What happened with Fort Liberty soldier who sued over COVID-19 … – The Fayetteville Observer

What happened with Fort Liberty soldier who sued over COVID-19 … – The Fayetteville Observer

FDA Finalizes Guidance on Development of COVID-19 Vaccines – Pharmaceutical Technology Magazine

FDA Finalizes Guidance on Development of COVID-19 Vaccines – Pharmaceutical Technology Magazine

October 25, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

FDA announced on Oct. 19, 2023 that it had issued the final guidance, Development and Licensure of Vaccines to Prevent COVID-19, to help sponsors with the clinical development and licensure of COVID-19 vaccines. The document does not address every consideration for satisfying requirements because some vaccines may need specific data, according to the agency. The final guidance reflects FDAs current thinking on the issue.

Given the need to ensure that sponsors are aware of our current recommendations to facilitate timely development of vaccines to prevent COVID-19, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 371(h)(1)(C)), and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agencys good guidance practices, the agency stated in the document.

The final guidance explains key considerations for chemistry, manufacturing, and controls including facilities and inspections; nonclinical data, such as toxicity studies; clinical trials, such as trial populations and trial design; post-licensure safety evaluations; and diagnostic and serological assays. In addition, the guidance discusses other safety considerations that should be addressed including demonstrating effectiveness, surrogate endpoints, and adequate datasets. If it is no longer possible to demonstrate vaccine effectiveness by way of conducting clinical disease endpoint efficacy studies, the use of a controlled human infection model to obtain evidence to support vaccine efficacy may be considered. However, many issues, including logistical, human subject protection, ethical, and scientific issues, would need to be satisfactorily addressed, FDA stated in the guidance.

Source: FDA


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FDA Finalizes Guidance on Development of COVID-19 Vaccines - Pharmaceutical Technology Magazine
Estimation of SARS-CoV-2 IgG Antibodies in Healthcare Worker-Administered Covishield and Covaxin Vaccines at a … – Cureus

Estimation of SARS-CoV-2 IgG Antibodies in Healthcare Worker-Administered Covishield and Covaxin Vaccines at a … – Cureus

October 25, 2023

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Factors associated with COVID-19 vaccination among pregnant … – Nature.com

Factors associated with COVID-19 vaccination among pregnant … – Nature.com

October 25, 2023

Study setting, study design, and population

This retrospective cohort study used linked data from the live birth and vaccination information systems in Rio de Janeiro city. Rio de Janeiro is the second largest city in Brazil, with an estimated population of 6,700,000. It has a monthly per capita income of 4 minimum wage, considered a high-income city compared to other regions of the country37 In 2021, the number of live births was 67,97338. In July 2022, the coverage of COVID-19 vaccination was 89% for the complete primary regimen and 57% for a booster dose in the general population above 18 years39.

The COVID-19 immunisation started in Rio de Janeiro city on January 20, 202140, initially for healthcare professionals, adults older than 60 years, and high-risk groups. Pregnant women with comorbidities started vaccination in March 2021; by May 2021, it was interrupted due to a severe adverse event related to the COVID-19 vaccine in this population. From July 07, 2021, vaccination was resumed and made available for all pregnant, breastfeeding or women planning to become pregnant41. CoronaVac (Sinovac/Butantan) and BNT162b2 (Pfizer/Biotech) were the recommended platforms.

For this investigation, we included all women who delivered live births in Rio de Janeiro city between 1st August 2021 and 31 July 2022. Our exclusion criteria were multiple births, ages less than 18 years or higher than 49 years, and records with missing or implausible gestational ages (> 44 weeks) (Fig. 2).

The Declaration of Live Birth, a legal document filled out by the health care professional who attends the birth, is entered into the Live Birth Information System (SINASC). It contains details on the mother (such as age, education, skin colour, and marital status), about the pregnancy (such as antenatal appointments, the gestational period, prior gestations, previous live births, and previous losses), and details about the newborn (e.g., birth weight, sex, APGAR score). In addition, all vaccinations provided in Brazil are documented in the National Immunization Program Information System (SI-PNI), along with the administration date of the first, second, and booster doses, with its platform type. The SINASC data initially available had records from women who gave a live birth in Rio de Janeiro city from January 1, 2020, to August 28, 2022. The SI-PNI data included vaccination records from January 19, 2021, to August 31, 2022 (Supplementary Figure 1, Table 1 and Table 2). The linkage between records from SI-PNI and SINASC allowed access to any vaccination that happened before, during and after the pregnancy period.

