Cancer research
The NHS in England is recruiting for the first large-scale trial of its kind, with hopes high that the personalised jabs could be a gamechanger
Thu 30 May 2024 19.01 EDT
Cancer vaccines are a form of immunotherapy. Unlike vaccines that protect from an infection, such as the Covid-19 jab, cancer vaccines treat people who already have the disease. They are designed to help the patients immune system recognise and then kill cancer cells and prevent them from coming back.
The jabs are custom built for each person, typically in just a few weeks. To make them, a sample of a patients tumour is removed during surgery, followed by DNA sequencing and in some cases the use of artificial intelligence. The result is a personalised anti-cancer jab specific to that patients tumour.
The cancer vaccines work by sending an instruction or blueprint to the patients cells to produce an antigen or protein that can distinguish cancer cells from normal cells. The jabs stimulate the immune system to act. The immune system makes antibodies that can recognise and attack the harmless versions of the disease. Once the patients body has made these antibodies it can recognise the disease if returns.
Scientists are studying many different types of cancer vaccines and how they might work in different forms of cancer. More research is needed to get a full picture of how well the vaccines work and which cancers they could treat. Experts believe they could be effective in a range of cancers, including but not limited to colorectal, lung, bladder, pancreatic and kidney.
Doctors have also begun trialling the worlds first personalised mRNA cancer vaccine for melanoma. Experts hailed its gamechanging potential to permanently cure the skin cancer. A phase 2 trial found that the vaccines dramatically reduced the risk of the cancer returning in melanoma patients.
Research is still at an early stage, so the jabs are mainly available as part of clinical trials. The NHS is launching a scheme that will give thousands of patients in England access to cancer vaccine trials.
The NHS scheme in England is the first of its kind worldwide. It aims to recruit thousands of cancer patients, with a matchmaking service putting them into clinical trials of the jabs that could help them.
It already has. The first NHS patient to join the Cancer Vaccine Launch Pad is Elliot Pfebve, a 55-year-old lecturer who had no symptoms and was diagnosed with colorectal cancer after a routine health check.
First, Pfebve had surgery to remove his tumour, followed by chemotherapy. His personalised vaccine was created by analysing his tumour to identify mutations specific to his own cancer. He then received his jab via an infusion at University Hospitals Birmingham NHS foundation trust, one of several sites taking part in a BioNTech colorectal cancer vaccine trial. It was designed with the same mRNA technology used to create the Pfizer/BioNTech Covid vaccine.
The principal investigator for the trial in Birmingham, Dr Victoria Kunene, said it was too early to say if the patient had been cured completely, but said she was extremely hopeful. Based on the limited data we currently have of the in-body response to the vaccine, this could prove to be a significant and positive development for patients, but more data is yet needed and we continue to recruit suitable patients to the trial to establish this further, she said.
The NHS has already enlisted dozens of patients to its Cancer Vaccine Launch Pad and will now accelerate recruitment, with thousands being offered access to cancer vaccine trials each year. Cancer patients can talk to their GP about whether they may be eligible to join the trials.
Vaccines have revolutionised medicine, protecting millions of people from measles and mumps, polio and coronavirus. They have also wiped out smallpox, one of the deadliest diseases in human history. Now experts believe they can form part of the toolbox needed to fight off cancer for good. They will not replace surgery, chemotherapy or radiotherapy any time soon but could play a key role in immunotherapy, the fourth weapon against cancer.
There are many challenges, and making personalised jabs for individual patients takes time, but the hope is that the process could speed up in future. Doctors and scientists have been working on cancer vaccines for decades but they have now reached a point where they are seeing real benefits for patients.
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Thursday, May 30, 2024
NIH-funded animal model results will inform vaccine development in humans.
Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published today in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.
HIV is genetically diverse making the virus difficult to target with a vaccine, but bNAbs may overcome that hurdle because they bind to parts of the virus that remain constant even when it mutates. Germline targeting is an immune system-stimulating approach that guides nave (precursor) B cells to develop into mature B cells that can produce bNAbs. A class of bNAbs called 10E8 is a priority for HIV vaccine development because it neutralizes a particularly broad range of HIV variants. The 10E8 bNAb binds to a conserved region of the glycoprotein gp41 on HIVs surface involved in its entry into human immune cells. Designing an immunogena molecule used in a vaccine that elicits a specific immune system responseto stimulate production of 10E8 bNAbs has been challenging because that key region of gp41 is hidden in a recessed crevice on HIVs surface. Prior vaccine immunogens have not generated bNAbs with the physical structure to reach and bind to gp41.
