A guide to vaccinology: from basic principles to new developments

Cancer Vaccine Breakthrough As Tests Show Positive Results On Patients With Tumours

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A cancer vaccine is one step closer to becoming a reality, according to the results of a trial.

The jab, known as mRNA-4359 and developed by Moderna, is currently aimed at people with advanced melanoma, lung cancer and other solid tumour cancers.

It is designed to prime the body to recognise and fight cancer cells has shown it could stimulate the immune system to help treat the disease more effectively, according to the results of an early trial.

For the first in-human study of the treatment, 19 patients with advanced solid tumours were given between one and nine doses of mRNA-4359.

Researchers found tumours did not grow and no new tumours appeared in eight of the 16 patients who were evaluated.

They also said the treatment was "well tolerated without serious side effects".

Researchers described the results as "an important first step" in potentially developing a new treatment for people with advanced cancers.

It uses mRNA technology, similar to Covid-19 vaccines, which teaches the immune system how cancer cells differ to healthy cells and mobilises it to destroy them.

A Covid-19 vaccine (PA Archive)

The results will be presented at the European Society of Medical Oncology conference in Barcelona by UK chief investigator Dr Debashis Sarker, a clinical reader in experimental oncology at King's College London and a consultant in medical oncology at Guy's & St Thomas' NHS Foundation trust.

He said: "This study evaluating an mRNA cancer immunotherapy is an important first step in hopefully developing a new treatment for patients with advanced cancers.

"We have shown that the therapy is well tolerated without serious side effects and can stimulate the body's immune system in a way that could help to treat cancer more effectively.

"However, as this study has only involved a small number of patients to date, it's too early to say how effective this could be for people with advanced stage cancer."

An 81-year-old man was the first person in the UK to receive the mRNA-4359 jab at Hammersmith Hospital in late October.

The patient – who wished to remain anonymous – has malignant melanoma skin cancer which is not responding to treatment.

The study is currently enrolling patients with specific cancers – namely melanoma and non-small-cell lung cancer – to have low doses of mRNA-4359 with pembrolizuma, also known as Keytruda.

Dr Sarkar described this as "a huge international effort across the UK, USA, Spain and Australia".

Kyle Holen, senior vice president and health of development, therapeutics and oncology at Moderna, added: "We are encouraged by the phase 1 results of mRNA-4359, which demonstrate its potential to elicit strong antigen-specific T-cell responses while maintaining a manageable safety profile.

"This novel approach could be a key component in shifting the tumour microenvironment toward a more immune-permissive state, offering potential hope for patients with advanced solid tumours."

The mRNA-4359 trial is one of a number of studies testing the effectiveness of jabs that are designed to fight cancer.

This includes the phase 3 trial of a personalised mRNA jab for melanoma – mRNA-4157 (V940) – which was given to a British patient earlier this year.

Scientists use a tumour sample, along with DNA sequencing and artificial intelligence, to create a jab specific to the patient's tumour.

Elsewhere, a lung cancer patient became the first in the UK to have a new vaccine to help fight the disease in August.

The trial of a jab called BNT116, made by BioNTech, is taking place across 34 research sites in seven countries, with six located in England and Wales.

Experimental MRNA Cancer Vaccine Shows Potential For Advanced Stage Cancer Patients In Phase 1 Trial

Interim data from the Phase I dose escalation part of the mRNA cancer immunotherapy (mRNA-4359), show promise in patients with advanced solid cancers.

The investigational mRNA cancer immunotherapy is targeted for patients with lung cancer, melanoma and other solid tumours. Nineteen patients with advanced stage cancers received between one and nine doses of the immunotherapy treatment. Scientists have found the immunotherapy created an immune response against cancer and was well tolerated, with adverse events including fatigue, injection site pain and fever.

Results from the Phase I trial, also the first-in-human study of the therapy, are being presented on Saturday, 14th September at the European Society of Medical Oncology conference in Barcelona by the UK Chief Investigator of the trial from King's College London and Guy's and St Thomas' NHS Foundation Trust. The trial is sponsored by Moderna.

The mRNA immunotherapy is just one of many cancer vaccines entering clinical trials around the world. The therapy works by presenting common markers of tumours to patients' immune systems, training them to recognise and fight cancer cells that express them and potentially eliminate cells that could supress the immune system.

The Phase I trial was designed to test the safety and tolerability of the immunotherapy, and secondary and tertiary objectives were to assess the radiographic and immunological responses.

