Good morning, good afternoon and good evening,
Today marks the start of World Immunization Week a time to celebrate some of the most powerful inventions in history vaccines.
Thanks to vaccines, smallpox has been eradicated, polio is on the brink, and many once-feared diseases can now be easily prevented, including measles, cervical cancer, yellow fever, pneumonia and diarrhoea.
Today, 84% of the worlds children have received three doses of the vaccine against diphtheria, tetanus and pertussis which is used as a marker of global vaccine coverage.
But only fifty years ago, in 1974, fewer than 5% of infants globally were vaccinated.
That was the year WHO launched the Expanded Programme on Immunization, or EPI.
The Smallpox Eradication Programme had shown that vaccines could eliminate or even eradicate some diseases.
Building on that success, EPI supported countries to establish standardized vaccination programmes against smallpox and six other diseases: diphtheria, measles, pertussis, polio, tetanus and tuberculosis.
In the five decades since then, every country has established immunization programmes with support from WHO and our partners.
Now called the Essential Programme of Immunization, EPI helps millions of children, adolescents and adults access vaccines against 30 diseases.
A new study led by WHO estimates that EPI has saved at least 154 million lives since 1974 an average of more than 8000 a day, and 6 every minute of every year for the past 50 years.
Thanks to immunization, a child born today is 40% more likely to see their fifth birthday than a child born 50 years ago.
And more and more lives are being saved as more and more diseases are becoming vaccine preventable, with newer vaccines against COVID-19, malaria, cholera, dengue, meningitis, RSV, Ebola and mpox, and more in development.
Immunization programmes are also the bedrock of primary health care in some of the most remote locations.
A child brought to a clinic for vaccination often receives other life-saving services, such as nutritional support, illness screenings or bed nets.
Over the past 50 years, EPI has achieved so much, but we cannot take these gains for granted. The COVID-19 pandemic disrupted routine immunization programmes globally, while in many countries, crisis and conflict means millions of people miss out on vaccines.
Around the world, WHO and our partners are supporting countries to respond to outbreaks, catch up on children missed during the pandemic, and provide access to vaccines in even the most difficult contexts.
In the past 50 years, EPI has shown what is possible when partners work together, including those who are joining us today UNICEF, Gavi and The Bill & Melinda Gates Foundation.
Today, we are launching a joint campaign called Humanly Possible, calling on world leaders to advocate for, support and fund vaccines and the immunization programmes that deliver these lifesaving products.
To say more, Im delighted to welcome Professor Jos Manuel Barroso, the Board Chair of Gavi, the Vaccine Alliance, and former President of the European Commission.
Jos Manuel, my friend, you have the floor.
[PROF BARROSO ADDRESSED THE MEDIA]
Thank you, Jos Manuel, for your partnership, and for everything Gavi has done to ensure more children benefit from the lifesaving power of vaccines.
One of WHOs founding partners in EPI 50 years ago was Unicef, so Im very pleased to welcome Dr Ephrem Lemango, Unicefs Associate Director for Health and Global Chief of Immunization.
Ephrem, welcome, and you have the floor.
[DR LEMANGO ADDRESSED THE MEDIA]
Thank you Ephrem, and my thanks once again to Unicef for its steadfast partnership over the past 50 years.
Lastly, so much of this would not be possible without the support of the Bill & Melinda Gates Foundation, so Im honoured to welcome Violaine Mitchell, Director of the Gates Foundations Immunization Team.
Violaine, welcome, and you have the floor.
[MS MITCHELL ADDRESSED THE MEDIA]
Thank you, Violaine, and my thanks to you and your colleagues at the Gates Foundation for everything you do to expand access to vaccines around the world.
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One disease for which there was no vaccine 50 years ago but there is now is meningitis.
Just last month, Nigeria became the first country to roll out the new Men5CV vaccine, which protects against the five major strains of bacterial meningitis in Africa.
The campaign aimed to vaccinate 1 million people across several States in northern Nigeria which had been hit hard by meningitis outbreaks.
I thank the Government of Nigeria and partners including Gavi, Unicef, PATH and the United Kingdom, who have been critical to the development and rollout of this vaccine.
Building on this success, WHO is working with governments and partners on future rollout plans, including in Niger.
For the first time, the Men5CV vaccine gives us real hope of being able to eliminate meningitis as a public health problem.
On Friday, I will join global health leaders in Paris for the first high-level meeting on defeating meningitis.
The Defeating Meningitis by 2030 roadmap requires an initial investment of 130 million US dollars, which is frankly loose change compared to the return that investment will deliver.
As well as preventing over 900,000 deaths and nearly 3 million cases of meningitis by 2030, defeating meningitis would save billions of dollars in health costs and lost productivity.
