New research announced Wednesday in the journal Science Translational Medicine looked at hemagglutinin. It's the protein that allows the flu virus to attach to a human cell and make a person sick.
Posted2024-05-01T17:05:03-0400-Updated2024-05-01T17:05:03-0400
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Global Microneedle Flu Vaccine Market
Dublin, May 02, 2024 (GLOBE NEWSWIRE) -- The "Microneedle Flu Vaccine Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2019-2029F" report has been added to ResearchAndMarkets.com's offering.
The advent of microneedle technology for flu vaccination presents a transformative approach in the pharmaceutical industry, leading to the noteworthy expansion of the Global Microneedle Flu Vaccine Market. With a standing valuation at USD 1.1 billion in 2023, the market is projected to ascend with a compound annual growth rate (CAGR) of 5.89%, reaching $1.54 billion by 2029.
Microneedle technology stands at the forefront of innovative vaccination methods, offering painless and minimally invasive alternatives to conventional flu shots. This technology is designed to administer vaccines directly into the skin's immune cell-rich areas, potentially eliciting stronger and faster immune responses. The incorporation of self-administered vaccination methods addresses the growing demand for efficient healthcare delivery systems, particularly highlighted by the pandemic's exigencies.
Increasing Acceptability Among Patients
The market's growth is further propelled by the widespread acceptance of microneedle vaccines for their perceived painlessness and user-friendliness. The microneedle patches' self-applicability feature plays a crucial role in mitigating vaccine hesitancy, improving patient compliance, and streamlining healthcare processes. Particularly in regions lacking refrigeration infrastructure, the heat stability of some microneedle vaccine formulations simplifies storage and transportation, making vaccinations more accessible and contributing to global vaccine equity.
Advancements in Vaccine Technology
Recent research and investments in the segment have led to prolific advancements, driving technological innovation across microneedle designs, manufacturing processes, and vaccine formulations. This has been paramount in diversifying the usage of microneedle technology, with applications potentially extending beyond influenza to target diseases like measles, polio, and even COVID-19.
Story continues
Challenging Horizons with Regulatory Complexities
Despite the optimistic outlook on market growth, the pathway is not without its impediments. High initial costs, stringent regulatory approvals, and the demand for standardization pose significant challenges that influence market dynamics. Success in navigating these hurdles depends heavily on the ability of companies to secure substantial investment and successfully pass through stringent regulatory vetting processes.
Solid Microneedles Emerging as the Market Leader
Segmentation insights reveal a notable lead by the Solid Microneedle segment, attributed to ease of use, patient comfort, and the consequent potential for widespread acceptance. Within vaccine types, Trivalent Flu Vaccines hold a dominant market share, spotlighting an area ripe for innovation and market penetration through microneedle technology.
North America Leading Regional Market Growth
In a geographical context, North America spearheads the Global Microneedle Flu Vaccine Market, thanks to its advanced healthcare system, leading-edge research capabilities, and responsive consumer base. These attributes have anchored North America as a pivotal region for the growth and adoption of microneedle flu vaccines.
The Solid Microneedle segment has demonstrated significant growth and is expected to continue its momentum, driven by patient preference and the promise of increased efficacy.
Trivalent Flu Vaccines harness the largest segment in vaccine types, leveraging a well-established market presence to introduce microneedle variants.
Key Attributes
Report Attribute
Details
No. of Pages
185
Forecast Period
2023-2029
Estimated Market Value (USD) in 2023
$1.1 Billion
Forecasted Market Value (USD) by 2029
$1.54 Billion
Compound Annual Growth Rate
5.8%
Regions Covered
Global
A selection of companies mentioned in this report includes, but is not limited to:
Debiotech SA
NanoPass Technologies Limited
Becton, Dickinson and Company
FluGen, Inc.
CosMED Pharmaceuticals Co. Ltd.
Microdermics Inc.
TSRL Inc
Vaxess Technologies
PFIZER, INC.
MERCK & CO. INC.
For more information about this report visit https://www.researchandmarkets.com/r/nakyio
About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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Alexandria, MN (56308) Today
Partly cloudy this morning. Increasing clouds with periods of showers this afternoon. High 59F. Winds WSW at 15 to 25 mph. Chance of rain 60%..
