guilfords brief cited a 2024 decision from the 9th US Circuit Court of Appeals holding that, through the PREP Act, Congress expressly foreclosed federal constitutional claims related to covered countermeasures.

Happel and Smith filed a petition on April 5 asking the states highest court to take their case.

The pandemic that occurred from 2020-2022 caused a seismic shift in the social, medical, political, and legal landscape of not only the State of North Carolina, not only the United States, but the world as a whole, Walker wrote. How the government chose to deal with the pandemic, especially concerning the administration of vaccines that had been granted emergency use authorizations, was and is a hotly contested issue, one that is certainly of significant public interest.

This public interest is even more significant when the issue revolves around the vaccination of a minor and the allegation that neither the minor nor the minors parent consented to the administration of the vaccine, Walker added.

The case deals with the interplay between duty of the courts of North Carolina to remedy constitutional and other legal violations and a federal law that defendants purport forecloses that opportunity, Walker wrote.

The trial court and the Court of Appeals interpreted the PREP Act so broadly as to shield nearly every act, no matter how egregious, from any legal consequence, according to the petition. Further, the Court of Appeals and the trial courts decision rendered totally useless N.C. Gen. Stat. 90-21.5(a1) which prohibited the very acts committed by defendants. It is now a law of aspiration, with no consequence for its blatant violation.

The quoted state law NCGS 90-21.5(a1) says, Notwithstanding any other provision of law to the contrary, a health care provider shall obtain written consent from a parent or legal guardian prior to administering any vaccine that has been granted emergency use authorization and is not yet fully approved by the United States Food and Drug Administration to an individual under 18 years of age.

The Appeals Court issued a unanimous March 5 decision against the mother and son despite labeling the forced vaccination egregious.

Plaintiffs argue the trial court erred in determining that the PREP Act is applicable to this case and provides immunity to both Defendants, Judge April Wood wrote. Due to the sweeping breadth of the federal liability immunity provision in the PREP Act, we are constrained to disagree.

Bound by the broad scope of immunity provided by the PREP Act, we are constrained to hold it shields Defendants, under the facts of this case, from Plaintiffs claims relating to the administration of the COVID-19 vaccine, Wood added.

In August 2021, Smith was a 14-year-old Western Guilford High School football player. His family learned in a letter from the Guilford schools that Smith might have been affected by a COVID-19 cluster involving the team. He would not be allowed to return to practice until getting a COVID test.

Free testing would be provided at Northwest Guilford High School. The letter indicated ONS Medical Society would conduct the testing and consent for testing is required, Wood wrote.

Smiths stepfather drove him to the testing site and waited outside the building. The teenager was asked to fill out a form while a clinic worker tried unsuccessfully to contact his mother. Smith and his family didnt know the clinic also provided COVID-19 vaccine shots.

After failing to make contact with Tanners mother, one of the workers instructed the other worker to give it to him anyway. Tanner stated he did not want a vaccine and was only expecting a test, but one of the workers administered a Pfizer COVID-19 vaccine to him, Wood wrote.

Happel and Smith filed suit in August 2022. A trial judge dismissed the case in March 2023.

Appellate judges ruled that both the school board and medical society were covered by the federal PREP Act. A declaration from the secretary of the US Department of Health and Human Services in March 2020 offered protection related to the COVID-19 vaccine.

[W]e hold ONS Medical Society is a covered person as a program planner that administered a vaccine clinic, and individually administered vaccines to individuals. The declaration clearly provides that a program planner may be a private sector employer or community group when it carries out the described activities including administration of a covered countermeasure, Wood wrote.

The same law also applied to the Guilford school board. We are convinced by the Secretarys interpretation in the declaration that a covered person under the PREP Act includes a state or local government . . . [that] provides a facility to administer or use a Covered Countermeasure. We hold this language includes the Board, which provided a facility Northwest Guilford High School for the administration of the COVID-19 vaccines, Wood wrote.

Wisely or not, the plain language of the PREP Act includes claims of battery and violations of state constitutional rights within the scope of its immunity, and it therefore shields Defendants from liability for Plaintiffs claims, Wood added.

The Appeals Court noted that North Carolinas General Assembly amended state law in 2021 to require parental consent before a vaccine granted emergency use authorization may be administered to a minor.

Its intent is to prevent the egregious conduct alleged in the case before us, and to safeguard the constitutional rights at issue Emilys parental right to the care and control of her child, and Tanners right to individual liberty, Wood wrote. Notwithstanding, the statute remains explicitly subject to any other provision of law to the contrary under the broad provision preempting state law in the PREP Act.

The PREP Act provides only one exception for a Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct. Because Plaintiffs have not made any such allegations in their complaint, we are constrained to conclude the PREP Act preempts the protections provided by state law, Wood wrote.

Judges Allegra Collins and Jeff Carpenter joined Woods decision.

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Teen disputes federal immunity in forced COVID vaccination lawsuit - Carolina Journal

Corneal nerve fiber morphology following COVID-19 infection in vaccinated and non-vaccinated population – Nature.com

July 24, 2024

SARS-COV-2 virus infection has been described to have significant impact on nearly all organs in the human body, primarily because of the direct influence of the virus and the extensive inflammatory response it triggers2. Many ophthalmic complications associated with viral infection have been recorded, including conjunctivitis, keratoconjunctivitis, dry eye disease, episcleritis, acute macular neuroretinopathy, venous and arterial retinal vascular occlusion, optic neuritis, intraretinal hemorrhages, uveitis, and endogenous endophthalmitis20,21,22,23. Several studies have reported neurological manifestations associated with COVID-19, including effects on the peripheral nervous system. The SARS-CoV-2 virus has been shown to potentially affect nerves and cause various neurological symptoms24,25,26.