The matching process used the maternal name, date of birth, zip code, and neighbourhood. We used the Jaro-Winkler string comparator to compare the similarity between string variables recorded in SINASC and SI-PNI. This algorithm calculates the similarity between two strings based on the number of shared characters and transpositions42. The resulting similarity score ranges between 0 (no similarity) and 1 (perfect similarity). We categorised the similarity scores into three categories: (0, 0.85), (0.85, 0.95), and (0.95, 1)]. We employed a three-step approach that checked for a string similarity score greater than 0.95, followed by exact matches for dates of birth and zip code. Any potential matches then underwent a manual review. After data linkage, the individual identifiers were removed, and the de-identified dataset was made available for analysis.

We estimated the date of the last period (DLP) using the date of delivery minus the days of pregnancy according to the gestational age at birth. We determined the date of conception by adding 14 days to the DLP. We defined the gestational period as the time between the date of conception and the date of birth. The vaccination status was determined using the dates of the vaccination registries compared to the gestational period.

Women who received at least one dose between the conception date and the date of delivery were considered vaccinated during pregnancy. Those who received all registered doses before the pregnancy period (before the conception date) were grouped as vaccinated before pregnancy. Those who received vaccines exclusively after the delivery date were assigned as vaccinated after pregnancy. Finally, women with no register of a vaccine dose were regarded as never vaccinated. We estimated vaccine uptake during pregnancy as the proportion of women who received any vaccination during pregnancy as a percentage of all births (Supplementary Table 3).

We divided variables into sociodemographic: age (1824, 2534, 35 years), education (07, 811, 12 years), self-identified skin colour (black, parda/brown, white, Asian, or Indigenous), and marital status (with or without a partner). And obstetric: the trimester of the first antenatal care appointment (first, second, or third), the total number of appointments (03, 46, or >6), the number of previous gestations (none, 12, or 3), the number of previous live births (none, 12, or 3), and the number of previous child loss (none or at least one). The Indigenous and Asian races were presented in the descriptive analysis and excluded from the logistic regression due to the small sample size.

We considered the length of pregnancy and the burden of COVID-19 infection during the study period to be a confounder a priori. Therefore, we included the month-year of birth and the gestational week at delivery as additional variables in the analyses.

We assessed each groups characteristics by describing categorical variables as frequencies and percentages, excluding missing data. Continuous variables, such as age and gestational age, were presented as the median and interquartile range (IQR). In the descriptive analysis, we stratified the groups by being vaccinated only before pregnancy, vaccinated with at least one dose during pregnancy, and never vaccinated.

To identify the factors associated with vaccine uptake in pregnant women, we compared only the population of women vaccinated during pregnancy with those who were never vaccinated during the study period. For each potential factor associated with uptake, we ran a bivariate logistic regression individually, describing the crude odds ratio (OR) and its associated 95% confidence interval, controlled by gestational age and month-year of birth (Supplementary Table 7).

In addition, we performed a multiple logistic regression using a hierarchical framework with two levels. In the first level, we had the socioeconomic variables: age, education, self-identified skin colour, and marital status. In the second level, we included all the variables above and the obstetrics variables: the total number of antenatal appointments, the number of previous live births, and the number of previous child losses.

In the first model of multiple logistic regression, we included only the socioeconomic variables. The overall effect of socioeconomic factors (the distal factors) was assessed in this model 1. In the second model, we included the obstetric variables in addition to the sociodemographic block. Therefore, the unconfounded effect of the obstetric variables was obtained in this model. Both models were also controlled by gestational age and month-year of birth. Missing data on each covariate were excluded from the analysis (Supplementary Table 8). The final adjusted odds ratio and 95% confidence intervals were described for each model separately (Supplementary Table 7). Data management and statistical analysis were conducted using IBM SPSS, Statistical Package for the Social Sciences, Version 28.0 (Armonk, NY: IBM Corp). The de-identified dataset and the programming codes can be made available under the request.

