The U.S. Food and Drug Administration fought back on Friday against what it calls the proliferation of misinformation by Floridas Surgeon General Joseph Ladapo about the safety of COVID-19 vaccines.
In a letter earlier this month to the FDA, Ladapo had questioned the agencys drug approval and raised alarms about what he sees as the risk of potential cancer posed by COVID mRNA vaccines. Ladapo,the leader of Floridas health department, said he believed the drug delivery system used by mRNA vaccines could be an efficient vehicle for delivering contaminant DNA into human cells.
But a top researcher with the FDA released a public response to Ladapo on Friday saying the Surgeon Generals scientific assertion regarding the cancer risk is implausible.
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, said the premise asserted by Ladapo that DNA contaminant could cause cancer in vaccine recipients is not scientifically accurate because there is no way that minute amounts of DNA fragments could find their way into the nucleus of human cells where DNA resides.
He added that this type of disinformation results in vaccine hesitancy.
Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19, Marks wrote. Indeed, only 11% of Floridians have received an updated COVID booster, despite the states large population of elderly who are most at risk for poor outcomes. Even more, only about a third of the states vulnerable long-term care population has had the updated shot, according to the Centers for Disease Control and Prevention.
We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines, Marks wrote in the response to Ladapo. Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.
(Article continues after the letter.)
In his Dec. 6 letter, Ladapo had pressed the FDA and CDC to answer three questions by Dec. 13: Was the risk of DNA integration evaluated by drug manufacturers and provided to the federal agencies; did FDA standards take the COVID vaccines delivery system into account; and was a risk evaluated of integration with reproductive cells beyond the local injection site?
Dr. Kawsar Talaat, an associate professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, says those three concerns have no scientific basis.
Her research expertise is in conducting clinical trials for a variety of vaccines to determine their safety and efficacy. The COVID vaccine enters the outer part of cell and the RNA works there. It wouldnt be possible for the DNA to integrate into the chromosomes since they are not even in same compartment, she said. Even if they were, the mechanism that allows that to happen is not included in the vaccine.
Talaat said Ladapo overlooks how much research on the mRNA COVID-19 vaccines has taken place.
There has not been a vaccine released into the population that has been under more scrutiny than the mRNA COVID vaccines, she said. There has not been any evidence thus far that there are any problems with integration with any DNA, or cancer as a result of the vaccines.
Talaat said she just had a 40-year-old friend with a health condition die of COVID-19.
These questions (raised by Ladapo) are designed to scare people rather than investigate true science, she said. What we do know is that COVID continues to kill thousands of people every month in the U.S. I think he is doing a disservice to the people of Florida by trying to scare them into not getting a vaccine that can be lifesaving.
(Article continues after the letter.)
Ladapo did not respond by the end of the business day on Friday to the Sun Sentinels request for comment about the FDA letter.
This isnt Ladapos first tussle with the FDA. In March, he was publicly rebuked by the FDA and CDC over his vaccine advice. Those agencies told him to stop disproportionately focusing public attention on the few instances of adverse effects from the COVID vaccine. Ladapo previously has painted the COVID vaccines as dangerous and claimed there have been no clinical trials on the effects of the new booster on human beings, a statement that the manufacturers say is false.
Sun Sentinel health reporter Cindy Goodman can be reached at cgoodman@sunsentinel.com.
Moderna-Merck Vaccine Halves Melanoma Recurrence Risk
Moderna and Merck announced on Thursday that a vaccine is showing promising results in treating melanoma, according to CBS News. To test the efficacy of the vaccine, they conducted an ongoing randomized trial in 157 patients with high-risk stage III and IV melanoma who first had surgery to completely remove cancerous growths. Compared with those who only received Keytruda (pembrolizumab), those who received both the vaccine and Keytruda were 49% less likely to die or have their cancer recur in 3 years. The companies have begun phase 3 trials of mRNA-4157 with Keytruda for those with stage III and IV melanoma; the FDA designated the treatment as a breakthrough therapy earlier this year to expedite its development and review since it is used to treat a life-threatening disease.
