Category: Vaccine

Dear Savvy Senior,

My husband and I recently turned 65 and would like to find out which vaccines are recommended and covered by Medicare?

New beneficiaries

Dear New, All recommended vaccines for adults age 65 and older should be covered by either Medicare Part B or Part D, but there are some coverage challenges you should be aware of. Heres a rundown of which vaccines are recommended by the Centers for Disease Control and Prevention (CDC) and how Medicare covers them.

COVID-19: Even though COVID-19 is no longer a public health emergency, it can still cause severe illness, particularly in older adults. Because the COVID virus continues to mutate, new vaccines are being developed to keep pace, so the CDC recommends that all seniors stay up to date with the latest COVID vaccines, including booster shots.

All COVID-19 shots are covered 100 percent by Medicare Part B.

Flu: Considered an annual vaccination, most people of all ages receive flu shots in the fall when flu season begins. The CDC recommends seniors, 65 and older get a high-dose flu shot for extra protection beyond what a standard flu shot offers. The Fluzone High Dose Quadrivalent, FLUAD Quadrivalent and FluBlok Quadrivalent are your three options.

Annual flu shots are covered under Medicare Part B.

Pneumonia: These vaccines help protect against pneumococcal disease, which can cause pneumonia, meningitis and other infections. The CDC recommends everyone 65 and older get a pneumococcal vaccine. There are several different vaccine options available, so talk to your doctor or pharmacists to find out which is best for you or visit the CDCs Pneumococcal Vaccination webpage at CDC.gov/vaccines/vpd/pneumo/public/index.html.

Medicare Part B covers both single-dose and two-dose pneumococcal shots once in your lifetime.

Shingles: Caused by the same virus that causes chicken pox, shingles is a painful, blistering skin rash that affects more than 1 million Americans every year. All people over age 50 are recommended to get the two-dose Shingrix vaccine, which is given two to six months apart, even if you previously received Zostavax. In 2020, Shingrix replaced Zostavax, which is no longer available in the U.S.

All Medicare Part D prescription drug plans cover shingles vaccinations, but coverage amounts, and reimbursement rules vary depending on where the shot is given. Check your plan.

Tdap: Tetanus, diphtheria, and pertussis (whooping cough) are diseases caused by bacteria that can lead to serious illness and death. Therefore, a one-time dose of the Tdap vaccine is recommended for all adults. If youve already had a Tdap shot, you should get a tetanus-diphtheria (Td) booster shot every 10 years.

All Medicare Part D plans cover these vaccinations.

RSV: Respiratory syncytial virus (RSV) can lead to pneumonia or bronchiolitis and can worsen other chronic conditions common among older adults, such as asthma and chronic obstructive pulmonary disease (COPD). The CDC recommends all adults, age 60 and older, talk to their doctor about getting one of the RSV vaccines (either Arexvy or Abrysvo), usually in the fall and winter months when the virus is most prevalent.

Most Medicare Part D plans cover the RSV vaccine, but not all. If your plan doesnt cover it, you can ask for a coverage exception. You can also pay for the shot out of pocket and then follow-up with your plan to get reimbursed. If you pay for the shot upfront, your plan must pay you back.

There are other vaccines you may need depending on your health, lifestyle or travel plans. To help you get a handle on which ones are appropriate for you, take the CDCs What Vaccines Do You Need? quiz at www2.cdc.gov/nip/adultimmsched. Also, talk to your doctor during your next visit about what vaccinations you should get.

Send your senior questions to: Savvy Senior, P.O. Box 5443, Norman, OK 73070, or visit SavvySenior.org. Jim Miller is a contributor to the NBC Today show and author of The Savvy Senior book.

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On Medicare? These vaccinations are covered. - East Idaho News

Electronic health record data from 40 U.S. health care systems during January 2021January 2022, showed that the risk for cardiac complications was significantly higher after COVID-19 infection than after mRNA COVID-19 vaccination among persons aged 5 years (8). Data from CDCs National Center for Health Statistics show a background mortality rate from diseases of the heart among Oregonians aged 1534 years of 2.9 and 4.1 deaths per 100,000, during 2019 and 2021, respectively. Although the rate was higher during the pandemic year of 2021, myocarditis remained an infrequent cause of death among persons in this age group. Detection of a small difference in mortality rate from myocarditis would require a larger sample size.