Periods of rain. Low 43F. Winds W at 10 to 15 mph. Chance of rain 90%. Rainfall near a quarter of an inch.
Updated: May 3, 2024 @ 11:28 am
Geneva (Precision Vaccinations News)
Over the past few years, significant media attention has been paid to detecting avian influenza (bird flu). While the overall human health risk is being evaluated, the World Health Organization (WHO) recently sharedclarifying data points.
During 2020, highly pathogenic avian influenza (HPAI) A(H5N1) clade 2.3.4.4b viruses arose from previously circulating influenza A(H5Nx) viruses. They spread predominantly via migratory birds to many parts of Africa, Asia, and Europe.
In late 2021, these bird flu viruses crossed to North America and, in late 2022, to South America.
According to the WHOstatement on April 26, 2024, the epizootic has led to unprecedented deaths in wild birds, domestic poultry, and various mammals such as bears.
The WHO has confirmed that relatively few human infections have been reported despite the high number of A(H5N1) clade 2.3.4.4b detections.
Since the beginning of 2021, 28 A(H5N1) detections in humans have been reported to the WHO.
Of the 28 human cases,all were sporadic infections in people exposed to A(H5N1) viruses through direct or indirect contact with infected birds, infected mammals, or contaminated environments, such as live poultry markets or other premises with infected animals.
Specifically, no human-to-human transmission has been reported in these cases.
However, active investigations are continuingto determine whether there is any.
Most A(H5N1) human cases reported in Europe and North America were asymptomatic or mild, with fatigue reported for the cases detected in the U.S.
On April 1, 2024, the Texas Department of State Health Servicesreported the first confirmed human case ofA(H5N1) virus in Texas. This person successfully recovered.
Based on available information, the WHO currently assesses the overall public health risk posed by A(H5N1) to be low. For those exposed to infected birds or animals or contaminated environments, the risk of infection is considered low to moderate.
Furthermore, investigations are ongoing to understand the risk to humans from consuming milk contaminated with the A(H5N1) virus. According to the WHO, dangerous zoonotic pathogens can be transmitted through unpasteurized milk.
As investigations continue in the U.S. and elsewhere, more information regarding 'contaminated cow milk' will be available in the coming days and weeks.
Historically, the U.S. CDChas advised against consuming un-cooked birds and mammals infected with avian influenza viruses.
The good news is that the U.S. FDA has already approved one bird flu vaccine (Audenz).
Asof April 28, 2024, the government has invested hundreds of millions in additional avian influenza vaccine candidate production. In late 2023, about 32 million bird flu vaccines were available in the U.S. National Strategic Stockpile.
An RNA-based vaccine approach that is effective against all virus strains and safe for infants and immunocompromised individuals.
Whether its the annual flu shot or the COVID-19 boosters, vaccines against viruses require constant tweaking and a bit of luck. Every year scientists estimate which influenza strains to include in the annual shot and COVID-19 is constantly monitored for new strains.
A new strategy toward a universal vaccine, which activates an ancient pathway of the immune system, could finally put an end to the chasing and guess work.
All vaccines work by stimulating the human immune system, but rather than pre-expose the immune system to a specific viral strain, the new shot is based on a piece of a viruss genome common to all strains. It is broadly applicable to any number of viruses, broadly effective against any variant of a virus, and safe for a broad spectrum of people, explained UC-Riverside virologist Rong Hai in a press release regarding a new universal vaccine.
Their strategy differs from traditional vaccines in that it doesnt use inactive viral proteins that provoke immune cells known as T-cells and create memory B-cells that recognize that specific protein in future infections.
Instead, the team is targeting another defense mechanism called short interfering RNAs or RNAi. A host a person, a mouse, anyone infected will produce small interfering RNAs as an immune response to viral infection. These RNAi then [inactivate the virus genes], said Shouwei Ding, lead author of the paper. This controls the copying of viral DNA or RNA, stopping the virus from assembling new particles to further the infection.
Unfortuntaly, many viruses produce proteins to counter this defence. However, in the current study, when the team mutated a virus to eliminate this counterattack, the weakened virus could behave as a vaccine, stimulating and boosting the hosts RNAi response.
To test the effectiveness, mice without T or B cells were given one injection of the new vaccine against a test virus called the Nodamura virus. The single jab protected the mice from a lethal dose of the virus for up to 90 days.
