Category: Vaccine

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More than 1.3 million winter vaccines delivered – gov.scot – The Scottish Government

October 13, 2022

Most vulnerable protected against COVID-19 and flu.

Over a million vaccines have been delivered to protect against the latest strains of flu and COVID-19 in the latest efforts to relieve pressure on the NHS over winter.

Frontline healthcare staff and the countrys most vulnerable have been immunised at speed with 80.2% of all care home residents being fully vaccinated since the rollout began in September.

The next groups in line for their vaccines over 65s and those at high-risk are receiving a scheduled appointment and 50-64 year olds will soon be invited to book an appointment. Anyone who has missed an appointment can reschedule through the NHS Inform online booking portal.

The COVID-19 vaccine is being given at the same time as the flu jab where possible, and so far 94% of those invited have had both at the same appointment. Over two million Scots will be offered both vaccines over the next three months a pace that aims to maintain Scotlands place as a leading nation on vaccine uptake.

Health Secretary Humza Yousaf said:

This impressive uptake is testament to the frontline staff who got us through the pandemic and continue to protect our population and NHS from the threats that winter brings.

Scotland remains steadfast in the effort to protect everyone continuing the huge success of the vaccination programme since it was first rolled out in December 2020.

COVID-19 has not gone away and I call on everyone to take up the offer of a booster as soon as their invitation arrives to protect themselves, their families and the NHS.

BACKGROUND

1,369,270 COVID-19 and flu vaccines have been delivered since the winter vaccine programme launched.

Both new bivalent vaccines, which target Omicron and the original variant of COVID-19, are being deployed alongside existing vaccines, though the vaccination individuals receive will depend on age and vaccine availability. Both the current and new bivalent vaccines provide good protection from severe illness and hospitalisation from known COVID-19 variants.

Rearrange or opt-out of your vaccination appointment | NHS inform

Winter vaccines | NHS inform

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More than 1.3 million winter vaccines delivered - gov.scot - The Scottish Government

Vaccine effectiveness of primary series and booster doses against covid-19 associated hospital admissions in the United States: living test negative…