To address this challenge, the researchers engineered immunogens on nanoparticles that mimic the appearance of a specific part of gp41. They vaccinated rhesus macaque monkeys and mice with those immunogens and elicited specific responses from the 10E8 B cell precursors and induced antibodies that showed signs of maturing into bNAbs that could reach the hidden gp41 region. They observed similar responses when they used mRNA-encoded nanoparticles in mice. The researchers also found that the same immunogens produced B cells that could mature to produce an additional type of gp41-directed bNAb called LN01. Finally, their laboratory analysis of human blood samples found that 10E8-class bNAb precursors occurred naturally in people without HIV, and that their immunogens bound to and isolated nave human B cells with 10E8-like features. Together these observations suggest that the promising immunization data from mice and macaques has the potential for translation to humans.
The research was conducted by the Scripps Consortium for HIV/AIDS Vaccine Development, one of two consortia supported by the National Institutes of Healths (NIH) National Institute of Allergy and Infectious Diseases (NIAID). The research also was supported by collaborating partners including the Bill & Melinda Gates Foundation and other NIH Institutes and Offices. According to the authors, these findings support the development of the immunogens as the first part of a multi-step vaccine regimen for humans. Their work further supports research in developing a germline-targeting strategy for priming the immune system to elicit a bNAb called VRC01. This bNAb was discovered by NIAID researchers almost 15 years ago. The goal of this line of research is to develop an HIV vaccine that generates multiple classes of bNAbs to prevent HIV.
Schiffner et al. Vaccination induces broadly neutralizing antibody precursors to HIV gp41. Nature Immunology DOI: 10.1038/s41590-024-01833-w (2024).
Angela Malaspina, program officer in NIAIDs Division of AIDS, is available to discuss this study.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIHTurning Discovery Into Health
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NEW YORK (AP) Reports of a rare nervous system disorder were more common than expected in older U.S. adults who got the new RSV vaccines, according to a Centers for Disease Control and Prevention report released Thursday thats similar to what the organization said earlier this year.
Government officials still say the benefits of the shots outweigh the risks.
The CDC and the U.S. Food and Drug Administration say theyre evaluating any risks, but do not plan to change their recommendation for the RSV shots, which is that patients 60 and older should talk to their doctor and then decide whether to be vaccinated.
More than 10 million older adults have gotten either Pfizer or GSK single-dose shots since early August to protect against respiratory syncytial virus, which is a common cause of cold-like symptoms and can be dangerous for infants and older people.
Health officials have estimated about two cases of Guillain-Barre syndrome in every 1 million people who receive the RSV vaccine within three weeks of getting the shot.
The new CDC report focused on 28 cases of the syndrome in people who were vaccinated, and all but one developed symptoms within 21 days. That translated to 1.5 cases per million in people who got the GSK RSV vaccine, and five cases per million in recipients of the Pfizer shot.
CDC officials presented similar findings on the RSV shots and Guillain-Barre syndrome at a February public meeting.
An estimated 3,000 to 6,000 people develop Guillain-Barre syndrome in the U.S. each year either after being infected by a virus or linked to a vaccination and its more common in older people, according to the CDC. Most people fully recover, but some have permanent nerve damage.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.
As various efforts to produce next-generation vaccines in Africa are being carried forward by the likes of the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, BioNTech is angling to turn its Kigali, Rwanda, facilitywhich opened in Decemberinto the continents first commercial-scale mRNA plant.
The Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTechs efforts to establish mRNA vaccine R&D, plus clinical and commercial manufacturing, at the German companys facility in Kigali. The goal is to establish an end-to-end vaccine ecosystem on the continent, which would help Africa better prepare for potential future epidemics and pandemics, BioNTech and CEPI said in a joint release.
BioNTech first unveiled plans for the Kigali plant in 2021 and inaugurated the facility late last year. The site leverages BioNTechs modular manufacturing units called BioNTainers, which are designed to produce a range of mRNA-based vaccines.
With the added help from CEPI, BioNTech figures its Kigali plant could become the first commercial mRNA facility in Africa, which would support the African Union and Africa CDCs goal to produce 60% of all locally required vaccine doses on the continent by 2040.
BioNTech aims to crank out shots for diseases such as malaria, mpox and tuberculosis at the plant. The company says its committed to providing affordable access to its shots, with plans to target low- and middle-income countries and give priority supply to African countries.
Further, BioNTech and CEPI plan to work together to rapidly respond to outbreaks in Africa caused by known viral threats or as-yet-unknown pathogens with epidemic or pandemic potential.
The majority of the $145 million offered up by CEPI is earmarked to help BioNTech establish clinical-scale manufacturing for mRNA-based shots in Kigali. As it stands, BioNTechis running clinical trials for tuberculosis, malaria and mpox vaccineprogramsin Europe, the U.S. and South Africa. The company plans to launch studies in Africa for its candidates against malaria, HIV and mpox.
In addition, BioNTech will leverage CEPIs investment to help provide manufacturing capacity for third-party projects, including those by African-based researchers, academic groups, local businesses, public-private partnerships and non-profit organizations.
Africa still has to import 99 percent of all the vaccines it needs to protect its people from potentially deadly diseases, meaning many are left waiting far too long to get the life-saving doses they need, Richard Hatchett, M.D., CEO of CEPI, said in a statement. This must change if the world is going to avoid the terrible inequity of vaccine distribution that so clearly exacerbated the effects of the COVID-19 pandemic.