Targeting the RNAi system has the added potential benefit of working in a broader range of individuals. Newborns and immunocompromised people, who generally have underdeveloped or dysfunctional immune systems, also make RNAis, meaning the vaccine could protect groups who cannot receive traditional vaccines, which typically rely on a fully functional immune system to work.
When tested with newborn mice, the vaccine was again effective. Thats why our next step is to use this same concept to generate a flu vaccine, so infants can be protected, said Ding.
According to Hai, viruses will likely have a hard time adapting to these vaccine, meaning updated boosters will be a thing of the past. Viruses may mutate in regions not targeted by traditional vaccines, he said. However, we are targeting their whole genome with thousands of small RNAs. They cannot escape this.
The team is working on a nasal spray delviery system to make it easier to adminster, and they believe the same strategy could work against several viruses with no current vaccines, such as dengue or SARS. This should be applicable to these viruses in an easy transfer of knowledge, said Ding.
Reference: Gang Chen, et al., Live-attenuated virus vaccine defective in RNAi suppression induces rapid protection in neonatal and adult mice lacking mature B and T cells, Proceedings of the National Academy of Sciences (2024). DOI: 10.1073/pnas.2321170121
Feature image credit: Mathurin NAPOLY / matnapo on Unsplash
In the first half of 2023, COVID-19 killed 42,670 people in the United States, while the flu killed about half that amount. Yet half as many people received the updated COVID booster as those who got the flu shoteven though COVID is twice as deadly as influenza.
In all, around 22% of people have received the new COVID booster, while 47% of people have had a flu vaccine. Experts said much of that COVID-shot resistance is due to the continued polarizing nature of the pandemic and of the COVID vaccine, which has been shown to reduce the risk for long COVID as well as serious acute viral infections and deaths.
"COVID shots are controversial and polarizing, whereas flu shots (for the most part) are not. The decision to get or not get a flu shot is made calmly," said Peter M. Sandman, PhD, an expert in risk communication who writes about COVID risks and our responses to them. Head over to Medscape to read the full story.
The federal government says it has taken steps toward developing a vaccine to protect against bird flu should it become a threat to humans. skodonnell/Getty Images hide caption
The federal government says it has taken steps toward developing a vaccine to protect against bird flu should it become a threat to humans.
The bird flu that's now spreading among cows doesn't yet appear to pose an imminent threat to most people. Scientists say the virus would need to mutate significantly to be able to transmit easily from human to human.
But federal health officials say they've started trying to develop a vaccine to protect people just in case a pandemic erupts.
"We've got some preparedness pieces in place that will give us a head start should we need a large-scale vaccination campaign in a pandemic situation," Dawn O'Connell, the assistant secretary for preparedness and response at the Health and Human Services Department, told NPR in an interview this week.
That includes two vaccines made from older, but similar strains of the virus that early testing indicates could protect people, O'Connell said. The government also has stocks of adjuvant, a substance that is used to increase a vaccine's effectiveness, O'Connell said.
"We actually have manufactured small lots of both of the candidates. So we have some to the tune of hundreds of thousands in prefilled syringes and in vials that could be deployed fairly quickly," she said.
The government also has the raw material to make 10 million additional doses within weeks, plus another 125 million doses within about four months, she said.
"You could imagine getting that first 100 million doses is going to be really important and is going to give us a good head start and then we would lean into the manufacturing from there to continue to ramp up," she said.
Assistant Health and Human Services Secretary for Preparedness and Response Dawn O'Connell. JIM WATSON/AFP via Getty Images hide caption
Assistant Health and Human Services Secretary for Preparedness and Response Dawn O'Connell.
No one knows how much of a risk the bird flu poses of causing a human epidemic, and so a vaccine may not become necessary.
Some outside experts agree the U.S. is well prepared to produce a vaccine. But some infectious disease specialists are skeptical about the nation's preparedness for this potential threat.
"The first thing we have to do is eliminate the happy talk," said Michael Osterholm, who runs the Center for Infectious Disease Research and Policy and the University of Minnesota.
"I think estimates of stockpiles that currently exist and the potential to use them should this emerge into a human pathogen where it's transmitted by humans to humans, have unfortunately been overstated," Osterholm said.
