Category: Vaccine

Page 128«..1020..127128129130..140150..»

New C.D.C. Director Seeks to Foster Trust in a Battered Agency – The New York Times

December 16, 2023

Dr. Mandy K. Cohen dropped by the Fox affiliate in Dallas in November, just days after the governor of Texas signed a law barring private employers from requiring Covid-19 shots. If she thought promoting vaccination would be a tough sell in a ruby-red state, Dr. Cohen, the new director of the Centers for Disease Control and Prevention, did not give any indication.

Im not just the C.D.C. director, Im also a mom, she said cheerily, noting on live television that her daughters, 9 and 11, had already received the latest Covid and flu shots. She added, So I wouldnt recommend something for the American people I wouldnt recommend for my own family.

It was the kind of stock phrase that Dr. Cohen has repeatedly invoked as she pursues a task that some public health experts fear is impossible: restoring Americans faith in public health, and in her battered agency. Five months into her tenure, with the Covid public health emergency officially over, the C.D.C.s new leader is relentlessly on message.

Americans trust in the agency, and in science more broadly, was badly damaged by the coronavirus pandemic, and the loss of faith is particularly pronounced among Republicans. In a recent survey by the Pew Research Center, 38 percent of Republicans said they had little or no confidence in scientists to act in the publics best interests, up from 14 percent in April 2020.

At the same time, the C.D.C.s winter vaccination campaign appears to be falling on deaf ears. On Thursday, the agency issued an alert warning that low vaccination rates for the flu, Covid and respiratory syncytial virus, known as R.S.V., could lead to severe disease and increased health care capacity strain in the coming weeks. And partisan divisions over vaccination persist: A KFF poll in September found that seven in 10 Democrats but just a quarter of Republicans planned to get the updated Covid shot.

Dr. Cohen, whom President Biden selected to succeed Dr. Rochelle P. Walensky, is responding with a nationwide media blitz. Since taking the helm of the C.D.C. in July, she has traveled the country, promoting vaccination in 19 cities in 13 states. She has visited 22 vaccination sites and has participated in dozens of interviews, including an appearance on NBCs Today just before Thanksgiving.

She has left a trail of social media posts in her wake, including a series of short videos, called Check-In With Dr. Cohen, that typically begin with some variation of the same greeting: Hi everyone, its Mandy Cohen!

In one video recorded on Long Island, Dr. Cohen and a county health official, wearing hard hats and vests, reported on how wastewater can help scientists track viruses and disease. In Dallas, she appeared with another county health official to talk about the importance of data, and with a nurse at a church health fair. And in Chicago, she stood by the president of the American Medical Association as he promoted vaccination.

When she speaks to reporters, she frequently brings up her children.

Science is important and yes, the data is important, Dr. Cohen said in an interview with The New York Times. But at the end of the day, were also all humans. And if we can have a human-to-human conversation about what I would do for my own kids, who I love and I want to be healthy, maybe that can connect us in a different way.

Dr. Cohen is taking over an agency that is in transition. Her predecessor, Dr. Walensky, who began serving at the start of the Biden administration and stepped down in June, commissioned a review of the C.D.C. that identified serious weaknesses in areas ranging from testing to data collection to communications. She then initiated an overhaul of the agency.

Dr. Cohen has said she is committed to carrying out that plan, which included setting up a new forecasting and analytics center, as well as structural changes intended to enable the agency to quickly translate its science into coherent policy recommendations. But even her staunchest allies say her top priority must be to change the way the public views her agency.

Restoring trust probably is the No. 1 challenge right now, said Dr. Judith Monroe, the president and chief executive of the C.D.C. Foundation, an independent nonprofit established by Congress to mobilize private-sector support for the agencys work. Because wheres your platform if folks dont trust what you say?

Experts agree that C.D.C. officials and other public health leaders made serious messaging missteps during the pandemic. Officials bred mistrust by speaking with certainty when there wasnt any and later changing their recommendations, said Brian C. Castrucci, the president and chief executive of the de Beaumont Foundation, a public health nonprofit that is partnering with Frank Luntz, a pollster and political strategist, to study attitudes toward public health.

Mr. Luntz, who rose to prominence working for Republicans, said his research had found that a significant portion of the public as much as 20 or 25 percent was now unreachable, because public health officials used language that sounded like it was lecturing, and almost abusive toward people who had legitimate doubts.

Based on Mr. Luntzs surveys and focus groups, the foundation has developed messaging guidance, including a communications cheat sheet, to help public health officials reach Americans of all political stripes. Dr. Tom Frieden, who served as C.D.C. director under President Barack Obama and has participated in the project, said Dr. Cohens communications style was in keeping with its findings.