Vaccination against meningitis, as part of an integrated with primary health care programme, can also help to combat antimicrobial resistance.
With the support of President Emmanuel Macron and the Government of France, and our partners here today, achieving the goals of the roadmap is feasible.
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Another disease for which vaccines have only recently been developed is malaria.
In the past two years, WHO has recommended the worlds first two malaria vaccines, which are now being rolled out in Africa and which could save tens of thousands of young lives every year.
Burkina Faso, Cameroon, Ghana, Kenya, Malawi and Sierra Leone are already delivering malaria vaccines through national immunization programmes, and many more countries are planning to introduce them in the coming weeks and throughout the year.
Alongside other tools including new types of bed nets, vaccines could help to reignite progress against malaria, which has stalled in recent years.
In 2022, malaria claimed the lives of an estimated 608 000 people worldwide and there were 249 million new cases.
Most cases and deaths are among children under 5 in in the poorest households in sub-Saharan Africa.
To truly address malaria, we have to address the inequity that drives it.
Tomorrow marks World Malaria Day. Together with the RBM Partnership and other partners, were drawing attention to the critical importance of health equity, gender equality and human rights in the fight against malaria.
===
Finally, vaccines are also playing a role in the response to dengue outbreaks around the world.
So far this year, more than 5.2 million cases of dengue have been reported from the Americas more than the total number of cases reported from that region last year, which was already the worst on record.
With warmer temperatures and the effects of climate change, other countries around the world must be ready to respond to increasing numbers of cases.
Last year, WHO recommended use of a new dengue vaccine for children aged 6 to 16 in areas where dengue is present.
Countries including Brazil are now using the vaccine, although the supply is constrained and the costs are still relatively high.
In February, WHO released 5 million US dollars from our Contingency Fund for Emergencies, to support priority countries to implement essential interventions against dengue. But the needs are immense and more support is needed from donors.
From the worlds oldest vaccine against smallpox, to the newest vaccines against meningitis, malaria and dengue, WHO remains committed to doing everything humanly possible to realise the lifesaving power of vaccines for everyone, everywhere.
Fadla, back to you.
A major landmark study to be published by The Lancet reveals that global immunization efforts have saved an estimated 154million lives or the equivalent of 6 lives every minute of every year over the past 50 years. The vast majority of lives saved 101million were those of infants.
The study, led by the World Health Organization (WHO), shows that immunization is the single greatest contribution of any health intervention to ensuring babies not only see their first birthdays but continue leading healthy lives into adulthood.
Of the vaccines included in the study, the measles vaccination had the most significant impact on reducing infant mortality, accounting for 60% of the lives saved due to immunization. This vaccine will likely remain the top contributor to preventing deaths in the future.
Over the past 50years, vaccination against 14diseases (diphtheria, Haemophilus influenzae type B, hepatitis B, Japanese encephalitis, measles, meningitis A, pertussis, invasive pneumococcal disease, polio, rotavirus, rubella, tetanus, tuberculosis, and yellow fever) has directly contributed to reducing infant deaths by 40% globally, and by more than 50% in the African Region.
"Vaccines are among the most powerful inventions in history, making once-feared diseases preventable, said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. Thanks to vaccines, smallpox has been eradicated, polio is on the brink, and with the more recent development of vaccines against diseases like malaria and cervical cancer, we are pushing back the frontiers of disease. With continued research, investment and collaboration, we can save millions more lives today and in the next 50years.
The study found that for each life saved through immunization, an average of 66years of full health were gained with a total of 10.2billion full health years gained over the five decades. As the result of vaccination against polio more than 20million people are able to walk today who would otherwise have been paralysed, and the world is on the verge of eradicating polio, once and for all.
These gains in childhood survival highlight the importance of protecting immunization progress in every country of the world and accelerating efforts to reach the 67million children who missed out on one or more vaccines during the pandemic years.
Released ahead of the 50th anniversary of the Expanded Programme on Immunization (EPI) to take place in May 2024, the study is the most comprehensive analysis of the programmes global and regional health impact over the past five decades.
Founded in 1974 by the World Health Assembly, EPI's original goal was to vaccinate all children against diphtheria, measles, pertussis, polio, tetanus, tuberculosis, as well as smallpox, the only human disease ever eradicated. Today, the programme, now referred to as the Essential Programme on Immunization, includes universal recommendations to vaccinate against 13diseases, and context-specific recommendations for another 17diseases, extending the reach of immunization beyond children, to adolescent and adults.
The study highlights that fewer than 5% of infants globally had access to routine immunization when EPI was launched. Today, 84% of infants are protected with 3 doses of the vaccine against diphtheria, tetanus and pertussis (DTP) the global marker for immunization coverage.
