Category: Covid-19 Vaccine

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State to use $6 million to bring COVID-19 vaccines to communities and homebound Granite Staters New Hampshire Bulletin – New Hampshire Bulletin

September 16, 2022

With final state approval in hand, the Department of Health and Human Services plans to use $6 million in federal pandemic money to bring COVID-19 testing and vaccines to Granite Staters neighborhoods and homes.

The money will allow the department to send three mobile vaccination vans into communities, providing not just vaccines and boosters but also telehealth access to a health care provider, according to its funding request to the Executive Council and Joint Legislative Fiscal Committee. A fourth van will be dedicated to home-based visits.

Both bodies approved the funding.

The state will dispatch the van upon request and intends to use some of the money for a call center that will schedule stops between October and March.

At a fiscal committee meeting Friday, Rep. Jess Edwards, an Auburn Republican who sits on the committee, raised concerns about the safety of administering a COVID-19 vaccine to children between 6 months and age 5, a group approved for the vaccine in June.

I think that its incumbent upon us that when we do something controversial, and injecting kids under 5 and (giving) boosters over 5 turns out to be a controversial issue, I think its important for us to demonstrate that were following the science, Edwards told Patricia Tilley, director of public health for the state.

At Edwards request, Tilley said the department will provide the public a summary of the studies and scientific literature it has reviewed in determining that it is safe to give that age group a COVID-19 vaccine. Tilley said the department is making the vaccine available to all eligible age groups based on scientific evidence and consideration of the risks of forgoing a COVID-19 vaccination.

We know that there are implications of long COVID for children who have had COVID-19 infections, Tilley told Edwards. There are other outcomes from myocarditis and some impacts around diabetes that are really concerning. And so, we think it is an effective policy to have vaccines available to children and to adults.

Tilley noted at the fiscal committee meeting that there is no requirement that children receive a COVID-19 vaccine to attend school or childcare programs. This is a decision that families can make for themselves and individuals can make for themselves, said Tilley.

The Food and Drug Administration authorized the COVID-19 vaccine for children ages 6 months to 5 three months ago. In July, the Kaiser Family Foundation said early uptake had been slow and began declining two weeks after the vaccine became available.

The organization reported that just 2.8 percent of children ages 6 months to 5 had been vaccinated, compared to 18.5 percent of children ages 5 to 11 in the weeks after they had access to the vaccine.

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State to use $6 million to bring COVID-19 vaccines to communities and homebound Granite Staters New Hampshire Bulletin - New Hampshire Bulletin

COVID-19 and RSV: A roundup of news on pediatric vaccines for these viruses – Drug Topics

September 16, 2022

William J. Muller, MD, PhD, discusses COVID-19 vaccinations for children of all ages and describes what is on the horizon for RSV.

This article originally appeared in the April 2022 issue of oursister publication Contemporary Pediatrics.

Could you explain in some detail what caused the delay in allowing children 4 years and younger to be eligible for the COVID-19 vaccine?

William J. Muller, MD, PhD: The Pfizer-BioNTech delay has been related to the second of the 2-dose series not inducing the same level of antibody response in younger children, those between the ages of 2 and 5 years. A lot of the pediatric studies have not been designed to show efficacy against preventing either symptomatic disease or hospitalization in this age group. Everybody is aware by now that children are not as severely affected as adults are by COVID-19. So it was reasonable for all the vaccine studies that Im aware of in children to be designed to use surrogate end pointsbasically, how good are the immune responses produced?and antibody levels are a reasonable surrogate for that. Thats the way that the companies have gone into studying these vaccines in children.

I think Pfizer-BioNTech was not expecting as low of an antibody response in that age group as they measured in later stages of the study. My understanding is they were encouraged by the FDA to ask for an authorization anyway, due to the Omicron surge. There was an expectation that maybe they could show some protection against either infection or some level of severity of disease, but that didnt really hold up. And it may be that because they had a data cutoff, it was too soon in the Omicron surge for there to be an effect. Or it just may be that its very difficult to show protection from infection with any respiratory virus vaccine. This is true for influenza as well. As you know, the goal of most vaccinations is to keep you from getting so sick that you are hospitalized or worse, and because thats an uncommon end point with children, you would need a huge study to show that there is that benefit.