Biden Administration to Impose Inflation Penalties on Drugmakers
The White House announced on Thursday that the Biden administration will implement inflation penalties on dozens of drugmakers to reduce out-of-pocket costs for Medicare recipients, according to CNBC. This is a result of President Joe Bidens Inflation Reduction Act (IRA), which includes a provision to penalize drugmakers for charging prices that rise faster than inflation for patients with Medicare coverage. The White House explained that the prices of 64 drugs this year increased faster than inflation, with 48 of these drugs doing so during the last quarter of 2023; the 48 drugs may be subject to inflation rebates in the first quarter of 2024 due to the IRA.
Urgent Need to Increase Respiratory Vaccine Coverage, CDC Says
The CDC issued an alert on Thursday urging health care providers to increase immunization coverage for influenza, COVID-19, and respiratory syncytial virus (RSV), according to Reuters. In the past 4 weeks, hospitalizations among all age groups increased by 200% for influenza, 60% for RSV, and 51% for COVID-19. The CDC noted that low vaccination rates, coupled with the ongoing increase in respiratory disease activity, could lead to more severe disease and increased health care capacity strain in the coming weeks. To prevent this, the CDC is suggesting that health care providers recommend antiviral medications for influenza and COVID-19 to all eligible patients.
(Adds vaccination details and background in paragraphs 5 to 7)
Dec 14 (Reuters) -
The U.S. Centers for Disease Control and Prevention (CDC) on Thursday issued an alert urging healthcare providers to increase immunization coverage for influenza, COVID-19 and respiratory syncytial virus (RSV).
The health regulator said that low vaccination rates, coupled with ongoing increases in respiratory disease activity, could lead to more severe disease and increased healthcare capacity strain in the coming weeks.
Healthcare providers should recommend antiviral medications for influenza and COVID-19 for all eligible patients, especially older adults and people with certain underlying medical condition, the CDC said.
In the past four weeks, hospitalizations among all age groups increased by 200% for influenza, 51% for COVID-19, and 60% for RSV, according to CDC data.
There were 7.4 million fewer influenza vaccine doses administered to adults in pharmacies and physician offices compared with the 20222023 influenza season.
Nearly 16% of U.S. adults aged 60 years and higher were reported to have taken an RSV vaccine and 36% of U.S. adults aged 65 years and higher took a COVID-19 shot for the 2023-2024 period.
Pfizer has COVID and RSV vaccines that are approved in the United States, while Moderna and Novavax have updated COVID shots that are approved in the country. (Reporting by Christy Santhosh; Editing by Maju Samuel)
A breast cancer tumor, credit NASA/Goddard Space Flight Center.T
A drug that targets the deadliest form of breast cancer has recently been found to elicit no side effects, and triggered an immune response in 75% of patients.
Conducted at the Cleveland Clinic with funding from the Pentagon, the vaccine was administered to 16 women in three separate doses. The form of the vaccine that went through trials is meant to stop the return of this aggressive form of cancer in those who have already been treated.
Further research will tool it to attack tumors in women who have yet to undergo treatment.
mRNA vaccines for cancer tumors are really where this technology comes into its own. Using a piece of the tumor to train immune cells like bloodhounds to search them out is far more effective than using it to train a single component of a constantly mutating virus, as was done to try and combat COVID-19.
It could be available in five years, estimates ABCs medical correspondent Dr. Jennifer Ashton, who didnt participate in the research.
According to Anixa Biosciences, the firm behind this vaccine, the drug will target a lactation protein, known as -lactalbumin, that is present in the majority of triple-negative breast cancer patients.
The data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development, stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.
OTHER CANCER DEVELOPMENT: Scientists Develop Personalized Anti-Cancer Vaccine That Works in Mice
This year, GNN reported on another cancer vaccine with immense promise; this one for melanoma, which is predicted to be the second-most common type of cancer in the US by 2040.
In a phase 2b trial, 107 participants were treated with both the vaccine and immunotherapy drug pembrolizumab. Their melanoma returned in only 24 patients (22.4%) within two years, compared with 20 out of 50 (40%) who received only pembrolizumab.
WATCH the story from GMA below
SHARE This Promising Treatment Coming Down The Pike With Your Friends
The U.S. Food and Drug Administration fought back on Friday against what it calls the proliferation of misinformation by Floridas Surgeon General Joseph Ladapo about the safety of COVID-19 vaccines.
In a letter earlier this month to the FDA, Ladapo had questioned the agencys drug approval and raised alarms about what he sees as the risk of potential cancer posed by COVID-19 mRNA vaccines. Ladapo, the leader of Floridas health department, said he believed the drug delivery system used by mRNA vaccines could be an efficient vehicle for delivering contaminant DNA into human cells.