October 11, 2022

Contributors: KA, JPR, and DS contributed equally to this work as lead author. WHS and MWT contributed equally to this work as senior author. Guarantors of this work include WHS (protocol and data integrity), KA (statistical analysis), ASL (viral sequencing laboratory methods), JDChappell (reverse transcription polymerase chain reaction laboratory methods), and NJT (antibody measurement methods). WHS was responsible for the decision to submit the manuscript, KA, JPR, DS, MWT, and WHS drafted the initial manuscript (without outside assistance). KA, JPR, DS, MG, AAG, TM, SG, BH, KT, JDCasey, NM, AZ, NIS, KWG, DCF, MH, DNH, HA, MP, AEF, MCE, MG, AM, NJJ, VS, JSS, IDP, SMB, ETM, AM, ASL, AK, CLH, LWB, CtL, AD, JGW, AJG, NQ, SYC, CM, CR, HB, JHK, JDChappell, NH, CGG, TR, WBS, AB, CJL, KH, SNL, NJT, SP, MLM, MMP, MWT, and WHS conceptualized the study methods. KA, MWT, CJL, KH, and YZ were responsible for statistical analysis and data management. WHS acquired funding. KA, JPR, DS, MG, AAG, TM, SG, DH, HKT, JDCasey, NM, AZ, NIS, KWG, DCF, MH, DNH, HA, MP, AEF, MCE, MG, AM, NJJ, VS, JSS, IDP, SMB, ETM, AM, ASL, AK, CLH, LWB, CtL, AD, JGW, AJG, NQ, SYC, CM, CR, HB, JHK, JDChappell, NH, CG, TR, WBS, AB, CJL, KH, SNL, NJT, SP, MLM, MMP, MWT, and WHS critically reviewed the manuscript for important intellectual content. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: Funding for this work was provided to all participating sites by the US Centers for Disease Control and Prevention. SMB reports grants from the National Institutes of Health (NIH) and Department of Defense (DoD), participation as the Data Safety Monitoring Board (DSMB) chair for Hamilton Ventilators, and participation as a member of the DSMB for New York University covid-19 clinical trials. JDCasey reports funding from NIH and DoD. SYC reports consulting fees from La Jolla Pharmaceuticals, PureTech Health, and Kiniska Pharmaceuticals, payments or honorariums from La Jolla Pharmaceuticals, and participation on a DSMB for an investigator initiated study conducted at UCLA. JDChappell reports grants and other support from NIH. AD reports consulting fees from ALung technologies. MCE reports payments or honorariums from Abbott Laboratory for sponsored talks. DCF reports consulting fees from Cytovale and participation on a DSMB for Medpace. AEF reports grants from NIH. MG reports grants from CDC, CDC-Abt Associates, CDC-Westat, and Janssen, and a leadership role as co-chair of the Infectious Disease and Immunization Committee of the Texas Pediatric Society, Texas Chapter of American Academy of Pediatrics. KWG reports funding from NIH/National Heart, Lung, and Blood Institute (NHLBI) for the ACTIV-4HT NECTAR trial. AAG reports grants from NIH, DoD, AbbVie, and Faron Pharmaceuticals. MG reports grants from NIH/NHLBI and Agency for Healthcare Research and Quality (AHRQ), consulting fees from Endpoint, a leadership role on the American Thoracic Society (ATS) executive committee and board as well as support from ATS for meeting travel expenses, and participation on a DSMB for Regeneron. CG reports grants from NIH, CDC, Food and Drug Administration, AHRQ, Sanofi, and Syneos Health and consulting fees from Pfizer, Merck, and Sanofi. DNH reports grants from NIH/NHLBI for the ACTIV-4HT NECTAR trial and Incyte and participation as a DSMB chair for the SAFE EVICT Trial of vitamin C in COVID-19. NH reports grants from NIH, Quidel, and Sanofi and honorariums for speaking at the American Academy of Pediatrics (AAP) conference. CLH reports grants from NIH and American Lung Association (ALA) and participation as a DSMB member for iSPY COVID and Team (ANZICS). NJJ reports grants from NIH/NHLBI/NINDS and the University of Washington Royalty Research Fund and payment for expert testimony for the Washington Department of Health. AK reports grants from United Therapeutics, Gilead Sciences, and 4D Medical and a leadership role on the guidelines committee for Chest. JHK reports grants from NIH/NIAID. ASL reports grants from CDC, NIH/NIAID, and Burroughs Wellcome Fund and consulting fees from Sanofi and Roche. CJL reports grants from NIH, DoD, CDC, bioMerieux, Entegrion, Endpoint Health, and AbbVie, patents for risk stratification in sepsis and septic shock, participation on DSMBs for clinical trials unrelated to the current work, a leadership role on the executive committee for the Board of Directors of the Association for Clinical and Translational Science, and stock options in Bioscape Digita. ETM reports grants from Merck, CDC, and NIH and payment/honorariums from the Michigan Infectious Disease Society. TM reports payment/honorariums from the Society of Hospital Medicine. AM reports grants from CDC and NIAID/NIH and participation on a DSMB for the FDA. IDP reports grants from NIH, Janssen, Regeneron, and Asahi Kasei Pharma. TR reports grants from AbbVie, consulting fees from Cumberland Pharmaceuticals, and Cytovale, membership on a DSMB for Sanofi, a leadership role as immediate past president of the American Society of Parenteral and Enteral Nutrition, and stock options in Cumberland Pharmaceuticals. WHS reports receiving the primary funding for this project from the CDC, and research funding from Merck and Gilead Sciences. WBS reports grants from the NIH/NHLBI.

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Vaccine effectiveness of primary series and booster doses against covid-19 associated hospital admissions in the United States: living test negative...

The first malaria vaccine is here. Let’s meet the moment – STAT

October 11, 2022

One child dies every two minutes from malaria. Wider use of a new vaccine can make a dent in that devastating statistic.

The World Health Organization recommends the vaccine for broad use in sub-Saharan Africa and other areas with moderate to high malaria transmission, after years of studies in some 900,000 children showed it to be safe and effective.

But despite this widely hailed breakthrough, the malaria vaccine hasnt been met with the enthusiasm we think it deserves. Some big players, like the Bill and Melinda Gates Foundation and the Global Fund donors we admire and partner with on several projects have lamented the vaccines relatively low reduction in severe malaria when used alone and say it costs too much, despite the clear cost-benefits and efficacy synergies the WHO demonstrated when piloting the vaccine in real-world contexts.