The present study has been approved by the Ethics Committee of Research Center Gonalo Moniz /Oswaldo Cruz Foundation, Salvador, Bahia, Brazil (IORG 0002090/OMB No. 0990-0279 valid until 01/27/2025), under the Certificate of Submission for Ethics Review No 63287822.0.0000.0040. The protocol and procedures presented in the project are in full accordance with the Brazilian legislation (Resolution CNS 466/2012) and the declaration of Helsinki regarding ethical standards in conducting research involving human beings. Due to the retrospective nature of the study, the need for informed consent was waived by the Ethics Committee of Research Center Gonalo Moniz /FIOCRUZ/BA.


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Factors associated with COVID-19 vaccination among pregnant ... - Nature.com
FTC Takes Action Against Makers of an ‘Invisible Mask’ They Falsely … – Federal Trade Commission News

FTC Takes Action Against Makers of an ‘Invisible Mask’ They Falsely … – Federal Trade Commission News

October 25, 2023

The Federal Trade Commission sued to stop four related defendants from deceptively marketing their 1 Virus Buster Invisible Mask

(Invisible Mask) that purportedly creates a three-foot barrier of protection against 99.9 percent of all viruses and bacteria, including COVID-19 without any scientific proof that the product actually works.

Despite receiving a warning letter that the FTC sent in July 2020, the New York-based defendants continued falsely advertising the Invisible Maska badge worn around the neckas a scientifically proven defense against COVID-19 and other diseases and that it was a government-approved device, according to the FTCs complaint.

Three of the four defendants have agreed to a proposed ordersettling the FTCs complaint, and will be banned from making unsupported health claims for products designed to prevent or treat COVID-19.

The defendants claims that their products can stand in for approved COVID-19 vaccines are bogus, said Samuel Levine, Director of the FTCs Bureau of Consumer Protection. The FTC will use every tool it has at its disposal to stop false and unsubstantiated health claims that endanger consumers.

The complaint alleges defendants Gary Kong, Timothy Wetzel, and the two companies they operate, K W Technology Inc. and K W Technology NV Inc., violated the FTC Act and the Covid Consumer Protection Act through their marketing and sale of the Invisible Mask on their own website, YouTube, and Facebook, where it was called The 1 Virus Buster Card.

This card, which was worn around the neck or clipped onto clothing, was sold using deceptive claims, the FTC says. For example, the defendants claimed their product uses quantum theory technology, combines known virus and bacteria killing compounds. It is safe, simple, and effective. All you need to do is hang it around your neck or attach it to your collar, close to your mouth and nose. . . it kills 99.9% of most harmful bacterial and viruses . . . within a three-foot radius.

The FTC contends the defendants have no reliable scientific evidence to support their claims that the Invisible Mask can prevent any human disease, and that despite contacting the FTC after receiving the warning letter and vowing to stop making such claims, they simply continued deceptively marketing the product.

The complaint also alleges the defendants falsely claimed that the Invisible Mask or its materials are government approved or made in a government-approved facility. They also falsely claimed the Invisible Mask had FDA Approval and that that the materials used to make it are EPA-approved. On their website the defendants posted a phony Certificate of Registration with the FDAs logo, despite the fact that no such agency certificate exists.

Three of the defendants have agreed to settle the FTCs complaint in this case. A proposed court order will ban defendants Kong and his two companies, K W Technology Inc. and K W Technology NV Inc., from advertising, promoting, or selling any product claiming to prevent or treat COVID-19, unless the claims are true and supported by scientific evidence. The order also will bar the defendants from making any health-related product claims unless they have scientific evidence that the claim is true and from making misrepresentations about products health benefits, performance, efficacy, safety, or side effects.

The order also prohibits the defendants from misrepresenting they have government approval, clearance, or authority for their products and product claims. Finally, it requires the payment of $150,000.