Nearly 94million of the estimated 154million lives saved since 1974, were a result of protection by measles vaccines. Yet, there were still 33million children who missed a measles vaccine dose in 2022: nearly 22million missed their first dose and an additional 11million missed their second dose.
Coverage of 95% or greater with 2doses of measles-containing vaccine is needed to protect communities from outbreaks. Currently, the global coverage rate of the first dose of measles vaccine is 83% and the second dose is 74%, contributing to a very high number of outbreaks across the world.
To increase immunization coverage, UNICEF, as one of the largest buyers of vaccines in the world, procures more than 2billion doses every year on behalf of countries and partners for reaching almost half of the worlds children. It also works to distribute vaccines to the last mile, ensuring that even remote and underserved communities have access to immunization services.
Thanks to vaccinations, more children now survive and thrive past their fifth birthday than at any other point in history, said UNICEF Executive Director Catherine Russell. This massive achievement is a credit to the collective efforts of governments, partners, scientists, healthcare workers, civil society, volunteers and parents themselves, all pulling in the same direction of keeping children safe from deadly diseases. We must build on the momentum and ensure that every child, everywhere, has access to life-saving immunizations.
In 2000, Gavi, the Vaccine Alliance, which includes WHO, UNICEF and the Bill & Melinda Gates Foundation (BMGF) as core founding members, was created to expand the impact of EPI and help the poorest countries in the world increase coverage, benefit from new, life-saving vaccines and expand the breadth of protection against an increasing number of vaccine-preventable diseases. This intensified effort in the most vulnerable parts of the world has helped to save more lives and further promote vaccine equity. Today, Gavi has helped protect a whole generation of children and now provides vaccines against 20 infectious diseases, including the HPV vaccine and vaccines for outbreaks of measles, cholera, yellow fever, Ebola and meningitis.
Gavi was established to build on the partnership and progress made possible by EPI, intensifying focus on protecting the most vulnerable around the world, said Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. In a little over two decades we have seen incredible progress protecting more than a billion children, helping halve childhood mortality in these countries, and providing billions in economic benefits. Vaccines are truly the best investment we can make in ensuring everyone, no matter where they are born, has an equal right to a healthy future: we must ensure these efforts are fully funded to protect the progress made and help countries address current challenges of their immunization programmes.
Immunization programmes have become the bedrock of primary health services in communities and countries due to their far reach and wide coverage. They provide not only an opportunity for vaccination but also enable other life-saving care to be provided, including nutritional support, maternal tetanus prevention, illness screenings and bed net distribution to protect families from diseases like malaria.
Since the study only covers the health impact of vaccination against 14 diseases, the number of lives saved due to vaccination is a conservative estimate and not a full account of the life-saving impact of vaccines. Societal, economic or educational impacts to health and well-being over the 50 years have also contributed to further reductions in mortality. Today, there are vaccines to protect against more than 30 life-threatening diseases.
While the HPV vaccine, which protects against cervical cancer in adults, was not included in the study, it is expected to prevent a high number of future deaths as countries work towards increasing immunization targets aimed at eliminating cervical cancer by 2030. New vaccine introductions, such as those for malaria, COVID-19, respiratory syncytial virus (RSV) and meningitis, as well as cholera and Ebola vaccines used during outbreaks, will further save lives in the next 50 years.
Global immunization programmes have shown what is humanly possible when many stakeholders, including heads of state, regional and global health agencies, scientists, charities, aid agencies, businesses, and communities work together.
Today, WHO, UNICEF, Gavi, and BMGF are unveiling Humanly Possible, a joint campaign, marking the annual World Immunization Week, 24-30 April 2024. The worldwide communication campaign calls on world leaders to advocate, support and fund vaccines and the immunization programmes that deliver these lifesaving products reaffirming their commitment to public health, while celebrating one of humanitys greatest achievements. The next 50 years of EPI will require not only reaching the children missing out on vaccines, but protecting grandparents from influenza, mothers from tetanus, adolescents from HPV and everyone from TB, and many other infectious diseases.
It's inspiring to see what vaccines have made possible over the last fifty years, thanks to the tireless efforts of governments, global partners and health workers to make them more accessible to more people, said Dr Chris Elias, president of Global Development at the Bill & Melinda Gates Foundation. We cannot let this incredible progress falter. By continuing to invest in immunization, we can ensure that every child and every person has the chance to live a healthy and productive life.
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For more information on WHO World Immunization Week 2024 campaign, visit World Immunization Week 2024 (who.int) and Humanly Possible campaign, http://itshumanlypossible.org.
