Category: Covid-19 Vaccine

CHICAGO (CBS) -- Thousands of lives could have been saved if the Food and Drug Administration and the Centers for Disease Control and Prevention approved COVID-19 boosters sooner, along with stronger public health messaging, according to a new study.

TheNorthwestern Universitystudy used Israel as a counterfactual or a "what if" scenario to see the possible outcomes that could have happened in the United States.

Researchers estimated that through June 2022, if the U.S. moved at a faster pace to approve it and get people boosted, an estimated 29,000 lives could have been saved -- matching Israel's uptake and speed.

Israel was used because it was the first country to launch the boosters as well as vaccinate its population in July 2021. Researchers used vaccination data, mortality data, and vaccine effectiveness from Milwaukee County, Wisconsin and Israel.

Vaccine availability and eligibility are one thing, but it also depends on people's willingness to get vaccinated. Inconsistent public health messaging also contributed to avoidable deaths, according to researchers.

"The slow, complex U.S. authorization process was combined with muddled public health advice on whether boosters were needed, how badly, when, and by whom," the study said. "Many vaccinated people received the (wrong) message: Two doses is good enough; I don't need a third. To be sure, the effect of faster approval and stronger messaging on booster take-up rates is unknown."

Researchers cite five likely factors that contributed to the slower U.S. approach: the US regulatory system, limited options presented to the Vaccines and Related Biological Products Advisory Committee, lack of urgency, low-quality data, and "much attention was focused on the wrong metric: vaccine effectiveness against death rather than remaining mortality risk."

"We provide evidence that this caution, during an ongoing pandemic, had a large cost in terms of lives lost," the study said.

Researchers hope this study can "inform policy judgments about how US regulators can do better in planning for and responding to the next pandemic."

The fullstudywas published on Monday, Dec. 4 in the Journal of Health Affairs.

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Study: Slow COVID-19 booster rollout cost thousands of lives - CBS News

MILWAUKEE Only 9% of Milwaukee County residents have gotten the updated COVID-19 vaccine. Dr. Ben Weston, the Chief Health Policy Advisor for Milwaukee County said that's putting people at risk.

"Even if you've gotten vaccines in the past, that immunity doesn't last forever. So, getting that fall vaccine is critical," Weston said.

He said a low vaccine rate is most concerning for older adults. Across the county, people 65 and older have a vaccine rate of about 29%. While that's higher than the general population, Weston said it's still not enough.

"That's just not nearly high enough to protect the most vulnerable in our community," Weston said.

The City of Milwaukee's numbers are worse. Just 5% of city residents have received the most updated booster of the vaccine. The Milwaukee Health Department said it will have off-site clinics throughout December to try and get more people vaccinated.

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Milwaukee County and City have low COVID vaccine rate; officials urge people to get vaccinated - TMJ4 News

Data source and study design

Using an ecological study design, we analyzed publicly available data from the WHO pooled vaccination dataset (n=228 WHO members) merged with the World Banks GNI per capita data (n=215 members). The WHO vaccination data are extracted and compiled from members reports and third parties [24]. The dataset is updated weekly with vaccine introduction and administration by WHO members. We used data as of June 4, 2022. A detailed description of the WHO vaccination dataset and data collection can be found elsewhere [7, 25]. The World Bank GNI per capita data is routinely collected and compiled using reports published by its member countries national statistical authorities, the Organization for Economic Cooperation and Development (OECD), the International Monetary Fund, or directly from countries official data. We selected 2019 GNI per capita data as an indicator of the WHO members economy prior to the pandemic. A detailed description of the World Bank dataset and data collection can be found elsewhere [26, 27]. We excluded WHO members with missing vaccination rates, or GNI per capita; thus, our sample size in the merged dataset was 192 members. All datasets are publicly available and de-identified, therefore, a review from an Institutional Review Board was not required.