In this study of 1,292 deaths among Oregon residents aged 1630 years during June 2021December 2022, none could definitively be attributed to cardiac causes within 100 days of receipt of an mRNA COVID-19 vaccine dose; one male died from undetermined causes 45 days after receipt of a COVID-19 vaccine. During May 1, 2021December 31, 2022, a total of 979,289 doses of COVID-19 vaccines were administered to Oregonians aged 1630 years (unpublished data, ALERT IIS, 2024.)

During the same period, COVID-19 was cited as the cause of death for 30 Oregon residents in this age group. Among these 30 decedents, ALERT IIS had records for 22 (73%), only three of whom had received any COVID-19 vaccination. Studies have shown significant reductions in COVID-19related mortality among vaccinated persons; during the first 2 years of COVID-19 vaccine availability in the United States, vaccination prevented an estimated 18.5 million hospitalizations and 3.2 million deaths (9).

The findings in this report are subject to at least two limitations. First, this report cannot exclude the possibility of vaccine-associated cardiac deaths >100 days after COVID-19 vaccine administration. However, published data indicate that potential adverse events associated with vaccinations tend to occur within 42 days of vaccine receipt (10). Second, small population size made it less likely that Oregon would see a rare event such as sudden cardiac death among adolescents and young adults.

These data do not support an association between receipt of mRNA COVID-19 vaccine and sudden cardiac death among previously healthy young persons. COVID-19 vaccination is recommended for all persons aged 6 months to prevent COVID-19 and complications, including death.

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Assessment of Risk for Sudden Cardiac Death Among... - CDC

Liver cancer is the sixth most common cancer in the world. Researchers estimate 905,700 people were diagnosed with liver cancer in 2020 and that number is expected to hit 1.4 million by 2040.

Hepatocellular carcinoma (HCC) is the most common type of liver cancer, accounting for more than 80% of all cases.

One of the newest treatment options for HCC is immunotherapy a treatment using a persons own immune system to fight the cancer. However, past studies show only 1520% of HCC diagnoses respond to immunotherapy and about 30% may be resistant.

Now, the results of a preliminary clinical trial show that people with HCC treated with immunotherapy and a personalized anti-tumor vaccine were twice as likely to experience tumor shrinkage compared to those receiving immunotherapy only.

The results of the trial were published April 7 in Nature Medicine.

This preliminary clinical trial was for GNOS-PV02 a personalized DNA vaccine created by Geneos Therapeutics.

Essentially GNOS-PV02 aims to (educate) the immune system to recognize antigens that are present in the cancer so that the immune system can better recognize and attack cancer cells, explained lead study author Mark Yarchoan, MD, associate professor of oncology at the Johns Hopkins Kimmel Cancer Center.

The vaccine is personalized for each individual patients cancer. Just the way that every person has a unique fingerprint, every cancer has its own set of unique antigens that are derived from unique DNA mutations within the cancer, Yarchoan told Medical News Today.

To make a personalized vaccine, first a biopsy is obtained of the cancer, and the cancer DNA is sequenced to identify the potential unique antigens within the cancer. Then a personalized vaccine is manufactured that encodes the unique antigens identified in the analysis of the tumor biopsy.

Mark Yarchoan, MD, lead study author

GNOS-PV02 was used in conjunction with the immunotherapy drug pembrolizumab, known under the brand name Keytruda.

The Food and Drug Administration (FDA) granted approval for pembrolizumab for the treatment of HCC in November 2018.

Despite recent advances in the treatment of HCC, only a minority of patients respond to contemporary systemic treatments and the prognosis for patients with advanced disease is inferior to most other tumor types, Yarchoan said.

Yarchoan noted that until recently, most cancer vaccines failed in the clinic, citing a number of potential reasons as to why.

One reason is that past cancer vaccines usually targeted antigens that werent specific enough to the cancer, he said. Most cancer antigens are unique to an individual cancer, and the technology to personalize cancer vaccines has only been possible very recently.