Previous authors reported increased corneal DC density and altered nerve fiber morphology in patients with and without long COVID-19. The difference was more pronounced in post-COVID patients with neurological symptoms at 4weeks7. Our previous study demonstrated peripheral small nerve fiber damage in the cornea associated with inflammatory DCs even after mild COVID-19 disease6.

To date, there is no direct evidence to support the theory that COVID-19 vaccines have neuroprotective effects. However, the vaccines may indirectly provide some neuroprotective benefits by reducing the risk of COVID-19 infection and its potential neurological complications. While the direct neuroprotective effects of COVID-19 vaccines are not yet fully understood, there is some evidence to suggest that vaccination may be associated with a lower risk of cognitive decline and dementia. A study published in the Journal of Alzheimer's Disease found that individuals who received the influenza vaccine had a lower risk of developing dementia compared to those who did not receive the vaccine. It is important to note that the COVID-19 vaccines are a new development, and long-term studies on their potential neuroprotective effects are still ongoing27. However, based on the available evidence, getting vaccinated against COVID-19 is an important step in reducing the risk of infection and potentially reducing the risk of neurological complications.

Besides the benefits of vaccines, several studies reported corneal complications following the administration of the COVID-19 vaccine including corneal graft rejection, herpes zoster ophthalmicus, herpes simplex keratitis, keratolysis and peripheral ulcerative keratitis28. Authors explained their findings with the vaccine-induced immunomodulation and that the increased vascular permeability following vaccination impairs the corneal immune privilege29,30. Significantly higher DC density of DC was observed in the non-vaccinated group compared to the control group. We observed a statistically significant difference in the size of mature DCs but the size of immature DCs did not differ significantly among the 3 groups. The area of mature DCs was the greatest in the non-vaccinated group followed by the vaccinated COVID-19 group, and the difference between the three groups was statistically significant. A previous case report demonstrated a highly elevated mature DC density during COVID-19 infection (237.532.13 cells/mm2) and activated DC clumps around corneal infiltrates as a result of an immune-mediated mechanism31.

The present investigation has certain limitations that should be taken into consideration when interpreting the outcomes. First, due to the low number of cases, we were unable to examine the differences between the vaccinations, and most of the study participants received not only mRNA-based vaccines but also vector-based and attenuated pathogen-containing vaccines or a combination of them. While a larger study population would always be advantageous, our numbers are similar to previously published cross-sectional comparative investigations3,5,6,7. Similarly powered studies support the relevance of our results. Second, since the SARS-CoV-2 virus changes over time causing various disease types with different severities, the included patients might have been affected by multiple virus variants. It should be emphasized that the vaccine is not neuroprotective in the absence of COVID-19 infection. However, in our study, a reduction in neurodegenerative complications was observed in vaccinated patients compared to unvaccinated patients, possibly due to a milder course of infection. Third, while our study identified statistically significant differences in corneal nerve fiber morphology between vaccinated and non-vaccinated individuals after COVID-19, it is crucial to acknowledge the substantial overlap on the graphs. This overlap suggests that despite the observed differences, the distributions of the nerve plexus parameters in the study groups largely coincide. Consequently, the clinical significance of these findings may be limited, as the overlapping spread indicates that individual variations within each group are considerable.

Our study investigated the role of the vaccine against COVID-19 in terms of the subbasal nerve fibers of the cornea, thus indirectly the peripheral nervous system. Our findings showed that corneal nerve fiber density, nerve branch density, nerve fiber length, nerve fiber total branch density, nerve fiber area and width was increased among the vaccinated subjects compared to the unvaccinated COVID-19 group. Corneal dendritic cell density and area were elevated in the unvaccinated group compared to the vaccinated patients within six months after the infection. In summary, our results suggest that SARS-CoV-2 vaccination may have a protective effect against the complications of COVID-19 disease on the corneal subbasal nerve fibers.

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Corneal nerve fiber morphology following COVID-19 infection in vaccinated and non-vaccinated population - Nature.com

No increase in birth defects found following COVID vaccination in pregnancy – University of Minnesota Twin Cities

July 24, 2024

A new study adds to the growing body of literature demonstrating the safety of COVID-19 vaccine use in pregnant women. The study, published in BMJ, showed no connection between COVID vaccination or infection in the first trimester of pregnancy and congenital birth defects.

The study is based on outcomes seen among 343,066 live-born single infants in Sweden, Denmark, and Norway with an estimated first trimester of pregnancy occurring from March 1, 2020, to February 14, 2022. The infants were followed up for at least 9 months after birth.

In the entire cohort, 17,704 infants (5.2%) had a major congenital anomaly, or 516 per 10,000 live births. Congenital anomalies included congenital heart defects; nervous system anomalies; eye anomalies; ear, face and neck anomalies; respiratory anomalies; oro-facial clefts; gastrointestinal anomalies; abdominal-wall defects; congenital anomalies of the kidney and urinary tract; genital anomalies; and limb anomalies.

A total of 10,229 infants (3% of the total) were exposed to COVID-19 infections during the first trimester of pregnancy. There was no increased risk for congenital defects associated with infection, with an adjusted odds ratio of 0.96 (95% confidence interval [CI], 0.87 to 1.05).

In general, first-trimester infections with COVID-19 were associated with mothers who had more children, lower educational level, and lower household income level, and were born in the Middle East or Africa.