Access photos and broll on immunization here.
About the data WHO led the analysis of the impact of the Expanded Programme on Immunization from 1974 to 2024 with input from researchers from University of Basel, Safinea Ltd., University of Washington, KidRisk Inc., Penn State University, London School of Hygiene & Tropical Medicine, University of Cape Town, Imperial College London, the Vaccine Impact Modelling Consortium, and Institute for Health Metrics and Evaluation. The analysis covers the global and regional health impact of vaccination against 14 diseases: diphtheria, Haemophilus influenzae type B, hepatitis B, Japanese encephalitis, measles, meningitis A, pertussis, invasive pneumococcal disease, polio, rotavirus, rubella, tetanus, tuberculosis, and yellow fever.
About WHO Dedicated to the health and well-being of all people and guided by science, the World Health Organization leads and champions global efforts to give everyone, everywhere, an equal chance at a safe and healthy life. We are the UN agency for health that connects nations, partners and people on the front lines in 150+ locations leading the worlds response to health emergencies, preventing disease, addressing the root causes of health issues and expanding access to medicines and health care. Our mission is to promote health, keep the world safe and serve the vulnerable.www.who.int
About UNICEF UNICEF works in some of the world's toughest places, to reach the world's most disadvantaged children. Across more than 190 countries and territories, we work for every child, everywhere, to build a better world for everyone. For more information about UNICEF and its work, visit: www.unicef.org. Follow UNICEF on Twitter, Facebook, Instagram and YouTube
About Gavi, the Vaccine Alliance Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate more than half the worlds children against some of the worlds deadliest diseases. Since its inception in 2000, Gavi has helped to immunize a whole generation over 1 billion children and prevented more than 17.3 million future deaths, helping to halve child mortality in 78 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningococcal and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation, above all the zero-dose children who have not received even a single vaccine shot. The Vaccine Alliance employs innovative finance and the latest technology from drones to biometrics to save lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more atwww.gavi.organd connect with us onFacebookandTwitter.
About the Bill & Melinda Gates Foundation Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving peoples health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all peopleespecially those with the fewest resourceshave access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of Co-chairs Bill Gates and Melinda French Gates and the board of trustees.
A cancer vaccine is being tested on British patients for the first time. The vaccine, regarded as a potentially potent tool to combat melanoma, could also halt the progression of lung, bladder and kidney cancers.
Invented uniquely for each patient within weeks, the transformative jab tells the immune system about recognising and eliminating malignant cells. Particularly encouraging results have emerged from phase-two tests o led by pharma heavyweights Moderna and MSD.
It significantly enhanced survival in people with melanoma and showed potential in preventing recurrence.
Given its promising trajectory, a definitive phase-three trial is now underway. Dr Heather Shaw, chief coordinating investigator of this UCL Hospitals NHS Foundation Trust-led study, expressed her optimism, The Mirror reports.
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She described it as one of the most exciting developments in a long time. She said: "This is one of the most exciting things we've seen in a really long time. This is a really finely honed tool. These things are hugely technical and finely generated for the patient. There is a real hope that these will be the game-changers in immunotherapy."
The treatment is known as individualised neoantigen therapy. It is created to target tumour neoantigens, substances expressed by tumours. These are markers on the tumour that can potentially be recognised by the immune system.
It involves an injection that carries coding for up to 34 neoantigens, triggering an immune response tailored to the unique mutations of a patient's cancer. To produce the vaccine, a tumour sample is surgically removed and then DNA sequencing along with artificial intelligence are employed in its development.
Dr Shaw is hopeful hat it could potentially cure cancer, stating: "Absolutely, that's the drive. With this therapy, what you're doing is dealing with the theoretical risk that the cancer could recur."
She explained that the aim of the treatment is to eradicate all cancer cells, including those not detectable by scans. The phase-three global trial is set to expand to include a broader patient group, seeking approximately 1,100 participants.
In the UK, the goal is to enlist at least 60 patients from eight centres, among them London, Manchester, Edinburgh, and Leeds. Phase-two results released in December indicated that individuals with serious high-risk melanomas who were treated with the vaccine in conjunction with MSD's immunotherapy drug Keytruda had a 49 per cent lower chance of death or cancer recurrence after three years compared to those who only received Keytruda.
The potential side effects of a groundbreaking cancer therapy are reportedly no more severe than those associated with the flu jab. Professor Lawrence Young, from the University of Warwick, commented: "This is one of the most exciting developments in modern cancer therapy. The hope is that this approach could be extended to other cancers such those of the lung and colon."
The treatment, which combines different therapies, is currently undergoing trials for bladder and kidney cancer at UCLH.