The primary outcome of interest was the cumulative number of persons fully vaccinated (i.e., receiving the required number of doses as per the vaccine guideline) per 100 population). Vaccination data were pooled from reports from members and WHO review of publicly available official data or data collected and published by third-party sites [28]. The population estimations for each country were extracted from the United Nations Department of Economic and Social Affairs, Eurostat, National Statistics Office Malta, The Government of the Pitcairn Islands, and Statistics Netherlands. A detailed description of the calculation can be found elsewhere [29, 30].

Cumulative persons vaccinated with at least one dose per 100population was the secondary outcome of interest.

GNI per capita was calculated by the Word bank in U.S. dollars using the Atlas conversion factor. We created a categorical variable to classify members into different income levels based on the World Banks 2019 Gross National Income thresholds. GNI was classified into low income (less than $1,026), lower-middle income ($1,026 to $3,995), upper-middle income ($3,996-$12,375) and high income (more than $12,375). A detailed description of the calculation can be found elsewhere [26, 27]. WHO regions were our secondary exposure. WHO regions are classified into the Africa, Americas, South-East Asia, Europe, Eastern Mediterranean, and Western Pacific regions based on members respective WHO regional offices [4].

The number of vaccine types in WHO members was the covariate. We include the number of vaccine types administered by WHO members as a covariate based on literature [20, 21] and a priori knowledge of possible confounding (availability of various vaccine choices). The number of COVID-19 vaccine types used by each WHO member was categorized into 1 to 3, 4 to 6, 7 to 9, and 10 to 12. We sourced the number of vaccine types data from the WHO data repository [28].

We performed descriptive statistical analyses to determine the cumulative meannumber of persons fully vaccinated per 100 populationstratified by GNI per capita,WHO region, and the number of vaccine types used by WHO members. We performed ANOVA tests to assess significant differences in COVID-19 vaccination by WHO members GNI per capita, region, and the number of vaccine type used. We also performed negative binomial regression to assess the association between the vaccination rates and GNI per capital, WHO region and the number of vaccine types using two models. We used the negative binomial regression model because the COVID-19 vaccination outcomes were rates normalized from count data (i.e., only non-negative integer), and it managed for overdispersion in the dataset.

The first model looked at the crude association between vaccination rates and GNI per capital, WHO region and the number of vaccine types respectively. The second model examined the association between vaccination rates and GNI per capital adjusted for WHO region and the number of vaccine types. To adjust for differential follow-up time in the reporting of vaccination data between countries, we offset in the regression the natural log of the time (in weeks) between April 9th, 2021, and the most recent date each country member reported/updated vaccination data to WHO. April 9th, 2021, was the oldest most recent date a member reported vaccination data to WHO as of June 4th, 2022, therefore, was selected as the baseline follow-up date. We used SAS version 9.4 and STATA 16.1 to perform the analyses.

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Association between Gross National Income per capita and COVID ... - BMC Public Health

The City of West Hollywood is encouraging community members to stay up to date on vaccinations and limit the spread of COVID-19 and seasonal influenza (flu) during the autumn and winter seasons.

The City of West Hollywood will host two Vaccination Clinics on Saturday, December 16, 2023 to provide community members, including adults and children six months and older, with free updated COVID-19 vaccines and up-to-date seasonal flu shots. The morning clinic will take place at the West Hollywood Sheriffs Station from 10 a.m. to 12:30 p.m., located at 780 N. San Vicente Boulevard. The afternoon clinic will take place at Fiesta Hall at Plummer Park from 1:30 p.m. to 4 p.m., located at 7377 Santa Monica Boulevard. Vaccinations will be provided on a drop-in basis; no advance registration is required.

Vaccination Clinics will be operated by the Los Angeles County Department of Public Health in partnership with the City of West Hollywood and the Office of Los Angeles County 3rd District Supervisor Lindsey P. Horvath.

Many respiratory viruses circulate year-round in the US and California, typically with more activity in the autumn and winter seasons (October through March). Respiratory viruses can cause cold or flu-like symptoms and serious illness in some people. Illness can be spread through coughing or sneezing, a lack of handwashing, or through indirect exposure in crowded indoor spaces. Being up to date on vaccines is important to help lessen transmission and severity of illness.