Youre there to empower people with information, not berate people to change their behavior, he said. I think Dr. Cohen gets that.

The morning before she was to leave for a two-day, three-city swing through Texas, Dr. Cohen huddled with her top aides and her infectious disease team at the C.D.C. headquarters in Atlanta for an update on the flu, Covid and R.S.V. which circulate during what the agency now calls the winter respiratory virus season. One benefit of that moniker: Winter viruses are less politically toxic than Covid.

The news was mixed. Hospitalizations from the flu were up slightly from last year. The rate of Covid vaccination was much lower than that of flu vaccination among health care workers not a good sign. A new monoclonal antibody shot to prevent R.S.V. in infants was in short supply, but 77,000 more doses had just been released. Texas was seeing an uptick in R.S.V.

But there was something else on Dr. Cohens mind. During her travels, she had been hearing from people who worried about side effects from vaccination and wanted more information about what federal health officials were doing to monitor vaccine safety. The C.D.C., she told her colleagues, needed to be able to tell a clear and concise story.

To that end, Dr. Cohen is changing the language that the C.D.C. uses to describe itself. Testifying last month before a House subcommittee in what was her first appearance before Congress in her new post, she described the agency as a critical national security asset a phrase that might have particular appeal to House Republicans, who have proposed cutting the C.D.C.s funding by $1.6 billion, or roughly one-sixth of its budget.

But M. Anthony Mills, a senior fellow at the conservative American Enterprise Institute who studies public trust in science, said the national security frame might not appeal to ordinary Americans who distrust the C.D.C. and other agencies like the National Institutes of Health and the Food and Drug Administration.

For Americans who believe N.I.H. lied about funding research that caused the pandemic, suspect the pharmaceutical industry is in bed with the F.D.A. and see public health efforts as an infringement on their freedom, that constellation of concerns doesnt have much to do with national security, he said.

Unlike Dr. Walensky, who had no prior government experience and made headlines for seeking out media training, Dr. Cohen is not a stranger to Washington or the spotlight.

She was a top official at the Centers for Medicare & Medicaid Services during the Obama administration. Later, as secretary of health and human services in North Carolina, she laid the groundwork for the Republican-controlled legislature to accept an expansion of Medicaid, and she helped steer the state through the pandemic.

After news reports that Mr. Biden was planning to pick Dr. Cohen for the directors post, more than two dozen congressional Republicans signed a letter accusing her of politicizing science. They cited her tenure in North Carolina, where she called for students and staff members in K-8 schools to wear masks and threatened legal action against a school district over its Covid policies.

But while her relationships with Republicans in North Carolina may have been tense, they never veered into vitriol, said State Representative Donny Lambeth, a Republican and a chair of the Health Committee in the North Carolina House of Representatives.

She was cool, calm and collected almost every time we had her in front of us, Mr. Lambeth said. She did not get rattled.

There were few fireworks during her congressional testimony last month. When Representative Daniel Crenshaw, Republican of Texas, pushed her to admit that the C.D.C. had been wrong during the pandemic, she politely ignored the request.

Representative Jeff Duncan, Republican of South Carolina, wanted to know if she had regrets about Covid restrictions from her time in North Carolina. Dr. Cohen did not admit to any. When he asked her pointedly if she would impose such restrictions today, she ducked the question, telling him instead that she was looking forward to a new chapter at the C.D.C.

The good news, she said, is were in a new place.

Read this article:

New C.D.C. Director Seeks to Foster Trust in a Battered Agency - The New York Times

UPDATE 3-Benefits of Moderna and Merck melanoma vaccine plus Keytruda extend to three years – Yahoo Finance

December 16, 2023

(Adds analyst comment, share changes in paragraphs 2-3)

By Michael Erman and Patrick Wingrove

Dec 14 (Reuters) - An experimental messenger RNA cancer vaccine developed by Moderna and Merck & Co paired with Merck's Keytruda cut the chance of recurrence or death from melanoma by half after three years, showing that benefits demonstrated a year ago have held up over time.

Moderna shares rose 11% in morning trading after having fallen 50% this year due to waning demand for COVID vaccines and questions about how well its mRNA influenza shot works compared to the current standard and whether the cancer vaccine will be successful. Two analysts said this data was a positive but incremental step.

Merck shares fell by 0.6% to $105.70 in morning trading.