The authors found that 29,135 of 152,261 infants (19%) included in a vaccination analysis were exposed to COVID-19 vaccination during the first trimester. All vaccines were two-dose mRNA vaccines.

"Mothers vaccinated against COVID-19 during the first trimester had higher education and household income, were more likely to have an underlying chronic disease, and were more likely to be overweight or obese," the authors said.

The authors found no significant increased risk of any major congenital anomaly among infants whose mothers were vaccinated against COVID-19 during the first trimester, with an adjusted odds ratio of 1.03 (95% CI, 0.97 to 1.0).

Overall, our findings support the current recommendations to vaccinate pregnant women against COVID-19.

"We add to the current evidence with our results showing that there appears to be no robust evidence of an increased risk of any of the subgroups of congenital anomalies," the authors concluded. "Overall, our findings support the current recommendations to vaccinate pregnant women against COVID-19."

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No increase in birth defects found following COVID vaccination in pregnancy - University of Minnesota Twin Cities

The U.S. Government and Gavi, the Vaccine Alliance – KFF

July 24, 2024

Key Facts

Created in 1999 and formally launched in January 2000, Gavi, the Vaccine Alliance (Gavi) is an independent public-private partnership and multilateral funding mechanism that aims to save lives and protect peoples health by increasing coverage and equitable and sustainable use of vaccines. Gavis main activities include supporting low- and middle-income countries access to new and underused vaccines for vulnerable children through financial support, technical expertise, and market-shaping efforts, such as negotiating with manufacturers, to help lower the cost of procuring vaccines. Gavi operates in five-year funding cycles, with a revised strategy and goals for each cycle. Each five-year strategy is accompanied by a vaccine investment strategy, which determines which vaccines will be made available to countries.

Gavis current five-year strategy, for the 2021-2025 period, which is its fifth strategy, includes four core goals:

1. introduce and scale-up vaccines,

2. strengthen health systems to increase equity in immunization,

3. improve sustainability of immunization programs, and

4. ensure healthy markets for vaccines and related products.

The current strategy emphasizes reducing the number of zero-dose children with the goal of reaching no zero-dose children by 2030; prioritizing programmatic and financial sustainability of country immunization programs; supporting countries that have phased out of Gavi support or have never been eligible for Gavi support; and providing more tailored approaches for Gavi countries to reach under-vaccinated populations, such as those living in remote or conflict settings, by encouraging countries to adopt strategies that reduce potential barriers to vaccination. Gavi is currently in the process of developing its sixth strategy.

In addition to Gavis role in routine childhood immunizations, Gavi was one of the organizations leading COVAX, a multilateral effort that supported the equitable development, procurement, and delivery of COVID-19 vaccines globally that began in 2020 and ended in 2023. Gavis role in COVAX was to facilitate the procurement and delivery of COVID-19 vaccines, with particular emphasis on low- and middle-income countries. Provision of COVID-19 vaccines and funding support to countries has now been integrated into Gavis regular programming; however, COVID-19 vaccine support will be discontinued after 2025.

Gavis Secretariat, with its main headquarters in Geneva and an office in Washington, D.C., carries out the day-to-day operations of the partnership. Gavi does not have program offices or staff based in recipient countries but rather relies on country health ministries and World Health Organization (WHO) regional offices to implement programs. Gavi is led by a Chief Executive Officer (CEO), currently Sania Nishtar.

The 28-member Gavi Board sets Gavis funding policies and strategic direction, and monitors program implementation. It includes 18 representative seats, nine seats for independent individuals, and one ex-officio non-voting seat for Gavis CEO. The 18 representative seats, as specified in Gavis statute, are as follows: donor country governments (5), implementing country governments (5), the WHO, the United Nations Childrens Fund (UNICEF), the World Bank, and the Bill & Melinda Gates Foundation, and one seat each for civil society groups, the vaccine industry in industrialized countries, the vaccine industry in developing countries, and technical health/research institutes. Additionally, several Board committees guide and advise the Board and the CEO on Gavi activities under their purview. The U.S. government is currently represented on Gavis Board as the Board member for the donor country government constituency and is a member of the Audit and Finance Committee, Programme and Policy Committee, and the Market-Sensitive Decisions Committee.

Since its 2000 launch, Gavi has received approximately $30 billion in financing, not including funding for COVAX (see Table 1). Approximately four-fifths (80%) of Gavis funding came from contributions provided by donor governments and private organizations and individuals. The top three government donors were the United Kingdom, the U.S. and Norway, while the largest private donor was the Gates Foundation.

Donors support Gavi through direct contributions as well as funding commitments to innovative financing mechanisms, the proceeds of which help support Gavis overall financing. These innovative financing mechanisms include the International Finance Facility-Immunisation (IFFIm) and the Pneumococcal Conjugate Vaccine (PCV) Advance Market Commitment (AMC). The IFFIm was created in 2006 and uses donor funding commitments to back the issuance of special bonds in capital markets, essentially providing up-front financing to Gavi. The PCV AMC began in 2010, and though it ended in 2020, it supported accelerated access to pneumococcal vaccines through up-front funding commitments from donors and continues to do so through contracts with manufacturers that extend until 2029. The U.S. does not provide support to either of these mechanisms.

In addition to financing Gavis regular activities, donors pledged additional resources to support the Gavi COVAX Advance Market Commitment (COVAX AMC), a financial mechanism within COVAX that supported low- and middle-income countries through procurement and distribution of COVID-19 vaccines; through 2023, Gavi received $12.3 billion from donor governments, private philanthropy, and innovative financing mechanisms for the COVAX AMC for vaccine procurement, delivery, and logistics.

