Latest news with #mRNA
Medscape
9 hours ago
- Health
- Medscape
FDA Approves Moderna's New COVID Vaccine With Restricted Use
The FDA has approved Moderna's new COVID-19 shot, an mRNA vaccine, with some limits on who can get it. The vaccine, called mNexspike, is for people who've previously received a COVID-19 shot and is mainly intended for adults ages 65 and older. People ages 12 to 64 may also get the shot if they have at least one medical condition that increases their risk for serious illness from COVID as defined by the CDC. COVID is caused by SARS-CoV-2 virus, which spreads from person to person and infects the airways. While some people may only have mild symptoms, older adults, or those with certain underlying health conditions such as heart disease, diabetes, obesity, cancer, or COPD, among other conditions, are at a higher risk for severe illness. Overall, COVID remains a serious health risk that caused over 47,000 deaths in the United States last year alone. Getting vaccinated is still one of the best ways to lower this risk, especially for those who are more likely to get seriously sick. Moderna said the FDA approved mNexspike based on results of a large study involving about 11,400 people ages 12 and older that showed it worked equally well and sometimes better than Spikevax, the original Moderna vaccine. The new shot showed about 9.3% better protection than Spikevax in people 12 and older and 13.5% better results in adults 65 and older. The mNexspike vaccine contains special genetic material (mRNA) that teaches the body to recognize parts of a key protein that helps the virus infect human cells. The new vaccine is based on the Omicron JN.1 COVID variant and helps your immune system make antibodies to protect you. Common side effects include pain, redness, or swelling from the injection, painfully swollen lymph nodes in the same arm, tiredness, headache, muscle or joint pain, chills, nausea, vomiting, and fever.
Medscape
19 hours ago
- Health
- Medscape
Will Federal Cuts Affect mRNA Cancer Vaccine Research?
If you've ever administered or received a COVID-19 vaccine, chances are it was based on messenger RNA (mRNA) technology — a medical breakthrough decades in the making and finally achieved thanks to the coordinated effort and enormous funding mobilized by the pandemic. The promise of mRNA vaccines is immense, researchers said. Several vaccines, including for influenza and respiratory syncytial virus, have been approved or are in the approval pipeline. Now the same technology is being tested in hundreds of clinical trials for conditions that include not only infectious diseases but also many kinds of cancer. And with the mRNA therapeutics market expected to grow to $30 billion by 2030, research momentum is strong — for now. But recent cuts in federal research grants and the current administration's skepticism about mRNA vaccines have raised concerns that mRNA studies, including for cancer vaccines, could stall just as these treatments are starting to reach patients. The Promise of mRNA Medicine for Cancer Every gene in your body encodes an mRNA. It sends genetic information from the cell nucleus to the cytoplasm, where proteins are created to carry out the cell's work. The lab-made mRNA used in vaccines tells the cell to make proteins that activate the desired response. The COVID-19 vaccine expresses COVID-19 genes, for instance, so the immune system learns to recognize and fight the virus. In cancer cases, immune cells (T-cells) must be activated against a tumor. Checkpoint modulators allow the T-cell to penetrate the tumor and destroy it. The first of these immunologic drugs was approved in 2011, and since then, they have revolutionized treatment for '20% of all advanced, deadly cancers,' effectively turning them into chronic diseases, said Elizabeth Jaffee, MD, PhD, deputy director of the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. But in the other 80% of cases, she said, the immune system fails to generate the T-cells needed because it doesn't recognize the tumor cells as abnormal. That's where mRNA could make a big impact. Researchers at Johns Hopkins and elsewhere have developed a personalized approach. First, they biopsy the tumor and sequence the sample's genome. Based on that, they design an mRNA vaccine, which is then injected into the patient to trigger T-cells that recognize the tumor as abnormal. With the help of a checkpoint modulator, the T-cells can then attack and destroy the tumor. The approach was tested at the Memorial Sloan Kettering Cancer Center, New York City, in an early clinical trial involving 16 patients with pancreatic cancer, which had a 5-year survival rate of 13%. Half of the participants received personalized mRNA vaccines, and the other half did not. '3 years later, the eight patients who got the vaccine appear to have disease-free survival,' Jaffee said. 'If we can push this vaccine method forward, we'll definitely have an effect on cancer.' Jaffee's team at Johns Hopkins is now conducting promising clinical trials on various gastrointestinal cancers — including colon cancer, gastric cancer, and a rare type of liver cancer. But Jaffee fears she could get an email saying her National Institutes of Health (NIH) grant will be cutoff within 24 hours. 