While Western drugmakers were able to rapidly develop and distribute vaccines during the COVID-19 pandemic, equitable access to those shots around the world became a big point of contention. In turn, many drugmakers, including BioNTech and its mRNA rival Moderna, launched efforts to expand in Africa.
Still, not all of those plans have come to fruition.
Earlier this year, Moderna said it was reevaluating its decision to build a $500 million manufacturing facility in Kenya, noting that it hadnt received any vaccine orders from the African continent since 2022. The Africa CDC was not pleased, arguing that Modernas effort to shift the blame onto the continent served to perpetuate the inequity that characterized the response to the COVID-19 pandemic.
Elsewhere, major health and philanthropic organizations have attempted to step up to the plate.
In October, for instance, the Gates Foundation said it would spread $40 million between a handful of companiesincluding Belgiums Quantoom, Senegals IPD and South Africas Biovacto develop and crank out mRNA vaccines for Africa and beyond.
And last April, WHO officially opened an mRNA vaccine hub in Cape Town, South Africa. The organization tapped South African biotech Afrigen Biologics for the sites pilot project, which revolves around leveraging the publicly available sequence of Modernas COVID shot to produce a local version of the prophylacticdubbed AfriVac 2121at lab scale.
The dean of the University of Nebraska Medical Centers College of Public Health is among more than a dozen experts who will review vaccine safety systems and communications about vaccine safety research in the United States.
Dr. Ali Khan has been appointed to a National Academies of Sciences Engineering and Medicine committee tasked with conducting an in-depth review of the systems, methods and processes of the federal Centers for Disease Control and Preventions Immunization Safety Office, focused heavily on the COVID-pandemic.
The committee, said Khan, a former CDC outbreak investigator, will provide recommendations at the end of the yearlong process for sustaining, maintaining and strengthening the offices monitoring systems and communications.
This couldnt be more important, he said. Since the pandemic, the nation has seen a marked increase in vaccine hesitancy and an increase in measles cases mainly in children who are not vaccinated for the highly infectious disease. During the pandemic, there also was outright distrust of absolutely great science.
To build trust, vaccine safety officials need to make sure there are robust safety systems in the U.S. and globally that can pick up signals of adverse events related to vaccines, even extremely rare ones, Khan said. Those officials also need to be able to communicate the comprehensive nature of those systems so people trust that officials have looked closely for such events.
We need to be able to assure people that they (are) getting the most accurate information ... thats not just accurate but trusted, Khan said. And I think these are some of the difficulties the committee is going to tackle.
Its also important for the public to understand that vaccine safety officials are independent from those making and promoting vaccines, he said, and to be able to trust that there are no hidden risks. During the pandemic, some people believed they would be magnetized if they received the vaccine or that the shots contained a chip that could be used to track them. Neither was true.
How do we develop systems so that people can trust that there is an office out there looking at this so when they say there is no chip in COVID vaccines or you dont get magnetized with COVID vaccines, they can trust that there is no chip in COVID vaccines and you dont get magnetized by COVID vaccines? he said.
Khan said all vaccines, just like all medical procedures, carry some risk, although most risks are very rare.
Vaccine safety is about making sure we fully understand what those risks are, however small, he said. Individuals then can gauge those risks against the benefits.
Health officials, in fact, recommended against using AstraZenecas COVID-19 vaccine after it was associated with a rare risk of blood clots, which was determined to outweigh the shots benefits.
Experts also disclosed the extremely small risk of myocarditis associated with mRNA vaccines, mostly after a second dose in young men, he said. But the CDC also explained that infection with the coronavirus itself carried a higher risk of heart inflammation.
We really need to make sure vaccine safety people are trusted to say, These are the actual risks, whatever they may be, he said. Thats critical moving forward.
In that regard, the pandemic provided an opportunity for learning. There will be a next pandemic, Khan said. And we need to make sure weve learned from the recent pandemic so were better able to prepare and can save lives in the next one.
Sharlyn Davis, 66, helps her father, Orie Staab, 90, both of Omaha, to vote early, ahead of next weeks primary, at the Douglas County Election Commission office at 12220 West Center Road on Tuesday.
Runners head west on Farnam Street during the Berkshire Hathaway Invest in Yourself 5K in Omaha on Sunday, May 5, 2024.
A runner goes south on 14th Street during the Berkshire Hathaway Invest in Yourself 5K in Omaha on Sunday, May 5, 2024. The race closed several streets in downtown Omaha.
Runners head west on Farnam Street during the Berkshire Hathaway Invest in Yourself 5K in Omaha on Sunday, May 5, 2024.
Danielle Herzog sits for a portrait with book "Where are you, Lou?" at her Omaha home on Thursday, May 2, 2024.