But a top researcher with the FDA released a public response to Ladapo on Friday saying the Surgeon Generals scientific assertion regarding the cancer risk is implausible.
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, said the premise asserted by Ladapo that DNA contaminant could cause cancer in vaccine recipients is not scientifically accurate because there is no way that minute amounts of DNA fragments could find their way into the nucleus of human cells where DNA resides.
He added that this type of disinformation results in vaccine hesitancy.
Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19, Marks wrote. Indeed, only 11% of Floridians have received an updated COVID-19 booster, despite the states large population of elderly who are most at risk for poor outcomes. Even more, only about a third of the states vulnerable long-term care population has had the updated shot, according to the Centers for Disease Control and Prevention.
We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines, Marks wrote in the response to Ladapo. Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.
In his Dec. 6 letter, Ladapo had pressed the FDA and CDC to answer three questions by Dec. 13: Was the risk of DNA integration evaluated by drug manufacturers and provided to the federal agencies; did FDA standards take the COVID-19 vaccines delivery system into account; and was a risk evaluated of integration with reproductive cells beyond the local injection site?
Dr. Kawsar Talaat, an associate professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, says those three concerns have no scientific basis.
Her research expertise is in conducting clinical trials for a variety of vaccines to determine their safety and efficacy. The COVID vaccine enters the outer part of cell and the RNA works there. It wouldnt be possible for the DNA to integrate into the chromosomes since they are not even in same compartment, she said. Even if they were, the mechanism that allows that to happen is not included in the vaccine.
Talaat said Ladapo overlooks how much research on the mRNA COVID-19 vaccines has taken place.
There has not been a vaccine released into the population that has been under more scrutiny than the mRNA COVID vaccines, she said. There has not been any evidence thus far that there are any problems with integration with any DNA, or cancer as a result of the vaccines.
Talaat said she just had a 40-year-old friend with a health condition die of COVID-19.
These questions (raised by Ladapo) are designed to scare people rather than investigate true science, she said. What we do know is that COVID continues to kill thousands of people every month in the U.S. I think he is doing a disservice to the people of Florida by trying to scare them into not getting a vaccine that can be lifesaving.
Ladapo did not respond by the end of the business day on Friday to the South Florida Sun Sentinels request for comment about the FDA letter.
This isnt Ladapos first tussle with the FDA. In March, he was publicly rebuked by the FDA and CDC over his vaccine advice. Those agencies told him to stop disproportionately focusing public attention on the few instances of adverse effects from the COVID-19 vaccine. Ladapo previously has painted the COVID vaccines as dangerous and claimed there have been no clinical trials on the effects of the new booster on human beings, a statement that the manufacturers say is false.
_____
Dr. Mandy K. Cohen dropped by the Fox affiliate in Dallas in November, just days after the governor of Texas signed a law barring private employers from requiring Covid-19 shots. If she thought promoting vaccination would be a tough sell in a ruby-red state, Dr. Cohen, the new director of the Centers for Disease Control and Prevention, did not give any indication.
Im not just the C.D.C. director, Im also a mom, she said cheerily, noting on live television that her daughters, 9 and 11, had already received the latest Covid and flu shots. She added, So I wouldnt recommend something for the American people I wouldnt recommend for my own family.
It was the kind of stock phrase that Dr. Cohen has repeatedly invoked as she pursues a task that some public health experts fear is impossible: restoring Americans faith in public health, and in her battered agency. Five months into her tenure, with the Covid public health emergency officially over, the C.D.C.s new leader is relentlessly on message.
Americans trust in the agency, and in science more broadly, was badly damaged by the coronavirus pandemic, and the loss of faith is particularly pronounced among Republicans. In a recent survey by the Pew Research Center, 38 percent of Republicans said they had little or no confidence in scientists to act in the publics best interests, up from 14 percent in April 2020.
At the same time, the C.D.C.s winter vaccination campaign appears to be falling on deaf ears. On Thursday, the agency issued an alert warning that low vaccination rates for the flu, Covid and respiratory syncytial virus, known as R.S.V., could lead to severe disease and increased health care capacity strain in the coming weeks. And partisan divisions over vaccination persist: A KFF poll in September found that seven in 10 Democrats but just a quarter of Republicans planned to get the updated Covid shot.