'We'll have to tell the patients that day, 'Sorry, we no longer have the money to treat you.' That would be devastating.' She says her team stands to lose $20 million in NIH funding — a gap they can't replace with private grants. While the NIH hasn't officially pulled funding from mRNA research, scientists worry that it could be the next target in this year's wave of NIH cuts — concerns prompted in part by reports of funding cuts for vaccine hesitancy research and of NIH officials instructing scientists to scrub mRNA references from their grant applications. Robert F. Kennedy, Jr, 'has been a strong critic of mRNA, and under his leadership, there have been emails asking for names of scientists working on mRNA research,' said Jeff Coller, PhD, professor of RNA biology and therapeutics at Johns Hopkins. 'This has been a pattern over the last few months. So we're concerned, and the industry is concerned.' The Health and Human Services (HHS) Secretary has publicly expressed skepticism about vaccines, particularly the mRNA-based COVID-19 vaccines. In 2021, he described them as'the deadliest vaccine ever made.' That same year, the Children's Health Defense — a nonprofit organization that Kennedy founded and led before joining the Trump Administration — petitioned the US Food and Drug Administration (FDA) to rescind its authorization for the vaccines. Recently, the group has suggested a link between mRNA vaccines and cancer. Last week, the HHS canceled a nearly $600 million contract with mRNA vaccine maker Moderna for the development of its bird flu vaccine for humans. The FDA has not yet approved any cancer vaccines, but one for late-stage melanoma, currently in a phase 3 clinical trial, is getting closer. Some expect a successful trial will lead to FDA approval of the melanoma vaccine. But Drew Weissman, MD, PhD — who shared a Nobel Prize with Katalin Kariko, PhD, for the discoveries behind the COVID-19 vaccine — is less confident. As a vaccine researcher at the University of Pennsylvania, Philadelphia, leading a team of 80 scientists through dozens of trials, he worried that government skepticism could make FDA approval an uphill battle for his and others' mRNA research. Who Will Pay for Cancer Vaccines? The explosion in mRNA research has been funded by a mix of federal grants and private investment, with the government money aimed at basic research. The Defense Advanced Research Projects Agency had invested about $1 billion in mRNA research starting in 2012, said Andrew Geall, PhD, co-founder and chief development officer of Replicate Bioscience, an mRNA startup in San Diego. 'Most major pharmaceutical companies have made investments in mRNA technology,' said Geall. So have many venture capital firms. His own company, which was started in 2020, has received $53 million in private funding. This year, he said, Replicate Bioscience published phase 1 clinical trial data on its mRNA vaccine for rabies. Moderna, one of the two major makers of COVID-19 vaccines, has conducted clinical trials on mRNA treatments for solid tumors. BioNTech, which codeveloped the other leading COVID-19 vaccine with Pfizer, is working on melanoma research. And Roche and Genentech are supporting Memorial Sloan Kettering's research on pancreatic cancer. If NIH terminates mRNA grants, pharma companies and other US investors 'will probably pull back,' Geall said. That's because they rely on publicly funded research to share the costs — and risks — of their developments, he said. In fact, private investment is already slowing down, as companies hedge their bets against an expected cutoff of mRNA research funding, Geall said. 'If we need to do clinical trials, we're probably going to go abroad.' While most mRNA research is based in the United States, other countries are advancing studies of their own, poised to take the lead if the United States drops the ball. A recent poll showed that 75% of the US scientists will move abroad if their funding here is cutoff. Foreign regulators like the European Medicines Agency are gearing up to approve mRNA vaccines being developed in their countries. If scientists in other nations develop new mRNA vaccines before our scientists do, their people would likely have access to mRNA vaccines sooner than Americans. Whether any of this could delay US mRNA studies — and if so, for how long — remains unknown. After all, mRNA research is still happening in the United States, and with fruitful results. If federal support for mRNA studies is cutoff, the research won't stop — at least, not 'in Europe or China' or elsewhere, Weissman said. 'But it's going to stop in the US'
Daily Mail
a day ago
- Business
- Daily Mail
Pfizer CEO goes to war with RFK Jr over mRNA vaccines amid cancer link