So, in this case, the Pfizer-BioNTech responsewhich is appropriateis that if the level of antibodies is too low, we may need a third dose in the age group of 2 to 5 years. Thats what theyre studying now, and it takes time to do that. They needed to bring all the participants back in for an additional dose, and they needed to get additional consent from the parents because that was not part of the initial study design. There are also concerns in adolescent and young adult males, in particular about possible cardiac effects of the mRNA vaccines, so that will be on their radar throughout the study. That added to the complexity and the amount of time it will take to get through all the data.

Thats for the Pfizer-BioNTech vaccine. We are safe with the Moderna vaccine, which is currently studying 2 doses for children aged 6 months to 12 years. The expectation is that 2 doses will be sufficient to induce an immune response.

As far as COVID-19 variants, going forward, where are we in trying to be proactive?

WJM: The mRNA vaccine platforms are easily adapted to generating new variant vaccines. The technology that goes into putting a piece of mRNA into the lipid nanoparticle that is delivered as part of the vaccine doesnt change when theres a new variant; only the material thats put into the vaccine would change. So from that standpoint, its not that difficult for a company to make a new vaccine for a variant.

Do the vaccines need to show the same level of efficacy? Probably not; I think they really need to show safety and some level of an immune response. All that said, it seems the existing vaccines now have a 3-dose series in adults; we dont know necessarily yet for children if 2 or 3 doses will be necessary for all the mRNA vaccines, but there are reasonably good data that the immune responses induced may still provide a level of protection that is reasonable. Whenever there is a new variant, there are basic science laboratories in various parts of the world that are poised to immediately do studies with model systems in which they can put the variants into a virus that is not pathogenic and ask the question Do the antibodies from some of the recipients of the vaccine provide some level of protection in a laboratory study?

With the Omicron surge being so big, we were able to get a pretty good idea of whether people who had received the vaccine were significantly less likely to have significant consequences from infection. And the answer is that they seem to be much more protected from infection. Children aged 5 years and older who have been eligible for vaccination were really protected from hospitalization during the Omicron surge, and even at our hospital [Ann & Robert H. Lurie Childrens Hospital of Chicago in Illinois], we have good evidence that the increased number of hospitalizations in children was largely among either the unvaccinated or those who were not eligible for the vaccine.

Do you foresee a time in the near future when COVID-19 vaccines will be a part of the annual vaccination schedule?

WJM: I think there will be an expectation of a recommended vaccine for children and adults on some scheduled basis. And I think that the unanswered question right now is Will we need it every year, like we recommend the influenza vaccine every year, or can it be spaced out over a longer time period? Its certainly too soon to tell if the current vaccines will offer lifelong protection. I dont think I would expect that to be true. But, you know, I dont want to get too far off from what we know now.

What about vaccines for other infectious diseases in pediatricsanything of particular interest?

WJM: There certainly has been a lot of discussion recently about another illness, which is of significant importance in pediatrics, notably RSV [respiratory syncytial virus]. Different strategies have been looked at to try to protect babies against severe disease from RSV infection. The first would be maternal vaccinationif the mom was able to get sufficient levels of antibodies, passive immunity could be passed from her to the baby. So far, those study findings have not necessarily shown protection. But as we learn more from the research, other vaccines might be developed to increase the mothers ability to generate a protective response that doesnt necessarily require the baby to get a separate immunization. I know that there are some studies as well that involve immunization of the baby, which could be active immunization for RSVsimilar to the COVID-19 vaccine, in which the immune response thats generated against the vaccine is whats providing protection. And then there is passive immunity: That would provide protection against RSV by getting an antibody into the baby as opposed to inducing the production of antibodies. So, we will have to wait and see.

