Moderna CEO Highlights Promising Cancer Vaccine Data: ‘Think About The Number Of Lives That Can Be Impact – Benzinga

Moderna CEO Highlights Promising Cancer Vaccine Data: ‘Think About The Number Of Lives That Can Be Impact – Benzinga

Vaccination encouraged for eligible groups as flu cases spike – News-Medical.Net

Vaccination encouraged for eligible groups as flu cases spike – News-Medical.Net

December 16, 2023

All those eligible for the flu vaccine are being urged to come forward as the UK Health Security Agency (UKHSA) published data showing a significant increase in the number of recorded flu cases.

The latest UKHSA data also shows there has been an increase in emergency department flu attendances and hospital admissions in the last week.

So far this year, flu vaccine uptake in eligible groups is similar to the last couple of years, although there is a particular need for pre-schoolers, pregnant women and those in the health and social care workforces to take up the offer.

From 4 to 10 December 2023, the UKHSA national influenza and COVID-19 surveillance report showed that:

Those aged 2 and 3 years are eligible for nasal spray flu vaccines, with parents and guardians also urged to book appointments to ensure the younger age group is protected.

With both flu and COVID-19 cases both circulating this winter, it is also vital all those eligible get both vaccines as soon as possible.

Due to the increase in levels of flu circulating in the community, UKHSA has recommended that it is now appropriate for antiviral medicines to be prescribed in primary care settings.

Those eligible for antivirals if they have flu include patients in clinical at-risk groups as well as any who are at risk of severe illness and complications from flu if not treated. This includes people in those groups who present with symptoms of flu and those who have been exposed to flu-like illnesses from someone they live with, including residents of care homes.

As has happened in flu seasons before the pandemic, following an UKHSA recommendation, the Chief Medical Officer together with the Chief Pharmaceutical Officer have issued an alert to the NHS notifying the healthcare system that antiviral medicines can now be prescribed and supplied for cases of community acquired influenza.

Dr Mary Ramsay, Director for Immunisation and Programmes at UKHSA, said:

Flu levels are on the rise, so get your vaccine now to make sure that you are Winter Strong, and before pharmacies and surgeries begin to close for the Christmas period. Pregnant women, their unborn babies and those in clinical risk groups are at higher risk of complication from flu. Taking up both the flu and COVID-19 vaccines provides the best protection for both pregnant women and their baby, reducing the risk of severe complications, intensive care needs, stillbirth, and prematurity.

If you are the parent of a child aged 2 or 3 years, don't forget that they are also eligible for the flu vaccine and this can be booked via your GP - the nasal spray will help prevent hospitalisations, reduce the spread of flu in the community and avoid you having to juggle a sick child with work and other commitments.

The NHS national booking system is closed. But eligible persons can still continue to speak to their GP, or alternatively a local pharmacist about getting their vaccination.

Flu antivirals are effective in helping to keep people out of hospital and preventing the virus spreading to other more vulnerable household and family members. Now that we are seeing flu increasing it's important that GPs consider the possibility of flu in respiratory patients and the use of antivirals in line with national guidance, particularly if they have ruled out COVID-19.

You can help reduce the spread of these infections by avoiding mixing with others where possible when showing signs of a respiratory illness like flu and COVID-19, particularly those who are more vulnerable."

Deputy Chief Medical Officer Professor Thomas Waite said:

The latest data indicates the flu season is very much underway and COVID-19 infections are increasing.

The use of antivirals against flu in primary care will help protect the most vulnerable over the winter. If you are eligible and have not managed to get vaccinated yet, now is the time."

Health Minister Maria Caulfield said:

Authorizing the use of antivirals indicates that flu is reaching more serious levels so it is important that we take care. I'd encourage anyone eligible who is yet to come forward for the vaccine to book an appointment and get protected as soon as possible.

These additional tools will help us relieve the pressure on our NHS as they cope with the busy Christmas and New Year periods and will provide extra protection not just for you but also for your loved ones."

The alert concerning flu antiviral medicine has been issued to primary care settings including GPs and community pharmacies in England.

The Department of Health and Social Care continues to work closely with the manufacturers of antiviral medicines, used in the treatment of flu, to monitor stocks and ensure that there are adequate supplies of these medicines available to meet UK demand.