Among the early participants in the trial is 52 year old musician Steve Young, whose seemingly innocuous "bump on the head", which he believes he had for about ten years, was diagnosed as melanoma.
Reflecting on his condition, Steve shared: "I spent two weeks just thinking 'This is it'. My dad died of emphysema when he was 57 and I actually thought, 'I'm going to die younger than my dad'."
However, upon learning about the trial, Steve's interest was immediately sparked. He said: "It really triggered my geek radar. I was just like, 'It sounds fascinating' and I still feel the same."
Vaccines typically function by introducing a benign fragment of bacteria or virus to stimulate an immune response. However, researchers have crafted a vaccine that employs a molecule known as 'messenger RNA' (mRNA), eschewing the use of live bacteria or viruses.
This innovative mRNA method instructs the body to generate antibodies that target and mark foreign pathogensor cancer cellsfor elimination. Although mRNA was discovered back in the 1960s, it wasn't until the recent pandemic that the first vaccines using this technology were introduced to the market.
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London: An international clinical trial testing a novel cancer immunotherapy, which may prevent skin cancer from recurring, has recruited its first patient in Britain this week. The mRNA-based technology, the vaccine tech used for some COVID vaccinations, is aimed at people who have already had high-risk melanomas - the most serious form of cancer - removed. For the trial, University College London Hospitals (UCLH) doctors are giving it alongside another drug, pembrolizumab or Keytruda, that also helps the immune system kill cancer cells.
One of the first patients to sign up for the trial is British musician Steve Young, 52, from Hertfordshire, east England, who was diagnosed with stage II melanoma, which was removed.
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The personalised treatment works by instructing the body to make up to 34 proteins, each targeting "neoantigens" identified by gene sequencing and thought to be driving the cancer in that particular patient. The neoantigens are proteins found only on the cancer cells, and the individualised neoantigen therapy is designed to prime the immune system to attack the tumour cells in each patient, while Keytruda blocks an immunological "brake" that protects the cancer.
The new Phase 3 clinical trial, being led by UCLH, is evaluating the combination of mRNA-4157 (V940) and Keytruda (pembrolizumab) versus a current standard of care (pembrolizumab) as a risk-reducing treatment option for patients with resected high-risk, stage IIB to IV melanoma.
It follows a successful Phase 2 study, which found that in patients with stage IIIB to IV resected melanoma, this treatment option almost halved the risk of cancer recurrence or death after three years compared with treatment with Keytruda alone among patients with advanced melanomas following surgical removal of cancer.
Melanoma is characterised by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with nearly 3,25,000 new cases diagnosed worldwide in 2020. In the UK, melanoma is the fifth most common type of cancer, accounting for about 8,400 new cases every year.
The mRNA technology was developed by Moderna in conjunction with Merck Sharp and Dohme (MSD), which used the learning from COVID research development and is expected to contribute to new treatments for cancer patients.
Researchers are now hoping that the Phase 3 study, which is running in several sites across the UK, will confirm the findings of the earlier trial. The Phase 3 trial, named INTerpath-001, will enrol around 1,089 patients across the world. The primary outcome measure is recurrence-free survival, with overall survival and metastasis-free survival as secondary outcomes.
V940-001 is a Phase 3 global, randomised, double-blind, placebo- and active-comparator-controlled study. This means Steve Young knows he is receiving Keytruda, but will not find out if he is getting the personalised cancer treatment or a placebo.
GlaxoSmithKline is suing Pfizer and BioNTech over alleged infringement of multiple GSK-owned patents in the creation of mRNA vaccines for COVID-19, the latest in a series of legal disputes between vaccine makers on the rights to the technology at the core of vaccines developed rapidly during the pandemic, often through collaboration between industry and the federal government. GSK alleges its patents are infringed in all dosage forms of the companies main mRNA vaccine for COVID-19 and subsequent bivalent vaccines for...
New claim from GlaxoSmithKline is latest in litany of lawsuits against rivals | US lawsuit, potentially worth billions of dollars, is filed as UK trial kicks off between Moderna, Pfizer and BioNTech.
GlaxoSmithKline (GSK) has entered the fray of COVID-19 vaccine lawsuits with a lawsuit that could cost Pfizer and BioNTech billions of dollars.
The mammoth biopharma firm filed a lawsuit yesterday, April 25, claiming that fellow UK firm Pfizer and Germany-based BioNTech infringed five patents related to its revolutionary messenger RNA (mRNA) technology in their blockbuster COVID-19 vaccines.
GSK alleges that it began to develop mRNA vaccines in 2008more than a decade before the SARS-CoV-2 disease emerged in 2019and that the defendants Comirnaty vaccine infringe its patent rights.