Only low- and middle-income countries with a Gross National Income (GNI) per capita below or equal to $1,730 on average over the last three years are eligible for Gavi support. In 2023, 54 countries were eligible for Gavi support; these included 23 of the 25 U.S. priority countries for maternal and child health assistance.

Recipient countries governments are expected to share responsibility for funding their national immunization efforts through Gavis co-financing requirements (introduced in 2008), determined according to country income level and transition status.As countries develop economically, they are expected to contribute a greater share of the funding required for immunization programs.Countries below the threshold (average of $1,730 GNI per capita over the past three years) and classified as low-income by the World Bank are initial self-financing countries, while countries below the threshold and classified as lower-middle income by the World Bank are in preparatory transition. Initial self-financing countries are responsible for co-financing the equivalent of $0.20 per dose each year. Countries in preparatory transition gradually increase their co-financing contribution each year. When a countrys income rises above the GNI per capita threshold, it moves into an eight-year accelerated transition period of increasing domestic financing share, after which the country is expected to fully fund its own immunization programs. As of 2023, 19 countries have transitioned out of Gavi financial support.

Additionally, as part of its 2021-2025 strategy, the Gavi Board approved limited support for countries that have transitioned out of Gavi eligibility and for middle-income countries (MICs) that have never been eligible for Gavi support. Recognizing that many formerly and never Gavi-eligible countries experience low coverage rates and have yet to make key vaccine introductions, an initial investment of $281 million was approved to provide limited support for 19 former and 26 never Gavi-eligible countries for political advocacy related to immunization, technical assistance, targeted assistance to reach under-vaccinated communities, and financial support for one-off costs and vaccine introductions.

Gavi provides grant financing to country programs in the following five areas:

Country allocations include funding ceilings, representing the maximum available funding each country can apply for during the 2021-2025 period, for all areas of support except vaccines. These ceilings are formulated based on a countrys number of zero-dose children, under-immunized children, birth cohort, and GNI per capita. For vaccines, all countries are required to pay a share of the cost of their Gavi-supported vaccines.

Additionally, Gavi has provided country support through emergency response funding, including: support for Ebola vaccination, allowing for up to $200 million in reprogrammed Gavi support for the COVID-19 response in Gavi-eligible countries, and other support for the COVID-19 response including the creation of COVAX (which helped expand access to COVID-19 vaccines in lower-income countries) and the COVID-19 Vaccine Delivery Partnership (CoVDP, which aimed to improve COVID-19 vaccine coverage in certain COVAX countries, with a particular emphasis on countries that were below 10% coverage in January 2022). In 2022, Gavi supported 40 outbreak response vaccination campaigns.

Since its launch in 2000, Gavi has provided approximately $23 billion to support country immunization programs (not including funding for COVAX). Over the past three years, 2020-2023, more than $7.3 billion has been disbursed, most of which has been for vaccine support (60%), followed by health systems strengthening (13%) (see Table 2).

Gavi reports it has helped to immunize more than 1 billion children in supported countries, including more than 68 million in 2022 alone, and supported 40 different vaccine introductions and preventive campaigns and 40 outbreak response campaigns in 2022. Additionally, Gavi support has helped avert more than 17.3 million deaths and contributed to more than $220 million in economic benefits, since its launch in 2000. Additionally, according to Gavi, its support has led to improved child health and immunization indicators across its supported countries. For example, the average vaccine coverage across multiple key Gavi-supported vaccines including the human papillomavirus (HPV) vaccine, inactivated polio vaccine, and pentavalent vaccine (the vaccine providing protection against diphtheria, tetanus, pertussis, hepatitis B, and Hib), among others was 56% in Gavi-supported countries in 2022, up from 48% in 2019 and higher than the global average of 53%. Lastly, Gavis work has contributed to vaccine market-shaping; for example, Gavi reports that its influence has helped lower the cost of the HPV vaccine from a price per dose of $4.50 in 2015 to $2.90 in 2022.

The U.S. government has supported Gavi since its creation. President Clinton made the initial U.S. pledge to the newly formed partnership in 2000, and the U.S. provided its first contribution in 2001. Currently, the U.S. supports Gavi through financial contributions, participation in Gavis governance, and by providing technical assistance. It also supports other global immunization that complement Gavis activities.

The U.S. has supported Gavi through direct contributions every year since 2001. Over the last 10 years, U.S. contributions grew from $175 million in FY 2014 to $300 million in FY 2024, which is the highest amount appropriated to Gavi thus far (see figure). Additionally, the U.S. recently pledged at least $1.58 billion to Gavi over the next five years as a sign ofsupport for Gavis upcoming replenishment. Congress provides funding for U.S. contributions to Gavi through the Global Health Programs account at the U.S. Agency for International Development (USAID), specifically within the maternal and child health budget line. See the KFF budget tracker and the KFF fact sheet on the U.S. Global Health Budget: Maternal & Child Health (MCH) for details on historical appropriations for Gavi.

Additionally, in response to the COVID-19 pandemic, the U.S. provided $4 billion in FY 2021 emergency funding to Gavi COVID-19 vaccine procurement and delivery support under COVAX, making the U.S. the largest donor to COVAX (33% of $12.3 billion received overall). In addition to its financial support for COVAX, the U.S. donated the largest number of COVID-19 vaccines to other countries.

A U.S. government representative (from USAID) is currently a Board member of the donor government constituency on the Gavi Board. The U.S. government is also represented on the Gavi Boards Audit and Finance Committee, Programme and Policy Committee, and Market Sensitive Decisions Committee.