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Vaccination encouraged for eligible groups as flu cases spike - News-Medical.Net
COVID-19 hospitalizations, vaccine rates and variants. What to know about COVID-19 going into the 2023 winter holidays – Milwaukee Journal Sentinel

COVID-19 hospitalizations, vaccine rates and variants. What to know about COVID-19 going into the 2023 winter holidays – Milwaukee Journal Sentinel

December 16, 2023

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Novel Dry-Powder Inhalable Vaccine Platform Developed by Researchers – Mirage News

Novel Dry-Powder Inhalable Vaccine Platform Developed by Researchers – Mirage News

December 16, 2023

Researchers from the Institute of Process Engineering (IPE) of the Chinese Academy of Sciences have proposed a new concept of "nanomicro composite" delivery and developed a single-dose dry-powder inhalable vaccine platform with a nanomicro composite multilevel structure against the future emerging and epidemic infectious diseases. The study was published in Nature.

In recent years, researchers have made significant progress in developing vaccines for respiratory infectious diseases. Most of these vaccines are administered through intramuscular injection, which primarily induces humoral immune responses and relies on blood antibodies to neutralize the virus. However, this approach fails to trigger mucosal immune responses and establish a robust immune barrier in the respiratory tract.

The adjuvants commonly used in combination with current vaccines, such as aluminum adjuvants, are unable to induce cellular immune responses and are ineffective in combating rapid viral mutations. Besides, the current liquid form of vaccines necessitates strict low-temperature storage conditions, and the two or three-dose vaccination schedule impacts the overall vaccination rate. There is an urgent need for interdisciplinary integration and innovative research concepts to develop safer and more efficient vaccines for respiratory infections.

In this study, Prof. MA Guanghui and Prof. WEI Wei from IPE, in collaboration with Prof. WANG Hengliang and ZHU Li from State Key Laboratory of Pathogen and Biosecurity, have developed a new vaccine platform to tackle these challenges.

This platform combines sustained-release microspheres with protein antigen nanoparticles. The nanoparticles' surface can simultaneously display multiple antigens, inducing a broad-spectrum immune response and expanding the range of vaccine protection. It also allows for the quick and convenient construction of other respiratory virus vaccines due to the flexibility of antigen presentation.

Besides, the platform's unique nano-micro composite structure enables efficient immune responses in the lungs by facilitating high-performance delivery. The antigen-nanoparticles can be efficiently taken up by antigen-presenting cells once they are released.

Moreover, this dry powder vaccine significantly reduces storage and transportation costs, making it suitable for areas with limited refrigeration facilities and improving immunization rates.

The sustained release of antigens in the vaccine induces long-lasting humoral, cellular, and mucosal immunity with just a single inhalation. Collaborating with Prof. HE Zhanlong from the Institute of Medical Biology of Chinese Academy of Medical Sciences, the researchers constructed the model of airborne protection, close contact protection and airborne transmission blocking, which effectively prevented the infection and transmission of the virus.

"The components of this nano-micro system used natural proteins and approved polymer materials, and the effectiveness and safety of the vaccine have been systematically studied in non-human primates, indicating its great potential for clinical translation," said Prof. WEI.


Read this article: Novel Dry-Powder Inhalable Vaccine Platform Developed by Researchers - Mirage News
Moderna’s RSV vaccine for older adults 84% effective and safe, clinical trial shows – University of Minnesota Twin Cities

Moderna’s RSV vaccine for older adults 84% effective and safe, clinical trial shows – University of Minnesota Twin Cities

December 16, 2023

Today, researchers from Moderna and around the globe report positive phase 2/3 results for its experimental respiratory syncytial virus (RSV) vaccine for people 60 years and older, with an efficacy of 83.7% and a good safety profile.

Published in the New England Journal of Medicine, the ongoing randomized, controlled trial involved 35,541 participants in 22 countries randomly assigned in a 1:1 ratio to receive one dose of the mRNA-1345 RSV vaccine or a saline placebo from November 2021 to October 2022. The median age was 68 years, 49.0% were women, 36.1% were non-White, 34.5% were Hispanic, and 29.1% were considered frail. The median follow-up was 112 days.

Moderna published the data in January before peer review.

This year, two RSV vaccines for older adultsmade by GlaxoSmithKline and Pfizer, the latter of which is also approved for use in pregnant women to protect their infantsand a long-acting monoclonal antibody to protect babies up to 19 months old were approved by the US Food and Drug Administration.

The study authors noted that older adults are at higher risk for severe RSV and death because of age-related immune-system weakening and a higher prevalence of underlying medical conditions.

"Consequently, the societal burden and health care utilization that are associated with RSV infection in older adults are substantial," they wrote. "As the worldwide population ages, the burden of RSV infection is expected to increasea situation that highlights the need for an RSV vaccine in this population."