Scientists and researchers working under the leadership of vaccinologist Christian Mandl, and Andrew Geall, the named inventor of the patents-in-suit, discovered formulations comprising lipids and mRNA molecules encoding a viral immunogen that provide protection from viral infection, said GSK in the 65-page complaint.
According to the District of Delaware suit, the team filed patent applications in 2010 for the five patents in suit which describe technology for delivering fragile mRNA into human cells (US patent numbers 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467.
GSK argues that the foundation of defendants technical and financial success with COVID-19 vaccines is the technology of its patented inventions.
Defendants have repeatedly touted the speed at which they produced their original COVID-19 vaccine and were later able to modify it to address new viral strains, but have consistently failed to acknowledge how they applied [its] revolutionary platform to do so.
The biopharma firm added that the defendants have reaped billions of dollars in revenue from infringing GSKs patents-in-suit and continue to benefit, without ever obtaining a licence.
mRNA lawsuits pile up
The complaint adds to the myriad high-stakes lawsuits in US and EU courts involving Pfizer and BioNTech, first brought by Moderna in August 2022.
Moderna claims that Pfizer and BioNTech infringed its patents related to mRNA innovations with their Comirnaty vaccine.
But in November, the US biotech firm suffered a setback after the European Patent Office (EPO) declared an mRNA patent held by the firm to be invalid.
And earlier this month, the defendants successfully paused the suit in the US until the resolution of two inter partes review (IPR) proceedings initiated by the Patent Trial and Appeal Board (PTAB).
In their appeal, they argued that Moderna had rewritten history to eliminate the contributions of many brilliant and dedicated scientists and place itself in the single, starring role.
The legal battle in the UK saw a trial kicked off at the High Court on Tuesday, April 23, after Pfizer and BioNTech sued Moderna in September 2022, seeking to revoke Moderna's mRNA technology.
Representing GSK is a large team from Desmarais, including John Desmarais, Todd Kraus, Amanda Potter, Karl Mullen and Alexander Walker; and Kelly Farnan and Sara Metzler at Richards, Layton & Finger.
Counsel for Pfizer and BioNTech have not yet been named.
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Pictured: Sign above the entrance to a U.S. courthouse/iStock,Mariakray
GSK on Thursday sued Pfizer and BioNTech, alleging that the pharma partners have infringed patents related to the mRNA technology of their COVID-19 vaccine Comirnaty, according to Reuters.
In its complaint, filed with the U.S. District Court of Delaware, GSK claims Pfizer and BioNTech made use of seminal mRNA research from Christian Mandl, who in 2008with a team of researcherssuccessfully addressed long-standing hurdles regarding the use of mRNA molecules as vaccines.
The Mandl team successfully overcame the many challenges and discovered the novel lipid and mRNA formulations and methods for their use to raise an immune response against immunogens, GSKs filing noted, adding that the company obtained exclusive rights to the Mandl research in 2015, when it bought a substantial portion of Novartis vaccines unit.
Despite its ownership, GSK alleges that Pfizer and BioNTech knowingly used the Mandl research to develop Comirnaty. BioNTech has cited the work of Mandls team in its patent applications, while Pfizer has likewise pointed to the Mandl research in at least one of its presentations.
Pfizer and BioNTechs mRNA vaccines exploit the fundamental technologies invented by the Mandl team, GSK wrote in its lawsuit, noting that the defendants did not acquire a license to practice the GSK inventions before or since commercializing their COVID-19 shots.
As compensation for the alleged patent infringement, GSK is seeking damages including an on-going license fee as well as related attorney fees and other expenses.
A Pfizer spokesperson in a statement to Reuters said that the company is confident in our IP position around Comirnaty and that it will vigorously defend its position against GSK. BioNTech declined to provide comment.
Thursdays lawsuit adds to Pfizer and BioNTechs legal troubles surrounding Comirnaty. The partners are also locked in a patent battle with Moderna, which in August 2022 claimed infringement on certain patented mRNA technology. Modernas lawsuit focuses on the specific chemical modifications to the mRNA molecule used in Comirnaty, as well as the process of encoding the full-length spike protein contained in a lipid nanoparticle.
Pfizer and BioNTech fired back in August 2023 and asked the U.S. Patent Trademark Office for an inter partes review, claiming that some of Modernas patents were invalid for being too broad and for seeking to claim ownership of established knowledge.
Last week, the U.S District Court of Massachusetts granted Pfizer and BioNTech motion to pause Modernas lawsuit until after the resolution of the inter partes proceedings.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
UK pharma major GSK (LSE: GSK) has launched a lawsuit against Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX).