But the other reason why cancer vaccines generally failed in the clinic is that they were used against advanced cancers, without any other immunotherapy, Yarchoan continued.

Weve learned that vaccines can cause immune cells to become exhausted before they can eliminate cancer cells. For this reason, contemporary cancer vaccines are often combined with other immune-activating therapies like pembrolizumab. This prevents the vaccine-induced T cells from becoming exhausted, he explained.

Researchers recruited 36 participants for this clinical trial. All participants received the combination of GNOS-PV02 vaccine and pembrolizumab.

At the end of the study, researchers found that almost one-third of participants experienced tumor shrinkage, which is about twice as many people seen in studies of immunotherapy alone for HCC.

Additionally, about 8% of the study participants had no evidence of a tumor after receiving the combination treatment.

The response rate on this study is high enough that I think its unlikely that the pembrolizumab alone did this it supports the idea that the vaccine contributed to the efficacy observed, Yarchoan said.

I think its also notable that the response rate was higher than pembrolizumab alone without a major increase in toxicity.

I think the results are highly encouraging, but larger randomized studies are needed to confirm the efficacy of personalized cancer vaccines and to define the optimal treatment sequence for their use. Larger clinical studies are being planned by (Geneos Therapeutics) and Im hopeful that such studies will confirm that this vaccine is an active agent.

Mark Yarchoan, MD, lead study author

After reviewing the results of this study, Anton Bilchik, MD, PhD, surgical oncologist, chief of medicine and Director of the Gastrointestinal and Hepatobiliary Program at Providence Saint Johns Cancer Institute in Santa Monica, CA, told MNT he was absolutely astonished at the results in this early vaccine trial.

HCC is one of the most common cancers in the world and its typically been very resistant to treatment, Bilchik explained. Recently, immunotherapy has been introduced as a possible treatment for patients with advanced HCC, but the response rates for immunotherapy have not been great.

What this study does is take patients own tumor and create a personalized vaccine, which doubles the response of the immunotherapy that is currently used for HCC, he continued. Not only are the results astonishing, but these are patients that have failed first-line treatment and are not amenable to resection or transplantation.

MNT also spoke with Martin Gutierrez, MD, director of Phase I research at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey, about this study.

(This is) very encouraging news, Gutierrez commented. (The next research step should be a) larger Phase II trial in first-line therapy.

When asked if we will see more personalized cancer vaccines in the future, Bilchik said absolutely.

This is the future. And what makes this approach unique is that not only are they using the patients own tumor biopsy cells to identify these mutations, but they take it a step further by using these computational algorithms to predict which genes can be recognized by the patients own immune system. So this is getting into the field of really advanced technology and then ultimately artificial intelligence.

Anton Bilchik, MD, PhD, surgical oncologist

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Liver cancer vaccine with immunotherapy shows promise in new trial - Medical News Today

Doses of cholera vaccine are being given to patients as fast as they are produced and the global stockpile has run completely dry, as deadly outbreaks of the disease continue to spread.

This does not shock anyone in the field of emergency epidemic response because the vaccine stockpile has been precariously low for years.

The surprise the good news, which is in itself surprising since cholera and good news are rarely used together is that three new vaccine makers are setting up production lines and joining the effort to replenish the stockpile.

And a fourth company, the only one that currently makes the vaccine, which is given orally, has been working at a pace that experts describe as heroic to expand its production.

Yet even with all this, the total global supply of the vaccine that will become available this year will be, at best, a quarter of what is needed.

At the end of February, countries had already reported 79,300 cases and 1,100 deaths from cholera this year. Since there is no uniform system for counting cases, this is most likely a gross underestimate.

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Global Stockpile of Cholera Vaccine Is Gone as Outbreaks Spread - The New York Times

In a historic move, Nigeria has become the first country in the world to roll out a new vaccine (called Men5CV) recommended by the World Health Organization (WHO), which protects people against five strains of the meningococcus bacteria. The vaccine and emergency vaccination activities are funded by Gavi, the Vaccine Alliance, which funds the global meningitis vaccine stockpile, and supports lower-income countries with routine vaccination against meningitis.