A participant carries an inflatable dolphin in the Berkshire Hathaway Invest in Yourself 5K in Omaha on Sunday, May 5, 2024. The dolphin was for members of the Disney Dolphin Run Club from Disney Elementary School to be able to find an adult they trust if needed in the race.
Runners start the Berkshire Hathaway Invest in Yourself 5K in Omaha on Sunday, May 5, 2024.
Nebraska's Rebekah Allick (5) and Nebraska's Bergen Reilly (2) go up for a block in the first set the Nebraska volleyball spring match vs. Denver at the University of Nebraska at Kearney on Saturday, May 4, 2024.
Fans watch the first set the Nebraska volleyball spring match vs. Denver at the University of Nebraska at Kearney on Saturday, May 4, 2024.
People run to the arena after being let in for the Berkshire Hathaway Annual Shareholders meeting at the CHI Health Center in Omaha on Saturday, May 4, 2024.
People line up on the skywalk from the Hilton Hotel for the Berkshire Hathaway Annual Shareholders meeting at the CHI Health Center in Omaha on Saturday, May 4, 2024.
People line up for the Berkshire Hathaway Annual Shareholders meeting at the CHI Health Center in Omaha on Saturday, May 4, 2024.
People run to the arena after being let in for the Berkshire Hathaway Annual Shareholders meeting at the CHI Health Center in Omaha on Saturday, May 4, 2024.
Omaha police block off the intersection of 22nd and O Streets as they investigate a shooting in Omaha on Sunday, May 12, 2024. One victim was transported to a local hospital with non-life threatening injuries, according to police.
Laurie Jones of Des Moines holds a sign as she and demonstrators gather across from the 2024 Berkshire Hathaway Annual Shareholders Meeting at the CHI Health Center to protest MidAmerican Energy's coal energy in Omaha on Saturday, May 4, 2024. MidAmerican Energy is owned by Berkshire Hathaway.
Students and community members gather outside the University of Nebraska Union in Lincoln on Wednesday, May 1, 2024.
Warren Buffett talks with Katie Farmer, president and CEO of BNSF Railway, at the BNSF booth during the 2024 Berkshire Hathaway Shareholder Shopping Day at CHI Health Center in Omaha on Friday, May 3, 2024.
Sophia Phillips, 14, of Omaha, tries on a cowboy hat during the 2024 Berkshire Hathaway Shareholder Shopping Day at CHI Health Center in Omaha on Friday, May 3, 2024.
Father Daniel Hendrickson, Creighton University President, points out the view from the chapel in the Jrme Nadal, SJ, Jesuit Residence at Creighton University in Omaha, Neb., on Thursday, May 2, 2024.
Omaha Duchesne's Izzy Johnson (0) goes up for a save during the second half of an Class B semifinal girls state soccer tournament match against Omaha Duchesne, at Morrison Stadium in Omaha on Saturday, May 11, 2024.
Workers clear water off of the track after a thunderstorm left the area with standing water at the Nebraska state track meet at Omaha Burke in Omaha on Wednesday, May 15, 2024.
Workers clear water off of the track after a thunderstorm left the track with standing water at the Nebraska state track meet at Omaha Burke in Omaha on Wednesday, May 15, 2024.
A downpour hits the track as a severe storm warning halts the Nebraska state track meet at Omaha Burke in Omaha on Wednesday, May 15, 2024.
A downpour hits the track as a severe storm warning halts the Nebraska state track meet at Omaha Burke in Omaha on Wednesday, May 15, 2024.
Fans and athletes seek cover as a severe thunderstorm warning hits the area at the Nebraska state track meet at Omaha Burke in Omaha on Wednesday, May 15, 2024.
Lincoln High's Brynn Tlamka prepares to compete in the Class A pole vault at the Nebraska state track meet at Omaha Burke in Omaha on Wednesday, May 15, 2024.
Wahoo's Jake Scanlon competes in the finals of the Class B shot put at the Nebraska state track meet at Omaha Burke in Omaha on Wednesday, May 15, 2024.
Gering's Creighton Beals crosses the finish line as Boys Town's Isaah Poteet-Brown falls on a hurdle in the Class B 300 meter hurdles at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
Milford's Isaac Roth falls during the in the Class B 300 meter hurdles at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
Auburn's Addison Darnell, left, hugs Sidney's Chloe Ahrens after they ran in the Class B 300 hurdles at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
From left: Seward's Kelsey Miller Auburn's Addison Darnell, Sidney's Chloe Ahrens compete in the Class B 300 hurdles at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
From left: Lincoln Southwest's Jackson Mowitz, Kearney's Zaire LaGrone-Miller, and Bellevue West's Asher Jenkins, compete in the Class A s00 meter dash at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
From left: Kearney's Zaire LaGrone-Miller, Bellevue West's Asher Jenkins, Omaha Westside's Preston Okafor compete in the Class A 100 meter dash at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
Elkhorn South's Zander Carson-Koestner stumbles at the start of the the Class A 800 meter run at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024. The race was restarted.