The U.S. also provides Gavi with technical support and expertise in the design, implementation, and evaluation of its programs in the field through partnerships with several U.S. agencies. For example, Gavis accelerated vaccine introduction programs have been conducted with technical support from the Centers for Disease Control and Prevention (CDC) and USAID, along with other partners.

Multilateral support of Gavi is one component of a broader set of global immunization activities of the U.S. government. The U.S. also provides bilateral (country-to-country) support for immunization through USAID, CDC, and other agencies, which focuses on strengthening routine immunization systems to deliver vaccines. U.S. multilateral and bilateral vaccine support are intended to be complementary. Indeed, many of the countries in which the U.S. carries out bilateral global immunization activities (provided as part of USAIDs maternal and child health efforts) also receive support from Gavi. See the KFF fact sheets on U.S. global MCH efforts and U.S. global polio efforts.

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The U.S. Government and Gavi, the Vaccine Alliance - KFF

How Can You Stay Protected From COVIDs Summer Surge? – AARP

July 24, 2024

Unlike influenza, RSV and other common respiratory illnesses, COVID-19 is not sitting out the summer season.

In many areas of the U.S., COVID cases, emergency department visits and hospitalizations are increasing. And adults 65 and older are especially feeling the impact of the summer surge, according to a recent report from the Centers for Disease Control and Prevention (CDC). At the end of June, hospitalization rates for this age group were roughly 14 times higher than for adults under 50.

While COVID continues its summer spread, fueled by highly contagious variants, infectious disease experts say older adults can do some things to protect themselves from falling ill from an infection.

If the last time you rolled up your sleeve for a COVID vaccine was last fall, you may be eligible for another shot this summer.

The CDC in February recommended that all adults 65 and older receive one additional dose of the vaccine that was updated and introduced in September. (People who are immunocompromised were already eligible for additional doses of the COVID-19 vaccine.) And William Schaffner, M.D., professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine, said its not too late to take advantage of this recommendation now if you didn't back in the spring.

Protection wanes over time, Schaffner says. And for [older people], who are frail, who have chronic underlying conditions, people who are immune compromised, by now their protection has diminished. So you can get another [shot] now, and then this fall, you can get the updated vaccine also.

Indeed, vaccine manufacturers are working on a new version of the coronavirus vaccine for 2024-2025 that targets the variants of the virus currently circulating and causing a significant share of infections in the U.S. The updated vaccines are expected in early fall around the same time the annual flu shot becomes available.

The COVID-19 vaccine currently available in pharmacies and clinics targets a coronavirus variant that is no longer circulating widely. Nevertheless, the vaccine still looks pretty good in protecting against severe disease, even when up against the newer variants, Schaffner says. Fortunately, these variants are all part of the omicron family, he adds, meaning they share similar traits. Omicron burst onto the scene in late 2021, and its descendants have been circulating ever since.

Wondering if its better to go ahead and get a shot now or wait until fall? Talk to your doctor, who can help you weigh your personal risks. You should also talk to your doctor if you are under 65 and worried about complications from COVID.

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How Can You Stay Protected From COVIDs Summer Surge? - AARP

Headed Back to School in 2024: An Update on Childrens Routine Vaccination Trends – KFF

July 24, 2024

Routine vaccination rates for kindergarten children ticked down during the COVID-19 pandemic and have yet to rebound while exemptions from school vaccination requirements have increased, likely contributing to a recent surge in measles cases. At the same time, vaccine hesitancy, fueled in part by vaccine misinformation, increased during the pandemic, and public opinion on vaccine requirements has become increasingly partisan. Vaccine policies have emerged as an election issue, with both former President Trump and Independent candidate Robert F. Kennedy (RFK) Jr. embracing anti-vaccination attitudes and contributing to vaccine misinformation. This is in sharp contrast to current President Biden who has supported vaccine mandates and taken action to expand access to vaccines for both children and adults. This issue brief further explores this changing landscape by examining the latest trends in childrens routine vaccination rates, the factors contributing to recent vaccination trends, and policy approaches to increasing vaccination rates as children head into a new school year. Key takeaways include:

The share of kindergarten children up to date on their vaccinations ticked down during the pandemic and has yet to rebound back to pre-pandemic levels. Datacollected and aggregated annually by the CDC from state and local immunization programs found that, during the 2022-2023 school year, 93% of kindergarteners had been vaccinated with all state-required vaccines, including MMR, DTaP (diphtheria, tetanus, and acellular pertussis), polio, and varicella. This is similar to the previous school year but lower than pre-pandemic levels (95%). For the third year in a row, the MMR vaccination rate fell below the Healthy People 2030 target rate of 95%, the level needed to prevent community transmission of measles, a highly contagious and life-threatening virus. This means approximately 250,000 school children were unvaccinated and unprotected against measles, and research shows the more unvaccinated children in a school, the larger risk of an outbreak becomes. While noting that widespread measles transmission risk remains low, the Centers for Disease Control and Prevention (CDC) reported 97 cases of measles in the first quarter of 2024, which is seventeen times more than the number in the first quarter of 2023.

Nearly three-quarters (37) of states had MMR vaccination rates below the target rate of 95% for the 2022-2023 school year, an increase from 28 states during the 2019-2020 (pre-pandemic) school year. Further, 12 states and D.C. reported rates below 90% for the 2022-2023 school year; in the 2019-2020 school year, only three states had MMR vaccination rates below 90%. Overall, MMR coverage rates among kindergarteners for the latest school year ranged from 81.3% in Idaho to 98.4% in Mississippi. There can also be variation in vaccination coverage within states, and, when there are clusters of unvaccinated people within a specific community, the risk of an outbreak is higher, as occurred in New York City in 2018-2019.