They are two of the biggest rivals in the world of pharma. But the CEO of drug giant Pfizer has sprung to Moderna 's defense following the Trump administration's decision to cut its funding for the development of a bird flu vaccine. The company was told that the Health and Human Services Department (HHS) had withdrawn a $766million grant awarded by the Biden administration to pay for development and purchase of its experimental shot. The HHS said an investigation found the project did not meet the scientific standards or safety expectations required for continued federal investment, but there is a sense that it is part of the new health secretary RFK Jr's push towards an anti-vaccine agenda. Pfizer CEO Albert Bourla has slammed this decision and at a conference on Friday, he said that Moderna's new vaccine, called mRNA-1018, is 'extremely well tested [and] the science is proven.' Referencing the fact that there have been around 1.5 billion mRNA vaccine shots against Covid-19 administered worldwide from his company alone, Bourla said they were 'probably the most utilized vaccine[s] in the history of humanity'. And if vaccination rates decline, it 'will not take a long time' for diseases to return Using the technology pioneered during the Covid pandemic, mRNA-based vaccines have been tested as cancer treatments, with some promising early results. In one research paper out of Penn State College of Medicine, the scientists note: 'mRNA vaccines are an attractive and powerful immunotherapeutic platform against cancer because of their high potency, specificity, versatility, rapid and large-scale development capability, low-cost manufacturing potential, and safety.' Bourla says that Pfizer - which does not rely on government funding, with most of its cash from sales and partnerships - will continue its investment into vaccines. HHS boss Robert F. Kennedy Jr has expressed deep skepticism regarding jabs, including the Covid shots — despite real-world evidence they saved millions of lives. Bourla says that the issue with this and other changes to US health agency policies is that they are 'not based on any scientific data.... It's just based on a belief.' Despite fiction between the government and the drug companies over vaccines, Bourla says there are 'several topics' in the medical sphere that they do agree upon - with cancer being one of these. 'We are working to address those things as we agree to disagree on the things that divide us,' Bourla added on the subject. The mRNA bird flu vaccine is based on the same technology as Pfizer 's and Moderna's Covid vaccines. The vaccine contains mRNA, which acts like a set of instructions for the body. Cells read the mRNA and temporarily produce a harmless piece of the bird flu virus like a decoy. The immune system recognizes this protein as a threat and builds defenses against it. If a person is later exposed to bird flu, their immune system is already trained to fight it off. Researchers tested the vaccine on mice and ferrets and observed a strong immune response in the animals. It was hoped it would produce similar successful results in the late stage trial, which is now on hold. RFK Jr's move to cut Moderna's vaccine funding comes despite growing concerns about the H5N1 bird flu strain that is tearing through poultry and dairy farms in the US At least 70 people in the US have been sickened and one person died. Scientists fear that continued mutation of the virus could allow it to become more virulent or more easily spread in people, with the possibility that it could trigger a pandemic. Moderna received $176 million in July 2024 and was due to receive an extra $590m after the package was approved in January under Biden. The January award would have supported a late-stage clinical trial that could have determined the vaccine's efficacy against pandemic viruses, including bird flu. The shot had already been tested in 300 healthy adults to gauge its safety. A Moderna spokesman said at the time: 'While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis.' It's uncertain whether Moderna will continue developing its bird flu vaccine without government funding. Meanwhile, Pfizer recently made a breakthrough with one of its drugs called Braftovi. While the prescription medicine is traditionally used to treat adults with skin cancer in combination with another drug, in a clinical trial, it was also found to double the length of time patients with an aggressive form of colorectal cancer lived with treatment. Researchers found cancer patients lived for an average of 30 months on the drug compared with 15.
CNN
4 days ago
- Business
- CNN
Pfizer CEO: HHS claims of ‘concealed safety concerns' on mRNA vaccines are ‘completely inaccurate'
Pharmaceutical rivals don't often come to each other's defense. But after the US Department of Health and Human Services terminated a contract with drugmaker Moderna to develop an mRNA bird flu vaccine, claiming that 'mRNA technology remains under-tested,' Pfizer's chief executive is speaking up. 'MRNA probably is the most utilized vaccine in the history of humanity,' Pfizer CEO Dr. Albert Bourla said Friday, noting that there have been about 1.5 billion mRNA vaccine doses against Covid-19 administered worldwide from his company alone – not counting those from Moderna. 'So it is extremely well-tested.' HHS said Wednesday that it was canceling at least $590 million in federal funding the previous administration had granted for Moderna to use its mRNA technology to develop pandemic influenza vaccines, including those against H5 avian flu viruses. The H5N1 strain has infected at least 70 people and killed one in the US since last year. 