The combination of the personalized cancer vaccine and Merck's blockbuster immunotherapy cut the risk of recurrence or death of the most deadly skin cancer by 49% compared with Keytruda alone in the midstage trial, the companies said.

The results come at a median point of three years into the study involving 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combination or Keytruda alone with the aim of delaying disease recurrence.

A year earlier, the study had shown a 44% reduction of recurrence or death.

"The durability of the responses is really strong, they're essentially rock solid through this time," Moderna President Stephen Hoge said in an interview. "This is a pretty significant improvement, a pretty dramatic improvement over standard of care with just Keytruda alone."

Morningstar analyst Karen Andersen said the new results could help Moderna and Merck make a case to the U.S. Food and Drug Administration for accelerated approval based on its midstage data.

The combination treatment has won U.S. breakthrough therapy and European Medicines Agency PRIME scheme designations, regulatory programs that aim to speed development of innovative treatments. Still, Hoge said that even with the new data it would be some time before the companies can file for approval of the treatment.

Story continues

The vaccine is custom-built based on an analysis of a patient's tumors after surgical removal. The vaccines are designed to train the immune system to recognize and attack specific mutations in cancer cells.

Moderna is currently building a dedicated facility in Massachusetts to produce the vaccine at commercial scale, which it hopes to finish sometime next year.

"We need to make sure that we have that near completion before we could even contemplate asking for approval," Hoge said.

He said the companies are engaging with regulators globally on the pathway for approval for the product.

They have already begun a confirmatory late-stage trial for the combination in melanoma, as well as one in non-small cell lung cancer that is already enrolling patients. (Reporting by Michael Erman; Editing by Bill Berkrot and Mark Porter)

See the original post here:

UPDATE 3-Benefits of Moderna and Merck melanoma vaccine plus Keytruda extend to three years - Yahoo Finance

Moderna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data … – Yahoo Finance

December 16, 2023

Moderna has submitted marketing authorizations globally for mRNA-1345 and continues to prepare for an expected 2024 marketing launch

CAMBRIDGE, MA / ACCESSWIRE / December 15, 2023 / Moderna, Inc. (Nasdaq:MRNA) today announced the publication of positive Phase 3 clinical study results evaluating mRNA-1345, its vaccine candidate for respiratory syncytial virus (RSV), in The New England Journal of Medicine.

The peer-reviewed article summarizes safety and efficacy data from ConquerRSV, the Company's Phase 2-3 trial evaluating mRNA-1345. An accompanying New England Journal of Medicine op-ed discusses these results as an important achievement in the realization of effective RSV vaccines as well as a milestone in the advancement of mRNA vaccines and medicines. Moderna is the only company to have developed an mRNA-based RSV vaccine. Top-line results from this study were previously announced in January 2023.

RSV is a highly contagious virus that causes severe disease across the age spectrum, including older adults. Each year in the U.S., RSV leads to approximately 60,000-160,000 hospitalizations and 6,000-10,000 deaths among older adults. Applications for mRNA-1345 have been submitted to regulators around the world. Moderna is actively preparing for an expected 2024 marketing launch of mRNA-1345 and believes its U.S. COVID-19 market share to date demonstrates the Company's ability to compete in the commercial market. If approved, mRNA-1345 would have a potential best-in-class profile and be the only ready-to-use RSV vaccine available in single-dose prefilled syringes.

About mRNA-1345

mRNA-1345 is an investigational RSV vaccine that consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs) as in the Moderna COVID-19 vaccines. The F glycoprotein is on the surface of the virus and is required for infection by helping the virus to enter host cells. It exists in two states, prefusion and postfusion. The prefusion conformation is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes.

Story continues

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company's development of a vaccine against RSV (mRNA-1345); the vaccine efficacy of mRNA-1345; the potential timing for regulatory approval of mRNA-1345; the potential for mRNA-1345 to reduce disease burden from RSV; the availability of mRNA-1345 in pre-filled syringes and the mechanism of action for mRNA-1345. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:

Elise Meyer Senior Director, Corporate Communications Elise.Meyer@modernatx.com

Investors:

Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

Read this article:

Moderna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data ... - Yahoo Finance

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

December 16, 2023

December 14, 2023 4:03 PM | 2 min read

Want to become an options master? In his free report, options expert Nic Chahine will give you access to the four bulletproof tips for beginners, the secret to scoring 411% gains with options, and his time-tested "plan" for success. Grab your free copy of Options 101: The Beginner's Guide ASAP.