Dr. Cohen, whom President Biden selected to succeed Dr. Rochelle P. Walensky, is responding with a nationwide media blitz. Since taking the helm of the C.D.C. in July, she has traveled the country, promoting vaccination in 19 cities in 13 states. She has visited 22 vaccination sites and has participated in dozens of interviews, including an appearance on NBCs Today just before Thanksgiving.
She has left a trail of social media posts in her wake, including a series of short videos, called Check-In With Dr. Cohen, that typically begin with some variation of the same greeting: Hi everyone, its Mandy Cohen!
In one video recorded on Long Island, Dr. Cohen and a county health official, wearing hard hats and vests, reported on how wastewater can help scientists track viruses and disease. In Dallas, she appeared with another county health official to talk about the importance of data, and with a nurse at a church health fair. And in Chicago, she stood by the president of the American Medical Association as he promoted vaccination.
When she speaks to reporters, she frequently brings up her children.
Science is important and yes, the data is important, Dr. Cohen said in an interview with The New York Times. But at the end of the day, were also all humans. And if we can have a human-to-human conversation about what I would do for my own kids, who I love and I want to be healthy, maybe that can connect us in a different way.
Dr. Cohen is taking over an agency that is in transition. Her predecessor, Dr. Walensky, who began serving at the start of the Biden administration and stepped down in June, commissioned a review of the C.D.C. that identified serious weaknesses in areas ranging from testing to data collection to communications. She then initiated an overhaul of the agency.
Dr. Cohen has said she is committed to carrying out that plan, which included setting up a new forecasting and analytics center, as well as structural changes intended to enable the agency to quickly translate its science into coherent policy recommendations. But even her staunchest allies say her top priority must be to change the way the public views her agency.
Restoring trust probably is the No. 1 challenge right now, said Dr. Judith Monroe, the president and chief executive of the C.D.C. Foundation, an independent nonprofit established by Congress to mobilize private-sector support for the agencys work. Because wheres your platform if folks dont trust what you say?
Experts agree that C.D.C. officials and other public health leaders made serious messaging missteps during the pandemic. Officials bred mistrust by speaking with certainty when there wasnt any and later changing their recommendations, said Brian C. Castrucci, the president and chief executive of the de Beaumont Foundation, a public health nonprofit that is partnering with Frank Luntz, a pollster and political strategist, to study attitudes toward public health.
Mr. Luntz, who rose to prominence working for Republicans, said his research had found that a significant portion of the public as much as 20 or 25 percent was now unreachable, because public health officials used language that sounded like it was lecturing, and almost abusive toward people who had legitimate doubts.
Based on Mr. Luntzs surveys and focus groups, the foundation has developed messaging guidance, including a communications cheat sheet, to help public health officials reach Americans of all political stripes. Dr. Tom Frieden, who served as C.D.C. director under President Barack Obama and has participated in the project, said Dr. Cohens communications style was in keeping with its findings.
Youre there to empower people with information, not berate people to change their behavior, he said. I think Dr. Cohen gets that.
The morning before she was to leave for a two-day, three-city swing through Texas, Dr. Cohen huddled with her top aides and her infectious disease team at the C.D.C. headquarters in Atlanta for an update on the flu, Covid and R.S.V. which circulate during what the agency now calls the winter respiratory virus season. One benefit of that moniker: Winter viruses are less politically toxic than Covid.
The news was mixed. Hospitalizations from the flu were up slightly from last year. The rate of Covid vaccination was much lower than that of flu vaccination among health care workers not a good sign. A new monoclonal antibody shot to prevent R.S.V. in infants was in short supply, but 77,000 more doses had just been released. Texas was seeing an uptick in R.S.V.
But there was something else on Dr. Cohens mind. During her travels, she had been hearing from people who worried about side effects from vaccination and wanted more information about what federal health officials were doing to monitor vaccine safety. The C.D.C., she told her colleagues, needed to be able to tell a clear and concise story.
To that end, Dr. Cohen is changing the language that the C.D.C. uses to describe itself. Testifying last month before a House subcommittee in what was her first appearance before Congress in her new post, she described the agency as a critical national security asset a phrase that might have particular appeal to House Republicans, who have proposed cutting the C.D.C.s funding by $1.6 billion, or roughly one-sixth of its budget.