For example, not enough testing has been done yet to know how well the two candidate vaccines would really work, especially since the virus would have likely changed if it becomes a real threat to people, Osterholm said.
"I don't have a lot of faith that those vaccines will offer a great deal of protection," he said.
And even if an effective vaccine was available, most flu vaccines are still produced with old-fashioned technology that relies on growing virus in eggs this can take months to make enough and can be unpredictable. The country would need more than 600 million doses because everyone would need two shots.
"Given those limitations, I think it's really critical for the federal government to take a much more aggressive posture," said Luciana Borio, a senior fellow for global health at the Council on Foreign Relations. "We can't afford to falsely reassure ourselves. We need to be more humble."
Borio and others argued the federal government's overly optimistic assessments are sending the wrong message to the public and to Congress, which would have to provide funding to really ramp up vaccine production.
"I do not think we are ready with our vaccine enterprise to be able to respond fast enough," said Rick Bright, who until 2020 worked at the Biomedical Advanced Research and Development Authority, or BARDA, a federal agency involved in pandemic research.
"There's a lot of gaps in our preparedness response. We don't have prioritization strategy on who to vaccinate first. We don't have distribution plan in place if we need to distribute vaccines," he said. "So there's a lot of work that needs to be done."
Bright thinks the government should develop a vaccine based on the strain of the virus that recently ratcheted up alarm when it infected a dairy worker in Texas.
"When we're starting with candidate vaccines that are from viruses in 2020 we're already perhaps four years behind the evolution of the virus," Bright said. "I would update those candidate vaccine viruses while we have the time."
The government should also start funding mRNA vaccine development directly, Bright said.
Bright, Osterholm, Borio and others worry that the response illustrates how little the country has learned from previous pandemics like COVID.
"It does feel like Ground Hog Day," said Jennifer Nuzzo, who heads Brown University's Pandemic Center. "We still seem to be stuck in reactive mode. We shouldn't be waiting for evidence that the virus is devastating us. We should be trying to act now to prevent the virus from devastating us."
In the interview with NPR, O'Connell of HHS acknowledged that the country could face problems developing and distributing a vaccine. But she stressed that beyond additional testing of one of the vaccine candidates, drug companies are also developing mRNA vaccines. The federal government is in talks to help with that too, she said.
"While we have a head start and we're not starting flat-footed as we did with COVID, that doesn't mean this is going to be simple and this is going to be easy," she said. "But I am pleased we have some tools to leverage."
In the short term, Nuzzo thinks the country should start vaccinating dairy workers as soon as possible.
"We need to protect farm workers and those exposed to raw milk," said Nuzzo.
That would protect workers' health and possibly help reduce the chances the virus would evolve to spread more easily among people, Nuzzo said.
During a briefing for reporters Wednesday, Vivien Dugan, director of the influenza division at the Centers for Disease Control and Prevention, said dairy worker vaccination might begin if any worrisome new changes are detected about the virus, such as changes in its genetic code.
Nuzzo and others said they are alarmed by the dearth of information being released by the federal government about the status of vaccine development and other important issues related to the virus.
"I wish there would be more transparency about what's going on because ultimately if we're ever going to ask people to use vaccines they need to understand the process by which they were generated so they can have confidence in that process. And we cannot do that at the last minute," Nuzzo said. "We saw the challenges of doing that in COVID and I do not want to see us do that again."
During Wednesday's briefing, David Boucher, who directs infectious disease preparedness for the federal Administration for Strategic Preparedness and Response, said two vaccine companies are already doing further testing of one of the two candidate vaccines.
The U.S. has two vaccines ready should the strain of bird flu circulating in dairy cows begin spreading easily to people, federal health officials said Wednesday. They could begin shipping doses widely within weeks, if needed.
So far, theres no evidence that H5N1 is spreading person-to-person, although one dairy worker in Texas who worked closely with infected cattle had a mild infection and developed conjunctivitis, or pinkeye, in April.
At a briefing Wednesday, government health officials said they are preparing for a potential scenario of H5N1 jumping from animal to person or person to person. The virus has taken off in dairy cows, infecting at least 36 herds across nine states, raising concerns that it could acquire mutations that would make it easier to spill over into humans.
Studies suggest that the vaccines will offer good cross-protection against cattle outbreak viruses, Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases, said on the call Wednesday.
