Category: Vaccine

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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What are cancer vaccines and have scientists finally found a cure? - The Guardian

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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Lessons for the 'next pandemic': UNMC's Khan named to national CDC vaccine study committee - Omaha World-Herald

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.

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BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa - FiercePharma

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.

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Guillain-Barre syndrome 'more common than expected' with RSV vaccine in older people, CDC reiterates - The Associated Press

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The week at Retraction Watch featured:

Our list of retracted or withdrawn COVID-19 papers isup past 400. There are nearly49,000 retractions in The Retraction Watch Database which is nowpart of Crossref. The Retraction Watch Hijacked Journal Checkernow contains more than 250 titles. And have you seen our leaderboard ofauthors with the most retractions lately or our list oftop 10 most highly cited retracted papers? What aboutThe Retraction Watch Mass Resignations List or ourlist of nearly 100 papers with evidence they were written by ChatGPT?

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Weekend reads: Another vaccine-autism retraction; 'Why We Commit Academic Fraud'; on a psilocybin-depression ... - Retraction Watch

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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NHS patients in England to be offered trials for world-first cancer vaccine - The Guardian

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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Modernas RSV shot wins FDA approval for use in older adults | Company Business News - Mint

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.

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Early Safety Findings Among Persons Aged 60 Years Who Received a Respiratory Syncytial Virus Vaccine United ... - CDC

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COVID-19 accounted for much more absenteeism than influenza among Greek healthcare personnel (HCP) with low vaccine uptake in 2022 and 2023, highlighting the need to stay current with vaccinations against both diseases, according to an observationalstudy led by a National Public Health Organization researcher in Athens.

For the study, published yesterday in the American Journal of Infection Control, the researchers tested symptomatic HCP at four hospitals for COVID-19 and flu from November 2022 to May 2023 to estimate the number of missed workdays by disease type. The SARS-CoV-2 Omicron variant was predominant during the study period.

"To our knowledge, this is the first study to compare the burden of COVID-19 and seasonal influenza among HCP using data from the same season," the authors wrote.

A total of 9.2% of HCP were fully vaccinated, and 90.8% were partially vaccinated, against COVID-19. Flu vaccination coverage was 23.1%. HCP with flu were less likely to be current with the flu vaccine than unvaccinated workers with COVID-19 (14.0% vs 26.2%).

In total, 4,245 missed workdays were associated with COVID-19, compared with 333 for flu.

Among 5,752 HCP, 734 COVID-19 (incidence, 12.8%) and 93 flu (1.6%) cases were detected.Two COVID-infected HCP were hospitalized for 4 and 5 days, respectively.

The average number of workdays missed was 5.8 for COVID-19 and 3.6 for flu. In total, 4,245 missed workdays were associated with COVID-19, compared with 333 for flu. Analyses estimated that, on average, HCP with COVID-19 were absent for 1.91 more days than those with flu.

"The shorter duration of work absence among HCP with influenza than those with COVID-19 may be attributed to the milder clinical course of influenza, the particular seasonal influenza strain, and to differences in absenteeism policies," the researchers wrote. "Indeed, although post-COVID-19 isolation is not mandatory as in the first pandemic waves, a five-days leave is common practice for HCP in Greece. In contrast, there are no official recommendations for HCP diagnosed with influenza."

The findings underscore the value of COVID-19 and flu vaccination in protecting HCP health and protecting healthcare services from absenteeism, they concluded.

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WHO launches dengue dashboard as global threat remains high - University of Minnesota Twin Cities

The current COVID-19 boosters targeting the Omicron XBB.1.5 subvariant are still offering solid protection against infection, hospitalizations, and death, but are somewhat limited in efficacy against illnesses caused by the JN.1 subvariant, now the dominant strain in the United States, according to a research letter yesterday in the New England Journal of Medicine.

Protection against infection 4 weeks after vaccination was 52%, and against COVID-related hospital illness it was 67%, but during the JN.1-dominant period it dropped to 44% and 60%, respectively.

The authors said the findings underscore the need for new boosters. Next week, the US Food and Drug Administration's VRBPAC (Vaccines and Related Biological Products Advisory Committee) will meet to select COVID and influenza strains to include in updated vaccines.

The elected strain will likely be the JN.1 subvariant.

"The relatively low effectiveness of the XBB.1.5 vaccines against the JN.1 subvariant, together with the waning effectiveness over time, underscores the need for new vaccines targeting the JN.1 strain," said first study author Dan-Yu Lin, PhD, in a press release from the University of North Carolina Gillings School of Public Health.

Lin and colleagues assessed the efficacy of the Moderna, Pfizer, and Novavax boosters from September 11, 2023, to February 21, 2024, in a cohort of approximately 1.8 million people captured in the Nebraska Electronic Disease Surveillance System and the Nebraska State Immunization Information System (NESIIS).

In total, 218,250 people in the cohort (11.9%) received XBB.1.5 vaccines, of whom 133,403 (61.1%) received the PfizerBioNTech vaccine and 84,307 (38.6%) received the Moderna vaccine, the authors said.

The researchers recorded a total of 21,988 SARS-CoV-2 infections, 1,364 COVID-19related hospitalizations, and 237 COVID-19related deaths in the cohort.

Efficacy peaked at 4 weeks

For all three booster vaccines targeting XBB.1.5, efficacy peaked at 1 month, with significant waning at 10 to 20 weeks.

At 4 weeks after vaccination, the XBB.1.5 vaccines were 52.2% effective at preventing infection (95% confidence interval [CI], 44.6% to 58.7%). Efficacy against infection dropped at 10 weeks to 2.6% (95% CI, 28.1% to 36.8%), and at 20 weeks to 20.4% (95% CI, 6.2% to 32.5%).

The boosters were 66.8% effective at preventing hospitalization at 4 weeks (95% CI, 51.7% to 77.1%), and decreased to 57.1% (95% CI, 40.4% to 69.2%) after 10 weeks.

"The effectiveness against death was higher than that against other end points; however, there remains substantial uncertainty owing to the small number of deaths," the authors said.

To assess how the booster performed against JN.1, the authors analyzed data comparing people who received the XBB.1.5 vaccines on or before October 25, 2023when JN.1. was first detected in Nebraskaand those who received them after October 25, 2023.

During that period, boosters provided 44.3% protection against infection at 4 weeks (95% CI, 33.5% to 53.4%) and 60.1% protection against hospitalization (95% CI, 30.9% to 77.0), which likewise waned over time.

"The vaccine effectiveness was lower in the second cohort than in the first cohort, which indicates that the XBB.1.5 vaccines were less protective against JN.1 than against XBB sublineages," the authors wrote.

It would be worthwhile to deploy new vaccines this fall that target the JN.1. strain.

"It would be worthwhile to deploy new vaccines this fall that target the JN.1. strain," Lin said in the release.

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Current COVID boosters offer good protection against severe outcomes but less so against JN.1 - University of Minnesota Twin Cities