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Other concerns include the logistical challenges in distributing the vaccine and the potential availability of more effective treatments in the future.

To be sure, promising treatments using monoclonal antibodies and an mRNA vaccine are under investigation. And early results on another experimental vaccine report higher efficacy than seen in earlier vaccines. But experimental vaccines have not been studied in the thousands of people required to establish a vaccine is safe and effective over the longer term.

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The malaria vaccine now in hand could save millions of lives in just a few years, and there is no time to wait.

Progress in the fight against malaria has stalled in recent years, and was then knocked off track by the pandemic. The world saw a 40% decline in malaria mortality from 2000 to 2015, and then mortality held steady for several years. But in 2020, deaths rose 12%, largely due to Covid-19-related disruptions.

Gavi, an alliance of countries and private funders working to boost global immunization, has pledged a $155.7 million investment via grants and other support to introduce the vaccine in Ghana, Malawi, and Kenya.

As public health practitioners in malaria prevention and control now working to save mothers and children from this devastating disease in several countries we cant fathom hesitating in embracing this groundbreaking tool now.

One objection to the vaccine, known as RTS,S, is its relative cost. The WHO estimates the average price to be $5 per dose, while existing interventions like insecticide-treated bed nets average about $1 each.

Yet the WHO found the vaccine to be overall highly cost effective, comparable to other new vaccines and malaria treatments, with no negative effect on the uptake of other preventive measures, such as insecticide-treated bed nets. A related hesitation is that the vaccines efficacy against severe malaria when used alone hovers around 30% in large trials. But taming the parasite that causes malaria with thousands more genes than a virus requires a multi-pronged plan of attack.

For example, when coupled with seasonal malaria chemoprevention (an antimalaria medicine given intensively at times of high transmission), the vaccine has been found to be 60% effective. The combination substantially lowered the incidence of severe malaria and death from malaria than either intervention alone. Its further proof that a variety of approaches can have a bigger impact when used in tandem.

And making the vaccine available as an option in addition to bed nets and seasonal malaria chemoprevention resulted in more than 90% of children under five having access to at least one of these tools.

These percentages arent just numbers on a page. They can translate to tens of thousands of lives saved.

Whats more, the additional public health impact of the vaccine on top of existing interventions is estimated at 200 to 700 deaths averted per 100,000 children vaccinated. The cost per life saved is comparable to other new vaccines.

What would that look like in real life?

Nigeria, Africas most populous nation, is home to an estimated 31 million children under age five. In 2020, more than 130,000 children in this age group perished due to malaria.

Using the lower-end value of 200 lives saved per 100,000 children vaccinated, that could translate into about 62,000 lives saved in just one year in Nigeria alone. These are children who will be alive, loved by their families, and hopefully able to enjoy bright and productive futures.

Another caution with the vaccine is the logistical complexity in distribution.

It is true that the vaccine requires four doses, more than many other childhood vaccines. That said, current seasonal malaria chemoprevention campaigns require three daily visits for four months, a similarly logistically challenging task that many countries in line for the malaria vaccine have mastered.

National scale-up of once-novel malaria interventions has historically led to a better understanding of their effectiveness and has yielded important lessons in operationalization. When insecticide-treated bed nets were being promoted for scale-up throughout Africa, for example, some doubted they could be made available for every person and feared potentially budget-busting costs. But once the effort began, approaches to reach isolated communities in cost-efficient ways were identified and coverage rates rose significantly, reaching previously unprotected people, including children under five. These campaigns have saved millions of lives.

Malarias ability to trick the human immune response and its sophisticated life cycle make it a wily adversary, turning the effort to combat it into a decades-long quest.

Vaccines have done amazing things for many of the worlds toughest health challenges, sometimes even creating the opportunity to eradicate a disease. But waiting for the perfect, 100% effective, one-dose, lifetime vaccine means waiting for years and millions more kids will die. Its time to use the full arsenal of tools to protect them.

Marian W. Wentworth is the president and CEO of Management Sciences for Health, a nonprofit that works to strengthen health systems around the world. Thomas Hall is the organizations senior principal technical advisor for malaria.