Vaccination Clinics will offer the latest versions of vaccines. The COVID-19 vaccine has been updated to target Omicron XBB strains, now the dominant strains in LA County. The flu vaccine is updated each year to provide the best match for dominant strains. Vaccines are safe and staying up to date on both flu and COVID-19 vaccinations is a powerful way to help prevent severe illness and hospitalization. People can get both vaccinations at the same time.

For additional details about vaccines, please visit the LA County Public Health vaccine information webpage at PublicHealth.lacounty.gov/Vaccines.

For community members who cannot attend the Vaccination Clinics on Saturday, December 16, 2023, there are many resources available to stay up to date on vaccines. To find a vaccination site or to make an appointment, please visit http://www.VaccinateLACounty.com. For more vaccine information, visit PublicHealth.lacounty.gov/Vaccines. Community members who are homebound or have difficulty leaving home safely can request a free home visit for vaccinations. Request an appointment at PublicHealth.lacounty.gov/VaxatHome. There should be no out-of-pocket costs for the updated COVID-19 vaccine, regardless of insurance or immigration status.

For additional information about vaccines, talk with your health care provider or pharmacist, or call the LA County Public Health Call Center at 1-833-540-0473, seven days a week, from 8 a.m. to 8 p.m. For reporters and members of the media seeking additional information about vaccinations in LA County, please contact the Los Angeles County Department of Public at media@ph.lacounty.gov. For people who are Deaf or hard of hearing, please call the City of West Hollywoods TTY line (323) 848-6496.

For up-to-date information about City of West Hollywood news and events, follow @wehocity on social media, sign-up for news updates at http://www.weho.org/email, and visit the Citys calendar of meetings and events at http://www.weho.org/calendar. West Hollywood City Hall is open for walk-in services at public counters or by appointment by visiting http://www.weho.org/appointments. City Hall services are accessible by phone at (323) 848-6400 and via website at http://www.weho.org. Receive text updates by texting WeHo to (323) 848-5000.

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City of West Hollywood will Host Two Vaccination Clinics on ... - City of West Hollywood

We present findings on COVID-19 vaccination delays and overdue or missed doses for almost half a million non-EU migrants and resettled refugees compared with the general population in England between 8 December 2020 and 20 April 2022. Refugees and migrants with non-white ethnicity were more likely to have a delayed second or third COVID-19 dose. Refugees and older migrants were more likely to not have received a second or third dose. These data hold immediate relevance to strengthening COVID-19 vaccination for migrants and identify important variability in uptake by age, visa type, and ethnicity.

Our findings highlight more overdue second and third doses (that is, not receiving a subsequent dose) in older migrants compared with their counterparts in England. Slower uptake could have been driven by greater language barriers, limited health literacy, digital exclusion or fear of side effects in older migrants18,19,20. Similar findings were found in a large cross-sectional study in Canada21. Decisions to not receive a second or third dose could also be associated with differences in perceived vulnerability to severe COVID-19 outcomes due to lower levels of underlying health issues in migrants compared with the general population in England22. Patterns in greater overdue second and third doses for older migrants remained even after the follow-up period was shortened to account for potential emigration or embarkations out of England once international travel resumed. In-depth qualitative exploration on the reasons behind older migrants lower uptake is needed especially given the importance of subsequent doses for protection against new variants.

Individuals on work visas were less likely to be overdue for a second or third dose than the England cohort. This may be due to firstly significant proportions of migrants working in health and social care23,24 who were initially prioritized for vaccination and eventually included in the United Kingdom government enforced vaccine mandate, and secondly, more stringent work visa sponsorship requirements may favour the entry of migrants with higher socio-economic status, which has been associated with lower vaccine hesitancy25,26. Conversely, refugees were more likely to be overdue for both second and third doses than the England cohort and were almost two times more likely to be delayed for their second or third dose, which is consistent with studies on low vaccine intent and under-immunization in other forced migrants12,27. Reasons for delays include access barriers, lack of accessible information in appropriate language, fear of vaccine side effects, or lack of familiarity/trust in the health system12,13,28. However, these estimates are probably an underestimation of true inequalities among other forced migrants as the refugee participants in this study are resettled refugees who received government support to facilitate early integration with appropriate health and social care services prior to their arrival.