Moderna, Inc. (NASDAQ:MRNA) CEO Stphane Bancelappeared on CNBC's "Squawk Box" Thursday to discuss the company's promising new cancer vaccine developed in partnership with Merck & Company, Inc. (NYSE: MRK).

What Happened: When combined with Keytruda,Moderna'snew vaccine candidatemRNA-4157 (V940)reduced the risk of relapse or death by 49% in melanoma patients and showed a 62% lower risk of the cancer spreading, the Moderna CEO said.

Enter your email and you'll also get Benzinga's ultimate morning update AND a free $30 gift card and more!

"It's a big day for patients, and we are so excited," Bancel said."We think it's a huge impact on melanoma, it's one in two people. Think about the number of lives that can be impacted, and people that can be saved and live a normal life despite a diagnosis of cancer."

Moderna's CEO told CNBCthe treatment may reach some markets in Europe and Asia by 2025 and could enter theU.S. market by 2028.

Why It Matters: Moderna shares are downmore than 50% year-to-date, and shares of rival drug-maker Pfizer, Inc. (NYSE:PFE) are down 49% this year. Someinvestors are concerned that many of thevaccinestocks that roseduring the pandemic will continue to fall alongsidedeclining demand for Covid vaccines.

When asked about the company's future growth, Bancel said, Number one: we are gaining market share in Covid so that is good for sales growth. We are launching RSV in 24 so thats going to be great for sales growth because we have no sales of RSV in 23, and we have seven Phase 3 products in the pipeline.

Related News: Pfizer Issues FY24 Forecast, Joins Target Hospitality, Southwest Airlines And Other Big Stocks Moving Lower On Wednesday

MRNA Price Action: According to data from Benzinga Pro, Moderna shares are up by more than 9% at $85.76 at the time of publication.

Image:Marco Verchfrom Flickr.

Want to become an options master? In his free report, options expert Nic Chahine will give you access to the four bulletproof tips for beginners, the secret to scoring 411% gains with options, and his time-tested "plan" for success. Grab your free copy of Options 101: The Beginner's Guide ASAP.

2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Follow this link:

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

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

jsonline.com wants to ensure the best experience for all of our readers, so we built our site to take advantage of the latest technology, making it faster and easier to use.

Unfortunately, your browser is not supported. Please download one of these browsers for the best experience on jsonline.com

See more here:

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

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.

Go here to see the original:

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

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

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."

Link:

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

Why isnt there a tuberculosis vaccine? – Vox.com

December 14, 2023

Few forces have killed off talented people before their time with quite the effectiveness of tuberculosis. Theres Chekhov, Chopin, Orwell, Kafka, Keats, Thoreau, Emily Bront all brought down by the bacterium before they reached the age of 50.

Their ranks are still growing. About 1.3 million people died of TB in 2022, and while deaths were falling pre-pandemic, the Covid-19 era saw progress stall. At this point, its annual death toll exceeds that of HIV/AIDS or malaria. The one vaccine against it was created in 1921 and does not protect adults or adolescents.

Yet the world has not mustered much in the way of resources against the disease. The New York Timess Stephanie Nolen notes that $5.8 billion a year in treatment funds and $1 billion a year in research funds goes to fighting TB in low- and middle-income countries. By contrast, the equivalent figure for HIV/AIDS treatment is about $20 billion annually. Thats a worthy cause, of course, but considering its enormous death toll, TB has drawn the short straw.

To some degree, the relative neglect of TB (including by me I write much more about malaria) has to do with the scale of the challenge it poses.

TB is a hard disease to vaccinate against. While most vaccines target viruses, TB is a bacterium, and one with a strange lifecycle. In the vast majority of people it infects, it is latent, not causing symptoms or becoming contagious. The population of people carrying around latent TB infections is truly massive. A recent study compiling blood test estimates found that about 24 percent of people on Earth have TB, with rates ranging from 1214 percent in Europe and the Americas to over a third in Africa and Southeast Asia.

A small share of people with these latent infections (from 5 to 15 percent) develop symptomatic, contagious cases. Often these are treatable with antibiotics but a significant share of cases are drug-resistant, access to antibiotics is uneven in low-income countries, and mortality is particularly high in people with both HIV and TB.

These dynamics complicate the task for a vaccine. Ideally you would want it to both reduce the share of people with latent infections and reduce the odds that those infections become active. But we dont have whats called a correlate of protection for TB: a set of indicators of a persons immune system that show they can resist initial infection, or can keep an infection from becoming active.

