Category: Vaccine

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.

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Your download email will arrive shortly

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

Country * UK USA Afghanistan land Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Cte d"Ivoire Croatia Cuba Curaao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Runion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo

Industry * Academia & Education Aerospace, Defense & Security Agriculture Asset Management Automotive Banking & Payments Chemicals Construction Consumer Foodservice Government, trade bodies and NGOs Health & Fitness Hospitals & Healthcare HR, Staffing & Recruitment Insurance Investment Banking Legal Services Management Consulting Marketing & Advertising Media & Publishing Medical Devices Mining Oil & Gas Packaging Pharmaceuticals Power & Utilities Private Equity Real Estate Retail Sport Technology Telecom Transportation & Logistics Travel, Tourism & Hospitality Venture Capital

Tick here to opt out of curated industry news, reports, and event updates from Pharmaceutical Technology.

Submit and download

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.

Give your business an edge with our leading industry insights.

Continued here:

AstraZeneca admits Covid-19 vaccine may cause blood clots in very rare cases - Pharmaceutical Technology

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.

Read more:

Two possible bird flu vaccines could be available within weeks, if needed - NBC News

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 rest is here:

Could the U.S. produce an effective bird flu vaccine for humans, if needed? : Shots - Health News - NPR

With Modernas COVID-19 sales on the backfoot following the switch to an endemic vaccine market, the Massachusetts-based biopharma is busy laying the groundwork for its next potential mRNA shot in respiratory syncytial virus (RSV). And despite a head start in the field by competitors GSK and Pfizer, Moderna remains confident that its vaccine candidate, mRNA-1345, will still have a niche to fill.

Moderna currently expects initial approvals of its RSV vaccine to start rolling in during the first half of 2024, the company said in a press release. In turn, the company is eyeing a potential U.S. launch in the fall, which would capitalize on its established commercial efforts in the seasonal COVID-19 immunization market, Moderna explained.

RSV is a seasonal cold virus, but one that can cause severe breathing problems and pneumonia in the elderly, the very young and the immunocompromised.

With mRNA-1345s potential approval, Moderna would be wading into a fierce vaccine war already brewing between GSK and Pfizer, which won historic nods for their own RSV shots last May and have both already been raking in sales.

That said, Modernas mRNA vaccineif approvedwould be the only shot on the market in a pre-filled syringe, which could offer a potential convenience edge over its competitors, the companys CEO, Stphane Bancel, said on a call with investors Thursday.

By removing preparation steps before administering its vaccine, Moderna is hoping to ease the burden on pharmacists and clinicians and potentially alleviate wait times for patients, too. The companys own research has found that the prefilled presentation of its shot was three to four times more efficient than vaccines requiring reconstitution, Moderna explained in its release.

As the company prepares for its expected RSV rollout, Modernas medical team has been working with pharmacies and hospital networks literally on a daily basis to help spread the word about its vaccine candidates safety and efficacy profile, as well as the potential benefits of its prefilled syringe formulation, Bancel said.

Meanwhile, the company also feels its data package should help level the playing field by supporting a parity recommendation from the CDCs Advisory Committee on Immunization Practices (ACIP) post-approval, Moderna president Stephen Hogue said on the investor call.

Although Moderna expects its RSV vaccine to be a key revenue contributor moving forward, the company has yet to release guidance around potential sales of mRNA-1345, the companys chief financial officer, Jamey Mock, said.

Moderna touched on its RSV launch plans as it reported $167 million in first-quarter sales for the year, down a whopping 91% from the $1.9 billion it generated over the same stretch in 2023 when the company was still profiting off delivered doses deferred from 2022.

Nevertheless, the sharp decline in COVID-19 vaccine sales was to be expected and Modernas sales haul for the quarter still managed to come out ahead of consensus expectations of $93 million, William Blair analysts Myles Minter and Sarah Schram wrote in a note to clients Thursday.

The analysts called the sales decline unsurprising thanks to the market shift from pandemic to endemic and declines in previously expected vaccination rates.

Further, Modernas reported net loss of $1.2 billion in the quarter proved less severe than expected, the William Blair team added, crediting Moderna for its cost-saving efforts and reduced operating expenses.

For the COVID-19 vaccine business, Moderna is now taking a regional approach, Bancel told investors. In the U.S., the company is working with public health officials, healthcare providers and pharmacies to increase vaccination coverage rates across the country, the CEO explained.