Sixty-four cases of RSV-linked lower respiratory tract disease with at least two signs or symptoms were confirmed (9 in the vaccine group and 55 in placebo recipients). Twenty cases of RSV-associated lower respiratory tract disease with at least three signs or symptoms occurred (3 in vaccine recipients and 17 in the placebo group). Twenty-six cases RSV-associated acute respiratory disease were reported in the vaccine group, and 82 were reported in placebo recipients.

The societal burden and health care utilization that are associated with RSV infection in older adults are substantial.

No cases of RSV-associated lower respiratory tract disease were observed in adults aged 80 years or older. Among participants with RSV-associated lower respiratory tract disease, lower rates of fever and of shortness of breath were reported among vaccine recipients than among the placebo group.

Vaccine efficacy (VE) was 83.7% (95.9% confidence interval [CI], 66.0% to 92.2%) against RSV-linked lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.4% CI, 34.8% to 95.3%) against RSV with three or more signs or symptoms.

VE against RSV-associated acute respiratory disease was 68.4% (95% CI, 50.9% to 79.7%). VE against RSV-linked lower respiratory tract disease with at least two and at least three signs or symptoms was 91.7% and 90.0%, respectively, for RSV A and 68.5% and 71.5%, respectively, for RSV B. VE was 78.5% against RSV-associated acute respiratory disease caused by RSV A and 51.7% against disease caused by subtype B.

Relative to placebo recipients, vaccine recipients had a higher rate of solicited local adverse reactions (58.7% vs 16.2%) and systemic adverse reactions (47.7% vs 32.9%). Most reactions were mild or moderate and transient. Serious adverse events occurred in 2.8% of participants in each group.

"This phase 23 efficacy trial showed that a single 50-g [microgram] dose of the mRNA-1345 vaccine in adults 60 years of age or older was efficacious against a spectrum of RSV-confirmed respiratory disease," the researchers wrote. "No safety concerns were evident."

In a related commentary, Amanda Cohn, MD, and Aron Hall, DVM, MSPH, of the Centers for Disease Control and Prevention, said that the population studied wasn't representative of the population of older adults who stand to benefit the most from the RSV vaccine, limiting generalizability and highlighting the ongoing need for more inclusion of those populations in clinical trials.

"For example, among persons hospitalized for RSV infection, a younger median age is observed among Black, Hispanic, and American Indian or Alaska Native persons than among White persons," they wrote. "Moreover, 75.9% of the trial participants had a score indicating 'fit' status on the frailty scale, and persons with immunocompromise were excluded from the trial."

Noting that the trial will continue to assess immune response to the vaccine for up to 24 months, Cohn and Hall wrote, "An important consideration will be how much protection an mRNA vaccine provides during subsequent RSV seasons and whether subsequent boosting will be appropriate. Such questions about duration of immunity, along with reactogenicity and cold-chain considerations, remain important areas for further evaluation in the implementation of mRNA vaccines."


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Moderna's RSV vaccine for older adults 84% effective and safe, clinical trial shows - University of Minnesota Twin Cities
Study: 4% of US collegiate athletes developed long COVID – University of Minnesota Twin Cities

Study: 4% of US collegiate athletes developed long COVID – University of Minnesota Twin Cities

December 14, 2023

A study of hospitalized Veterans Affairs (VA) patients found that combination therapy was not associated with decreased mortality for multidrug-resistant (MDR) Acinetobacter infections, researchers reported yesterday in Antimicrobial Stewardship & Healthcare Epidemiology.

The retrospective cohort study, led by a team of VA researchers, looked at VA patients who were hospitalized with MDR Acinetobacter bacteremia and received antibiotics 2 days prior through 5 days after the culture date from 2012 through 2018. The aim was to assess the impact of antibiotic treatments on in-hospital, 30-day, and 1-year mortality and costs.

MDRAcinetobacter spp.was identified in 184 patients. Most patients were older (mean age, 67 years), White, non-Hispanic men. The vast majority of cultures identified wereA baumannii (90%), while 3% wereA lwoffii,and 7% were otherAcinetobacter species.Half (50.5%) of the infected patients died in hospital, 44% within 30 days, and 67.9% within 1 year.