Nigeria is one of the 26 meningitis hyper-endemic countries of Africa, situated in the area known as the African Meningitis Belt. Last year, there was a 50% jump in annual meningitis cases reported across Africa.

In Nigeria, an outbreak of Neisseria meningitidis (meningococcus) serogroup C outbreak led to 1742 suspected meningitis cases, including 101 confirmed cases and 153 deaths in seven of 36 Nigerian states (Adamawa, Bauchi, Gombe, Jigawa, Katsina, Yobe, Zamfara) between 1 October 2023 and 11 March 2024. To quell the deadly outbreak, a vaccination campaign has been undertaken on 25--28 March 2024 to initially reach more than one million people aged 1-29 years.

Meningitis is a serious infection that leads to the inflammation of the membranes (meninges) that surround and protect the brain and spinal cord. There are multiple causes of meningitis, including viral, bacterial, fungal and parasitic pathogens. Symptoms often include headache, fever and stiff neck. Bacterial meningitis is the most serious, can also result in septicaemia (blood poisoning), and can seriously disable or kill within 24 hours those that contract it.

Meningitis is an old and deadly foe, but this new vaccine holds the potential to change the trajectory of the disease, preventing future outbreaks and saving many lives, said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. Nigerias rollout brings us one step closer to our goal to eliminate meningitis by 2030.

The revolutionary new vaccine offers a powerful shield against the five major strains of the meningococcal bacteria (A, C, W, Y and X) in a single shot. All five strains cause meningitis and blood poisoning. This provides broader protection than the current vaccine used in much of Africa, which is only effective against the A strain.

The new vaccine has the potential to significantly reduce meningitis cases and advance progress in defeating meningitis. This is especially important for countries like Nigeria where multiple serogroups are prevalent. The new vaccine uses the same technology as the meningitis A conjugate vaccine (MenAfriVac), which wiped out meningococcal A epidemics in Nigeria.

Northern Nigeria, particularly the states of Jigawa, Bauchi and Yobe were badly hit by the deadly outbreak of meningitis, and this vaccine provides health workers with a new tool to both stop this outbreak but also put the country on a path to elimination, said Prof. Muhammad Ali Pate of the Nigerian Ministry of Health and Social Welfare. Weve done a lot of work preparing health workers and the health system for the rollout of this new vaccine. We got an invaluable support from our populations despite this fasting period and from our community leaders especially the Emir of Gumel in Jigawa state who personally launched the vaccination campaign in the state. Well be monitoring progress closely and hopefully expanding the immunization in the coming months and years to accelerate progress.

This new multivalent conjugate vaccine was 13 years in the making and was based on a partnership between PATH and the Serum Institute of India. Financing from the UK governments Foreign, Commonwealth and Development Office was critical to its development.

In July 2023, WHO prequalified the new Men5CV vaccine (which has brand name MenFive) and in October 2023 issued an official recommendation to countries to introduce the new vaccine. Gavi allocated resources for the Men5CV rollout in December 2023, which is currently available for outbreak response through the emergency stockpile managed by the International Coordinating Group (ICG) on Vaccine Provision, while roll-out through mass preventive campaigns is expected to start in 2025 across countries of the Meningitis Belt.

The rollout of one million vaccines in northern Nigeria will help save lives, prevent long-term illness and boost our goal of defeating meningitis globally by 2030, said Andrew Mitchell, UK Minister for Development and Africa. This is exactly the kind of scientific innovation, supported by the UK, which I hope is replicated in years to come to help us drive further breakthroughs, including wiping out other diseases.

WHO has been supporting the Nigeria Centre for Disease Control and Prevention (NCDC) in responding to the meningitis outbreak in the country. This includes disease surveillance, active case finding, sample testing, and case management. WHO and partners have also played a vital role in supporting Nigeria to prepare for the rollout of the new vaccine and training health workers.