Eight out of sixteen patients who could have their responses evaluated were able to demonstrate their tumour size did not grow and no new tumours appeared.

Data also showed the mRNA immunotherapy could activate the immune system in many patients, generating immune cells in the blood that could recognise the two proteins of interest (PD-L1 and IDO1). Researchers were able to show in some patients that the immunotherapy can increase levels of important immune cells that can kill cancer cells as well as reduced levels of other immune cells that can prevent the immune system from fighting cancer.

The results should be treated with caution, say the study authors, as the sample size was small and the primary objective of the study was to test for safety and determine the optimal dose of the immunotherapy. However, these promising early results support further research into mRNA-4359.

The trial continues to recruit patients with melanoma and lung cancer in combination with the immunotherapy drug pembrolizumab to provide more information on the safety and efficacy of the therapy.

The UK's Chief Investigator of the trial Dr Debashis Sarker, a Clinical Reader in Experimental Oncology at King's College London and a consultant in medical oncology at Guy's and St Thomas' NHS Foundation Trust, said: "This study evaluating an mRNA cancer immunotherapy is an important first step in hopefully developing a new treatment for patients with advanced cancers.

"We have shown that the therapy is well tolerated without serious side effects and can stimulate the body's immune system in a way that could help to treat cancer more effectively. However, as this study has only involved a small number of patients to date, it's too early to say how effective this could be for people with advanced stage cancer.

"The trial continues to recruit patients with melanoma and lung cancers and is a huge international effort across the UK, USA, Spain and Australia."

Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology, said: "We are encouraged by the Phase 1 results of mRNA-4359, which demonstrate its potential to elicit strong antigen-specific T-cell responses while maintaining a manageable safety profile.

"This novel approach could be a key component in shifting the tumour microenvironment toward a more immune-permissive state, offering potential hope for patients with advanced solid tumours."

COVID Vaccine Distrust Growing Among Americans, Survey Finds: 'Should Be A Personal Choice'

A growing number of Americans are skeptical of vaccines for COVID and other infectious diseases, according to the most recent national health survey by the Annenberg Public Policy Center at the University of Pennsylvania.

More than a quarter of respondents (28%) said they believe the COVID vaccines have contributed to thousands of deaths, according to a press release. This is an increase from 22% in June 2021.

Meanwhile, 22% of respondents said they are under the assumption that it is safer to contract COVID than it would be to get vaccinated — an increase from 10% in April 2021.

NEW COVID VACCINES GET FDA APPROVAL FOR 2024-2025 SEASON

Also, 15% of Americans said they believe the vaccine "changes people's DNA," up from 8% since the last survey.

The survey gathered input from nearly 1,500 U.S. Adults.

A growing number of Americans are skeptical of vaccines for COVID and other infectious diseases, according to the most recent national health survey by the Annenberg Public Policy Center at the University of Pennsylvania. (iStock)

"Belief in these three misconceptions is associated with increased reluctance to vaccinate," said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center and director of the survey, in the release.

The survey also found that only 20% of people are "somewhat or very worried" that they or a family member will be infected with COVID, compared to 25% in February 2024 and 35% in October 2023, the researchers shared.

RISKS ASSOCIATED WITH THE COVID VACCINE IDENTIFIED IN STUDY

The results come just after the U.S. Food and Drug Administration (FDA)'s approval of updated COVID vaccines.

"With the CDC reporting that COVID-19 infection remains an ongoing threat and an updated vaccine available, now is the time to ramp up awareness both of the value of vaccinating against COVID-19 and of the risks of contracting the disease," Jamieson added.

Fox News Digital reached out to the study researchers for comment.

The results come just after the U.S. Food and Drug Administration (FDA)'s approval of updated COVID vaccines. (PASCAL GUYOT/AFP via Getty Images)

Dr. Brett Osborn, a Florida neurosurgeon and longevity expert, was not involved in the survey but commented on its findings to Fox News Digital.

"Mainstream narratives continue to emphasize the safety and efficacy of COVID-19 vaccines, but it's important to take a closer look at the full picture, particularly when considering the risks and benefits of vaccination versus natural immunity — especially in 2024," he said.

One of the most publicized risks associated with mRNA vaccines is myocarditis, an inflammation of the heart muscle, Osborn noted — particularly in younger males.

"It's important to take a closer look at the full picture … when considering the risks and benefits."

"Although rare, the occurrence of myocarditis is a serious risk, leading to hospitalization and, in some cases, long-term health issues or death," he said. 