Penicillins/beta-lactamase inhibitor combinations (51.1%) and carbapenems (51.6%) were the most prescribed antibiotics. In unadjusted analysis, extended-spectrum cephalosporins and penicillins/beta-lactamase inhibitor combinations were associated with a decreased odds of 30-day mortality, but the effect was insignificant after adjustment (adjusted odds ratio (aOR), 0.47; 95% confidence interval [CI], 0.21 to 1.05 and aOR, 0.75; 95% CI, 0.37 to 1.53, respectively). There was no association between combination therapy vs monotherapy and 30-day mortality (aOR, 1.55; 95% CI, 0.72 to 3.32).

The results are noteworthy, the authors say, because while the Sanford Guide and the Infectious Diseases Society of America recommend combination therapy (high-dose ampicillin-sulbactam plus an additional agent) for treating severe MDRAcinetobacterinfections, the findings add to evidence from prior studies that have found limited improved clinical outcomes with combination therapy.

"Our results provide additional comparative effectiveness demonstrating a lack of benefit to combination therapy given within 2 through +5 days from the culture date," they wrote.


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Study: 4% of US collegiate athletes developed long COVID - University of Minnesota Twin Cities
COVID-19 vaccination eased anxiety, insomnia, and depression in Chinese adults, study finds – News-Medical.Net

COVID-19 vaccination eased anxiety, insomnia, and depression in Chinese adults, study finds – News-Medical.Net

December 14, 2023

In a recent study published in the journal Scientific Reports, researchers examined the effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination on insomnia, depression, and anxiety.

The coronavirus disease 2019 (COVID-19) pandemic has unprecedentedly impacted society. Evidence suggests increased rates of psychiatric disorders during the pandemic. Further, studies have observed a reduced prevalence of anxiety and depressive symptoms among people vaccinated for COVID-19 compared to non-vaccinated individuals in the United States (US).

Likewise, another study revealed that the prevalence of these symptoms declined after vaccination in Bangladesh. Although over 3.5 billion vaccine doses have been administered in China until April 2023, data on the effects of vaccination on mental health outcomes are limited.

Study: SARS-CoV-2 vaccination may improve anxious, insomnia and depressive symptoms among Chinese population aged 1875 years during the COVID-19 pandemic. Image Credit:aslysun/ Shutterstock

The present study investigated whether COVID-19 vaccination could mitigate insomnia, anxiety, and depressive symptoms during the pandemic. Chinese adults aged 1875 who could complete online questionnaires were recruited. Individuals with psychiatric diseases or incomplete data were excluded.

The team developed a standard questionnaire for demographics and socioeconomic indicators. The seven-item generalized anxiety disorder (GAD-7) assessment was used to examine anxiety symptoms. GAD-7 scores 14, 59, 1014, and 1521 indicated minimal, mild, moderate, and severe symptoms, respectively.

A GAD-7 score 5 was deemed the critical value for anxiety. The Athens Insomnia Scale (AIS)-8 was used to assess symptoms of insomnia. AIS-8 scores ranged between 0 and 24. The AIS-8 score of six points was deemed critical for diagnosing insomnia with clinical significance. The patient health questionnaire (PHQ-9) was used to evaluate depressive symptoms.

PHQ-9 scores ranged between 0 and 27, with higher scores indicating more severe depression. A PHQ-9 score 5 indicated clinical depressive disorder. The researchers used the hierarchical regression method to examine the effects of vaccination on insomnia, depression, and anxiety symptoms.

Flowchart of the sample selection.

In total, 9,452 individuals, aged 35.97 on average, were included. Of these, 76.2% were vaccinated, while the remainder were non-vaccinated. Over 71% of participants were urban residents, 68.5% were married, and 85% had a monthly income 10,000 RMB. Overall, 17.7% of respondents had symptoms of anxiety, 22.7% had symptoms of insomnia, and 28.4% showed depressive symptoms.

The median PHQ-9, GAD-7, and AIS-8 scores of non-vaccinated individuals were 6, 3, and 4 points, respectively, and were considerably higher than for vaccinated individuals. The COVID-19 vaccination significantly decreased the prevalence of severe symptoms of anxiety or depression. Anxiety prevalence (9.7%) in the vaccinated group was substantially lower than in the non-vaccinated group (43.7%).

Moreover, individuals with anxiety were younger than those without. Likewise, the prevalence of insomnia was lower in the vaccinated group (16.2%) compared to non-vaccinated individuals (43.7%). Further, insomnia prevalence in people with anxiety was 63.3% compared to 4.3% among those without anxiety. Besides, depressive symptoms were less prevalent among vaccinated individuals (19.7%) than in the non-vaccinated group (56.1%).