William J. Muller, MD, PhD, is an attending physician of infectious diseases and scientific director of clinical and community trials at the Stanley Manne Childrens Research Institute at Ann & Robert H. Lurie Childrens Hospital of Chicago and an associate professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

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COVID-19 and RSV: A roundup of news on pediatric vaccines for these viruses - Drug Topics

Novavax Nuvaxovid COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the European Union for Use as a Booster for Adults Aged 18…

September 16, 2022

Novavax Nuvaxovid COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the European Union for Use as a Booster for Adults Aged 18 and Older

GAITHERSBURG, Md., Sept. 12, 2022 /PRNewswire/ -- Novavax,Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has approved the expanded conditional marketing authorization (CMA) ofNuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) as a homologous and heterologous booster for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for adults aged 18 and older. The approval follows the recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use on September 1, 2022.

"We are pleased to offer the first protein-based vaccine as both a primary series and booster in the European Union," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As we continue to explore best practices for managing COVID-19 long term, we have ongoing trials further exploring Nuvaxovid's efficacy and safety as a booster andpreclinical data has indicated that our vaccine induces immune response against Omicron variants, including BA.4/5."

The expanded CMA was based on data from Novavax' Phase 2 trialconducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovidinduced a robust antibody response when used as a heterologous third booster dose.

In the Novavax-sponsored trials, following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events (AE), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.

Nuvaxovid has also been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is actively under review in other markets.

The EC previously granted CMAfor Nuvaxovid to prevent COVID-19 in adults aged 18 and older in December 2021. Additionally, the EC granted expanded CMA for Nuvaxovid to prevent COVID-19 in adolescents aged 12 through 17 in July 2022.

Trade Name in the U.S.The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Important Safety Information

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

About Nuvaxovid (NVX-CoV2373)

Nuvaxovid is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Nuvaxovidis packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovidworldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 Trials

The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (thePRE-fusion protein subunitVaccineEfficacyNovavaxTrial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations inthe U.S.andMexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in theNew England Journal of Medicine(NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the United States, compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S.Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published inNEJM.

About Matrix-M Adjuvant

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S., EC and the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating its COVID-19-Influenza Combination vaccine candidate in a Phase 1/2 clinical trial, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visitwww.novavax.comand connect with us on LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including an Omicron strain based vaccine and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza combination investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety intended utilization, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.govand http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:InvestorsErika Schultz | 240-268-2022ir@novavax.com

MediaAli Chartan or Giovanna Chandler | 202-709-5563 media@novavax.com

SOURCE Novavax, Inc.

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Novavax Nuvaxovid COVID-19 Vaccine Granted Expanded Conditional Marketing Authorization in the European Union for Use as a Booster for Adults Aged 18...

The end of the COVID-19 pandemic is in sight: WHO – UN News

September 16, 2022

We have never been in a better position to end the pandemic, Tedros Adhanom Ghebreyesus told journalists during his regular weekly press conference.

The UN health agencys Director-General explained however, that the world is not there yet.

A marathon runner does not stop when the finish line comes into view. She runs harder, with all the energy she has left. So must we. We can see the finish line. Were in a winning position. But now is the worst time to stop running, he underscored.

He also warned that if the world does not take the opportunity now, there is still a risk of more variants, deaths, disruption, and uncertainty.

So, lets seize this opportunity, he urged, announcing that WHO is releasing six short policy briefs that outline the key actions that all governments must take now to finish the race.

ADB/Richard Atrero de Guzman

People wear protective masks in Tokyo, Japan.

The policy briefs are a summary, based on the evidence and experience of the last 32 months, outlining what works best to save lives, protect health systems, and avoid social and economic disruption.

[They] are an urgent call for governments to take a hard look at their policies and strengthen them for COVID-19 and future pathogens with pandemic potential, Tedros explained.

The documents, which are available online, include recommendations regarding vaccination of most at-risk groups, continued testing and sequencing of the SARS-CoV-2 virus, and integrating effective treatment for COVID-19 into primary healthcare systems.