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The first malaria vaccine is here. Let's meet the moment - STAT

As Vaccine Mandates Fuel Military Recruiting Crisis, Coast Guard Lifesaver Waits to Be Terminated for Objecting – CBN.com

October 11, 2022

WASHINGTON - Pentagon leaders admit a serious recruiting crisis threatens U.S. military readiness for decades to come. Yet, hundreds of service members continue to be discharged for refusing to get the COVID-19 vaccine.

A group of Republican lawmakers wants answers to why the vaccine mandate remains in place, even after the president publicly declared the pandemic over.

In the U.S. Coast Guard, more than 2,500 members are on-record for refusing a COVID vaccine. Many have been discharged, while others are still waiting on the official order.

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CBN News recently spoke with a Coast Guard member who's continuing to serve even with his job in limbo.

For those serving at Air Station Clearwater, in Florida, they're spending the time they have left saving lives in search and rescue efforts following Hurricane Ian.

"That's what I signed up to do. I have a passion for this job... I love the people I work with and I love the impact that we have on the people we serve, on the people we help," said Aviation Survival Technician First Class Chad Watson.

Watson has served in the military for 18 years. With just two years left until he's eligible to retire, he's now among those facing discharge.

"Weighing the risk versus gain, you know we're taught to do that our whole career. Well, the risk of getting COVID for me is very minimal, with the effects that it has, and what it can do to me versus the effects of the vaccine, which is unknown. So, going back to the risk, why would I take an unknown risk when I know that there's a minimal risk on something else," Watson explained to CBN News.

GOP lawmakers are pushing to save the jobs of people in his situation.

"The nature and effectiveness of the vaccine haveevolved. It started with, 'Absolutely it stops the spread...' But I think it's pretty clear now that it doesn't stop the spread. It's more of a decision on what type of symptoms you want to incur or risk in your personal capacity, making it much more of a personal health decision," U.S. Rep. Mike Waltz (R-FL) said during a military readiness hearing.

In a recent letter to Defense Secretary Lloyd Austin, Republicans on the House Armed Services Committee demanded answers on the status of the military's vaccine mandate. They point out that members of the Armed Forces are now one of only a few groups left in the executive branch still subject to termination for failure to take the vaccine.

They also reference the following statement from President Biden during a recent 60 Minutes interview. "The pandemic is over. If you notice no one is wearing masks, everybody seems to be in pretty good shape," Biden said.

So far, there's been no reconsideration from the military. Watson says he hopes the DOD will reverse the decision, not only for his own career but due to the strain more discharges would put on those still serving.

"In my job alone we're understaffed by a lot. We're about 89 percent capacity from where we should be and we're going to lose potentially 19 more from where we're currently at if they discharge us and release us from active duty," Watson said.

Republicans say this will be a top priority if they take back the House and Senate in November. In the meantime, they wait on answers from the Pentagon.

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As Vaccine Mandates Fuel Military Recruiting Crisis, Coast Guard Lifesaver Waits to Be Terminated for Objecting - CBN.com

New HHS Report: COVID-19 Vaccinations in 2021 Linked to More than 650000 Fewer COVID-19 Hospitalizations and Over 300000 Fewer Deaths Among Medicare…

October 11, 2022

A new report from the U.S. Department of Health and Human Services (HHS) shows that the Biden Administration's historic vaccination program, which has gotten over 90 percent of seniors fully vaccinated and over 70 percent of seniors a booster shot, is linked to more than 650,000 fewer COVID-19 hospitalizations and more than 300,000 fewer deaths among seniors and other Americans enrolled in Medicare. The study, which was conducted by researchers with HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE), underscores the importance of Americans particularly seniors and others at high-risk of serious outcomes getting an updated COVID-19 vaccine this fall.

"This report reaffirms what we have said all along: COVID-19 vaccines save lives and prevent hospitalizations," said HHS Secretary Xavier Becerra. "We now have updated COVID vaccines designed to protect you against the Omicron strain of COVID that makes up almost all COVID cases in the U.S. The Biden-Harris Administration has ensured that updated vaccines are available at tens of thousands of locations nationwide. Over 90 percent of Americans live within 5 miles of where they can access these vaccines for free. I urge everyone eligible to get an updated COVID vaccine to protect yourself ahead of the fall and winter."