The prevalence of depressive symptoms was significantly higher among individuals with insomnia (81.7%) or anxiety (93.4%) compared to those without insomnia or anxiety. The researchers noted a significant association between the COVID-19 vaccination and anxiety symptoms. That is, the vaccinated group had about 85% lower anxiety risk than the non-vaccinated group, adjusted for potential confounders (age, sex, marital status, income, education, and occupation).

Further, vaccinated individuals had a 74.9% lower risk of insomnia than non-vaccinated participants, adjusted for confounders. When additionally adjusted for anxiety symptoms, the vaccinated group had 40% lower odds of insomnia compared to the non-vaccinated group. Besides, vaccinated participants also had about 80% lower risk of depression than non-vaccinated subjectsthis association was sustained after additionally adjusting for anxiety or insomnia.

To summarize, the researchers investigated whether COVID-19 vaccination has a positive impact on symptoms of depression, anxiety, and insomnia during the pandemic. Vaccinated individuals showed significantly lower scores on the PHQ-9, AIS-8, and GAD-7 scales than non-vaccinated individuals. Moreover, vaccination was associated with a reduced risk of depressive, anxiety, and insomnia symptoms.

The studys limitations include its non-generalizability to other populations, including minors and elderly individuals. Moreover, the self-reported nature of the study may have introduced some level of (reporting) bias. Besides, the significant difference in size between the vaccinated and non-vaccinated groups might reduce statistical power. Taken together, the findings illustrate that the COVID-19 vaccination may help alleviate anxiety, insomnia, and depression.


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COVID-19 vaccination eased anxiety, insomnia, and depression in Chinese adults, study finds - News-Medical.Net
Novavax’s Updated COVID-19 Vaccine Now Available in Germany – Dec 11, 2023 – Novavax Investor Relations

Novavax’s Updated COVID-19 Vaccine Now Available in Germany – Dec 11, 2023 – Novavax Investor Relations

December 14, 2023

FOR MEDICAL AUDIENCES ONLY

Novavaxs updated protein-based non-mRNA COVID-19 vaccine is now available for use in Germany for the prevention of COVID-19 in individuals aged 12 and older.

We are pleased that our vaccine is now available for healthcare providers to start vaccinating communities across Germany before the holidays. Freedom of choice for either non-mRNA or mRNA options as part of a diverse vaccine portfolio is critical to ensuring healthcare providers have options to help protect communities across Germany against COVID-19 this vaccination season and in future.

Non-clinical datashowed that Novavax's updated 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.1,2

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) in Germany 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, 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, available at www.sec.gov and 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.

References:

Markov PV, Ghafari M, Beer M, et al. The evolution of SARS-CoV-2. Nat Rev Microbiol. 2023;21(6):361-379. doi:1


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Novavax's Updated COVID-19 Vaccine Now Available in Germany - Dec 11, 2023 - Novavax Investor Relations
The WHO Continues Endorsing Monovalent XBB.1.5 COVID-19 Vaccines – Precision Vaccinations

The WHO Continues Endorsing Monovalent XBB.1.5 COVID-19 Vaccines – Precision Vaccinations

December 14, 2023

Geneva (Precision Vaccinations News)

The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) today announced that given the current SARS-CoV-2 coronavirus evolution and the breadth in immune responses demonstrated by monovalent XBB.1.5 vaccines against circulating variants, the TAG-CO-VAC advises retaining the current COVID-19 vaccine antigen composition (monovalent XBB.1.5) as the COVID-19 vaccine antigen.

Although neutralizing antibody titres have been shown to be important correlates of protection from SARS-CoV-2 infection and estimates of vaccine effectiveness (VE), there are multiple components of immune protection elicited by infection and/or vaccination.

Estimates of VE against currently circulating SARS-CoV-2 variants, including XBB descendent lineages, are limited in terms of the number of studies, geographic diversity, vaccine platforms evaluated, populations assessed, duration of follow-up and comparative estimates for monovalent XBB.1.5 vaccines versus other formulations.

As of December 13, 2023, data on the immune responses following XBB descendent lineage infection or XBB.1.5 vaccination are largely restricted to neutralizing antibodies, and data on other aspects of the immune response, including cellular immunity, are limitedin terms of the number of studies, vaccine platforms evaluated, populations assessed, duration of follow-up and comparative estimates for monovalent XBB.1.5 vaccines versus other formulations.

The World Health Organization says other vaccine formulations and/or platforms that achieve robust neutralizing antibody responses against currently circulating variants, including XBB- and BA.2.86 descendent lineages, can also be considered.