They also urge authorities to have plans for future surges, including the securing of supplies, equipment, and extra health workers.

The briefs also contain communications advice, including training health workers to identify and address misinformation, as well as creating high-quality informative materials.

Novavax/Patrick Seibert

A laboratory scientist works on the Novavax COVID-19 vaccine.

Tedros underscored that WHO has been working since New Years Eve 2019 to fight against the spread of COVID and will continue to do so until the pandemic is truly over.

We can end this pandemic together, but only if all countries, manufacturers, communities and individuals step up and seize this opportunity, he said.

Dr. Maria Van Kerkhove, WHOs technical lead on COVID-19, highlighted that the virus is still intensely circulating around the world and that the agency believes that case numbers being reported are an underestimate.

We expect that there are going to be future waves of infection, potentially at different time points throughout the world caused by different subvariants of Omicron or even different variants of concern, she said, reiterating her previous warning that the more the virus circulates, the more opportunities it has to mutate.

However, she said, these future waves do not need to translate into waves or death because there are now effective tools such as vaccines and antivirals specifically for COVID-19.

Originally posted here:

The end of the COVID-19 pandemic is in sight: WHO - UN News

Hundreds of Americans still dying of COVID-19 each day ahead of the fall – ABC News

September 16, 2022

It has been more than two and half years since the onset of the COVID-19 pandemic, and despite a return to a new form of normality for many people across the country, there are still hundreds of Americans dying from the virus every day, a grim reality of the pandemic's continued destruction.

The U.S. is currently averaging just under 400 daily COVID-19 related deaths. Although the daily number of fatalities is far lower than it was at the nation's peak, in January 2021, 3,400 Americans died of COVID-19 each day.

"The seven-day average daily deaths are still too high, about 375 per day well above the around 200 deaths a day we saw earlier this spring and, in my mind, far too high for a vaccine-preventable disease," Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said during a White House press briefing with the COVID-19 response team last week.

Over the last seven days, the U.S. has reported 2,500 deaths, and since the beginning of 2022, more than 221,000 Americans have died because of COVID-19.

The vast majority of Americans who are currently dying of COVID-19 are over the age of 75. Although more than 92% of Americans of the age of 65 have been fully vaccinated, many are not up to date on COVID-19 vaccinations, and are at a higher risk for severe disease due to the virus.

The persistently high death rate, alongside concerns over the potential threat of a COVID-19 resurgence, has reignited the call for all Americans to get vaccinated. It is particularly important for those older or more vulnerable to get vaccinated and boosted with the new bivalent shots, which target not only the original strain of the virus, but also the omicron variant, experts said.

"Were calling on all Americans: Roll up your sleeve to get your COVID-19 vaccine shot," White House COVID-19 Coordinator Dr. Ashish Jha said during a press briefing last week. "If youre 12 and above and previously vaccinated, its time to go get an updated COVID-19 shot."

As the vaccine rollout expands, Jha added the administration plans to put "special efforts" into reaching older Americans, people living in congregate care settings such as nursing homes, and others who may be particularly vulnerable to COVID-19.

Throughout the summer, COVID-19 case and hospitalization numbers have oscillated widely across the country. Numbers appeared to be on the decline, but in recent weeks, the number of U.S. wastewater sites reporting increases in the presence of COVID-19 in their samples appears to be back on the rise, after declines seen throughout the latter part of the summer.

In the U.S., about 50% of wastewater sites, which are currently providing data to the CDC, have reported an increase in the presence of the COVID-19 virus in their wastewater, over the last 15 days, up from the 40% of sites reporting increases, last month, according to federal data.

Several sites across the Northeast, in particular, appear to be seeing notable increases. In Boston, wastewater levels had plateaued, after a spring and summer surge, but in recent weeks, data indicates that COVID-19 sampling levels have increased again to their highest level in two months.

However, it is important to note that data is unavailable for many areas of the country, particularly across much of the South and the West.