Today's report reflects the benefits that the COVID-19 vaccines have had on our seniors and our economy. In addition to the reductions in severe COVID-19 health outcomes, reductions in COVID-19 hospitalizations were associated with savings of more than $16 billion in direct medical costs.

All racial and ethnic groups and all 50 states experienced reduced numbers of COVID-19 deaths and hospitalizations linked to vaccination, highlighting the importance of achieving high levels of vaccinations in the US to save lives.

Recently, the Food and Drug Administration's (FDA's) authorized, and the Centers for Disease Control and Prevention's (CDC's) recommended the use of an updated COVID-19 vaccine designed for the Omicron variant most prevalent in the U.S. Following the FDA and CDC action, Secretary Becerra issued a directive to ensure the updated vaccines are widely available. The Biden-Harris Administration hasoutlined plan to get Americans an updated COVID-19 vaccine shot this Fall.

Read the ASPE report on COVID-19 vaccination.

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New HHS Report: COVID-19 Vaccinations in 2021 Linked to More than 650000 Fewer COVID-19 Hospitalizations and Over 300000 Fewer Deaths Among Medicare...

How story-telling is helping girls access the HPV vaccine in Ethiopia and Tanzania – Gavi, the Vaccine Alliance

October 11, 2022

Things that are important to girls shouldnt be decided by anybody other than girls, says Jitu, a member of the Ethiopia Youth Advisory Panel for Girl Effect, an international non-profit organisation that uses media and technology to unlock the power of girls and women.

The HPV vaccine has radical effects on cervical cancer rates in the UK, the incidence of cervical cancer among women in their 20s who had been offered the vaccine aged 12-13 was reduced by 87%. The HPV virus is responsible for about 90% of cervical cancers, so the vaccine hugely reduces the risk of developing the cancer later in life.

However, in Ethiopia and Tanzania, this incredible benefit is not reaching every girl.

Tanzania and Ethiopia both introduced HPV nationally for 14-year-old girls, with support from Gavi, the Vaccine Alliance, in 2018. While 78% of eligible girls were reported to have received a first dose by the end of 2019 in Tanzania, second dose coverage stood at 49%. The COVID-19 pandemic has further complicated vaccination efforts. In 2021 Ethiopia launched a vaccination campaign for girls who missed out on either of the doses due to school closures.

Liya Haile, Country Director for Girl Effect in Ethiopia, says, There are three key barriers to women getting vaccines. Gender barriers, including myths about how the vaccine affects women. There are social norm barriers, with girls feeling uncomfortable about going to health centres. And there are knowledge and logistical barriers, with many people not knowing what the HPV vaccine is for, or how to get it.

In a 2021 study of 400 parents in Addis Ababa, more than a quarter had never heard about the HPV vaccine, and over a third had a negative attitude towards it.

Edlawit, another member of Girl Effects Ethiopia Youth Advisory Panel explains further how social norms negatively impact girls:

For a girl in rural Ethiopia, a lack of information, access to medical facilities and traditional opinions make it increasingly difficult to identify, discuss, and seek help for any health-related issues. For girls in semi-urban and urban communities of Ethiopia, while access to medical facilities is much better, discussing health matters of those deemed private parts is generally frowned upon.

Girl Effect, with Gavi, are acting to change this through social and behaviour change communications.

Girl Effect uses a mix of approaches tailored to their target audience, and what that audience has access to. The team has already had great success in Ethiopia with Yegna, a youth brand reaching 9.8million people nationwide through its TV drama, social media, music and clubs. Yegna has used storytelling to engage and inform girls and women about the HPV vaccine and its benefits. Girl Effects impact survey found that girls who had watched Yegna were two times more likely to be aware of the HPV vaccine than non-watchers.

There is on the ground community engagement, too, partnering with government and non-government agencies who know their communities, and who are able to provide the infrastructure that enables access to healthcare.

Girl Effects Youth Advisory Panels are part of this community engagement. They have multiple roles, from assisting with researching, reviewing drama and social-media content, field visits to test youth services, designing marketing materials, to brainstorming new ways to engage young people.

Edlawit explains that the resulting communications should never be about scaring young people into action but instead helping them to make informed decisions. Im excited not to be a voice of doom and negativity but that of hope and a solution. There are so many scary diseases out there that make it seem like an unending cycle of fear and concern. Encouraging other girls about the HPV vaccine makes it one less disease to worry about for them.