The Commission voted 3-0 to file the complaint and proposed stipulated order against defendants Kong, K W Technology Inc. and K W Technology NV Inc. The FTC filed the documents in the U.S. District Court for the Eastern District of New York. Litigation continues against defendant Wetzel, who did not agree to the proposed settlement.

The lead attorney on the matter is Robin L. Rock of the FTCs Southeast Region.


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FTC Takes Action Against Makers of an 'Invisible Mask' They Falsely ... - Federal Trade Commission News
Intestinal fungi may worsen lung inflammation in severe COVID-19 … – University of Minnesota Twin Cities

Intestinal fungi may worsen lung inflammation in severe COVID-19 … – University of Minnesota Twin Cities

October 25, 2023

Stephanie Rossow / CDC

In severely ill COVID-19 patients, some kinds of fungi can thrive in the intestines, exacerbating the virus's characteristic inflammation and leading to an outsized immune response against the fungi for up to 1 year after infection, suggests a study published yesterday in Nature Immunology.

Weill Cornell Medicine and New York Presbyterian researchers analyzed blood samples from patients with severe COVID-19, finding immunoglobulin G (IgG) antibodies against fungi commonly found in the gut and an increase in neutrophil immune cells in the lungs.

They then used mouse models to confirm that fungi in the gut, especially strains of Candida albicans yeast, provoked the production of more neutrophils in the blood and lungs. The mice also had signs of inflammation when infected with SARS-CoV-2.

Patient blood samples showed signs of persistent immune-system changes believed to be related to long COVID. At 1 year postinfection, the blood still contained antifungal antibodies, and stem cells that give rise to neutrophils were primed to attack fungi.

Severe and long COVID-19 were not thought to involve fungal blooms in the intestines that, in addition to the virus, can impact patients immunity.

The immune protein interleukin-6, induced by fungi, seemed to increase levels of both neutrophils in the lungs and fungal antibodies. The use of IL-6 blockers or antifungal drugs in patients or mice, however, reduced levels of neutrophils and fungal antibodies. Patients treated with the anti-inflammatory drug tocilizumab saw sustained reductions in IgG antibodies against both C albicans and neutrophil progenitors.

"Severe and long COVID-19 were not thought to involve fungal blooms in the intestines that, in addition to the virus, can impact patients immunity," senior author Iliyan Iliev, PhD, of Weill Cornell Medicine, said in a college news release.

The authors said the findings don't change the guidelines for treating severe or long COVID, but they may someday lead to tailored treatment, such as the use of antifungal antibodies to identify patients eligible for a therapy targeting the fungi or the immunologic changes they trigger. The antifungal antibodies may also be a marker of increased risk of long COVID or other infectious inflammatory conditions.


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Intestinal fungi may worsen lung inflammation in severe COVID-19 ... - University of Minnesota Twin Cities
Research shows small reduction in long COVID with antiviral use – University of Minnesota Twin Cities

Research shows small reduction in long COVID with antiviral use – University of Minnesota Twin Cities

October 25, 2023

Stephanie Rossow / CDC

In severely ill COVID-19 patients, some kinds of fungi can thrive in the intestines, exacerbating the virus's characteristic inflammation and leading to an outsized immune response against the fungi for up to 1 year after infection, suggests a study published yesterday in Nature Immunology.

Weill Cornell Medicine and New York Presbyterian researchers analyzed blood samples from patients with severe COVID-19, finding immunoglobulin G (IgG) antibodies against fungi commonly found in the gut and an increase in neutrophil immune cells in the lungs.

They then used mouse models to confirm that fungi in the gut, especially strains of Candida albicans yeast, provoked the production of more neutrophils in the blood and lungs. The mice also had signs of inflammation when infected with SARS-CoV-2.

Patient blood samples showed signs of persistent immune-system changes believed to be related to long COVID. At 1 year postinfection, the blood still contained antifungal antibodies, and stem cells that give rise to neutrophils were primed to attack fungi.

Severe and long COVID-19 were not thought to involve fungal blooms in the intestines that, in addition to the virus, can impact patients immunity.