Year after year, meningococcal meningitis has tormented countries across Africa, said Dr Nanthalile Mugala, PATH's Chief of Africa Region. The introduction of MenFive in Nigeria heralds a transformative era in the fight against meningococcal meningitis in Africa. Building on the legacy of previous vaccination efforts, this milestone reflects over a decade of unwavering, innovative partnerships. The promise of MenFive lies not just in its immediate impact but in the countless lives it stands to protect in the years to come, moving us closer to a future free from the threat of this disease.

In 2019, WHO and partners launched the global roadmap to defeating meningitis by 2030. The roadmap sets a comprehensive vision towards a world free of meningitis, and has three goals:

With outbreaks of infectious diseases on the rise worldwide, new innovations such as MenFiveare critical in helping us fight back," saidAurlia Nguyen, Chief Programme Officer atGavi, the Vaccine Alliance, which funds the global stockpile as well as vaccine rollout in lower-income countries. "This first shipment signals the start ofGavisupport for a multivalent meningococcal conjugate vaccine (MMCV) program, which, with the required donor funding for our next five years of work, will see pentavalent meningococcal conjugate vaccinesrolled out in high-risk countries. Thanks to vaccines, we have eliminated large and disruptive outbreaks of meningitis A in Africa: now we have a tool to respond to other serogroups that still cause large outbreaks resulting in long-term disability and deaths."

Following Nigerias meningitis vaccine campaign, a major milestone on the road to defeat meningitis is the international summit on meningitis taking place in Paris in April 2024 where leaders will come together to celebrate progress, identify challenges and assess next steps. It is also an opportunity for country leaders and key partners to commit politically and financially to accelerate progress towards eliminating meningitis as a public health problem by 2030.

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In world first, Nigeria introduces new 5-in-1 vaccine against meningitis - World Health Organization (WHO)

Bill Gates Called For A 'Universal Flu Vaccine,' Now The CDC Director Says The Organization Is 'Activated' After Issuing Bird Flu Alert

Bill Gates warned about the risk of pandemics well before COVID-19.

In 2018, he predicted that "there is a significant probability of a large and lethal, modern-day pandemic occurring in our lifetimes" because of "the continual emergence of new pathogens, the increasing risk of a bioterror attack and how connected our world is through air travel."

The same year, Gates announced a $12 million initiative to "accelerate the development of a universal flu vaccine."

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Now, after a Texas man recently became infected with bird flu after close contact with an infected cow, scientists are concerned about the potential of a pandemic worse than COVID.

John Fulton, founder of Canadian pharmaceutical company BioNiagara, warns that this strand of bird flu "appears to be 100 times worse than COVID, or it could be if it mutates and maintains its high case fatality rate."

For now, the Centers for Disease Control and Prevention (CDC) is telling the public to remain calm, with its Principal Deputy Director Dr. Nirav D. Shah saying, "The risk overall for the general public remains low."

Trending: This Future of Gaming startup disrupting a $272 billion industry is now letting anyone invest for a limited time.

However, in light of the increasing number of cattle herds in America contracting the bird flu virus, Shah stresses the CDC is prepared for what may be ahead, saying, "Make no mistake, the CDC is activated as a result of these findings."

If a pandemic breaks out, investors won't have to reach too deep into history for ideas on how markets will react, given the 2020 COVID pandemic that rocked financial markets and the broader economy.

Pandemic darling mRNA vaccine-makers such as BioNTech SE (NASDAQ:BNTX) and Moderna Inc. (NASDAQ:MRNA) have seen their stocks fall 76% and 77% from their respective peaks but could be poised to bounce back if fears around the bird flu virus continue to escalate.

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Gates-backed German mRNA company CureVac (NASDAQ:CVAC) has climbed even further to reach its past all-time high, with its stock down over 97% since then.

Humanity can only hope bird flu doesn't begin to spread easily via person-to-person transmission.

From 2003 to 2016, the virus has killed over 50% of people infected, while the current bird flu outbreak has already hit at least 82 million birds across 48 states.

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Bill Gates Called For A 'Universal Flu Vaccine,' Now The CDC Director Says The Organization Is 'Activated' After ... - Yahoo Finance

(Precision Vaccinations News)

It has become clear that Brazil is currently facing its largest dengue fever outbreak. While two dengue vaccines have been approved for use in the country, each one has its own set of issues.