That makes testing treatments and vaccines tricky and expensive. Testing needs to be truly massive in scale, given the relatively small share of people who gain new latent infections, or see infections go active, in a given year. M72, the most promising vaccine candidate as of right now, is currently undergoing a phase III trial with a staggering 26,000 participants. It cost donors $550 million to fund it more than half the annual research budget for TB. And theres still a chance it wont work, or even that the trial wont pick up enough cases to show anything either way.

If every promising TB vaccine costs more than half a billion dollars to test, we are not going to test very many. Even if M72 works, and I very much hope it does, it may still have limitations, as the existing vaccine for children does; and there may be other models that are cheaper to manufacture, or that prove more effective. We want to be testing those, too, and we wont if testing them is prohibitively expensive.

In 2016, the FDA approved a cholera vaccine whose phase III test only included 197 people. Thats a tiny fraction of the 26,000 in the TB vaccine trial. This earlier trial was much, much cheaper but still resulted in a working, approved vaccine.

What was the trick? The cholera vaccine was assessed using a challenge trial. 134 of the volunteers in the study actually ingested the cholera bacterium after receiving their vaccine or placebo. Those who got infected were, of course, given antibiotics, fluids, and other necessary treatments. No one got hurt. But their sacrifice enabled researchers to find an effective cholera vaccine for a fraction of the price of a field trial with thousands of people.

Human challenge trials are a tested and reliable method, having been used for decades with great success to develop malaria treatments and prophylactics. But they have yet to be used on tuberculosis. Developing a challenge approach takes time, and while that investment has been made for malaria and cholera, it hasnt been for TB yet. Thats a shame, because they could provide a way around the huge numbers of people TB trials typically need to detect results. Instead of waiting months for a handful out of a group of thousands of participants to be exposed to TB, researchers could expose several dozen volunteers at once, see how much protection vaccines offer, and proceed from there.

This may sound dangerous at first glance, but the risks are small. As with other challenge trials, the researchers would use a weakened or attenuated version of the pathogen and would provide immediate and comprehensive treatment. One paper examining the idea estimated that a challenge trial would pose a risk of death of about 1 in 1,600, at the high end. For context, thats less than half the death risk associated with working as a trucker for five years, and about one-sixth the danger of working as a logger for five years. We let people do those things for money because we value lumber and quick shipping. Theres something to be said for letting people take more modest risks to save lives.

Luckily, several researchers are trying to develop models for tuberculosis challenges. One would use the 1921 vaccine itself as a substitute for the bacterium, because the vaccine is already in essence an attenuated form of TB. Given that the vaccine is already broadly accepted, it seems hard to argue with the acceptability of this approach. Another option involves an artificial strain of tuberculosis that has been modified to rely on certain compounds that can be withdrawn at any time, effectively offering a kill switch for the bacteria and allowing study researchers to fully cure participants at the end of the trial. Both of these could provide a pathway to challenge trials with extremely minimal risks for participants.

Helen McShane, Eric Rubin, Sarah Fortune, and the dozens of other researchers developing these models are, I think, doing some of the highest-impact work in global health right now. But they need help: regular funding, collaborative drug agencies, and a general public thats supportive of letting volunteers contribute to the fight against tuberculosis this way.

A version of this newsletter originally appeared in the Future Perfect newsletter. Sign up here!

Contributions are a key part of the future of Vox

Readers rely on Vox for clear, nuanced coverage that not only illuminates the issues, but poses solutions, too. And we rely on help from our readers: Advertising and grants cover the majority of our costs, but we count on contributions to help us close the gaps in our budget. In fact, were looking to reach 95,000 individual contributions before the end of the year. Will you make the next contribution right now? Our average gift is just $20 and it goes a long way in helping us keep our work free. Vox is here to help everyone understand whats shaping the world not just the people who can afford to pay for a subscription. We believe thats an important part of building a more equal society. Join that mission by making a contribution today.

Yes, I'll give $5/month

Yes, I'll give $5/month

We accept credit card, Apple Pay, and Google Pay. You can also contribute via

The rest is here:

Why isnt there a tuberculosis vaccine? - Vox.com

Three Years After Covid-19 Vaccine Rollout, CDC Still Gets Messaging Wrong – Forbes

December 14, 2023

Control and Prevention Director Mandy Cohen testifies before the House Oversight and Investigations Subcommittee November 30, 2023. The committee heard testimony on the topic of "Unmasking Challenges CDC Faces in Rebuilding Public Trust Amid Respiratory Illness Season." (Photo by Win McNamee/Getty Images) Getty Images

As U.S. Covid-19 hospitalizations and deaths increase this month as a result of yet another wave of infections sweeping the nation, the Centers for Disease Control and Prevention is telling people to get vaccinated. However, as its main message, instead of touting the vaccines effectiveness at greatly reducing the risk of severe disease and death the CDC asserts the vaccines ability to prevent the spread of Covid-19, which is largely inaccurate. Such problematic messaging may exacerbate the publics decline in trust in the CDC.