Sidney's Chloe Ahrens celebrates her win in the Class B 100 meter hurdles at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
Holdrege's Rylan Landin competes in the Class B pole vault at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
Millard West's Kate Hessel competes in the Class A high jump at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
Papillion-La Vista South's Zaidah Lightener competes in the Class A triple jump at the Nebraska state track meet at Omaha Burke in Omaha on Thursday, May 16, 2024.
A large whole appeared in Center Street near 67th Street after a break in a 24-inch transmission water main inOmaha on Tuesday, May 21, 2024. MUD says " preliminary information indicates it was related to the excess rainfall and flooding."
An early-morning storm knock tree branches onto the Pacific Street sign on 42nd Street in Omaha on Tuesday, May 21, 2024.
The sign for Amateur Coffee located at 3913 Cuming St., is reflected in water on the floor. The shop was closed due to flooding after heavy rains in Omaha on Tuesday, May 21, 2024.
Water pours out of a parking lot onto the ground near 46th and Farnam Streets in Omaha on Tuesday, May 21, 2024.
An Omaha police officer and an employee of nearby Dingman's Collision Center push a car that had been caught in flood waters out of Saddle Creek Road north of 50th Street in Omaha on Tuesday, May 21, 2024.
Members of the grounds crew spread dirt on the right field line trying to make the field playable again after heavy rains delayed the Big Ten baseball tournament at Charles Schwab Field in Omaha on Tuesday, May 21, 2024.
Dark clouds portend the storm approaching that delayed the Big Ten baseball tournament at Charles Schwab Field in Omaha on Tuesday, May 21, 2024.
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Cancer research
Jab personalised for individuals tumours hailed as gamechanger amid high hopes of stopping disease returning
Thu 30 May 2024 19.01 EDT
Thousands of patients in England are to be fast-tracked into groundbreaking trials of personalised cancer vaccines in a revolutionary world-first NHS matchmaking scheme to save lives.
The gamechanging jabs, which aim to provide a permanent cure, are custom-built for each patient in just a few weeks. They are tailored to the individuals tumours and work by telling their body to hunt and kill any cancer cells and prevent the disease from coming back.
Under the new scheme, the first of its kind in the world, patients who meet the eligibility criteria and agree to have a blood test and sample of their cancer tissue analysed will gain immediate access to clinical trials for the new vaccines that experts say represent a new dawn of treatments for cancer.
The head of NHS England, Amanda Pritchard, hailed the development as a landmark moment for patients. The NHS is in a unique position to deliver this kind of world-leading research at size and scale, she said.
Research into cancer vaccines is at an early stage, but trials have already shown they can be effective at killing off any remaining tumour cells after surgery and dramatically cut the risk of cancer returning.
The NHS has enrolled dozens of patients on to its scheme, the Cancer Vaccine Launch Pad, with thousands more to be enlisted at 30 NHS sites across England. The first trials are expected to focus on colorectal, skin, lung, bladder, pancreatic and kidney cancer, officials said, but other forms of the disease could be added in future.
As more of these trials get up and running at hospitals across the country, our national matchmaking service will ensure as many eligible patients as possible get the opportunity to access them, Pritchard said.
Details of the scheme were revealed on the eve of the worlds largest cancer conference, the annual meeting of the American Society of Clinical Oncology (Asco) in Chicago, where tens of thousands of oncologists, health researchers and scientists will convene this weekend.
The German biotech company BioNTech, one of the companies partnering with the NHS on the trials, will present new preliminary data at the Asco conference tomorrow on how measuring circulating tumour DNA could help increase early detection of colorectal cancer.
Iain Foulkes, the executive director of research and innovation at Cancer Research UK, said it was incredibly exciting that patients were accessing personalised jabs in a development that will be a gamechanger in the fight against cancer. Clinical trials like this are vital in helping more people live longer, better lives, free from the fear of cancer, he said.
The first NHS patient to join the Cancer Vaccine Launch Pad is Elliot Pfebve. The 55-year-old lecturer at Coventry University had no symptoms and was diagnosed with colorectal cancer after a routine health check with his GP. He had surgery to remove his tumour and 30cm of his large intestine, followed by chemotherapy.
Pfebve then received his personalised cancer vaccine at University Hospitals Birmingham NHS foundation trust, one of several sites taking part in the BioNTech colorectal cancer vaccine trial. It was designed with the same mRNA technology used to create the Pfizer/BioNTech Covid vaccine.
Through the potential of this trial, if it is successful, it may help thousands, if not millions of people, so they can have hope, Pfebve said. I hope this will help other people.
His vaccine was created by analysing his tumour to identify mutations specific to his cancer. Doctors then used this data to create a personalised cancer vaccine.
Being part of this trial has been a really important decision in my life, both for me and my family, said Pfebve. Having been through the difficulty of diagnosis and debilitating chemotherapy, it felt wonderful to be able to take part in something which could lead to a new way of treating cancer, and if others can benefit from what the trial might discover, then thats great, too.