Migrants with non-white ethnicities were more likely to be delayed for their second dose than migrants with a white ethnicity. This could reflect the unique challenges that being both a migrant and an ethnic minority have on vaccine access as a result of healthcare entitlement, language, literacy and other communication barriers2,29. As some ethnic minority communities experienced higher severe acute respiratory syndrome coronavirus 2 exposure and subsequent COVID-19 infection, second dose delays could have also influenced by following official guidance to wait at least 4weeks after an infection before receiving the next dose30,31. However, those differences disappeared for the third dose, perhaps due to the rapid roll-out of the booster (third dose) programme or more targeted vaccination campaigns. With evidence clearly demonstrating the disproportionate impact of COVID-19 on ethnic minority groups in England, there was a commitment from the United Kingdom government to support bespoke vaccination campaigns targeting ethnic minority communities to increase vaccine and booster uptake32. Still older migrants across all ethnic groups were less likely to return for their third dose than their counterparts within the same ethnic group in the England cohort. Conversely, another study found migrants arriving before 2011 from Black African, South Asian and Other ethnicities had a higher total first dose uptake than their United Kingdom-born counterparts15. Further research is needed in exploring predictors of vaccine uptake such as migration status (for example, migrants and non-migrants), visa type within ethnic groups, and socio-economic status.

Strengths of this study include a large study population with information on migration history linked to vaccination records that cover the primary course of COVID-19 vaccination and the initial booster (third dose) campaign recommended for adults in England. Our comparison dataset OpenSAFELY has been found to be largely representative of the general population in England across age, sex, deprivation level, and region33.

Key limitations of this study include that the Million Migrant-NIMS cohort is not representative of the entire migrant population in England, with a study population consisting of resettled refugees and migrants from non-EU countries who entered on longer-term visas and have an NHS number. Irregular migrants (for example, undocumented migrants, refused asylum seekers, visa overstayers, and children born to irregular migrant couples), migrants on a temporary visa, EU and European Economic Area migrants, non-EU migrants from low-incidence tuberculosis (TB) countries who do not require a pre-entry TB screening as part of visa application and non-EU migrants who emigrated before the start of either health screening programme were not captured. Importantly, some of these groups like irregular migrants could be in more vulnerable situations. Although only half of the Million Migrant cohort with NHS numbers linked to at least one NIMS COVID-19 record, the demographic profile between the two cohorts was broadly similar but the representativeness of our findings as a result could be limited.

There are several potential sources of bias in the linkage methodology that could impact the generalizability of our findings. An individual might not have linked in either the PDS or NIMS COVID-19 vaccination dataset if they never arrived in England, were resident in Scotland, Northern Ireland or Wales, they were never allocated an NHS number, or their linkage variables were recorded incorrectly or inconsistently. Linkage error due to missing or mis-recorded identifiers could result in a selection bias if the missed matches were not missing completely at random. Because the linkage to a NIMS COVID-19 vaccination record relied on having an NHS number, the cohort excluded migrants without any previous contact with health services and who may have been less likely to receive a vaccine. This selection criteria into the cohort probably overestimated vaccine coverage.

Although there is some certainty that individuals who receive an entry visa to the United Kingdom migrate, when and whether they leave after their visa expires is less certain34. Similarly for those with overdue or missed doses, lack of data on emigration during the study period could have led to an over-ascertainment of vaccination overdue. However, for individuals who were most likely to have remained in England for the duration of the study period such as those on refugee, settlement and dependent, and family visas, these estimates are broadly robust and can be helpful indicators of second and third dose uptake35. Importantly, the highest rate of vaccination overdue were found in these subgroups and older migrants, even after the study period was shortened and newly arrived migrants on short-term visas (for example, individuals on student, work, and working holiday visas arriving in the last 5years) were excluded to account for travel out of England.