Both of the vaccine candidates are already in the nations stockpile in limited quantities, officials said in a previous interview.
The Centers for Disease Control and Prevention also said Wednesday that it is testing blood samples from people previously vaccinated with an influenza vaccine to see if it generates an immune response, although it didnt say which vaccine.
Dawn OConnell, assistant secretary for preparedness and response at the Department of Health and Human Services, told NBC News earlier there are hundreds of thousands of prefilled syringes and vials ready to ship, if needed.
Weve been investing in a library of antigens to move out as quickly as possible should we begin to see a highly transmissible flu strain circulate, OConnell said.
H5N1 doesnt transmit easily between people, although global health officials remain concerned due to its high mortality rate, which hovers around 50%, according to the World Health Organization.
There are no signs the virus is mutating to be more transmissible between people, officials said Wednesday.
Vivien Dugan, who heads the CDC's influenza division, said that the government would begin looking at vaccination if there were alterations in the viruss genetic code that would affect its existing countermeasures. It currently has a number of antiviral medications in supply that target influenza viruses, including Tamiflu.
The people needing vaccination and the number of doses that the U.S. would require would hinge on how the virus changes and how widespread the outbreak becomes, experts say.
Right now, there are over 100 people, most of whom work with farm animals, being monitored for signs of infection, officials said.
Should the U.S. need the vaccines, the federal government could ship out hundreds of thousands of doses within a few weeks, OConnell said.
It could have over 100 million doses shipped within three to four months.
Health officials expect that people will need two doses of that vaccine, OConnell added, meaning 100 million doses is only enough for 50 million people.
Again, given this is a hypothetical, its possible the U.S. may not need that many vaccines. But it could also produce more, if needed, OConnell said.
They are produced using traditional vaccine technology that has been the standard approach to vaccines for decades. However, the process can take months.
OConnell said the U.S. is also pursuing a third vaccine based on the same mRNA-technology used in Pfizers and Modernas Covid vaccines. She added that an mRNA vaccine could be quicker to manufacture because you can switch in and switch out the genetic sequencing very easily.
All three vaccines would also need approval from the Food and Drug Administration before they can be distributed across the U.S.
In a statement, the FDA said it is actively engaged with other federal health agencies in assessing pandemic influenza vaccine candidates should the need for a vaccine arise.
Dr. William Schaffner, an infectious disease expert at the Vanderbilt University Medical Center, said having vaccine candidates on hand is important because it reduces the time needed to get the shots in peoples arms.
During the 2009 H1N1 swine flu pandemic, researchers eventually developed a vaccine to prevent the spread of the virus, but by the time the shots were manufactured and ready to be distributed, the outbreak had already petered out, he said.
Its very good that we have reduced the time necessary to create a vaccine by having candidates already available, should they be needed, he said.
Despite the government having two vaccine candidates, there are still a number of questions, including how much protection the shots would provide against infection and severe illness, said Dr. Judith ODonnell, director of infection prevention and control at Penn Presbyterian Medical Center in Philadelphia.
Theres a lot we dont know about these candidate vaccines and how theyll work, she said.
The U.S. has contracts with three manufacturers for pandemic influenza vaccines: GlaxoSmithKline, CSL Seqirus and Sanofi. One of the vaccine candidates is from CSL Sequirus.
A spokesperson for CSL Seqirus said the company has no data available on vaccine effectiveness because the number of human cases of H5N1 is too low for studies.
However, a phase 2 study testing a vaccine that targets a virus closely related to H5N1 shows that it generates a promising immune response and should cross-react with the H5N1 viruses currently circulating in cattle in the U.S, the spokesperson said.
OConnell said the government has a number of potential adjuvants, substances added to vaccines to boost the immune response, that could be used if needed.
During the pandemic, the virus was typically severe in older adults and people with underlying health conditions. However, the 2009 H1N1 swine flu virus disproportionately affected young people. Its unclear how this strain of H5N1 would affect people because human infections are rare.
ODonnell said that given the amount of vaccine skepticism, as well as vaccine fatigue from the pandemic, the government would also likely need to begin a vaccine campaign to persuade people to get vaccinated.
Its very disheartening to see so much vaccine skepticism and vaccine fatigue, she said.
Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
AstraZeneca has been embroiled in a class action lawsuit for its Covid-19 vaccine, admitting that the vaccine may cause incidences of thrombosis with thrombocytopenia syndrome (TTS).
As reported by The Telegraph on 28 April, the pharma giant wrote in a legal document submitted to the UK High Court in February, It is admitted that the AstraZeneca vaccine can, invery rarecases, cause TTS. The causal mechanism is not known. TTS is known to cause blood clots and low blood platelet counts.
A total of 51 cases have been filed in the High Court by victims and their families, with The Telegraph reporting that the plaintiffs are seeking compensation valued at approximately GBP 100m.
The vaccine, sold under brand names Covishield and Vaxzevria, has previously been linked to a risk of blood clots. In April 2021, the European Medicines Agencys (EMA) safety committee reported that a jab of the vaccine was associated with blood clots in the brain, abdomen, and arteries as well as thrombocytopenia. At the time, the EMA and the UK Medicines and Healthcare products Regulatory Agency (MHRA) declared that the benefits of the vaccine outweighed the potential risks and encouraged people to get vaccinated.
In a November 2021 press release, AstraZeneca reported that two billion doses of its vaccine were supplied to countries across the world less than 12 months after the first approval. The pharma giant also saw profits from its Covid-19 vaccine for the first time in 2022 and reported that it had delivered approximately 102 million doses of its vaccine through COVAX in Q4 2022.
AstraZenecas admission follows a year of legal battles for the lawsuit that alleges that the vaccine caused death and serious injury in multiple instances. According to The Telegraph, the first case was filed in 2023 when a patient reported that the vaccination left him with a permanent brain injury that developed from a blood clot and a bleed in the brain.
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As per a 29 April coroners report from the UK Courts and Tribunals Judiciary, the death of a 28-year-old patient is the latest case to associate blood clot side effects to AstraZenecas vaccine. The report concluded that the patient died from cerebral venous sinus thrombosis and Covid-19 vaccine-induced immune thrombotic thrombocytopenia.
This is not the first time in recent months that AstraZeneca has been embattled with lawsuits. In October 2023, the company paid $425m (352.37m) to settle lawsuits that claimed its heartburn medications, Nexium (esomeprazole) and Prilosec (omeprazole), caused chronic kidney disease.
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Last week, Moderna and Merck launched a large clinical trial in the UK of a promising new cancer therapy: a personalized vaccine that targets a specific set of mutations found in each individuals tumor. This study is enrolling patients with melanoma. But the companies have also launched a phase III trial for lung cancer. And earlier this month BioNTech and Genentech announced that a personalized vaccine they developed in collaboration shows promise in pancreatic cancer, which has a notoriously poor survival rate.
Drug developers have been working for decades on vaccines to help the bodys immune system fight cancer, without much success. But promising results in the past year suggest that the strategy may be reaching a turning point. Will these therapies finally live up to their promise?
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This week in The Checkup, lets talk cancer vaccines. (And, you guessed it, mRNA.)
Long before companies leveraged mRNA to fight covid, they were developing mRNA vaccines to combat cancer. BioNTech delivered its first mRNA vaccines to people with treatment-resistant melanoma nearly a decade ago. But when the pandemic hit, development of mRNA vaccines jumped into warp drive. Now dozens of trials are underway to test whether these shots can transform cancer the way they did covid.
Recent news has some experts cautiously optimistic. In December, Merck and Moderna announced results from an earlier trial that included 150 people with melanoma who had undergone surgery to have their cancer removed. Doctors administered nine doses of the vaccine over about six months, as well as whats known as an immune checkpoint inhibitor. After three years of follow-up, the combination had cut the risk of recurrence or death by almost half compared with the checkpoint inhibitor alone.
The new results reported by BioNTech and Genentech, from a small trial of 16 patients with pancreatic cancer, are equally exciting. After surgery to remove the cancer, the participants received immunotherapy, followed by the cancer vaccine and a standard chemotherapy regimen. Half of them responded to the vaccine, and three years after treatment, six of those people still had not had a recurrence of their cancer. The other two had relapsed. Of the eight participants who did not respond to the vaccine, seven had relapsed. Some of these patients might not have responded because they lacked a spleen, which plays an important role in the immune system. The organ was removed as part of their cancer treatment.