As Gavi and Girl Effect move into the next phase, the goal is to address zero-dose children and those who are under-vaccinated. Young women are often the key decision makers when it comes to family health, particularly the health of babies and children in Ethiopia, the median age for women to have their first child is 20.

This kind of work, says Haile, is much more successful when organisations partner up and share expertise. Its a natural partnership, especially for the HPV vaccine. Gavi knows vaccinations, and no one knows girls like Girl Effect.

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How story-telling is helping girls access the HPV vaccine in Ethiopia and Tanzania - Gavi, the Vaccine Alliance

What is the association of SARS-CoV-2 vaccination with the risk of PASC in patients with SARDs? – News-Medical.Net

October 11, 2022

Findings of a new study posted onmedRxiv* preprint serverdepicted that fully vaccinated patients withsystemic autoimmune rheumatic diseases (SARDs) harbor a lower propensity to developing long COVID symptoms compared to SARDs patientswho are not fully vaccinated.

These results emphasize the importance of coronavirus disease 2019 (COVID-19) vaccination and illustrate the impact of immune responses during the acute phase of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on the post-acute sequelae of COVID-19 (PASC) among SARD patients.

Post-acute sequelae of COVID-19, also referred to as long COVID or PASC, depends on the duration of persistence of symptoms in the acute phase of the viral infection. Some of these symptoms persist for at least a month after the acute infection, while others linger longer a minimum of three months. Meanwhile, PASC affects 20-50% of COVID-19 patients.

The probability of developing PASC is influenced by the severity of the acute infection. Individuals with systemic autoimmune rheumatic diseases (SARDs) are at an increased risk of developing severe COVID-19. Additionally, due to the compromised immunity, this group of patients is likely to respond inadequately to vaccines, further accentuating their chances of developing PASC.

Symptoms of PASC include fatigue, arthralgias, myalgias, anosmia, palpitations, cough, dyspnea, and impaired executive function. Altered immunity, together with immunosuppressive therapies, predisposes patients of SARD to develop severe acute COVID-19. However, the impact of vaccination status among SARD patients on the risk of developing PASC remains unclear.

This prospective study explored the impacts of vaccination status in reducing the risk of PASC in SARD patients.

The study was conducted in a multicenter healthcare facility (Mass General Brigham, MGB), including two tertiary hospitals, twelve community hospitals, and the associated outpatient centers in Massachusetts. A nasopharyngeal swab test or polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infected individuals at least 18 years of age were selected between March 2020 to July 2022. All selected patients also had been diagnosed with rheumatic disease. SARD diagnoses were also reconfirmed.

Patients were deemed fully vaccinated if the date of diagnosis of SARS-CoV-2 infection was at least two weeks after completing the recommended vaccination schedule as prescribed by the Centers for Disease Control and Prevention (CDC), United States. The CDC recommendations suggest two doses of any messenger ribonucleic acid (mRNA) COVID-19 vaccine; two doses of mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech), or a single dose of Ad26.COV2.S vaccine (Johnson & Johnson- Janssen).

All the other patients were considered partially vaccinated or unvaccinated on the date of SARS-CoV-2 infection diagnosis (index date). SARDs were categorized as vasculitis, inflammatory arthritis, connective tissue disease, or other.

The participants were enrolled 28 days post a confirmed COVID-19 positive test result. Patients who had completed 90 days of the survey post-COVID-19 diagnosis were analyzed for the definition of SARD according to the WHO.

Out of the 280 patients analyzed, 41% had breakthrough SAR-CoV-2 infection, and the remaining (59%) had non-breakthrough SARS-CoV-2 infection (partially vaccinated or unvaccinated at the index date). Both these groups had similar demographics gender, age, ethnicity, race, SARD category, and smoking status.

Most participants in both groups were females; the mean ages were comparable. Most of the patients had never smoked and were Whites. Further, the comorbidities were identical between the groups, except for obesity, which was more common in the non-breakthrough infection group.

Among SARD categories, inflammatory arthritis was the most common. Disease-modifying anti-rheumatic drugs (DMARDs), most frequently used during COVID-19 were hydroxychloroquine, methotrexate, and mycophenolate. The most common targeted synthetic and biologic DMARDs were tumor necrosis factor (TNF) inhibitors, Janus-kinase inhibitors (JAK inhibitors), and anti-CD20 monoclonal antibodies.