Several determinants for COVID-19 vaccination coverage were included in this analysis, but no data were available on clinical vulnerability, accommodation (for example, living with someone with a clinical vulnerability or in a care home) or high-risk occupations, all of which were prioritized risk factors for early vaccination in England36. We had no information on death, contraindications, or emigration out of the country; all of which could artificially inflate our denominator for vaccination overdue. Our sensitivity analyses measuring the impact emigration (restricting the follow-up period and excluding shorter-term visa holders) showed minimal effect on our estimates. Lastly, we restricted our analyses to those over the age of 16 for first dose and over 18 for second and third doses, limiting the generalizability of our data to those under the age of 16.

Our findings hold immediate relevance to strengthening COVID-19 vaccination and other routine immunizations for migrants and identify important variability in uptake by age, visa type and ethnicity. Most migrants in our cohort, in particular older migrants and refugees, were more likely to be overdue for their second and third doses than Englands general population. These findings highlight slower vaccination uptake for some migrant groups and reinforce the importance of migrant-inclusive policies and services to ensure equitable access36. Box 1 summarizes key policy and practice areas of relevance to improve COVID-19 vaccination uptake in migrants in the United Kingdom and other European countries.

It remains important to better understand the drivers of low and delayed vaccine uptake in migrant populations and why refugees and older migrants are not returning to receive their second or third dose of the COVID-19 vaccination. The extent to which these are structural or personal barriers, the role of vaccine hesitancy and misinformation, and the impact of policies resulting in the exclusion of some migrant groups from accessing health and vaccination systems need to be further elucidated. As immunity wanes and new COVID-19 boosters are needed for emerging variants, understanding vaccination coverage for high-risk groups such as migrants will be essential for an adequate and equitable response.

Key policy and practice areas requiring action:

Co-design context and culturally appropriate vaccination campaigns and research with international, national, regional and local migrant community organizations to ensure accessibility and culturally appropriate services and to better understand barriers and facilitators to vaccination systems on arrival.

Explore opportunities with stakeholders to strengthen data collection around vaccination uptake and country of birth, visa category and time since arrival in the host country.

Improved consideration of migrant populations in the evaluation and delivery of vaccination programmes for COVID-19 and routine vaccinations.

Further research the causes of uptake variations, including differences between different types of migrants.

Read more:

COVID-19 vaccination coverage for half a million non-EU migrants ... - Nature.com

TAMPA, Fla. COVID-19 cases are rising again, but theres still confusion over who should get them.

A lot of people just dont know what they should be doing, said Dr. Jill Roberts, Associate Professor at the USF College of Public Health.

The latest numbers from the CDC show that only about 16% of adults in the United States have received the latest COVID-19 booster.

The vaccination rate is much lower than experts hoped for.

Part of that may be difficulty in actually getting it out there. There's a lot of miscommunication about who should take it, who should not take it, said Roberts.

Health officials believe the initial confusion created a lasting impact.

Officially, the CDC recommends that all people 6 months old and older stay up to date on COVID-19 vaccines.

In our most vulnerable population, thats very, very important. So our elderly patients, our patients with immune-compromised or those caring or living with those individuals, said Dr. Laura Arline, Chief Quality Officer for BayCare.

However, some doctors believe that the reality for everyone else is that its more nuanced for each person, especially when it comes to kids.

In the pediatric population, high-risk kids would have a much more significant benefit to it, but I see really low benefit at this point to children, especially if theyve had COVID or a previous vaccine because they have the immunity, said Dr. David Berger, a certified pediatrician at Wholistic Pediatrics and Family Care.

If a child is healthy and isnt around anyone over 65 or whos immunocompromised, some experts said they may be fine without the shot.