Over in Europe, meanwhile, the company is actively engaged in a 2024 tender program that could see Moderna deliver millions of doses annually for up to four years, Bancel added.

And as for the rest of the world, Moderna is overhauling its commercial teams to help prioritize markets that provide greater commercial focus and impact, he explained. Bancel pointed to the companys recent agreement to provide Brazil with 12.5 million doses of its COVID shot Spikevax in the second quarter as a prime example of that strategy.

Looking ahead, the company reaffirmed its expectation to generate roughly $4 billion in 2024. That sum will likely represent a low point for the company ahead of a planned return to growth in 2025, Modernas CFO Mock said.

Read more:

Moderna gears up for potential RSV vaccine launch this fall after better-than-expected first quarter - FiercePharma

This article first appeared in The Checkup,MIT Technology Reviewsweekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first,sign up here.

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?

Dont settle for half the story. Get paywall-free access to technology news for the here and now.

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)

More here:

Cancer vaccines are having a renaissance - MIT Technology Review

Play Video

In a first-ever human clinical trial of four adult patients, an mRNA cancer vaccine developed at the University of Florida quickly reprogrammed the immune system to attack glioblastoma, the most aggressive and lethal brain tumor.

The results mirror those in 10 pet dog patients suffering from naturally occurring brain tumors whose owners approved of their participation, as they had no other treatment options, as well as results from preclinical mouse models. The breakthrough now will be tested in a Phase 1 pediatric clinical trial for brain cancer.

Reported May 1 in the journal Cell, the discovery represents a potential new way to recruit the immune system to fight notoriously treatment-resistant cancers using an iteration of mRNA technology and lipid nanoparticles, similar to COVID-19 vaccines, but with two key differences: use of a patients own tumor cells to create a personalized vaccine, and a newly engineered complex delivery mechanism within the vaccine.

Instead of us injecting single particles, were injecting clusters of particles that are wrapping around each other like onions, like a bag full of onions, said senior author Elias Sayour, M.D., Ph.D., a UF Health pediatric oncologist who pioneered the new vaccine, which like other immunotherapies attempts to educate the immune system that a tumor is foreign. And the reason weve done that in the context of cancer is these clusters alert the immune system in a much more profound way than single particles would.

Among the most impressive findings was how quickly the new method, delivered intravenously, spurred a vigorous immune-system response to reject the tumor, said Sayour, principal investigator of the RNA Engineering Laboratory within UFs Preston A. Wells Jr. Center for Brain Tumor Therapy and a UF Health Cancer Center and McKnight Brain Institute investigator who led the multi-institution research team.

In less than 48 hours, we could see these tumors shifting from what we refer to as cold immune cold, very few immune cells, very silenced immune response to hot, very active immune response, he said. That was very surprising given how quick this happened, and what that told us is we were able to activate the early part of the immune system very rapidly against these cancers, and thats critical to unlock the later effects of the immune response.

Glioblastoma is among the most devastating diagnoses, with median survival around 15 months. Current standard of care involves surgery, radiation and some combination of chemotherapy.

The new publication is the culmination of promising translational results over seven years of studies, starting in preclinical mouse models and then in a clinical trial of 10 pet dogs that had spontaneously developed terminal brain cancer and had no other treatment options. That trial was conducted with owners consent in collaboration with the UF College of Veterinary Medicine. Dogs offer a naturally occurring model for malignant glioma because they are the only other species that develops spontaneous brain tumors with some frequency, said Sheila Carrera-Justiz, D.V.M., a veterinary neurologist at the UF College of Veterinary Medicine who is partnering with Sayour on the clinical trials. Gliomas in dogs are universally terminal, she said.

After treating pet dogs that had spontaneously developed brain cancer with personalized mRNA vaccines, Sayours team advanced the research to a small Food and Drug Administration-approved clinical trial designed to ensure safety and test feasibility before expanding to a larger trial.

In a cohort of four patients, genetic material called RNA was extracted from each patients own surgically removed tumor, and then messenger RNA, or mRNA the blueprint of what is inside every cell, including tumor cells was amplified and wrapped in the newly designed high-tech packaging of biocompatible lipid nanoparticles, to make tumor cells look like a dangerous virus when reinjected into the bloodstream and prompt an immune-system response. The vaccine was personalized to each patient with a goal of getting the most out of their unique immune system.