FollowingWHO SAGE policy, vaccination programs can continue to use any of the 12 WHO emergency-use listed or prequalified COVID-19 vaccines.

As previously stated, the TAG-CO-VAC continues to encourage the further development of vaccines that may improve protection against infection and reduce transmission of the SARS-CoV-2 virus.


See the original post here: The WHO Continues Endorsing Monovalent XBB.1.5 COVID-19 Vaccines - Precision Vaccinations
Novavax’s Updated COVID-19 Vaccine Now Available in Austria – Dec 11, 2023 – Novavax Investor Relations

Novavax’s Updated COVID-19 Vaccine Now Available in Austria – Dec 11, 2023 – Novavax Investor Relations

December 14, 2023

FOR MEDICAL AUDIENCES ONLY

Novavaxs updated protein-based non-mRNA COVID-19 vaccine is now available for use in Austria for the prevention of COVID-19 in individuals aged 12 and older.

Healthcare professionals may order the updated vaccine directly from the Bundesbeschaffung GmbH, Austrias Federal Procurement Agency. We believe a diverse vaccine portfolio with both non-mRNA and mRNA options is critical to helping to protect Austrian communities against COVID-19 and particularly important as we head into the holiday season.

Non-clinical datashowed that Novavax's updated 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.1,2

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) in Austria 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; 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, available at www.sec.gov and 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.

References:


See more here: Novavax's Updated COVID-19 Vaccine Now Available in Austria - Dec 11, 2023 - Novavax Investor Relations
Switch from selling COVID-19 drugs on market rather than to governments continues to sting at Pfizer – ABC News

Switch from selling COVID-19 drugs on market rather than to governments continues to sting at Pfizer – ABC News

December 14, 2023

Pfizers forecast for sales of its COVID-19 vaccine and treatment next year falls more than $5 billion short of the Wall Street consensus

By

TOM MURPHY AP Health Writer

December 13, 2023, 7:52 AM ET

3 min read

Pfizer heads into 2024 with a lower-than-expected sales forecast for its COVID-19 vaccine and treatment after weaker demand had already forced it to trim 2023 projections.

The drugmaker announced on Wednesday initial expectations for the new year that include about $8 billion in combined sales from its Comirnaty vaccine and the treatment Paxlovid. That falls more than $5 billion short of estimates on Wall Street.

The companys forecast for overall earnings and revenue next year also missed consensus. Pfizer shares continued their largely year-long slide in midday trading.

Pfizer leaders told analysts Wednesday that they expect vaccination and treatment rates to be about the same next year as they were in 2023. But they wanted to be conservative and offer a good floor for expectations to avoid creating any more uncertainty, CEO Albert Bourla said.

In mid-October, Pfizer said sales of both the vaccine and treatment were turning out weaker than expected. The company cut revenue projections for this year by $9 billion. Two weeks later, Pfizer said sales of the treatment and vaccine had slid 97% and 70%, respectively, in the third quarter.

Comirnaty and Paxlovid combined to rake in more than $56 billion in sales last year, easily making them Pfizer's two top-selling products.

But a down year for both was widely expected as demand slid and drugmakers switched to selling on the commercial market instead relying on the more stable payout of bulk government contracts.

Bourla also noted Wednesday in a call with analysts that the virus that triggered a global pandemic in 2020 is no longer top of mind, and that theres some COVID-19 fatigue and anti-vaccine rhetoric in the market.

Chief Financial Officer David Denton also called the virus unpredictable and said it was hard to model its performance. Even so, he said Pfizer expects both the market-leading treatment and vaccine to remain significant products.

They meet a very large and high unmet need of the patient population around the globe, he said.

The company said that it expects full-year revenue in 2024 of between $58.5 billion and $61.5 billion, short of the $62.7 billion that Wall Street was expecting, according to a survey of industry analysts by FactSet.

The New York drugmaker expects to post per-share earnings of between $2.05 and $2.25 next year. Wall Street was projecting earnings of around $3.17 per share.

Pfizer also said that it was expanding its cost-cutting program by $500 million. Company leaders noted that recently acquired cancer treatment developer Seagen will start contributing revenue in the new year.

The company said it had no plans to cut its quarterly dividend which now totals 41 cents per share.

Shares of Pfizer Inc. slid more than 8% to $26.12 in late-morning trading while broader indexes climbed.

The stock had already already shed more than 44% of its value so far this year.


View original post here: Switch from selling COVID-19 drugs on market rather than to governments continues to sting at Pfizer - ABC News