The suit accuses the companies of breaching GSK mRNA vaccine technology patents in their development of the Comirnaty vaccine for COVID-19. The jab swiftly became a top-selling pharma product to help the world to move on from the pandemic, earning Pfizer $43 billion in global revenue in one year alone.
GSK claims that the research in question
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Reuters
Apr 25, 2024 at 3:50 pm GMT
** Shares of vaccine makers Pfizer PFE.N and BioNTech BNTX.O fall between 2% to 3%
** Drugmaker GlaxoSmithKline GSK.L sues BNTX and PFE accusing them of infringing its patents related to messenger RNA (mRNA) technology in the companies' blockbuster COVID-19 vaccines
** GSK says that PFE and BNTX's Comirnaty vaccines violate its patent rights in mRNA-vaccine innovations developed "more than a decade before" the outbreak of the COVID-19 pandemic
** GSK also asked the Delaware federal court for an unspecified amount of monetary damages from both companies that includes an ongoing patent-licensing fee
** A Pfizer spokesperson said in a statement that the company is "confident in our IP position around Comirnaty" and intends to "vigorously defend" against GSK's claims, while a BioNTech spokesperson declined to comment
** Including session moves, PFE down 11.3% and BNTX down 18.1% YTD
Reporting by Sneha S K in Bengaluru
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Pfizer-BioNTech
The Pfizer-BioNTech vaccine (brand name: Comirnaty) was granted full Food and Drug Administration (FDA) approval in August 2021 for people ages 16 and older. Before that, it was the first COVID vaccine to receive FDA Emergency Use Authorization (EUA) back in December 2020, after the company reported that its vaccine was highly effective at preventing symptomatic disease. This is a messenger RNA (mRNA) vaccine, which uses a relatively new technology. It must be stored in freezer-level temperatures, which can make it more difficult to distribute than some other vaccines.
Status: Pfizers vaccine has been updated over time to target new virus variants. First introduced in December 2020, the original COVID mRNA vaccines from both Pfizer and Moderna protected against the original SARS-CoV-2 virus. They were replaced in September 2022 by bivalent vaccines, which targeted both the original virus and Omicron variants BA.4 and BA.5. New updated vaccines in September 2023 replaced the bivalent shots with ones targeting the XBB lineage of the Omicron variant.
The original and bivalent vaccines are no longer in use, and it has yet to be decided whether updated shots will be administered annually, like the flu shot.
Who can get it: People 6 months and older. The CDC has specific recommendations for the following groups, noting that anyone who recently had COVID may need to consider delaying their vaccination by 3 months:
Possible side effects: Pain, redness, or swelling at the site where the shot was administered, and/or tiredness, headache, muscle pain, chills, fever, or nausea throughout the rest of the body. If these side effects occur, they should go away in a few days. A few side effects are serious, but rare. These include anaphylaxis, a severe reaction that is treatable with epinephrine (the drug in EPIPENs).
FDA warnings: The FDA added a warning label on the mRNA vaccines regarding serious (but rare) cases of inflammation of the heart muscle (myocarditis) and of the outer lining of the heart (pericarditis) in adolescents and young adults, more often occurring after the second dose of an mRNA vaccine. The inflammation, in most cases, gets better on its own without treatment.
How it works: It uses mRNA technology, which is a way of sending instructions to host cells in the body for making copies of a spike protein (like the spikes you see sticking out of the coronavirus in pictures). Our cells recognize that this protein doesnt belong, and the immune system reacts by activating immune cells and producing antibodies. This will prompt the body to recognize and attack the real SARS CoV-2 spike protein if you become exposed to the actual virus.
How well it works: The 2023-2024 updated vaccines were approved based on preclinical studies of their efficacy against the latest circulating strains. Some people may still become infected even though they have been vaccinated, but the goal of the vaccines now is to prevent severe disease, hospitalization and death. Research has suggested that people who are infected after vaccination also are less likely to report Long COVID (defined as signs, symptoms, and conditions that continue or develop after acute COVID infection), compared to those who were not vaccinated.
In its preclinical data, Pfizers updated COVID vaccine produced strong immune responses to XBB.1.5.
In its recommendations for the most recent vaccines, the CDC also cited a study showing the risk of cardiac complications, including myocarditis (an inflammation of the heart muscle), in males 12-17 years old was 1.85.6 times higher after a COVID infection compared to after COVID vaccination.
In December 2020, Pfizer-BioNTechs Phase 3 clinical data for its original vaccine showed 95% efficacy for preventing symptomatic COVID. Later data on real-world effectiveness for adults showed that the protection from the mRNA two-dose primary series waned over time, suggesting that updated vaccines would be needed to bring the immune system back to robust levels.