The demonstration that making an mRNA cancer vaccine in this fashion generates similar and strong responses across mice, pet dogs that have developed cancer spontaneously and human patients with brain cancer is a really important finding, because oftentimes we dont know how well the preclinical studies in animals are going to translate into similar responses in patients, said Duane Mitchell, M.D., Ph.D., director of the UF Clinical and Translational Science Institute and the UF Brain Tumor Immunotherapy Program and a co-author of the paper. And while mRNA vaccines and therapeutics are certainly a hot topic since the COVID pandemic, this is a novel and unique way of delivering the mRNA to generate these really significant and rapid immune responses that were seeing across animals and humans.

While too early in the trial to assess the clinical effects of the vaccine, the patients either lived disease-free longer than expected or survived longer than expected.

The 10 pet dogs lived a median of 139 days, compared with a median survival of 30 to 60 days typical for dogs with the condition.

The next step, through support from the Food and Drug Administration and the CureSearch for Childrens Cancer foundation, will be an expanded Phase I clinical trial to include up to 24 adult and pediatric patients to validate the findings. Once an optimal and safe dose is confirmed, an estimated 25 children would participate in Phase 2, said Sayour, an associate professor in the Lillian S. Wells Department of Neurosurgery and the department of pediatrics in the UF College of Medicine, part of UF Health.

For the new clinical trial, Sayours lab will partner with a multi-institution consortium, the Pediatric Neuro-Oncology Consortium, to send the immunotherapy treatment to childrens hospitals across the country. They will do this by receiving an individual patients tumor, manufacturing the personalized vaccine at UF and sending it back to the patients medical team, said Sayour, co-leader of the Immuno-Oncology and Microbiome research program at the UF Health Cancer Center.

Despite the promising results, the authors said one limitation is continued uncertainty about how best to harness the immune system while minimizing the potential for adverse side effects.

I am hopeful that this could be a new paradigm for how we treat patients, a new platform technology for how we can modulate the immune system, said Sayour, the Stop Children's Cancer/Bonnie R. Freeman Professor for Pediatric Oncology Research. I am hopeful for how this could now synergize with other immunotherapies and perhaps unlock those immunotherapies. We showed in this paper that you actually can have synergy with other types of immunotherapies, so maybe now we can have a combination approach of immunotherapy.

Sayour and Mitchell hold patents related to the vaccine which are under option to license by iOncologi Inc., a biotech company born as a spin out from UF in which Mitchell holds interest.

Read more from the original source:

New mRNA cancer vaccine triggers fierce immune response to fight malignant brain tumor - UF Health News

AstraZeneca, the company that sold the vaccination in India, acknowledged in court a day ago that the Covid injection can have an uncommon side effect. As a result, the parents of the woman who is said to have died after taking the vaccine have chosen to sue Serum Institute of India (SII). With the revelation of AstraZeneca's admission, the parents are optimistic of justice. The multinational pharmaceutical company is facing legal action from a class-action lawsuit alleging that the Covid-19 vaccine, which it co-developed with the University of Oxford, resulted in fatalities and severe injuries, including thrombosis with thrombocytopenia syndrome (TTS), a dangerous side effect that lowers platelet counts and causes blood clots. Karunya, the daughter of Venugopalan Govindan, passed away in July 2021 following her Covishield vaccination. Nonetheless, the government-appointed national committee found insufficient evidence to draw the conclusion that the vaccine was the cause of her death. This is the result of AstraZeneca's admission in court documents that a rare adverse effect of their vaccination could be reduced platelet count and blood clotting. AstraZeneca is being sued in a class-action case in the UK.

Expand

Read more:

After Covishield vaccine side effects disclosed, grieving parents move to court against Serum Institute o - The Times of India

Let me start with a disclaimer: The subject of todays newsletter will make some readers uncomfortable. It makes me a little uncomfortable.

The Times has just published an article about Americans who believe they suffered serious side effects from a Covid vaccine. More than 13,000 of them have filed vaccine-injury claims with the federal government.

My colleague Apoorva Mandavilli tells some of their stories in the article, including those of several people who work in medicine and science:

Ilka Warshawsky, a 58-year-old pathologist, said she lost all hearing in her right ear shortly after receiving a Covid booster shot.

Dr. Gregory Poland, 68 no less than the editor in chief of Vaccine, a scientific journal said that a loud whooshing sound in his ears had accompanied every moment since his first Covid shot.