The trials principal investigator, Dr Victoria Kunene, said it was too early to say if Pfebve had been cured completely, but said she was extremely hopeful.
Based on the limited data we currently have of the in-body response to the vaccine, this could prove to be a significant and positive development for patients, but more data is yet needed and we continue to recruit suitable patients to the trial to establish this further.
Cancer vaccines are designed to induce an immune response that may prevent cancer from returning after surgery to remove tumours, by stimulating a patients immune system to recognise and destroy any remaining cancer cells and stop them coming back.
Seeing Elliot receive his first treatment as part of the Cancer Vaccine Launch Pad is a landmark moment for patients and the health service as we seek to develop better and more effective ways to stop this disease, Pritchard said.
Last month the Guardian reported how doctors had begun trialling the worlds first personalised mRNA cancer vaccine for melanoma, as experts hailed its gamechanging potential to permanently cure cancer.
Prof Peter Johnson, NHS Englands national clinical director for cancer, said: We know that even after a successful operation, cancers can sometimes return because a few cancer cells are left in the body, but using a vaccine to target those remaining cells may be a way to stop this happening.
Access to clinical trials could provide another option for patients and their families, and Im delighted that through our national launch pad we will be widening the opportunities to be part of these trials for many more people, with thousands of patients expected to be recruited in the next year.
NHS officials said vaccines being tested in the trials aimed to help patients with different forms of cancer and, if successfully developed, researched and approved, could become part of standard care.
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V-safe (https://vsafe.cdc.gov) is a voluntary, active U.S. surveillance system that sends web surveys to enrolled participants on days 07 after vaccination, based on the reported vaccination date. V-safe surveys for adults aged 60 years who received an RSV vaccine were available starting October 20, 2023. Daily surveys include questions about local injection site and systemic reactions and health impacts experienced. Participants reporting medical care for symptoms are also prompted to complete a VAERS report.
VAERS (https://vaers.hhs.gov) accepts reports of adverse events from health care providers, vaccine manufacturers, and members of the public (5). Reports to VAERS generally cannot be used to determine causal associations between adverse events and vaccination. Medical Dictionary for Regulatory Activities Preferred Terms (MedDRA PTs) are assigned by VAERS staff members to signs, symptoms, and diagnostic findings in VAERS reports.** Reports of serious events (including death) to VAERS during May 3, 2023April 14, 2024, and relevant available medical records were reviewed by CDC experts to form a clinical impression of each reported outcome (6). Using selected MedDRA PTs, a search was performed to identify outcomes of interest, including GBS and immune thrombocytopenia (ITP), multiple cases of which were identified in clinical reviews of serious reports.
Symptoms and health impacts reported during the week after RSV vaccination were described for V-safe participants aged 60 years who were vaccinated during May 3, 2023April 14, 2024, and completed one or more daily surveys. Primary VAERS adverse event reports after RSV vaccination for persons aged 60 years were described by serious and nonserious classification and MedDRA PTs. All analyses were conducted using SAS software (version 9.4; SAS Institute). Reporting rates for GBS reports that met the Brighton Collaboration case definition (6) were estimated using available doses administered as the denominator. This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.***
During May 3, 2023April 14, 2024, a total of 16,220 V-safe participants aged 60 years reported receiving an RSV vaccine and completed at least one daily survey (Table 1). The median age of these participants was 70 years (range=6094 years), 9,684 (59.7%) were women, 6,402 (39.5%) received GSK vaccine, 3,882 (23.9%) received Pfizer vaccine, and 5,936 (36.6%) did not know the manufacturer of the vaccine they received. Approximately one third (5,043; 31.1%) of participants reported receiving one or more other vaccines during the same visit; those most commonly reported were COVID-19 (3,370; 20.8%) and influenza (2,630; 16.2%) vaccines. During the week after vaccination, 6,328 (39.0%) participants reported symptoms they considered possibly related to RSV vaccination. Injection site symptoms were reported by 2,808 (43.9%) participants who received GSK vaccine and 787 (20.3%) who received Pfizer vaccine. Most injection site symptoms were mild (3,351; 20.7%) or moderate (1,889; 11.6%) (Table 2). Systemic symptoms were reported by 2,344 (36.6%) who received GSK and 839 (21.6%) who received Pfizer. Most systemic symptoms were mild (1,997; 12.3%) or moderate (2,184; 13.5%). The most frequently reported symptoms after RSV vaccination were pain at or near the injection site (5,026; 31.0%), fatigue or tiredness (3,327; 20.5%), and muscle or body aches (2,843; 17.5%). Among those who reported other symptoms, those most commonly reported were sore throat (54; 0.3%), dizziness (38; 0.2%), and runny nose (38; 0.2%).