'We concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable,' an HHS spokesperson said, claiming, 'the reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.' Asked his response to those comments, Bourla responded, 'both of them are completely inaccurate.' The pharma giant's chief spoke with CNN on Friday as Pfizer presented new data on a colorectal cancer drug at the American Society of Clinical Oncology, or ASCO, conference in Chicago, the world's largest meeting on cancer research. Pfizer's drug, Braftovi, was shown to double the length of time patients with an aggressive form of colorectal cancer lived with treatment: an average of 30 months compared with 15 in a clinical trial. It's a 'very, very important finding,' Bourla said, noting that colorectal cancer rates, 'particularly among younger people, are skyrocketing right now.' And while Pfizer is making big bets on cancer research, its CEO said he's not taking his foot off the pedal with investment in vaccines either, despite a 'very big gap' between the company and HHS – particularly Secretary Robert F. Kennedy Jr. – on their approaches to the subject. 'The science is proven,' Bourla said. 'The things they will do that will reduce, maybe, vaccination rates will come back and bite us.' Diseases will return, he said, and 'that will not take a long time.' Already, the US is experiencing one of its largest measles outbreaks since the disease was declared eliminated in this country in 2000, and rates of whooping cough, or pertussis, have increased as well. The recurrence of disease probably 'means that immediately they will have to reverse it,' Bourla said, suggesting that there will be public health efforts to increase vaccination rates in response, and 'they will go back to what every country in the world is doing.' Bourla worked with the first Trump administration to advance the company's Covid-19 vaccine through Operation Warp Speed in 2020, although he noted that Pfizer didn't accept federal funding to support vaccine development, only for the purchase of vaccines after the fact. He said that despite the gap on vaccines, 'when you speak with them, including Secretary Kennedy, I have found several topics that we are in, surprisingly, alignment.' Taking on cancer is one key area of agreement, according to the company. Bourla cited executive orders from President Donald Trump encompassing issues like addressing shorter market exclusivity for pills compared with injectable medicines under the Inflation Reduction Act – something the industry calls the 'pill penalty' – drug discounts to hospitals in a program known as 340B, and ratcheting up scrutiny on pharmacy benefit managers' role in drug pricing. 'We are working to address those things as we agree to disagree on the things that divide us,' Bourla said. He noted that he is against the administration's proposed 40% budget cut for the National Institutes of Health, emphasizing that the US is 'the dominant scientific force in biomedical sciences right now, and it is because we have created this ecosystem,' in which NIH funding supports academic research that can lead to new discoveries picked up by the pharmaceutical industry and made into medicines. 'If we break any link of this chain of this large ecosystem,' Bourla said, 'that's not good for us, and actually, it's a gift to our friends in China.' Bourla also took issue with HHS's actions on Covid-19 vaccines in the past two weeks: saying that the US Food and Drug Administration will change the way it approves updated shots for people who aren't in vulnerable groups and that the US Centers for Disease Control and Prevention will no longer recommend Covid-19 vaccines to healthy children and pregnant women. In previous years, Covid-19 vaccines had been updated in a similar way to seasonal flu shots, based on evidence that they generate an immune response; clinical trials that are required to show a vaccine's effect in preventing cases of disease are thought to take too long, potentially, to be feasible every season. What's more, the FDA and its advisers had previously deemed the vaccine updates small enough to not change their safety profile. Asked whether Pfizer would be able to run clinical trials quickly enough to make updated vaccines available to everyone, not just those in vulnerable groups, Bourla said, 'You are raising some very real concerns that we have.' Bourla noted that the implications of the Trump administration's changes to US health agency policies aren't entirely clear. But 'the issue is that that is not based on any scientific data. It's just based on a belief.' 'The appropriate process has not been followed; this is not just: the secretary or someone at a high level issues, let's say, a new rule,' he said. 'You need to follow a process which is reviews, experts, professional staff of FDA and all of that.' Dorit Reiss, a professor of law at UC Law San Francisco, suggested that HHS's 'bad administrative procedure' in announcing the updated CDC recommendations 'will be an issue' if they're challenged in court. Would Pfizer consider filing a lawsuit? 'My initial reaction is that I would prefer to find solutions but not create tensions,' Bourla replied. 'But of course, if we feel that we have to, we will.' Overall, the CEO emphasized that he has found the administration willing to engage in discussions, noting that 'we maintain a very, very close relationship' with the White House. 'I can't complain they don't listen to us,' Bourla said.