Shaun Barcavage, 54, a nurse practitioner in New York City, has experienced a ringing sound in his ears, a racing heart and pain in his eyes, mouth and genitals for more than three years. I cant get the government to help me, Barcavage said. I am told Im not real.

This subject is uncomfortable because it feeds into false stories about the Covid vaccines that many Americans have come to believe namely, that the vaccines are ineffective or have side effects that exceed their benefits. Robert F. Kennedy Jr., the independent presidential candidate, has promoted these stories, as have some Republican politicians and conservative media figures. The scale of misinformation, Dr. Joshua Sharfstein of Johns Hopkins University told Apoorva, is staggering.

So let me be clear: The benefits of the Covid vaccines have far outweighed the downsides, according to a voluminous amount of data and scientific studies from around the world. In the U.S. alone, the vaccines have saved at least several hundred thousand lives and perhaps more than one million, studies estimate. Rates of death, hospitalization and serious illness have all been much higher among the unvaccinated than the vaccinated.

Here is data from the C.D.C., in a chart by my colleague Ashley Wu:

Not only are the vaccines benefits enormous, but the true toll of the side effects may be lower than the perceived toll: Experts told Apoorva that some people who believe Covid vaccines have harmed them are probably wrong about the cause of their problems.

We are having trouble retrieving the article content.

Please enable JavaScript in your browser settings.

Thank you for your patience while we verify access. If you are in Reader mode please exit andlog intoyour Times account, orsubscribefor all of The Times.

Thank you for your patience while we verify access.

Already a subscriber?Log in.

Want all of The Times?Subscribe.

More:

The Side Effects of Covid Vaccines - The New York Times

Whooping cough might sound like a Victorian disease, but the bacterial infection has made a dramatic comeback in recent months across Europe, Asia, and America.

The 100-day cough known clinically as pertussis infects the lungs and respiratory system, causing severe coughing fits and flu-like symptoms that can persist for months.

Complications are particularly severe in infants under six months, where the infection can develop into pneumonia, seizures and, in some cases, death. Babies who survive may have long-term neurological or lung damage.

Whooping cough is cyclical and naturally peaks every three-to-five years. It is also endemic to all regions of the planet, according to the World Health Organization (WHO), meaning it occurs naturally in populations.

A jab developed in the 1950s helped to almost eliminate the disease in Britain.

But a steady decline in vaccine uptake coupled with a resurgence of respiratory diseases following Covid lockdowns have contributed to rapidly rising case numbers with this year the worst on record since the mid-1980s.

In January and February alone, England recorded 1,468 cases compared to just 823 for the whole of 2023.

In the Czech Republic, cases are so widespread that criminal charges were filed against Pragues mayor, accusing him of allowing the infection to spread through reckless public health decisions. So far, the country has seen over 6,300 infections since January, and at least three infant deaths.

Parts of Asia are also struggling to contain the disease. In the Philippines, 54 babies have died this year, whilst in China, 30,000 have come down with the infection since January.

This outbreak is huge, and its not dissimilar to what we saw 40 years ago, explained Dr Paul Hunter, Professor of Medicine at the University of East Anglia.

When Covid hit, a lot of vaccination rates fell which is certainly contributing to what were seeing now worldwide, he said.

Health systems worldwide fell behind on routine jabs for preventable diseases during the Covid-19 years, with the largest sustained decline in childhood vaccinations in over three decades.

During that time, the WHO estimated around 25 million children missed out on doses of the pertussis vaccine, which is combined with the jab for polio, diphtheria, and hepatitis B in the UK.

Immunisation rates are still struggling to catch up, allowing communicable diseases to spread more quickly through populations. For instance, cases of measles have soared across the world to the point where more than half the planet is at high risk of an outbreak.

Another key problem is that vaccination uptake is steadily declining in pregnant women. If you vaccinate the mother, you protect the baby and they are the ones most at risk, said Dr Hunter.

Pregnant women need to be vaccinated to protect their newborns against whooping cough, because they cannot be jabbed themselves until they are two months old.

Mothers pass antibodies to their infants via the placenta, which in turn bridges the critical protection gap between birth and eight weeks the time when a child is most vulnerable to serious illness.

Babies born to women vaccinated at least a week before birth have a 91 per cent reduced risk of becoming ill with whooping cough in their first weeks of life, compared to babies whose mothers have not been vaccinated, according to the NHS.