The immune protein interleukin-6, induced by fungi, seemed to increase levels of both neutrophils in the lungs and fungal antibodies. The use of IL-6 blockers or antifungal drugs in patients or mice, however, reduced levels of neutrophils and fungal antibodies. Patients treated with the anti-inflammatory drug tocilizumab saw sustained reductions in IgG antibodies against both C albicans and neutrophil progenitors.

"Severe and long COVID-19 were not thought to involve fungal blooms in the intestines that, in addition to the virus, can impact patients immunity," senior author Iliyan Iliev, PhD, of Weill Cornell Medicine, said in a college news release.

The authors said the findings don't change the guidelines for treating severe or long COVID, but they may someday lead to tailored treatment, such as the use of antifungal antibodies to identify patients eligible for a therapy targeting the fungi or the immunologic changes they trigger. The antifungal antibodies may also be a marker of increased risk of long COVID or other infectious inflammatory conditions.


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Research shows small reduction in long COVID with antiviral use - University of Minnesota Twin Cities
UWHealth: Latest influenza and updated COVID-19 vaccine now … – WisPolitics.com

UWHealth: Latest influenza and updated COVID-19 vaccine now … – WisPolitics.com

October 25, 2023

MADISON, Wis. As the respiratory illness season begins, UW Health is encouraging everyone to get the latest influenza and updated COVID-19 vaccines to protect themselves and their loved ones.

Both vaccines are now available at UW Health, and patients can schedule their appointments via MyChart or by calling their primary care clinic. Non-UW Health patients can find the shots at local pharmacies or by contacting their primary care providers.

UW Health patients in the Madison area can also get both shots at theUW Health John Wall Drive Thru Cliniclocated at 3819John Wall Drive. Any patient five years and older can receive the vaccines while in their vehicle at this location. Younger patients will need to receive vaccines at a traditional clinic visit. In addition to COVID-19 and influenza vaccines, other routine vaccines for children and adults are available at this location. Appointments shouldbe scheduled but are not necessary. The John Wall Drive Thru Clinic is open seven days a week, 7:30 a.m. to 5 p.m.

Getting vaccinated does not mean a person cannot catch a respiratory virus, but if they do, it protects an individual from potentially developing severe symptoms and reduces the risk of hospitalization or death, according to Dr. Jim Conway, medical director, UW Health immunization program, and an infectious disease physician with UW Health Kids.

By getting vaccinated you decrease your chances of getting infected, or, if you do get infected, it makes your life easier with a milder case, said Conway, also a professor of pediatrics at the University of Wisconsin School of Medicine and Public Health. Today is not too soon to schedule your appointment and it is never too late in the season to get the protection given by these vaccines. Everyone doing their part helps keep the community healthy.

The updated 2023-2024 COVID-19 vaccine is recommended for everyone 6 months of age or older, regardless of previous vaccinations or infections, he said.

It doesnt matter if you had a previous booster series, no vaccines or had a previous infection, you should definitely get the updated COVID-19 vaccine, Conway said.

Anyone six months of age or older can get the latest influenza vaccine each year as well. Some individuals who are immunocompromised might need two doses of the updated COVID-19 vaccine. Older individuals should receive one of the higher potency influenza vaccines, he said.

COVID-19 vaccines are no longer provided free of charge from the federal government. A patients insurance will be billed for the vaccines. Most insurers will cover vaccine fees, but some do not. Before scheduling a visit, patients should call the customer service number listed on their insurance card to find out if their plan covers these fees. Conway also recommends visitingwww.vaccines.govfor more information on vaccine coverage.


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MSD launches bovine coronavirus vaccine in the UK – VetSurgeon.org

MSD launches bovine coronavirus vaccine in the UK – VetSurgeon.org

October 25, 2023

Bovilis Nasalgen-C can be used for the active immunisation of calves from the day of birth onwards to reduce clinical signs of upper respiratory tract disease and nasal viral shedding from infection with BCoV.

MSD says respiratory disease in UK calves is widespread and comes at a high cost from an emotional and business productivity perspective.

It is also continually highlighted as a critical area for overuse of antibiotics.

Despite all this, there is an under use of vaccination in the UK cattle sector1.