The U.S. is currently reporting about 70,000 new cases a day. This comes as testing levels have plummeted in recent months, with now under 350,000 tests reported each day the lowest total since the onset of the pandemic.

However, hospital admission levels continue to fall nationally. About 4,500 virus-positive Americans are entering the hospital each day, down by about 8.4% in the last week.

There are currently about 33,000 virus-positive Americans receiving care in the U.S., down from about 37,000 total patients receiving care, one week ago. Overall, the totals remain significantly lower than at the nation's peak in January, when there were more than 160,000 patients hospitalized with the virus.

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Hundreds of Americans still dying of COVID-19 each day ahead of the fall - ABC News

MRI analysis offers new insight into vaccine-related lymphadenopathy in the general population – Health Imaging

September 16, 2022

A new paper published in Radiology offers updated insight into the presentations of COVID vaccine-related lymphadenopathythis time as visualized on chest MRI exams.

To date, research pertaining to reactive lymphadenopathy has focused mostly on patients with cancer who are routinely staged and monitored via PET/CT or in women undergoing breast cancer screening and/or imaging with mammography and ultrasound. While these studies have helped mold current recommendations regarding the the timing of imaging after COVID vaccination in these patients, there remains a lack of data regarding a more general population, authors of the study suggested.

Recommendations in the early days of 2021 are provisional, and more appropriate management strategies for vaccination-related lymphadenopathy are needed in both the general population and high-risk oncology patients, corresponding author of the paper Takeharu Yoshikawa, of the Department of Computational Diagnostic Radiology and Preventive Medicine at the University of Tokyo Hospital, and colleagues wrote [1].

This study sought to add to the conversation with data that include both men and women300 males and 133 females, to be exactof varying ages. Pre- and post-vaccination chest MRIs were obtained for each patient from June to October 2021. Various metrics were compared between the two scans, including imaging features and other patient health data (time of vaccination, age, etc.).

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MRI analysis offers new insight into vaccine-related lymphadenopathy in the general population - Health Imaging

‘Pride in the Park’ event offers monkeypox and Covid-19 vaccines – KTBS

September 12, 2022

SHREVEPORT, La. - ThePride in the Park Family Festivalreturned toBetty Virginia Park onSaturday, Sept. 10.

Hosted by PACE, the festival celebratedthe lives of Northwest Louisianas LGBTQ community.

The Center of Excellence for Emerging Threats (CEVT) at LSU Health Shreveport was on-hand to offer community COVID-19 vaccinations to those ages 5 and up. The CEVT also offered monkeypox vaccines onsite for individuals who meet vaccine criteria.

Also in attendance at the event were Shreveport mayoral candidates, Tracy Mendels and LeVette Fuller.

The park was teeming with food trucks, entertainers, vendors, and other festivities throughout the day.

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'Pride in the Park' event offers monkeypox and Covid-19 vaccines - KTBS

DHS urges COVID-19 vaccination for a healthy school year – The Baldwin Bulletin

September 12, 2022

As the 2022-2023 school year begins, the Wisconsin Department of Health Services (DHS) urges parents and guardians to get their children vaccinated against COVID-19. DHS also encourages anyone planning to attend in-person classes at a college or university to stay up to date on their COVID-19 vaccines.

Our mission as we approach the school year is to ensure that every student and our dedicated educators and staff can stay safe, healthy, and in school, said DHS Deputy Secretary Deb Standridge. A critical part of making this possible is ensuring that everyone is vaccinated against COVID-19. Even as new variants emerge, the COVID-19 vaccines continue to do their job of preventing serious illness that can lead to hospitalization and even death. We urge all parents and guardians to help protect our school communities and protect their children against the virus.

Everyone 6 months and older is eligible to receive vaccination against COVID-19. Nearly 389,000 Wisconsin school-age youth ages 5 to 17 have already received their primary series of a COVID-19 vaccine. However, approximately 75% of Wisconsin 5-to-11-year-olds and about 40% of 12-to-17-year-olds are not fully vaccinated against COVID-19. COVID-19 vaccines remain available to all Wisconsinites at no cost.