But vaccine hesitancy influenced in part by disinformation on social media has meant uptake has fallen dramatically over the past ten or so years.

In Britain, around 70 per cent of pregnant women were jabbed for pertussis in 2017. But by 2023, that number dropped to around 58 per cent, according to the UK Health Security Agency.

Another key change, says Dr. Hunter, is the shift in the early 2010s from a whole-cell to an acellular vaccine for whooping cough.

In the past, pertussis vaccines were made using whole, inactivated Bordetella pertussis bacteria. These vaccines were highly effective but had some adverse side effects, including fever, mild allergic reactions, and in a very small number of babies, neurological damage although there is debate over whether the jab was responsible.

Starting in the early 2010s, many countries, including Britain, transitioned to using acellular pertussis vaccines. These jabs contain only specific proteins of the Bordetella pertussis bacterium. They cause fewer side effects, whilst still providing protection although it is slightly less effective.

There is certainly a view that, in part, the change in vaccine can explain the slight rise in cases beginning in the early 2010s, and could be playing a role in the current outbreaks, explained Dr Hunter.

Much is still to be understood about why whooping cough is on the rise this might be a one-off, and we could return to pre-Covid levels of the disease. But its also plausible that this is the future and that pertussis is here to stay, he added.

Protect yourself and your family by learning more about Global Health Security

Visit link:

The '100-day cough' can be lethal in babies so what is behind its global rise? - The Telegraph

By Cassidy Morrison Senior Health Reporter For Dailymail.Com 16:12 03 May 2024, updated 17:35 03 May 2024

Americans who claim they were badly injured by the Covid vaccines feel they are being ignored and gaslighted by the government.

Over 13,000 formal complaints about adverse reactions to the shots have been filedsince 2021 - but only 19 percent have been reviewed.

And just 12 patients have been compensated at an average of about $3,600, a figure which some have called insultingly low given the debilitating health issues they have been left with.

Experts say that researchers who've tried to investigate the little-understood side effect profile of Covid vaccines have been blocked by government officials and scientists who fear that even entertaining the possibility that vaccines can cause harm would fuel the anti-vax, which become bigger and louder during the pandemic.

Still, people are suffering from a range of conditions that came on soon after getting their first shot, including brain damage, tinnitus, neurological syndromes, facial paralysis, heart trouble, and shingles.

Unlike several countries like Australia, Canada, and Denmark, which have centralized health records compiled on a single database, the US has no such thing, leaving scientists to sift through reports of mild to severe side effects, of which there are more than four million lodged to the CDCs voluntary adverse reporting website.

Before Michelle Zimmerman, 37, had to say goodbye to her career as a neuroscientist, her regular 20-mile bike rides, and her lectures on the latest in AI, she had received the Johnson & Johnson vaccine in 2021.

No longer able to stand up on her own for long periods of time, and eventually diagnosed with brain damage, Dr Zimmerman had to move back in with her parents. She is convinced the vaccine she got came from a contaminated batch.

She told the New York Times: When I let myself think about the devastation of what this has done to my life, and how much Ive lost, sometimes it feels even too hard to comprehend.

Dr Zimmerman submitted her application for the Covid vaccine compensation program in October 2021, but it took two years for that claim to be acknowledged by the federal government. She has yet to receive any help from government officials.

She is far from the only one who has submitted such a claim. The Health Resources and Services Administrations Countermeasures Injury Compensation Program (CICP), 13,116 claims have been filed, of which more than 10,000 are still in review.

Twelve claims have been compensated at an average of about $3,600. This is because the office recognizes so few side effects as stemming from the Covid vaccine.

Shaun Barcavage, a 54-year-old nurse practitioner in New York, said that merely standing up would make his heart race ever since he got his first Covid shot.

His symptoms suggested postural orthostatic tachycardia syndrome (POTS), a condition in which the body cannot regulate the flow of blood properly, causing lightheadedness, fainting, and rapid heartbeat.

POTS has been tenuously linked to the vaccines, but more often with Covid infection itself.

Mr Barcavage, who in his career has worked on clinical trials for both HIV and Covid, said: I cant get the government to help me. I am told Im not real. Im told Im rare. Im told Im coincidence.

And Dr Gregory Poland, 68, who edits the journal Vaccine, has had a loud whoosing sound in his ears accompany every single second since he got his shot, and now fears never having a silent moment again.