Theres no doubt that the COVID vaccines, at least for the short term, do keep people out of hospitals and worse. But also recognizing that if it isn't an immunologically compromised, a chemo patient, or some other genetic immunodeficiency, most kids are healthy, and overall, the majority of kids dont get hospitalized, said Berger.

Locally, doctors arent currently seeing much of an increase in kids being hospitalized with COVID-19 infections.

In the last few months, it sort of stayed steady, more of a plateau. Maybe a little bit of an increase recently, but nothing significant, said Dr. Sara Kirby, Medical Director for AdventHealth Tampa's Pediatric ER.

However, doctors agree the vaccine does still offer protection and reduces the chance of severe disease.

The COVID shots are now pretty much widely available. Its a good match between the vaccine and the strains that are going around, so I would recommend it, said Roberts.

The vaccines are safe, and they are effective against the current variants. So it is worth getting, said Arline.

Overall, they recommend talking to your doctor to see whats best for your family.

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Doctors work to clarify confusion over COVID-19 vaccine ... - ABC Action News Tampa Bay

Data source

The present study used the TriNetX COVID-19 Network, an international collaboration of health research platforms that compiles de-identified patient data from electronic health records (EHRs). These records encompass a wide variety of patient information, including demographic details, medical diagnoses, procedures, medication records, laboratory results, genomic data, and types of healthcare organization visits. Over 120 healthcare organizations (HCOs) worldwide, predominantly academic health centers, have contributed data from their main hospitals, affiliated institutions, and outpatient clinics to TriNetX. For this specific analysis, we utilized the COVID-19 network, encompassing data from more than 114 million patients from 87 HCOs. TriNetX offers integrated tools for patient-level data analysis and delivers aggregated results to the researchers. Detailed information on the database can be accessed online [24]. Written informed consent was not required because TriNetX contains anonymized data. The Institutional Review Board of the Chi Mei Medical Center approved the study protocol (no. 11202002).

In the patient selection process, the TriNetX database was used, which contains 86 HCOs as of July 4, 2023. The initial patient pool consisted of individuals who had visited these HCOs at least twice between March 1, 2020, and January 1, 2023. Patients who tested positive for SARS-CoV-2 or were diagnosed with COVID-19 between January 1, 2022, and January 1, 2023, and those who were prescribed antiviral agents and were initially hospitalized were identified from this pool. The prescribed antiviral medications included molnupiravir, remdesivir, and nirmatrelvir plus ritonavir. The selection process was identical for all patients diagnosed with influenza within the same timeframe. The analysis was restricted to patients aged18.

Subsequently, several exclusion criteria were used. For the COVID-19 group, patients who were also diagnosed with influenza and those with long-term COVID-related symptoms one year before the index date were excluded. Similarly, for the influenza group, patients who tested positive for SARS-CoV-2 or were diagnosed with COVID-19 and those with long-term COVID-related symptoms one year before the index date were excluded.

Finally, patient selection involved propensity score matching on a 1:1 basis for age at index, race, sex, adverse socioeconomic determinants of health, and comorbid medical conditions. This resulted in two comparable groups for this study: a COVID-19 and an influenza group (Tables S1 and S2).

We considered 47 variables to adjust for imbalances in baseline characteristics between the COVID-19 and influenza groups. The list included both confirmed and suspected risk factors for COVID-19 and more severe cases of the illness, such as demographics (eg, age, sex, and ethnicity), adverse socioeconomic determinants of health (including "problems related to education and literacy," "problems related to employment and unemployment," and "problems related to housing and economic circumstances," as defined by ICD-10), and comorbidities (such as obesity, hyperlipidemia, hypertension, diabetes mellitus, chronic kidney disease, asthma, chronic lower respiratory diseases, ischemic heart disease, neoplasm, chronic liver diseases, stroke, dementia, rheumatoid arthritis, lupus, psoriasis, human immunodeficiency virus infection, mood disorders, and psychotic disorders).