As of April 12, 2024, vaccine producers are focused on protecting more Brazilians against the virus over the next year.

Sanofi Pasteur's Dengvaxia vaccine is meant for individuals aged 9-45 who already have dengue. It requires three doses and pre-administration testing.

On the other hand, Takeda's second-generationQDENGA (TAK-003)two-dose vaccine is also approved for use, but it has already sold out its production for 2024.

As of January2024, the Ministry of Healthforecastedthat 5.2 million doses will be delivered in 2024. Unfortunately, that amount will leave millions of people unprotected this year.

Furthermore, an article published by The New England Journal of Medicine in January 2024 stated that the Butantan-DVsingle-dose vaccine candidateoffers protection against all four dengue virus serotypes without regard to dengue baseline serostatus and across a wide age range.

In addition to the logistical and economic benefits, Butantan-DV rapid protection may be necessary if Brazil's dengueoutbreak accelerates.

The development of this noveltetravalent dengue vaccine began at Butantan Institute in 2010, using a formulation created by researchers affiliated with the U.S. NIH.

Based on recent phase 3 clinical trial results, Butantan Instituteplansto submit a report to ANVISAin 2024,applyingfor the vaccine's registration.

"The cost of dengue in Brazil is absurd," virologistMaurcio Lacerda Nogueira said in a press release in February 2024.

"The (Butantan-DV) vaccine is expected to reduce mortality and hospitalizations due to the disease, so the Brazilian government's investment of several hundred million reais in developing an indigenous vaccine will have a huge impact on public health."

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Brazil Produced Dengue Vaccine May Arrive in 2024 Precision Vaccinations News - Precision Vaccinations

Danjuma Adda is the past president of the World Hepatitis Alliance and a fellow with the Aspen Voices Fellowship. He is the founder of Appreciate You Organization in Nigeria, which works to improve access to hepatitis testing and increase awareness about the disease. Ida is also living with HBV.

Chronic HBV infection remains a significant global health challenge, leading to approximately 1.1 million deaths in 2022, primarily from cirrhosis and hepatocellular carcinoma, according to WHO. In 2022, an estimated 254 million people worldwide were living with HBV, with the highest prevalence in the African and Western Pacific regions, where 65% of these cases are found.

There has not been any significant improvement in the diagnosis and treatment of hepatitis B. The prevalence of hepatitis B is alarming, with the disease claiming over 270,000 lives annually in Africa. The rate of diagnosis is dire; only about 3% of hepatitis cases are diagnosed, and merely 2% of those diagnosed receive treatment.

The primary transmission routes of HBV are from mother to child at birth and through horizontal household contact. Despite the severity of the disease, there has been notable progress in preventing perinatal HBV transmission through universal infant vaccination programs. The administration of a hepatitis B vaccine within 24 hours of birth has been shown to be 90-95% effective in preventing the infection and has significantly reduced the incidence among children. However, global coverage of this birth-dose vaccination is still low at 45%, and even lower in the WHO African region at 18%.

The WHO recommends that newborns should receive the HBV vaccine within 24 hours of birth, or as early as possible. This is a critical measure to prevent new infections and it's important to remember that this is a cancer-preventing vaccine. To ensure all babies are vaccinated, we need to strengthen immunization systems so that these vaccines are readily available, especially in delivery rooms, not just outside where access can be limited after business hours or on weekends. It's crucial that the vaccines are accessible exactly where and when the babies are born.

For those already living with HBV, treatments such as tenofovir or entecavir have been highly effective in slowing the progression of liver disease and reducing the incidence of liver cancer, improving long-term survival rates. A substantial gap in diagnosis and treatment persists only 13% of those with HBV were diagnosed in 2022, and a mere 3% received treatment.

To ensure all babies are vaccinated, we need to strengthen immunization systems so that these vaccines are readily available, especially in delivery rooms, not just outside where access can be limited after business hours or on weekends. It's crucial that the vaccines are accessible exactly where and when the babies are born.