Changes in state vaccination policies can have implications for childrens vaccination rates. As of 2023, all states and DC require children to be vaccinated against certain diseases, including MMR, in order to attend public schools, though exemptions are allowed in certain circumstances. All statesallowa medical exemption, and 46states(including D.C.) allow for a religious or personal belief exemption (or both).In recent years, some groups and state legislators have pushed to relax requirements and expand vaccine exemptions for school children. For example, some states have proposed requiring schools to include exemption information in all communications about vaccines, eliminating non-medical exemptions in child-care settings, and establishing a childrens vaccination Bill of Rights that emphasizes religious freedom. While many of these efforts have been unsuccessful or are still pending, some bills have become state law. Debate and hesitancy over COVID-19 vaccine mandates has spilled over into attitudes towards requiring vaccines for public schools, likely increasing exemptions and challenges to school vaccine requirements.

As vaccination rates for kindergarten children slightly declined, the share of kindergarten children with an exemption from one or more required vaccination slightly increased. The share of children claiming an exemption from one or more vaccinations rose from 2.5% in the 2019-2020 (pre-pandemic) school year to 3.0% in the 2022-2023 school year, the highest national exemption rate to date. While a seemingly very small increase, any increases in exemptions limit the overall share of children able to be vaccinated and make it more difficult to reach vaccination rate goals. Non-medical exemptions accounted for most of the exemptions. Non-medical exemptions increased from 2.2% to 2.8% while medical exemptions actually declined slightly from 0.3% to 0.2% from 2020-2021 to 2022-2023. The 2020-2021 school year was the lowest point for exemptions claimed during the pandemic era, with the share of children reporting any exemption dipping to 2.2% before rising to 3.0% by the 2022-2023 school year.

Overall, most states (36) have experienced an increase in the share of kindergarteners claiming an exemption for one or more vaccines since the pandemic began. Ten states in the 2022-2023 school year had exemption rates over 5%, meaning those states could not reach vaccination coverage rates at or above 95% even if all non-exempt children were vaccinated. However, rates shown here are for exemptions to one or more vaccines, so potentially achievable coverage rates could vary by vaccine type. In the reporting of this data, the CDC notes they did not asses the cause of the rise in exemptions, meaning the increases could mean a rise in vaccine hesitancy or an increase in issues accessing vaccines. Higher exemption rates are associated with lower vaccination coverage rates, meaning states with more children claiming exemptions report lower vaccination coverage rates. Studies have also shown that increases in exemption rates are associated with increased risk for disease outbreaks.

The impact of the pandemic on vaccination rates for other age groups (beyond kindergarteners) is more mixed, but data show widening disparities. The latest data from a CDC surveyof teens ages 13-17 (National Immunization Survey (NIS) -Teen) shows that vaccination coverage rates have lagged for some birth cohorts but not others. The latest data for young children (aged 24 months) from another CDC survey(NIS Child) shows that overall vaccination rates remained stable during the pandemic but disparities persisted, with the gap in vaccination rates between children living below poverty and children with higher household incomes widening. Another literature review found pandemic-related declines in routine vaccinations across a number of age groups and noted that the pandemic exacerbated existing disparities in vaccination rates.

Flu vaccination rates for children are over three times higher than COVID-19 vaccination rates. While both the flu and COVID-19 vaccines are included in the Advisory Committee on Immunization Practices (ACIP) recommended pediatric immunization schedule, they are not required for school attendance, and some states have even banned student COVID-19 vaccine mandates. The cumulative share of children ages six months through 17 with a flu vaccine during the 2023-2024 season was 54% while share with the updated 2023-2024 COVID-19 vaccine was 15%. Some of this variation in uptake may reflect parental views and concerns.KFFs COVID-19 Vaccine Monitorfrom September 2023 found most parents said they would not get their child the new COVID-19 vaccine including six in ten parents of teenagers (those between the ages of 12 and 17), and two-thirds of parents of children ages 5 to 11 (64%) and ages 6 months to 4 years old (66%). Larger shares of parents said they were confident in the safety of both the flu vaccine (68%) and the RSV vaccine (63%) compared to the COVID-19 vaccine (48%). Further, overall childrens flu vaccination coverage declined during the pandemic and has yet to rebound back to pre-pandemic levels.

There are a number of factors contributing to recent vaccination trends, including shifts in public opinion and rising vaccine hesitancy, potentially fueled by vaccine misinformation. A KFF Health Misinformation Tracking Poll in March 2024 found that about one in five parents had heard the false claim that a measles vaccine is more dangerous than getting the measles. While most of the public correctly viewed the claim as probably or definitely false, a majority expressed at least some uncertainty. This echoes findings of previous KFF research and highlights the pervasiveness of false and inaccurate informationand its impact on vaccination rates. While confidence in vaccines remained high, KFF polling in September 2023 found that three in ten adults said parents should be able to decidenot to vaccinate their children against MMR, even if that may create risks for others. This was up from 16% who said the same in anOctober 2019 Pew Research Center poll. While vaccine hesitancy has always been a challenge, early data show misinformation related to the COVID-19 vaccine increased vaccine hesitancy and may be impacting broader vaccine uptake.