Over the course of the pandemic, many children fell behind on their routine childhood vaccinations. Back-to-school time is an ideal opportunity to get caught up on those vaccines and get the COVID-19 vaccine, too, said Bureau of Communicable Disease Director Traci DeSalvo. Cooler fall weather, schools being in session, and the coming winter mean people will spend more time inside and in closer proximity to each other. Vaccination remains the best way to prevent a surge in COVID-19 cases and a disruption in our schools, universities and lives.

In addition to vaccination, DHS and schools statewide continue to prepare to keep kids safe and healthy during the upcoming school year. The Centers for Disease Control and Prevention (CDC) has released updated COVID-19 Operational Guidance for K-12 Schools and Early Care and Education Programs(link is external). DHS supports the updated CDC guidance and encourages each school or school district to closely monitor the COVID-19 Community Levels in their county, along with vaccination rates, illness among students, teachers, and staff, outbreaks, and the age of students served by the school, and adjust their policies as necessary.

Parents, guardians, and students are encouraged to take actions to help prevent the spread of COVID-19 this school year by:

Staying up to date with COVID-19 vaccinations by ensuring all family members have received their recommended vaccine and booster doses.

Staying prepared by knowing the COVID-19 community levels in your area and how to access testing services. Many schools statewide will once again offer COVID-19 testing services and every U.S. household remains eligible to receive free at-home tests that can be ordered online at covid.gov. Many health insurers will also cover as many as eight free at-home tests per person each month. Check with your health insurer about how to get reimbursed.

Taking action if exposed to COVID-19 by monitoring for symptoms, wearing a mask around others indoors, and getting tested on day five following exposure.

Staying home when sick with COVID-19 or any other illness to prevent spreading it to others.

DHS will continue to offer support programs for schools and early childhood education facilities as the school year begins, including access to mobile vaccination clinics, a K-12 COVID-19 testing program, and stockpile of personal protective equipment (PPE) that includes child-size masks. During the 2021-2022 school year, the states K-12 COVID-19 Testing Program supported participating schools and districts in administering more than 800,000 tests to students and staff. In addition, DHS provided schools with approximately 1.4 million pieces of PPE, such as gloves and masks.

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DHS urges COVID-19 vaccination for a healthy school year - The Baldwin Bulletin

New Bivalent Formulations of COVID-19 Vaccine Now Offered at SMCHD – The Southern Maryland Chronicle

September 12, 2022

LEONARDTOWN, MD (September 9, 2022) By amendedauthorization from the U.S. Food and Drug Administration, the St. Marys County Health Department (SMCHD) will now offer the new bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 vaccines for use as a single booster dose at least two months following primary or prior booster vaccination. The bivalent vaccines are administered after the original series has already been completed.

The updated booster is a formula that both boosts immunity against the original coronavirus strain and protects against the newer Omicron variants that account for most of the current cases. The Moderna bivalent COVID-19 vaccine is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech bivalent COVID-19 vaccine is authorized for use as a single booster dose in individuals 12 years of age and older.

These updated vaccines will enhance protection against COVID-19 and its variants, including the newer Omicron strains that are circulating and causing both new and repeat infections, said Dr. Meena Brewster, St. Marys County Health Officer. As new variants of the virus emerge, we expect vaccines will be updated similarly to how we update the flu vaccine. This should help community members better protect themselves from severe illness and infection.

For more information or to make a vaccine appointment, please visit:smchd.org/covid-19-vaccineand select the patient age group for available clinic dates.

Call SMCHD at (301) 475-4330 for questions or assistance making an appointment over the phone. Please review theallergy guidanceand theFAQs for SMCHD COVID-19 Vaccinationbefore registering for a vaccine appointment. COVID-19 vaccines are also available through primary care offices and local pharmacies.

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New Bivalent Formulations of COVID-19 Vaccine Now Offered at SMCHD - The Southern Maryland Chronicle

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