Nationwide Covid-19 deaths are rising again. The weekly total is over 2,000 for the first time since the beginning of the year. In the past week, the average weekly death toll increased by 25%, while hospitalizations are up by nearly 18%.

After a tally of more than 1.2 million Covid-19 deaths since the beginning of the pandemic, the last thing the U.S. wants to see is a winter spike.

As countermeasures, people whove tested positive, have symptoms or been exposed to someone with Covid-19 should consider the use of KN95 or N95 masks, proper ventilation in public indoor settings and avoidance of close contact with others. Furthermore, its advised to get vaccinated or receive updated boosters, especially those in at-risk categories such as the elderly and immune-compromised.

But CDCs messaging on vaccination leaves something to be desired. This week, the agency posted: The only thing we want you to spread this holiday season is love and cheer. Prevent the spread of #flu, #COVID, and #RSV by getting vaccinated.

While vaccination is certainly recommended as a way to diminish the chance of serious illness, its not going to do much to curb the spread of Covid-19. Its erroneous to suggest that vaccines are an effective tool to prevent transmission of the coronavirus.

Messaging matters, especially when it emanates from a public health agency thats been under fire for several years for inconsistent and at times wrong messages.

Theres plenty of evidence to support the use of vaccines to reduce disease severity and death. This is indeed what the CDC ought to emphasize when it addresses the public about the need for vaccination and boosters.

Since Covid-19 vaccines became widely available in the spring of 2021, there has been a sizable gap in the fatality rate between the unvaccinated and vaccinated.

A Commonwealth Fund study estimated that through November 2022, Covid-19 vaccines prevented more than 18.5 million U.S. hospitalizations and 3.2 million deaths.

By the end of 2022, data began to show that the majority of Covid-19 deaths were among the vaccinated. But this doesnt imply that vaccines and boosters are ineffective. The absolute number of deaths may now be higher in vaccinated individuals, but this is because there are far more vaccinated than unvaccinated individuals.

Its the relative rates of Covid-19 fatalities among the unvaccinated versus the vaccinated that are relevant. These rates demonstrate unequivocally the effectiveness of vaccines. Its clear, for example, from the chart below, which enumerates Covid-19 deaths per 100,000 people stratified by vaccination status, that being vaccinated protects against death.

The disparity in death rate between the unvaccinated and vaccinated did shrink in early 2023. The last posted data point in the graph is April 2023. For the nation as a whole we dont have more recent data. However, for a state like Washington we do. There continues to be a differential in death rates and severity of illness. From September 14 to October 11, 2023, unvaccinated individuals in the state of Washington were between 1.3 and 2.5 times more likely to die from Covid-19 compared to those who received at least one booster dose in addition to having completed the primary series of two vaccinations. And from October 6 to November 2, 2023, unvaccinated individuals were between two and 4.5 times more likely to be hospitalized with Covid-19 than those who received at least one booster dose on top of the first two shots.

Its this kind of evidence that should be highlighted in CDCs messaging on the importance of vaccines in the effort to prevent severe illness and death from Covid-19.

I'm an independent healthcare analyst with more than 24 years of experience analyzing healthcare and pharmaceuticals. Specifically, I analyze the value (costs and benefits) of biologics and pharmaceuticals, patient access to prescription drugs, the regulatory framework for drug development and reimbursement, and ethics with respect to the distribution of healthcare resources. I have approximately 110 publications in peer-reviewed journals, in addition to hundreds of articles in newspapers and periodicals. I have also presented my work at numerous trade, industry, and academic conferences. From 1999 to 2017 I was a research associate professor at the Tufts Center for the Study of Drug Development. Prior to my Tufts appointment, I was a post-doctoral fellow at the University of Pennsylvania, and I completed my PhD in economics at the University of Amsterdam. Before pursuing my PhD I was a management consultant at Accenture in The Hague, Netherlands. Currently, and for the past 6 years, I work on a freelance basis on a variety of research, teaching, and writing projects.

The rest is here:

Three Years After Covid-19 Vaccine Rollout, CDC Still Gets Messaging Wrong - Forbes

Page 128«..1020..127128129130..140150..»