Additional risks include neurological complications, including Guillain-Barré syndrome, and other nervous system-related issues like acute disseminated encephalomyelitis (ADEM), the doctor said. 

Studies have consistently shown that natural immunity, developed after recovering from an infection, is often more comprehensive and longer-lasting than vaccine-induced immunity, a doctor noted. (iStock)

"While these are not common, their existence is undeniable, and they highlight the need for further discussion about the potential risks of vaccination, especially given the lack of long-term studies," he told Fox News Digital. 

"After all, these vaccines are only several years old and, therefore, have not been vetted appropriately – so, in essence, Americans are the 'study cohort.'"

CDC RECOMMENDS ADDITIONAL COVID VACCINE FOR ADULTS 65 AND OVER

As far as whether the vaccine changes humans' DNA, Osborn said that is a myth.

"The mRNA in these vaccines instructs cells to produce a spike protein, which triggers an immune response, and then the mRNA is quickly broken down and eliminated from the body," he said. 

"There is no evidence to suggest that mRNA can integrate into human DNA."

The COVID landscape has "drastically changed" since it emerged in 2020, a doctor said. "The current strains of the virus, being RNA-based, have undergone numerous mutations that have generally made them less virulent." (Jeff Kowalsky/AFP via Getty Images))

The doctor called for transparent communication from health authorities to dispel myths, while also addressing legitimate concerns about the long-term effects of "novel vaccine technology."

Osborn also pointed out that the COVID landscape has "drastically changed" since the virus emerged in 2020.

"The current strains of the virus, being RNA-based, have undergone numerous mutations that have generally made them less virulent," he said. 

"This is not about being anti-vaccine, but about making informed, balanced decisions based on the current scientific evidence and the realities of the virus."

"As a result, for the vast majority of the population — particularly those who are healthy and under 60 — a COVID-19 infection today is more likely to result in mild, flu-like symptoms rather than severe illness or death."

In light of this, Osborn said, it may be reasonable to question the push for widespread vaccination — "especially when natural infection can lead to robust, long-lasting immunity."

"There is a big upsurge of COVID FLirt subvariants right now, and the vaccine specifically covers these," a doctor told Fox News Digital. (iStock)

Studies have consistently shown that natural immunity, developed after recovering from an infection, is often more comprehensive and longer-lasting than vaccine-induced immunity, according to Osborn.

"While vaccines have played an essential role in controlling the pandemic, the evolving landscape demands a nuanced approach that respects individual choice, acknowledges the risks in the context of the benefits, and recognizes the power of natural immunity," the doctor said.

"This is not about being anti-vaccine, but about making informed, balanced decisions based on the current scientific evidence and the realities of the virus as it exists today."

FLORIDA SURGEON GENERAL WARNS AGAINST COVID VACCINE

Dr. Marc Siegel, senior medical analyst for Fox News and clinical professor of medicine at NYU Langone Medical Center, said he recommends the updated COVID vaccines for high-risk groups.

"I believe the vaccines remain effective at decreasing risks of severe disease and long COVID, and should especially be considered in high-risk groups, including those with chronic diseases and the elderly," he told Fox News Digital just after the FDA's approval of the new vaccines for 2024-2025. 

"For the vast majority of the population — particularly those who are healthy and under 60 — a COVID-19 infection today is more likely to result in mild, flu-like symptoms rather than severe illness or death," a doctor said. (iStock)

"Beyond this, it should be a personal choice, a discussion between doctor and patient, keeping in mind that viral load and transmission does decrease somewhat in the period after immunization."

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Regarding the potential side effects, Siegel stated that the risks of the virus — including myocarditis and brain fog — are "far greater," and that the vaccine decreases those risks. 

"It's far from perfect, but still quite useful," the doctor said. 

"I believe the vaccines remain effective at decreasing risks of severe disease and long COVID, and should especially be considered in high-risk groups."

"There is a big upsurge of COVID FLirt subvariants right now, and the vaccine specifically covers these."

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The Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months of age and older receive the updated COVID-19 vaccination. That includes women who are pregnant or breastfeeding. 

As of the week ending Aug. 24, the Centers for Disease Control and Prevention (CDC) reported that 17% of COVID tests were positive.

For more Health articles, visit www.Foxnews.Com/health

Meanwhile, 2.5% of those visiting emergency departments were diagnosed as COVID-19 — a drop of 1% from the prior week.

The percentage of deaths related to COVID was 2.2%, per the CDC, up from 1.9% the prior week.

Melissa Rudy is senior health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to melissa.Rudy@fox.Com.

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