Infections during the SARS-CoV-2 Omicron variant dominance (since December 2021), were more common among breakthrough COVID-19 infection patients. Further, patients with breakthrough infection suffered more from sore throat and nasal congestion or rhinorrhea and were given monoclonal antibodies or nirmatrelvir/ritonavir more often compared to those with non-breakthrough infection. Of note, the latter group mostly experienced joint pain, anosmia, and dysgeusia. Furthermore, non-breakthrough infection patients appeared to be hospitalized more frequently than breakthrough infection patients.

Both on day 28 and day 90, patients with breakthrough infections were found to be less likely to suffer from PASC. The time spent after the resolution of symptoms was 28.9 days more for the breakthrough group. In addition, this group had more days devoid of symptoms during the follow-up period.

Of note, the results of the questionnaire revealed less severe fatigue and pain in patients with breakthrough infections. The health-related quality of life and functional status scores were equivalent among the groups.

Patient-reported PASC relating the overall health status, pain, functional status, fatigue, frequency of flares of the underlying SARD, and the timing of flares of SARD was also comparable amongst the groups.

Fully vaccinated SARD patients are at a lower risk for severe COVID-19 outcomes and harbor a lower predilection to developing PASC. Although vaccinated SARD patients are more prone to breakthrough infections, the risk of severe outcomes, as well as long COVID, are lower than those in unvaccinated SARD patients. However, the incidence of PASC persists in SARD patients despite vaccination; its severity, too, remains unaffected by the vaccination status.

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What is the association of SARS-CoV-2 vaccination with the risk of PASC in patients with SARDs? - News-Medical.Net

askST: What you need to know about Singapore’s new Covid-19 vaccination strategy – The Straits Times

October 11, 2022

SINGAPORE - Singapore is transitioning to a new strategy for Covid-19 vaccinations, with a focus on being up to date, rather than based on the total number of shots received.

At the same time, the Government has lifted all remaining vaccination-differentiated measures, including removing the requirement for vaccination for events with more than 500 participants or dining in at eateries.

What does this mean for those who are thinking of whether to get a second booster?

The Straits Times has the answers.

Singapore now requires that people get two shots of an mRNA vaccine, with an additional booster dose administered at least five months after completing the primary series of the first two shots.

As things return to normality, the country will also transition to a new strategy of up-to-date vaccination, instead of counting the number of shots and boosters individuals receive. This is a similar approach to howinfluenza vaccinations are administered seasonally.

Individuals will be considered up-to-date with their Covid-19 vaccination if they have received at least the minimum protection. This comprises three doses of an mRNA vaccine or the Novavax/Nuvaxovid vaccine, or four shots of Sinovac-Coronvac or Sinopharm vaccines. They must havereceived their last vaccine dose within the past year.

- After achieving minimum protection - those aged 50 years and above should receive an additional booster dose of an mRNA vaccine between five months and one year from their last dose.

- Those aged five to 11 years old should complete three mRNA or Novavax/Nuvaxovid doses, or four Sinovac-CoronaVac doses, to achieve minimum protection. They can receive a booster dose of the Pfizer-BioNTech/Comirnaty vaccine five months after the last dose. It is the only Covid-19 vaccine recommended for this age group.

- Those between six months and four years should take two doses of the Moderna Spikevax vaccine at least eight weeks apart, or three doses of the Pfizer-BioNTech/Comirnaty vaccine, with the first two doses three weeks apart and a third dose at least eight weeks after the second. The Pfizer BioNTech/Comirnaty vaccine for children below five should be available end of this year. No boosters are recommended for this age group yet.

The bivalent Covid-19 vaccines include a component of the original virus strain to provide broad protection against Covid-19 and a component of the Omicron variant to provide better protection against the Omicron strain.

The Moderna bivalent vaccine approved by the Health Sciences Authority (HSA) in September targets the original Sars-CoV-2 strain of the virus as well as the Omicron BA.1 variant.

At the time, HSA said preliminary data suggested that the Moderna bivalent vaccine was also effective against the Omicron BA.4 and BA.5 variants, and others such as the Delta and Gamma variants.