Views and refusal of childhood vaccines have also become more partisansince the COVID-19 pandemic. The same KFF poll found 40% of Republicans said parents should be able to decide not to vaccinate their children (up from 20% in 2019), compared with 14% of Democrats. Further, former Republican President Donald Trump is the first president to openly support anti-vaccination attitudes and share vaccine misinformation. In his recent campaigning, Trump has continued to share anti-vaccine attitudes and stated he will not give one penny to any school that has a vaccine mandate (his campaign later said he meant COVID-19 mandates only). Independent candidate RFK Jr. also has a long record of opposing immunizations and spreading vaccine misinformation, making candidate vaccine attitudes one of many key topics this election.

In addition to rising vaccine hesitancy, disruptions that led to missed or delayed preventive care appointments early in the pandemic likely contributed to declines in vaccination rates. For example, for children enrolled in Medicaid or CHIP, well-child visit rates declined during the pandemic, and declines in vaccination rates may be, in part, associated with declines in well-child visits. Even before the pandemic, many children in Medicaid or CHIP did not receive a well-child visit within a year period, signaling children may also be experiencing barriers to accessing care.

There are a number of policy options and strategies that can be used to increase vaccination rates, including media outreach, incentives, parent-friendly websites, school-based vaccination clinics, and school vaccination requirements.Preventive care visits are also an importantcomponentwhen addressing routine vaccination rates, and efforts to promote access to care and increase well-child visits could potentially improve vaccination rates. To increase access to vaccines, some states have expanded the scope of pharmacists practice to include administration of routine vaccinations for children, and others are working to address rural health workforce shortages. Establishing and fostering trust between parents and providers, community leaders, and public health departments can also help to combat vaccine hesitancy. KFF polling has found pediatricians areconsideredhighly trusted sources of information by parents, and strong provider recommendations can help reduce disparities in vaccination coverage. School vaccine mandates and limiting exemptions can also be a tool to increase vaccine uptake, though recent trends show more states are working to loosen exemption requirements.

Medicaid coversfour in tenchildren in the U.S., including 8 in 10 children living inpovertyand overhalfof Black, Hispanic, and American Indian and Alaska Native (AIAN) children, making Medicaid an important tool for facilitating access to vaccines for children and reducing disparities in vaccination rates. There have been a number of recent state and federal actions aimed at improving access to care in Medicaid and CHIP, which could in turn help provide timely access to vaccines. This includes provisions to strengthen access to comprehensive health services, expand Medicaid coverage of school-based care, and promote stable coverage for children. The federally fundedVaccines for Children program(VFC) provides vaccines at no cost for children who are uninsured or underinsured, AIAN children, and children with Medicaid, and Bidens latest budget also proposes expanding the program to children in separate CHIP programs.

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Headed Back to School in 2024: An Update on Childrens Routine Vaccination Trends - KFF

Mobile vaccine program aims to boost COVID-19 vaccination rates in Arizona – KJZZ

July 24, 2024

The Centers for Disease Control and Prevention recommends everyone six months and older should stay up-to-date with COVID-19 vaccines. And the state health department is bringing back a program to get more Arizonans vaccinated.

In 2021, when COVID-19 vaccines first became widely available, the Arizona Department of Health Services launched a mobile vaccine program, but it has been on pause since 2023. Now, the department is starting up the CDC initiative again.

Jessie Barbosa, health equity program manager with the health department, said the mobile program brings free vaccines vulnerable groups who might have barriers to accessing the shots.

"Perhaps theyre homebound and need a vaccine administered in their home or they're living in a long-term care facility or skilled nursing facility or they live in a rural area, which is considered a vaccine desert," Barbosa said.

Barbosa said the program will continue at least through 2025.

Long-term care facilities or community-based organizations can request to host a pop-up vaccine event through the health department website.

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Mobile vaccine program aims to boost COVID-19 vaccination rates in Arizona - KJZZ

COVID-19 Vaccine Safety: Balancing Rare Side Effects with Public Health Benefits – Frontline

July 24, 2024

In the US, more than 13,000 recipients of COVID-19 vaccines have filed injury claims with the federal government. In India, Venugopalan Govindans daughter Karunya died in July 2021 after taking the Covishield vaccine that was co-developed by AstraZeneca and Oxford University. He is contemplating moving the courts even though the national committee set up by the Indian government did not find sufficient evidence to conclude that her death was caused by the vaccine.

A new controversy has arisen in respect of Covishield because in February 2024 AstraZeneca admitted to a court in the UK that in very rare cases the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS), in which blood clots form in unusual places, such as the brain and abdomen, with reduced blood platelet count. The patient suffers from many problems, including severe headache, shortness of breath, blurring of vision, and chest and abdominal pain. AstraZeneca informed the court that the causal mechanism is not known, that is, the biological process by which Covishield can cause TTS is unknown. Further, the company said that TTS is known to happen even in individuals who may not have taken Covishield. Incidentally, TTS has also been linked to Johnson and Johnsons vaccine Janssen.

The side effects of vaccines require serious attention. Apoorva Mandavilli, a reporter on science and global health and a member of the team that won the 2021 Pulitzer Prize for Public Service for coverage of the pandemic, wrote an article on May 3, 2024, in The New York Times, on the basis of her conversations with dozens of experts in vaccine science, policymakers, and people who said they had experienced serious side effects after receiving a COVID-19 vaccine.

Also Read | Has COVID truly exposed the broken global order?

I was touched when I read the experience of Gregory Poland, a very well-known vaccine researcher whom I know personally. Dr Poland and I were members of a global consortium that carried out research on various aspects of different vaccines, including response, side effects, and so on, funded by the US National Institutes of Health. Dr Poland later served as the chief editor of the journal Vaccine. He told Mandavilli that he might never hear silence again; a loud whooshing sound in his ears has accompanied every waking moment since his first shot of a COVID-19 vaccine. He has written to the US Centers for Disease Control and Prevention (CDC) about his condition but has only received polite responses. If an internationally renowned vaccine researcher such as Dr Poland gets only a lukewarm response from the CDC, one wonders whether the common man facing a vaccine-related health problem will even elicit a response.