The primary outcome of this study was a composite outcome consisting of 12 clinical features of post-COVID conditions, observed 90180days after the index event. These features include chest/throat pain, abnormal breathing, abdominal symptoms, fatigue/malaise, anxiety/depression, pain, headache, cognitive dysfunction, myalgia, loss of taste or smell, sleep disturbances, coughing, and palpitations [25,26,27].

We investigated the secondary outcomes of all-cause hospitalization, all-cause emergency department (ED) visits, and deaths during the follow-up period. Table S3 provides additional details regarding the diagnostic, visiting, and procedural codes used to define these outcomes [21, 28, 29].

We used the built-in propensity score-matching (PSM) function of the TriNetX platform to ensure a 1:1 match between the participants in the COVID-19 and influenza groups. This was achieved using a nearest-neighbor greedy matching algorithm with a caliper width of 0.1 pooled standard deviation. Standard differences were then computed to assess the balance between groups, with differences in absolute values<0.1, indicating a good match between groups [30].

Subsequently, we performed KaplanMeier analysis, followed by log-rank tests and calculation of hazard ratio (HR) with 95% confidence intervals (CI) to compare the two groups. Statistical significance was set at p<0.05. The HR was used to describe the relative risk of post-COVID conditions based on a comparison of time-to-event rates calculated using a proportional hazard model, which is a built-in function in TriNetX.

For subgroup analysis, we compared the primary and secondary outcomes between the two groups, stratified by age (1864 and65years), sex, vaccine status (unvaccinated, 1 or 2 doses of vaccine, boosted), and race (Caucasian and non-Caucasian). The vaccine type used was Pfizer with CPT code 91,307 (0051A, 0052A, 0071A, 0072A), Janssen 91,303 (0031A), Novavax (0041A, 0042A), and Moderna 91,301 (0011A, 0012A, 0013A, 0111A).

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Comparison of post-acute sequelae following hospitalization for ... - BMC Medicine

Cleveland Clinic researchers believe they have found a way to improve COVID-19 vaccines by strengthening and prolonging their effectiveness. Those researchers took a page from the herpes virus to help human cells better learn from messenger RNA COVID-19 vaccines how to recognize and subsequently fight the virus that causes COVID-19, the Clinic announced Monday.

Messenger RNA (mRNA) vaccines, like the original COVID-19 vaccines produced by Pfizer and Moderna in 2020, teach the body's cells how to make copies of the coronavirus' spike protein, according to the American Heart Association. If someone is exposed to the real virus later, their body will recognize it and know how to fight it off, according to the Centers for Disease Control and Prevention.

"mRNA vaccines give our bodies the genetic instructions they need to build pieces of the pathogen that our immune systems can respond to. In this way, mRNA vaccines act a lot like the viruses we fight against," said Dr. Jae Jung, director of Cleveland Clinic's Global Center for Pathogen & Human Health Research.

Viruses have their own genetic makeup, but they don't know how to carry out the instructions written in their genes. As a result, they trick infected host cells into reading the foreign genetic material and making proteins for the virus. Jung's research team took this knowledge and used it to improve how host cells read genetic material in mRNA vaccines.

Viral genes use different DNA and RNA sequences than human genes, making it difficult for host cells to produce the protein the virus is asking for. Jung likened this to saying "Hello" in different languages infected cells can determine what protein the viral genes want them to produce, but the language difference complicates the instructions.

Think of it like using different spellings of the same word when writing out instructions, said Dokyun "Leo" Kim, a graduate student in Jung's lab. Infected cells can figure out what protein the viral genes want them to make, but the spelling differences mean it's a little harder to read the instructions.

Jung used the herpes virus to draw inspiration on how to trick the body's cells into responding better to mRNA COVID-19 vaccines. His previous work determined that the herpes virus had developed a tool called a "trans-inducer" to avoid loss of efficiency.