The FDA granted the Moderna vaccine (brand name: Spikevax) full approval for people 18 and older in January 2022, upgrading the vaccines EUA, which was granted in December 2020 (a week after Pfizer-BioNTech). Moderna uses the same mRNA technology as Pfizer-BioNTech and had a similarly high efficacy at preventing symptomatic disease when the companies applied for authorization; it also needs to be stored in freezer-level temperatures.
Status: Modernas COVID vaccine has been updated over time to target new virus variants. First introduced in December 2020, the original COVID mRNA vaccines aimed to protect against the original SARS-CoV-2 virus. They were replaced in September 2022 by bivalent vaccines designed to prevent both the original virus, and Omicron variants BA.4 and BA.5. New updated vaccines in September 2023 replaced the bivalent shots with ones targeting the XBB lineage of the Omicron variant.
The original and bivalent vaccines are no longer in use, and it has yet to be decided whether updated shots will be administered annually, like the flu shot.
Who can get it: People ages 6 months and older. The CDC has specific recommendations for the following groups, noting that anyone who recently had COVID may need to consider delaying their vaccination by 3 months:
Possible side effects: The side effects are similar to Pfizer-BioNTechs vaccine: Pain, redness, or swelling at the site where the shot was administeredand/or tiredness, headache, muscle pain, chills, fever, or nausea throughout the rest of the body. If any of these side effects occur, they should go away in a few days. A few side effects are serious, but rare. These include anaphylaxis, a severe reaction that is treatable with epinephrine (the drug in EPIPENs).
FDA warnings: The FDA placed a warning label on the Moderna vaccine regarding a likely association with reported cases of heart inflammation in young adults. This inflammation may occur in the heart muscle (myocarditis) or in the outer lining of the heart (pericarditis)it more often occurs after the second dose of an mRNA vaccine. The inflammation, in most cases, gets better on its own without treatment.
How it works: Similar to the Pfizer vaccine, this is an mRNA vaccine that sends host cells in the body instructions for making a spike protein that will train the immune system to recognize it. The immune system will then attack the spike protein the next time it sees one (attached to the actual SARS CoV-2 virus).
How well it works: The 2023-2024 updated vaccines were approved based on preclinical studies of their efficacy against the latest circulating strains. Some people may still become infected even though they have been vaccinated, but the goal of the vaccines now is to prevent severe disease, hospitalization, and death. Research has suggested that people who are infected after vaccination also are less likely to report Long COVID compared to those who were not vaccinated.
To support its 2023-2024 updated shot, Moderna shared clinical trial data that showed a strong immune response against some of the variants that are common now, including XBB.1.5, EG.5, and FL.1.5.1. Antibody responses after vaccination were about 17-times higher against XBB 1.5 and about 10-times higher against BA.2.86.
In its recommendations for the most recent vaccines, the CDC also cited a study showing the risk of cardiac complications, including myocarditis (an inflammation of the heart muscle), in males 12-17 years old was 1.85.6 times higher after a COVID infection compared to after COVID vaccination.
Modernas initial Phase 3 clinical data in December 2020 was similar to Pfizer-BioNTechsboth vaccines showed about 95% efficacy for prevention of COVID. Later data on real-world effectiveness for adults showed that the protection from the mRNA two-dose primary series wanes over time, but booster doses brought the immune system back to robust levels.
The Novavax vaccine (brand names: Nuvaxovid and Covovax) was the fourth COVID vaccine to be administered in the U.S (after Johnson & Johnson, which is no longer available). This vaccine, which is a protein adjuvant, had a 90% efficacy in its clinical trial, performing almost as well as the mRNA vaccines in their early trials. It is simpler to make than some of the other vaccines and can be stored in a refrigerator, making it easier to distribute.
Status: The FDA amended its earlier Novavax authorization to allow for a new adjuvanted 2023-2024 Novavax vaccine for ages 12 and older to target the XBB.1.5 strain in October 2023, a few weeks after the updated mRNA shots were approved. The Novavax vaccine is the only non-mRNA updated COVID vaccine available in the U.S.
The previous Novavax vaccine is no longer authorized in the U.S.
Who can get it: People 12 and older. There are specific recommendations for the following groups:
Possible side effects: Injection site tenderness, fatigue, headache, muscle pain. There were rare cases of myocarditis and pericarditis (six cases in 40,000 participants) in the clinical trial.
How well it works: Novavax has reported that its updated COVID vaccine can generate an immune response against emerging strains of the coronavirus. Earlier studies of its original vaccine showed it to be 90% effective overall against lab-confirmed, symptomatic infection and 100% effective against moderate and severe disease in Phase 3 trial results published in The New England Journal of Medicine in December 2021.