During the week after vaccination, 1,264 (7.8%) participants reported that they were unable to complete their normal daily activities because of the reported symptoms; 68 (0.4%) reported receiving medical care for the reported symptoms. Among those who reported receiving medical care, five completed a report to VAERS; events reported were chalazion, lower than normal blood pressure, exacerbation of chronic obstructive pulmonary disease, injection site pain, and suspected lichen planus.
During May 3, 2023April 14, 2024, VAERS received and processed 3,200 reports of adverse events among persons aged 60 years who reported receiving an RSV vaccine (Table 3), including 2,191 (68.5%) for GSK vaccine, 921 (28.8%) for Pfizer, and 88 (2.8%) for which the vaccine manufacturer was unknown. The median age of persons for whom a VAERS report was received was 72 years (range=60112 years), and 2,237 (69.9%) reports were for women. At least one other vaccine was received at the same visit for approximately one third (1,050; 32.8%) of reports, with influenza vaccine administered most commonly (625; 19.5%). Among the 3,200 VAERS reports, 346 (10.8%) specified a vaccination error (e.g., product administered at an inappropriate site, extra dose administered, or incorrect route of product administration); 64 (2.0%) reports also indicated that an adverse health event had occurred. Overall, 2,919 (91.2%) reports were classified as nonserious, including 2,026 (92.5%) after receipt of GSK vaccine and 821 (89.1%) after receipt of Pfizer vaccine. Commonly reported events included pain in an extremity (384; 13.2%), headache (376; 12.9%), pain (373; 12.8%), injection site pain (370; 12.7%), and fatigue (355; 12.2%).
Among all VAERS reports, 281 (8.8%) were classified as serious, including 216 (6.8%) for hospitalization, 81 (2.5%) for a life-threatening illness, 66 (2.1%) for a permanent disability, and 34 (1.1%) for death. Clinical impressions of serious reports included stroke or transient ischemic attack (24), GBS (37; 28 met case definition), atrial fibrillation (14), other thromboembolic event (13), encephalitis or aseptic meningitis (11), immune thrombocytopenia (11), sepsis, bacteremia, or both (11), and shoulder pain (11). Among the 28 reports of GBS after vaccination that met case definition, 11 (39.3%) were after GSK vaccine (1.5 reports per 1 million doses administered), and 17 (60.3%) were after Pfizer vaccine (5.0 reports per 1 million doses administered). For the 18 reports of death with sufficient information for review, reported causes of death were acute respiratory distress syndrome, bronchopneumonia, cardiac event, cardiopulmonary arrest, ehrlichiosis, GBS (two), hepatic encephalopathy, hypoxic respiratory failure, multifocal leukoencephalopathy, respiratory failure, rhabdomyolysis, RSV infection, sepsis, sepsis secondary to pneumonia, Pseudomonas bacteremia, varicella-zoster virus meningoencephalitis, and vascular dementia.
Moderna Inc. gained US approval for its RSV vaccine in older adults, giving the biotech company a second product as it seeks to move beyond its reliance on the fading market for Covid-19 shots.
Also Read: The Covid Vaccine Windfall Turns on Pfizer and Moderna
The US Food and Drug Administration approved Cambridge, Massachusetts-based Modernas vaccine against respiratory syncytial virus, a flu-like illness that affects elderly adults and babies most severely, according to a statement Friday. The decision had earlier been expected by May 12, and was delayed because of administrative constraints" at the agency, Moderna said earlier this month.
Modernas shot, called mRESVIA, was cleared for use in adults 60 and older and will compete with products that arrived last year from GSK Plc and Pfizer Inc. Those two generated about $2.4 billion in sales combined, with GSK emerging as the clear leader.
Also Read: Covishield vaccine side effects: Ex-ICMR scientist says only 7 in 10 lakh may face risk
The vaccines effectiveness declined 5% during a follow-up analysis performed for the FDA, which could put Modernas shot at a disadvantage, according to Bloomberg Intelligence analysts. Moderna shares fell as much as 7.1% as of 2:41 p.m. in New York. They had rallied in recent weeks on speculation the company might develop a vaccine against a form of bird flu thats been spreading in cattle and has infected three US farmworkers.
Moderna said it expects to have mRESVIA available in the US for this falls respiratory virus season.
The approval is a big moment for Moderna, which previously only had just one product, its Covid shot. Like rival Pfizer, Modernas stock price has plunged as the world moves on from the pandemic. The RSV shot the first ever drug using mRNA technology approved for a disease other than Covid gives it another much-needed revenue stream.
Also Read: AstraZeneca to withdraw sales of Covid-19 vaccine globally
Although later to market, Moderna is betting on a potential advantage over Pfizer and GSK: It has the only RSV shot that comes in a pre-filled syringe thats easier for pharmacists to administer than others that require multiple steps. Bloomberg Intelligence expects the RSV market for seniors to be worth $11 billion by 2032, with GSK holding a 45% share, Pfizer having 35% and Moderna with 20%.