CNN
4 days ago
- Business
- CNN
Pfizer CEO: HHS claims of ‘concealed safety concerns' on mRNA vaccines are ‘completely inaccurate'
Pharmaceutical rivals don't often come to each other's defense. But after the US Department of Health and Human Services terminated a contract with drugmaker Moderna to develop an mRNA bird flu vaccine, claiming that 'mRNA technology remains under-tested,' Pfizer's chief executive is speaking up. 'MRNA probably is the most utilized vaccine in the history of humanity,' Pfizer CEO Dr. Albert Bourla said Friday, noting that there have been about 1.5 billion mRNA vaccine doses against Covid-19 administered worldwide from his company alone – not counting those from Moderna. 'So it is extremely well-tested.' HHS said Wednesday that it was canceling at least $590 million in federal funding the previous administration had granted for Moderna to use its mRNA technology to develop pandemic influenza vaccines, including those against H5 avian flu viruses. The H5N1 strain has infected at least 70 people and killed one in the US since last year. 'We concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable,' an HHS spokesperson said, claiming, 'the reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.' Asked his response to those comments, Bourla responded, 'both of them are completely inaccurate.' The pharma giant's chief spoke with CNN on Friday as Pfizer presented new data on a colorectal cancer drug at the American Society of Clinical Oncology, or ASCO, conference in Chicago, the world's largest meeting on cancer research. Pfizer's drug, Braftovi, was shown to double the length of time patients with an aggressive form of colorectal cancer lived with treatment: an average of 30 months compared with 15 in a clinical trial. It's a 'very, very important finding,' Bourla said, noting that colorectal cancer rates, 'particularly among younger people, are skyrocketing right now.' And while Pfizer is making big bets on cancer research, its CEO said he's not taking his foot off the pedal with investment in vaccines either, despite a 'very big gap' between the company and HHS – particularly Secretary Robert F. Kennedy Jr. – on their approaches to the subject. 'The science is proven,' Bourla said. 'The things they will do that will reduce, maybe, vaccination rates will come back and bite us.' Diseases will return, he said, and 'that will not take a long time.' Already, the US is experiencing one of its largest measles outbreaks since the disease was declared eliminated in this country in 2000, and rates of whooping cough, or pertussis, have increased as well. The recurrence of disease probably 'means that immediately they will have to reverse it,' Bourla said, suggesting that there will be public health efforts to increase vaccination rates in response, and 'they will go back to what every country in the world is doing.' Bourla worked with the first Trump administration to advance the company's Covid-19 vaccine through Operation Warp Speed in 2020, although he noted that Pfizer didn't accept federal funding to support vaccine development, only for the purchase of vaccines after the fact. He said that despite the gap on vaccines, 'when you speak with them, including Secretary Kennedy, I have found several topics that we are in, surprisingly, alignment.' Taking on cancer is one key area of agreement, according to the company. Bourla cited executive orders from President Donald Trump encompassing issues like addressing shorter market exclusivity for pills compared with injectable medicines under the Inflation Reduction Act – something the industry calls the 'pill penalty' – drug discounts to hospitals in a program known as 340B, and ratcheting up scrutiny on pharmacy benefit managers' role in drug pricing. 'We are working to address those things as we agree to disagree on the things that divide us,' Bourla said. He noted that he is against the administration's proposed 40% budget cut for the National Institutes of Health, emphasizing that the US is 'the dominant scientific force in biomedical sciences right now, and it is because we have created this ecosystem,' in which NIH funding supports academic research that can lead to new discoveries picked up by the pharmaceutical industry and made into medicines. 'If we break any link of this chain of this large ecosystem,' Bourla said, 'that's not good for us, and actually, it's a gift to our friends in China.' Bourla also took issue with HHS's actions on Covid-19 vaccines in the past two weeks: saying that the US Food and Drug Administration will change the way it approves updated shots for people who aren't in vulnerable groups and that the US Centers for Disease Control and Prevention will no longer recommend Covid-19 vaccines to healthy children and pregnant women. In previous years, Covid-19 vaccines had been updated in a similar way to seasonal flu shots, based on evidence that they generate an immune response; clinical trials that are required to show a vaccine's effect in preventing cases of disease are thought to take too long, potentially, to be feasible every season. What's more, the FDA and its advisers had previously deemed the vaccine updates small enough to not change their safety profile. Asked whether Pfizer would be able to run clinical trials quickly enough to make updated vaccines available to everyone, not just those in vulnerable groups, Bourla said, 'You are raising some very real concerns that we have.' Bourla noted that the implications of the Trump administration's changes to US health agency policies aren't entirely clear. But 'the issue is that that is not based on any scientific data. It's just based on a belief.' 'The appropriate process has not been followed; this is not just: the secretary or someone at a high level issues, let's say, a new rule,' he said. 'You need to follow a process which is reviews, experts, professional staff of FDA and all of that.' Dorit Reiss, a professor of law at UC Law San Francisco, suggested that HHS's 'bad administrative procedure' in announcing the updated CDC recommendations 'will be an issue' if they're challenged in court. Would Pfizer consider filing a lawsuit? 'My initial reaction is that I would prefer to find solutions but not create tensions,' Bourla replied. 'But of course, if we feel that we have to, we will.' Overall, the CEO emphasized that he has found the administration willing to engage in discussions, noting that 'we maintain a very, very close relationship' with the White House. 'I can't complain they don't listen to us,' Bourla said.