Achieving the WHO's elimination goals, which aim for 90% testing coverage and 80% treatment coverage, will require a significant overhaul of the current approaches to diagnosing and treating HBV. This includes simplifying treatment criteria, diagnostic methods, and care pathways to enhance access to vital testing and treatment services.

Reference

Easterbrook P, Luhmann N, Bajis, et. al. WHO 2024 Hepatitis B Guidelines: An Opportunity to Transform Care. The Lancet. Published April 10, 2024. Accessed April 12, 2024. DOI: https://doi.org/10.1016/S2468-1253(24)00089-X

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Hepatitis B Virus (HBV) Bridges Gap Between Policy and Implementation in Vaccine Coverage - Contagionlive.com

An experimental approach to treating pancreatic cancer with the messenger RNA (mRNA)-based therapeutic cancer vaccine candidate autogene cevumeran continues to show potential to stimulate an immune response that may reduce the risk of the disease returning after surgery.

New results from a phase 1 clinical trial show that the cancer vaccine candidate activated immune cells that persisted in the body up to three years after treatment in certain patients. In addition, a vaccine-induced immune response correlated with reduced risk of the cancer coming back.

The latest data from the phase 1 trial show that we are on the right track. This investigational mRNA vaccine can trigger T cells the cells that mobilize anti-tumor immune responses that may recognize pancreatic cancers as foreign, says Memorial Sloan Kettering Cancer Center (MSK) pancreatic cancer surgeon-scientist Vinod Balachandran, MD. Moreover, we continue to detect vaccine-stimulated T cells at substantial frequencies in patients blood up to three years after vaccination.

Autogene cevumeran (BNT122, RO7198457) was developed through a collaboration between BioNTech, an immunotherapy company, and Genentech, a member of the Roche Group. Dr. Balachandran, who led the phase 1 trial, presented the latest results at the American Association for Cancer Research Annual Meeting in San Diego.

Pancreatic cancer is one of the deadliest cancers, and even with surgery, only about 12% of patients are alive five years after diagnosis. Chemotherapy, radiation, targeted therapy, and current immunotherapies are also largely ineffective against pancreatic cancer, so new therapies are urgently needed for patients who face this disease.

The investigational mRNA cancer vaccines were custom-made for every participant in the phase 1 clinical trial based on the mutational profile of each individual tumor. The cancer vaccines teach T cells to recognize proteins called neoantigens that are found exclusively in each patients pancreatic tumor. In this way, these vaccines alert the immune system that the cancer cells are foreign. The goal of this approach is to train the body to protect itself against cancer cells.

Initial results from the phase 1 trial, reported May 2023 in Nature, showed the vaccine was well tolerated and that it activated immune cells in half of treated patients. The latest results are based on following patients for a median of three years after the investigational treatment. The team was able to track vaccine-induced T cells with the help of computational biologist Benjamin Greenbaum, PhD.

Our findings thus far show that this vaccine candidate can induce a lasting immune response up to three years in some patients, explains Dr. Balachandran, a member of the Human Oncology and Pathogenesis Program and the David M. Rubenstein Center for Pancreatic Cancer Research at MSK. As these are critical features of an effective cancer vaccine, the results continue to support the approach of using customized mRNA vaccines to target neoantigens in each patients tumor.

The investigator-initiated, single-center trial involved studying 16 MSK patients who received autogene cevumeran,along with an immunotherapy drug called atezolizumab and a chemotherapy regimen called mFOLFIRINOX. At the three-year median follow-up:

A phase 2 clinical trial (NCT05968326), sponsored by Genentech in collaboration with BioNTech, will evaluate the efficacy and safety of autogene cevumeran in a larger patient group. The new study, which began in July 2023, will enroll approximately 260 patients at various sites around the world, including MSK.

Given the positive data from our phase 1 trial, we are excited to evaluate individualized mRNA cancer vaccine candidates in more pancreatic cancer patients, Dr. Balachandran says.

The phase 2 trial will study whether the mRNA approach works better than the current standard treatment. Patients will be randomly split into two groups:

The trial is open to people with newly diagnosed pancreatic cancer eligible for surgery, who have not had other treatment (such as chemotherapy, immunotherapy, or radiation therapy) and who fit other specific criteria.