Advisers to theUS Centers for Disease Control and Prevention are expected to meet in late June to make recommendations about this years RSV shots, such as which ones to take and how often.
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This story has been published from a wire agency feed without modifications to the text.
The bird flu outbreak in U.S. dairy cows is prompting development of new, next-generation mRNA vaccines akin to COVID-19 shots that are being tested in both animals and people.
Next month, the U.S. Agriculture Department is to begin testing a vaccine developed by University of Pennsylvania researchers by giving it to calves. The idea: If vaccinating cows protects dairy workers, that could mean fewer chances for the virus to jump into people and mutate in ways that could spur human-to-human spread.
Meanwhile. the U.S. Department of Health and Human Services has been talking to manufacturers about possible mRNA flu vaccines for people that, if needed, could supplement millions of bird flu vaccine doses already in government hands.
If theres a pandemic, theres going to be a huge demand for vaccine, said Richard Webby, a flu researcher at St. Jude Childrens Research Hospital in Memphis. The more different (vaccine manufacturing) platforms that can respond to that, the better.
The bird flu virus has been spreading among more animal species in scores of countries since 2020. It was detected in U.S. dairy herds in March, although investigators think it may have been in cows since December. This week, the USDA announced it had been found in alpacas for the first time.
At least three people all workers at farms with infected cows have been diagnosed with bird flu, although the illnesses were considered mild.
But earlier versions of the same H5N1 flu virus have been highly lethal to humans in other parts of the world. Officials are taking steps to be prepared if the virus mutates in a way to make it more deadly or enables it to spread more easily from person to person.
Traditionally, most flu vaccines are made via an egg-based manufacturing process thats been used for more than 70 years. It involves injecting a candidate virus into fertilized chicken eggs, which are incubated for several days to allow the viruses to grow. Fluid is harvested from the eggs and is used as the basis for vaccines, with killed or weakened virus priming the bodys immune system.
Rather than eggs also vulnerable to bird flu-caused supply constraints some flu vaccine is made in giant vats of cells.
Officials say they already have two candidate vaccines for people that appear to be well-matched to the bird flu virus in U.S. dairy herds. The Centers for Disease Control and Prevention used the circulating bird flu virus as the seed strain for them.
The government has hundreds of thousands of vaccine doses in pre-filled syringes and vials that likely could go out in a matter of weeks, if needed, federal health officials say.
They also say they have bulk antigen that could generate nearly 10 million more doses that could be filled, finished and distributed in a matter of a few months. CSL Seqirus, which manufactures cell-based flu vaccine, this week announced that the government hired it to fill and finish about 4.8 million of those doses. The work could be done by late summer, U.S. health officials said this week.
But the production lines for flu vaccines are already working on this falls seasonal shots work that would have to be interrupted to produce millions more doses of bird flu vaccine. So the government has been pursuing another, quicker approach: the mRNA technology used to produce the primary vaccines deployed against COVID-19.
These messenger RNA vaccines are made using a small section of genetic material from the virus. The genetic blueprint is designed to teach the body how to make a protein used to build immunity.
The pharmaceutical company Moderna already has a bird flu mRNA vaccine in very early-stage human testing. In a statement, Moderna confirmed that we are in discussions with the U.S. government on advancing our pandemic flu candidate.
Similar work has been going on at Pfizer. Company researchers in December gave human volunteers an mRNA vaccine against a bird flu strain thats similar to but not exactly the same as the one in cows. Since then, researchers have performed a lab experiment exposing blood samples from those volunteers to the strain seen in dairy farms, and saw a notable increases in antibody responses, Pfizer said in a statement.
As for the vaccine for cows, Penn immunologist Scott Hensley worked with mRNA pioneer and Nobel laureate Drew Weissman to produce the experimental doses. Hensley said that vaccine is similar to the Moderna one for people.
In first-step testing, mice and ferrets produced high levels of bird flu virus-fighting antibodies after vaccination.
In another experiment, researchers vaccinated one group of ferrets and deliberately infected them, and then compared what happened to ferrets that hadnt been vaccinated. All the vaccinated animals survived and the unvaccinated did not, Hensley said.
The vaccine was really successful, said Webby, whose lab did that work last year in collaboration with Hensley.
The cow study will be akin to the first-step testing initially done in smaller animals. The plan is for initially about 10 calves to be vaccinated, half with one dose and half with another. Then their blood will be drawn and examined to look for how much bird flu-fighting antibodies were produced.
The USDA study first will have to determine the right dose for such a large animal, Hensley said, before testing if it protects them like it did smaller animals.
What scares me the most is the amount of interaction between cattle and humans, Hensley said.
Were not talking about an animal that lives on a mountain top, he said. If this was a bobcat outbreak Id feel bad for the bobcats, but thats not a big human risk.
If a vaccine reduces the amount of virus in the cow, then ultimately we reduce the chance that a mutant virus that spreads in humans is going to emerge, he said.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.