The hope is that the strategy will work in many different kinds of cancer. In addition to pancreatic cancer, BioNTechs personalized vaccine is being tested in colorectal cancer, melanoma, and metastatic cancers.
The purpose of a cancer vaccine is to train the immune system to better recognize malignant cells, so it can destroy them. The immune system has the capacity to clear cancer cells if it can find them. But tumors are slippery. They can hide in plain sight and employ all sorts of tricks to evade our immune defenses. And cancer cells often look like the bodys own cells because, well, they are the bodys own cells.
There are differences between cancer cells and healthy cells, however. Cancer cells acquire mutations that help them grow and survive, and some of those mutations give rise to proteins that stud the surface of the cellso-called neoantigens.
Personalized cancer vaccines like the ones Moderna and BioNTech are developing are tailored to each patients particular cancer. The researchers collect a piece of the patients tumor and a sample of healthy cells. They sequence these two samples and compare them in order to identify mutations that are specific to the tumor. Those mutations are then fed into an AI algorithm that selects those most likely to elicit an immune response. Together these neoantigens form a kind of police sketch of the tumor, a rough picture that helps the immune system recognize cancerous cells.
A lot of immunotherapies stimulate the immune response in a nonspecific waythat is, not directly against the cancer, said Patrick Ott, director of the Center for Personal Cancer Vaccines at the Dana-Farber Cancer Institute, in a 2022 interview. Personalized cancer vaccines can direct the immune response to exactly where it needs to be.
How many neoantigens do you need to create that sketch? We dont really know what the magical number is, says Michelle Brown, vice president of individualized neoantigen therapy at Moderna. Modernas vaccine has 34. It comes down to what we could fit on the mRNA strand, and it gives us multiple shots to ensure that the immune system is stimulated in the right way, she says. BioNTech is using 20.
The neoantigens are put on an mRNA strand and injected into the patient. From there, they are taken up by cells and translated into proteins, and those proteins are expressed on the cells surface, raising an immune response
mRNA isnt the only way to teach the immune system to recognize neoantigens. Researchers are also delivering neoantigens as DNA, as peptides, or via immune cells or viral vectors. And many companies are working on off the shelf cancer vaccines that arent personalized, which would save time and expense. Out of about 400 ongoing clinical trials assessing cancer vaccines last fall, roughly 50 included personalized vaccines.
Theres no guarantee any of these strategies will pan out. Even if they do, success in one type of cancer doesnt automatically mean success against all. Plenty of cancer therapies have shown enormous promise initially, only to fail when theyre moved into large clinical trials.
But the burst of renewed interest and activity around cancer vaccines is encouraging. And personalized vaccines might have a shot at succeeding where others have failed. The strategy makes sense for a lot of different tumor types and a lot of different settings, Brown says. With this technology, we really have a lot of aspirations.
mRNA vaccines transformed the pandemic. But they can do so much more. In this feature from 2023, Jessica Hamzelou covered the myriad other uses of these shots, including fighting cancer.
This article from 2020 covers some of the background on BioNTechs efforts to develop personalized cancer vaccines. Adam Piore had the story.
Years before the pandemic, Emily Mullin wrote about early efforts to develop personalized cancer vaccinesthe promise and the pitfalls.
Yes, theres bird flu in the nations milk supply. About one in five samples had evidence of the H5N1 virus. But new testing by the FDA suggests that the virus is unable to replicate. Pasteurization works! (NYT)
Studies in which volunteers are deliberately infected with covidso-called challenge trialshave been floated as a way to test drugs and vaccines, and even to learn more about the virus. But it turns out its tougher to infect people than you might think. (Nature)
When should women get their first mammogram to screen for breast cancer? Its a matter of hot debate. In 2009, an expert panel raised the age from 40 to 50. This week they lowered it to 40 again in response to rising cancer rates among younger women. Women with an average risk of breast cancer should get screened every two years, the panel says. (NYT)
Wastewater surveillance helped us track covid. Why not H5N1? A team of researchers from New York argues it might be our best tool for monitoring the spread of this virus. (Stat)
Long read: This story looks at how AI could help us better understand how babies learn language, and focuses on the lab I covered in this story about an AI model trained on the sights and sounds experienced by a single baby. (NYT)