Speaking at BCVA last week, Paul Burr MRCVS, director of Biobest Laboratories said: Recent UK studies show bovine coronavirus being the most prevalent virus found in routine disease screening and nasal swab samples taken during a bovine respiratory disease outbreak.

"BCoV was found in 39% of over 400 nasal swab samples taken between 2020 and 2022 from BRD affected cattle on UK farms2.

KatBaxter-Smith, veterinary adviser with MSD Animal Health, said: Whilst the pathogenicity of BCoV within the BRD complex remains an unknown quantity, its ubiquitous presence in the UK cattle population and the recent human experience of coronavirus as a significant respiratory pathogen suggests a need for a re-evaluation of BRD control by vets and farmers.

Just as coronavirus is a pathogen associated with the common cold and Covid-19, BCoV is a proven pathogen that directly impacts the calf respiratory tract.

"Consequently, the availability of this new BRD vaccine presents veterinary professionals with another tool in their armoury to improve control of this costly disease.

If diagnostics suggest BCoV is implicated in any BRD problem, the availability of Bovilis Nasalgen-C allows UK cattle farmers to effectively administer protection for young calves via a single 2ml intranasal dose that can quickly reach the site of action.

"This will support the development of immunity against BCoV early in life, the onset of which starts five days after administration and has a 12-week duration.

Bovilis Nasalgen-C comes can be used on the same day with Bovilis INtranasal RSP Live, which offers protection against both Bovine Respiratory Syncytial Virus (BRSV) and Parainfluenza-3 Virus (Pi3).

Bovilis Nasalgen-C can be stored for up to 24 hours at room temperature after reconstitution, can be given to cattle using a syringe or applicator device and is available in one, five and 20 dose packs, suitable for both small and large herds.

References:

PS: Whilst you're here, take a moment to see our latest job opportunities for vets.


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West Virginia official accused of approving $34M in COVID-19 … – Williamson Daily News

West Virginia official accused of approving $34M in COVID-19 … – Williamson Daily News

October 25, 2023

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Read this article: West Virginia official accused of approving $34M in COVID-19 ... - Williamson Daily News
New COVID-19 variant expected to become dominant strain this winter – WKRC TV Cincinnati

New COVID-19 variant expected to become dominant strain this winter – WKRC TV Cincinnati

October 25, 2023

New COVID-19 variant expected to become dominant strain this winter

by Liz Bonis & Megan Burgasser, WKRC

(WKRC)

CINCINNATI (WKRC) - Infectious disease specialists are closely monitoring the newest COVID-19 variant. Its expected to become the dominant strain this fall and winter.

This newest variant is in the family tree from Omicron and its growth is soaring.

The new COVID-19 vaccine does offer protection against it, targeting Omicrons descendants.

So, this is its own vaccine itself. We aren't boosting on an old version of the vaccine, so anybody that's not had the vaccine in the past two months is a candidate for the new vaccine, said Ben Prewitt, a Kroger Health pharmacist.

The HV.1 danger is that it appears to be spreading rapidly among those who come into close contact with others. It's working its way around current immunity.

HV.1 made up just 0.5% of cases in late July. Now, the Centers for Disease Control and Prevention estimates it has overtaken EG.5, which has been the dominant strain until now.

HV. 1 is now responsible for one in five new cases. Its highly transmissible, but so far, does not appear to be more severe.

Wilma Hancock chose to get the COVID-19 vaccine anyway.

Because Ive had it, I dont want to get it again, said Hancock.

Getting the vaccine can reduce the viral load in a persons body, so the person becomes less likely to transmit HV.1 or another variant to others.

As for HV.1s symptoms, its mainly a cough, fatigue, runny nose, and congestion. Those are common with other respiratory illnesses, so its suggested that a person take an at-home COVID-19 test at the first sign of any symptoms. If its negative, test again a day or two later.

Medications to ease the symptoms for those at risk, such as Paxlovid, need to be started within five days of symptom onset.

To find where the new COVID-19 vaccine is available: Schedule Your COVID-19 Vaccine or Booster Online, click here.

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Excerpt from: New COVID-19 variant expected to become dominant strain this winter - WKRC TV Cincinnati