On May 5, 2023, the WHO declared that COVID-19 was no longer a public health emergency of international concern. But the virus is still killing people around the world. Various strains of SARS-CoV-2, the coronavirus that causes COVID-19, continue to circulate in most populations, including in India. There is always a chance that new variants will emerge and cause new cases and fatalities. One recalls that SARS-CoV-2 emerged in late 2019, and there have been seven million reported deaths from COVID-19. Because of weak systems of death registration, the number of reported deaths during the pandemic was a gross underestimate. A study published in the medical journal The Lancet found that although 5.94 million deaths due to COVID-19 were reported between January 1, 2020, and December 31, 2021, the estimated actual number of deaths in that period was between 17 and 20 million. The extent of underestimation varied across countries; India was among the top. For improved monitoring of pandemics in the future, it is necessary to strengthen death registration systems globally.

Due to weak systems of death registration globally, the number of reported deaths during the pandemic was a gross underestimate. | Photo Credit: Niranjan Shrestha/AP

The COVID-19 pandemic witnessed the triumph of science and technology. Multiple safe and effective vaccines were developed in record time and first authorised for emergency use in December 2020. Bharat Biotech developed an indigenous vaccine in collaboration with the Indian Council of Medical Research-National Institute of Virology. A wholly new class of vaccines (mRNA vaccine) was developed for human use, which resulted in the award of a Nobel Prize in 2023 to Katalin Karik and Drew Weissman. However, the scaling up of vaccine production took time. Therefore, the global distribution of vaccines was far from equitable, and overcoming it was a major challenge. India (notably, Serum Institute of India) played a major role in the scale-up operations to make the vaccine widely available.

Vaccine hesitancy was also a serious challenge. A systematic study on vaccine uptake published in March 2023 in Journal of Infection and Public Health found that [c]oncerns about COVID-19 vaccine safety, negative side effects, rapid development of the COVID-19 vaccine, and uncertainty about vaccine effectiveness were associated with reluctance to be vaccinated. False stories that COVID-19 vaccines are ineffective or that their side effects far exceed their benefits have been promoted by many influential people, including politicians. Facts indicate otherwise. A study by The Lancet Infectious Diseases estimated, on the basis of official reported COVID-19 deaths, that vaccinations prevented 14.4 million deaths from COVID-19 in 185 countries and territories in 2021. But, because many countries had banned the use of Covishield citing side effects, people in India have asked why the government here did not ban its use. Delhi Health Minister Saurabh Bharadwaj correctly demanded on April 30, 2024: The Central government should urgently address the alleged side effects of the vaccine because millions of people in India have been vaccinated with Covishield. As on that date, over 1.7 billion doses of Covishield had been administered in India.

The only way to prevent adverse events arising from vaccination and improve vaccines is by conducting scientific studies on vaccine safety, not by banning a vaccine because of the occurrence of very rare side effects. After all, no drug or vaccine is completely safe. Yet, we use these when the benefit of usage far outweighs the risk.

Of course, it is sad that Karunya died not long after taking Covishield. However, in order for her family to get compensation for her death, it must be proved on the basis of reliable and valid scientific evidence that her death was the direct result of the vaccine. This is not an easy task, particularly because an adverse outcome of vaccination, which may sometimes also result in death, is very rare. The WHOs Global Advisory Committee on Vaccine Safety calculated that the risk of TTS for a person living in the UK is 1 in 2,50,000 recipients of the AstraZeneca-Oxford vaccine, while for a recipient in the EU it is 1 in 1,00,000. We do not have an estimate for India, but it is expected to be similar.

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Occasionally, an adverse health outcome usually encountered after vaccination is also observed in people who did not take the vaccine. The background rate of TTS in the non-vaccinated population may be similar as reported in a study involving the health records of 38.6 million people in six European countries. Therefore, to scientifically prove that an adverse outcome is due to vaccination is inordinately difficult. Unfortunately, in India or even globally, there is not a central database where reports of adverse outcomes of vaccination are available. It is extremely important to create such national databases and preferably a global database. Fortunately, an international network has been formed with experts in vaccine safety, biology, and other relevant disciplines to conduct scientific studies on reported side effects of vaccines.

Also, fortunately, in spite of misinformation about vaccines and occasional reports of adverse events encountered after vaccination, the vast majority of people around the world still trust vaccines. The results of a survey conducted on 23,000 adults in 23 countries, published in Nature Medicine on April 29 stated: A total of 60.8 percent expressed being more willing to get vaccinated for diseases other than Covid-19 as a result of their experience during the pandemic. Based on a detailed analysis of the responses obtained in the survey, this report concluded that vaccine hesitancy and trust challenges remain for public health practitioners, underscoring the need for targeted, culturally sensitive health communication strategies. An even greater challenge is possibly overcoming the barriers of poverty and inequity in access to vaccines. The global health system must wake up to this challenge so that future pandemics can be prevented or if they occur can be, handled with less misery for humankind than one witnessed during the COVID-19 pandemic.

Partha P. Majumder is a National Science Chair (Scientific Excellence), government of India, and a former president of the West Bengal Academy of Science & Technology and the Indian Academy of Sciences.

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COVID-19 Vaccine Safety: Balancing Rare Side Effects with Public Health Benefits - Frontline

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