The Expert Committee on Covid-19 Vaccination has recommended the use of the bivalent vaccine to replace the existing formulation.

This means the original Moderna Spikevax vaccine will be replaced with the bivalent version starting Friday, and made available for people aged 18 and above.

See the article here:

askST: What you need to know about Singapore's new Covid-19 vaccination strategy - The Straits Times

Advanced Covid strain that beats vaccine may emerge this winter: US experts – Business Standard

October 11, 2022

It wont be shocking if a new, more dangerous Covid variety emerges this winter, said American immunologist Dr Anthony Fauci, reported Livemint. He warned that the world must be prepared for the chance that another strain could emerge that would evade the immunological response that vaccines have induced in people.

While speaking at an event with the USC Annenberg Center for Health Journalism, he said that there is always a risk of upsurges during the winter months. He warned people to not let their guards down. He added that even though things appear to be going well, it be too soon to say that the pandemic is over.

Fauci stressed how people experienced similar mild pandemic pattern in 2021 summers and then in winters a stronger Omicron strain speared and triggered a record breaking increase in cases. He added that since then, numerous sub-variants of Omicron have mushroomed and taken over in the United States of America.

According to Fauci, a brand-new, more contagious variant might be in play this winter. A recent study found that several of the new sub-variants, including one known as BA.4.6, appear to withstand immunity even more effectively than BA.5, Livemint reported. However, it is unknown whether any of the new sub-variants will replace BA.5 as the primary Covid strain.

Fauci added that this makes getting a new Covid booster made for omicrons even more essential. He advised people to receive the latest vaccine, which targets the predominant variant circulating in the population.

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Advanced Covid strain that beats vaccine may emerge this winter: US experts - Business Standard

Bio-Thera Solutions Announces Details of Poster Presentation of a Highly Thermal Stable Recombinant Bivalent Nanoparticle Vaccine Containing Spikes of…

October 11, 2022

GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced today the details of its poster presentation at the Vaccines Summit 2022, being held from October 11-13 in Washington D.C. Bio-Thera will present research and preclinical results of a highly thermal stable recombinant bivalent nanoparticle vaccine containing spikes of SARS-CoV-2 Omicron and Delta, showing high immunogenicity and potentially offering broad cross-protection against ever evolving Covid-19 variants.

Preclinical studies showed that the candidate vaccine was highly immunogenic in both mice and rats, could elicit robust broadly cross-reactive neutralizing antibodies against all major SARS-Cov-2 variants. The candidate vaccine protected all the K18-hACE2 transgenic mice challenged with lethal dose of Omicron variant from body weight loss and death, with undetectable live virus in their lung tissues. This vaccine candidate leverages the self-assembled stable nanoparticles, is formulated with Bio-Theras proprietary formulation platform, and is highly stable across a broad range of temperature from freezing to over 40-degree Celsius. This vaccine candidate thus could be a valuable strategy for vaccination against the ever-changing SARS-CoV-2, especially for the remote and low-income regions in the globe.

Details of the presentation are as follows:

Presentation Title: Highly Thermal Stable Recombinant Bivalent Nanoparticle Vaccine Containing Spikes of SARS-CoV-2 Omicron and Delta Shows High Immunogenicity and Potentially Offers Broad Cross-Protection

Session Title: Poster presentation session

Session Date and Time: Tuesday, October 11, from 6:00 PM 7:00 PM EDT

Location: Sheraton Reston Hotel, 11810 Sunrise Valley Dr, Reston, VA 20191 at Foyer area

Poster Board Number: P-011

About Bio-Thera SolutionsBio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and has two approved products, QLETLI and POBEVCY in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on immuno-oncology, ADC targeted therapies, autoimmune diseases, and other severe and emerging unmet medical needs. For more information, please visit http://www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

Cautionary Note Regarding Forward-Looking StatementsThis news release contains certain forward-looking statements relating to the aforementioned vaccine candidate or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing could, may, should, will, would, anticipate, believe, plan, promising, potentially, or similar expressions. They reflect the companys current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the companys financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the companys views or otherwise.

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Bio-Thera Solutions Announces Details of Poster Presentation of a Highly Thermal Stable Recombinant Bivalent Nanoparticle Vaccine Containing Spikes of...

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