Jung's lab partnered with Dr. Kun Li to create and test alterations of the COVID-19 mRNA vaccine in mice. According to Cleveland Clinic, they found that adding the "efficiency element" from the herpes virus to the COVID-19 mRNA vaccine greatly improved the immune response and protected against lethal levels of infection in preclinical trials. Jung said this protection was good for up to 20 weeks following vaccination.

"We generated the SARS-CoV-2 spike mRNA with the herpes virus glycoprotein coding usage system. Then there is a translator. Herpes virus has a translator we call that a transducer. We put [them] together, then when you print the human cell, they produce a higher amount of spike protein," Jung said.

Jung noted these modifications to the mRNA COVID-19 vaccine could potentially be applied to other vaccines, like the new Respiratory Syncytial Virus vaccine, but research has a long way to go. His lab is currently applying the same knowledge to other vaccines, like those for Zika virus, so that his research has additional examples before the next stage.

He also said his team isn't sure if these new modifications to the mRNA COVID-19 vaccine would reduce the frequency of booster shots required to keep them updated.

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Here's how Cleveland Clinic researchers used the herpes virus to ... - ideastream

(MASS APPEAL) The COVID-19 pandemic seems like it was both ages ago and yesterday, but here in late 2023 were more than 2 years past the pandemic yet it is still affecting our health and that of our loved ones and workplaces.

Im joined by Dr. Jerome Adams, an anesthesiologist and Former U.S. Surgeon General, to talk about the latest with COVID-19.

Visit modernatx.com for more information.

Sponsored by: Moderna

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The latest COVID-19 vaccine information - WWLP.com

GAITHERSBURG, Md., Nov. 28, 2023 /PRNewswire/ --Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant,today announced that Nuvaxovid XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older. The EUL assists WHO member states in assessing vaccines with the aim of expediting availability and enables the WHO's 194 member states to expedite regulatory approvals to import and administer the vaccine.

"The WHO Emergency Use Listing of our updated protein-based non-mRNA COVID-19 vaccine enables expedited regulatory approvals for its 194 member states and UN procurement agencies, such as UNICEF, thereby supporting equitable access to our vaccine around the world," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Rural or hard-to-reach areas can benefit from our vaccine's ease of transport and storage profile. As part of a diversified vaccine portfolio, our vaccine can play an important role in helping to protect people around the globe against the latest variants."

Novavax's vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, decreasing the carbon footprint and reducing wastage.1-4

The EUL was based on non-clinical datashowing that Novavax's COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.5,6

In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

Novavax's updated COVID-19 vaccine is also authorized in the U.S. and the European Union, and is under review in other markets.

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

NOVAVAX COVID-19 VACCINE, ADJUVANTED (2023-2024 FORMULA) AUTHORIZED USESNovavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

IMPORTANT SAFETY INFORMATION What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted? Tell your vaccination provider about all of your or your child's medical conditions, including if you or your child:

Who should not get the Novavax COVID-19 Vaccine, Adjuvanted? A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:

What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted? There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine:

Side effects that have been reported in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:

Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, Adjuvanted include:

These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied.

What should I do about side effects? If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.

Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 18008227967 or report online to https://vaers.hhs.gov/reportevent.html. Please include "Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA" in the first line of box #18 of the report form.

In addition, you can report side effects to Novavax, Inc., using the following contact information: Website: http://www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).

What about pregnancy or breastfeeding? If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com.

Please see the Fact Sheet for Recipients and Caregiversfor more information. Reporting Adverse Events and Vaccine Administration Errors

About Nuvaxovid XBB.1.5 2023-2024 Formula (NVX-CoV2601) NVX-CoV2601 is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2 to 8C, enabling the use of existing vaccine supply and cold chain channels.

About Matrix-M Adjuvant When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

About Novavax Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visit novavax.comand LinkedInfor more information.

Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine 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; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; 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's Annual Report on Form 10-K for the year ended December 31, 2022 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, availableat 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 240-268-2022 [emailprotected]

MediaAli Chartan 240-720-7804 [emailprotected]

References:

SOURCE NOVAVAX, INC

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