His colleagues at the CDC did not take on his pleas for further research into the post-vaccine phenomenon.

Covid vaccines from Pfizer and BioNTech as well as Johnson and Johnson which is no longer available have been credited with averted at least three million deaths in the US and around 20 million globally due to the virus.

But even the best vaccines are not perfect, and when given to more than 270 million Americans in nearly 677 million doses, adverse reactions are bound to crop up.

Scientists fear the minority of vaccine recipients who have experienced severe reactions that have upended their lives are being ignored by federal officials with the power to initiate and fund more research into the matter.

DrAkiko Iwasaki, an immunologist and vaccine expert at Yale University, said: 'At least long Covid has been somewhat recognized', added people complaining of post-vaccine injuries are 'just completely ignored and dismissed and gaslighted.'

Dr Janet Woodcock, who headed the FDA from January 2021 through February 2022 during a crucial time which which early vaccines and treatments were being reviewed, told the New York Times that she wished government officials would hear those people out.

She said: I feel bad for those people. I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously.

Im disappointed in myself. I did a lot of things I feel very good about, but this is one of the few things I feel I just didnt bring it home.

The understaffed office heading the complaints database has left suffering Americans feeling let down by what was meant to be a highly specific, high efficient means of recourse for Covid shot recipients.

Renee France, 49 of Seattle, developed a form of facial paralysis called Bells palsy causing one side of her face to droop, which can be a reaction to a viral infection as well as the flu vaccine. She also developed shingles that caused a severe rash that crossed her face and debilitated her for weeks.

She submitted her claim to the database two times but heard nothing back. Like many other patients, her doctor dismissed her fears that the symptoms were side effects of her Covid shot. People have complained of being brushed off and labeled anti-vax by family and friends, despite their support for vaccines.

Dr. Buddy Creech, 50, who led several Covid vaccine trials at Vanderbilt University and suffered tinnitus and racing heartbeat for about a week after each shot, said: When our patients experience a side effect that may or may not be related to the vaccine, we owe it to them to investigate that as completely as we can.

Countries that store patient data in a single place have conducted more extensive research into side effects simply because they can spot them easier.

The CDCs adverse events reporting system is voluntary, so anyone can file a report, and the reports are not verified by the agency as being true or unbiased.

In addition to poring over the CDC system, researchers have to sift through insurance claims, and even then there are gaps.

Shots given at mass vaccination sites that cropped up in parking lots across the country did not file vaccine claims with insurers.

Rebecca Chandler, a vaccine safety expert at the Coalition for Epidemic Preparedness Innovations, said: Its harder to see signals when you have so many people, and things are happening in different parts of the country, and theyre not all collected in the same system.

But in China, Europe, and Israel, scientists have actively sought out instances of adverse reactions, even mild ones, in order to study them further.

Patients with the condition appear to suffer from symptoms similar to 'Long Covid' - including persistent headaches, intense tiredness and abnormal heart rate and blood pressure.

The European Medicines Agency has uncovered and linked facial paralysis and numbness to the Pfizer and Moderna shots, which the US has not, despite there being nearly 3,000 reports of facial paralysis on the CDCs voluntary database.

And Israeli authorities were first to spot an unusual side effect in April 2021 primarily among young men after a second dose of a Pfizer or Moderna shot inflammation of the heart muscle, also known as myocarditis.

Meanwhile, the CDC maintained there was no strong link between heart inflammation and Covid vaccines. That continued until the agency decided the following May to investigate a smattering of reports of heart inflammation in teenagers that occurred just a few days after they got a dose of the Pfizer or Moderna vaccines.

But despite the 16,700 reports of tinnitus, the 9,000 reports of vertigo, the 7,000 reports of irregularly fast heart beat, the 3,800 reports of Bells palsy, or any of the other millions of adverse event reports submitted to the CDCs system, the NIH is not conducting thorough research into the matter.

Dr William Murphy, a cancer researcher of 12 years at the NIH who has been pushing for these investigations, said that officials told him the same hackneyed phrase he had been hearing for years: the virus is worse.

He said: Yes, the virus is worse, but that doesnt obviate doing research to make sure that there may be other options.

Go here to see the original:

Neurosurgeon, 37, and nurse, 54, claim they were left brain damaged and paralyzed from Covid vaccines - as the - Daily Mail