Here, Dr. Balachandran explains how this new approach has been developed to treat one of the deadliest cancers. It all began with discoveries in his lab about pancreatic cancer and a global collaboration with Genentech and BioNTech in the middle of the COVID-19 pandemic.

There has been great interest in using immunotherapy for pancreatic cancer because nothing else has worked very well. We thought immunotherapy held promise because of research we began about eight years ago. A small subset of patients with pancreatic cancer manage to beat the odds and survive after their tumor is removed. We looked at the tumors taken from these select patients and saw that the tumors had an especially large number of immune cells in them, especially T cells. Something in the tumor cells seemed to be sending out a signal that alerted the T cells and drew them in.

We later found that these signals were proteins called neoantigens that T cells recognize as foreign, triggering the immune system attack. When tumor cells divide, they accumulate these neoantigens, which are caused by genetic mutations. In most people with pancreatic cancer, these neoantigens are not detected by immune cells, so the immune system does not perceive the tumor cells as threats. But in our study, we saw that neoantigens in the long-term pancreatic cancer survivors were different they did not escape notice. They, in effect, uncloaked the tumors to T cells, causing the T cells to recognize them.

We found that T cells recognizing these neoantigens circulated in the blood of these rare patients for up to 12 years after the pancreatic tumors had been removed by surgery. The T cells had memory of the neoantigens as a threat.

My colleagues and I published our findings about immune protection in long-term pancreatic cancer survivors in Nature in November 2017. While working on this, we were also looking for ways to deliver neoantigens to patients as vaccines. We were particularly interested in mRNA vaccines, a technology that we thought was quite promising. The vaccines use mRNA, a piece of genetic code, to teach cells in your body to make a protein that will trigger an immune response.

Coincidentally, at this time, BioNTech co-founder and CEO Uur ahin, MD, emailed us that he had read our paper and was interested in our ideas. He and his team were working with Genentech on individualized neoantigen-based mRNA immunotherapies. In late 2017, we flew to Mainz, Germany, where BioNTech is based. We discussed the potential of therapeutic mRNA cancer vaccines for pancreatic cancer as well as the possible use of the mRNA platform they have developed.

Designing a cancer vaccine tailored to an individual is complex. Because cancers arise from our own cells, it is much harder for the immune system to distinguish proteins in cancer cells as foreign compared with proteins in pathogens like viruses. But important advances in cancer biology, the development of novel biotechnologies, and genomic sequencing now make it possible to design vaccines that can tell the difference.

This builds on important work done at MSK that has shown how critical tumor mutations are to triggering an immune response. In parallel with our work, major discoveries in mRNA technology over the past decades by scientists such as professor ahin and BioNTech co-founder and Chief Medical Officer zlem Treci, MD, paved the way to use mRNA in medicine. We all felt optimistic about the potential and decided to move ahead.

After a patient has a pancreatic tumor surgically removed, the tumor is genetically sequenced to look for up to 20 mutations that have the highest likelihood to produce the best neoantigens those that look the most foreign to the immune system. The cancer vaccine candidate is manufactured with mRNA specific to these neoantigens found in that individuals tumor.

The process to design and manufacture individualized vaccines for cancer treatment is more complex than making a preventive vaccine for an infectious disease, where each vaccine is the same and can be manufactured in large batches. An individualized therapeutic mRNA cancer vaccine must be tailored to each patients tumor. To do this, we take a sample of the tumor that is removed during the required cancer surgery and ship the sample to BioNTech in Germany. They analyze the tumor sample, and design and manufacture the cancer vaccine candidate, which is then sent back to New York.

The vaccine is infused into a persons bloodstream. In some patients it can cause immune cells called dendritic cells to make the neoantigen proteins. And in some cases, the dendritic cells also train the rest of the immune system, including T cells, to recognize and attack tumor cells that express these same proteins. With the T cells on high alert to destroy cells bearing these proteins, the cancer may have a lower chance of returning.

In patients treated in the phase 1 study, we are continuing to examine if vaccine-induced T cells last and remain functional long-term and how these features associate with patient outcomes.

This story was originally posted in July 2023 and has been updated.

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