But M. Anthony Mills, a senior fellow at the conservative American Enterprise Institute who studies public trust in science, said the national security frame might not appeal to ordinary Americans who distrust the C.D.C. and other agencies like the National Institutes of Health and the Food and Drug Administration.
For Americans who believe N.I.H. lied about funding research that caused the pandemic, suspect the pharmaceutical industry is in bed with the F.D.A. and see public health efforts as an infringement on their freedom, that constellation of concerns doesnt have much to do with national security, he said.
Unlike Dr. Walensky, who had no prior government experience and made headlines for seeking out media training, Dr. Cohen is not a stranger to Washington or the spotlight.
She was a top official at the Centers for Medicare & Medicaid Services during the Obama administration. Later, as secretary of health and human services in North Carolina, she laid the groundwork for the Republican-controlled legislature to accept an expansion of Medicaid, and she helped steer the state through the pandemic.
After news reports that Mr. Biden was planning to pick Dr. Cohen for the directors post, more than two dozen congressional Republicans signed a letter accusing her of politicizing science. They cited her tenure in North Carolina, where she called for students and staff members in K-8 schools to wear masks and threatened legal action against a school district over its Covid policies.
But while her relationships with Republicans in North Carolina may have been tense, they never veered into vitriol, said State Representative Donny Lambeth, a Republican and a chair of the Health Committee in the North Carolina House of Representatives.
She was cool, calm and collected almost every time we had her in front of us, Mr. Lambeth said. She did not get rattled.
There were few fireworks during her congressional testimony last month. When Representative Daniel Crenshaw, Republican of Texas, pushed her to admit that the C.D.C. had been wrong during the pandemic, she politely ignored the request.
Representative Jeff Duncan, Republican of South Carolina, wanted to know if she had regrets about Covid restrictions from her time in North Carolina. Dr. Cohen did not admit to any. When he asked her pointedly if she would impose such restrictions today, she ducked the question, telling him instead that she was looking forward to a new chapter at the C.D.C.
The good news, she said, is were in a new place.
Moderna (MRNA) shares have jumped by over 9% on Thursday in relation to positive trial results in Moderna and Merck's (MRK) collaborative skin cancer treatment that utilizes both a vaccine and the drug Keytruda. Additionally, Pfizer (PFE) disappointed investors this week over the pharmaceutical company's 2024 guidance.
Yahoo Finance Health Reporter Anjalee Khemlani details the top stories and biggest drivers behind pharmaceutical stocks Thursday.
For more expert insight and the latest market action, click here to watch this full episode of Yahoo Finance Live.
- Shares of Moderna popping today on positive trial data for a skin cancer treatment. Moderna developing the vaccine alongside Merck, but those shares little changed today. Here with more is Yahoo Finance's, Anjali Khemlani. Anj.
ANJALI KHEMLANI: Hi, Julie. Well, yes. So, of course, Moderna out with this update on its cancer vaccine that it is testing in tandem with Merck's Keytruda, that blockbuster cancer drug. And what they found is that the drug in tandem with the vaccine can reduce the risk of recurrence of melanoma-- late stage melanoma-- by up to 49% after three years. That's a really huge number in terms of the protection that it can give patients.
So that's where the jump is coming from today. Moderna finally getting a little bit of positive news for its stock. We know that it's been a little bit under pressure because of the lack of movement in its pipeline ever since the one vaccine that they do have to their name, which is the COVID-19 vaccine.
So I had a chance to catch up with the CEO earlier today. And we were talking about that and the leadership changes that the company has been through as well. And how he is now going to be looking over commercial progress. And he wants to, in his words, obsess over it. So looks like Moderna is in for some hard times ahead.
- Yeah, and Anj, I want to switch names to another name here. Checking out Pfizer today under some pressure. It's down more than 2%. It looks like that's off this 2024 outlook. What's new there?
Story continues
ANJALI KHEMLANI: That's right. First of all, I just want to point out, I never thought I'd have to say these two companies names in the same breath again since COVID. But here we are again. So Pfizer--
- Because they're both facing some similar challenges moving past that era.
ANJALI KHEMLANI: Absolutely. And that is where the pressure on Pfizer comes from. Downgrading its 2024 outlook to be basically flat compared to 2023. And saying that its COVID portfolio is estimated to bring in just $8 billion. That's a lot less than what the Street was looking for and estimating.
But in the call yesterday, Pfizer CEO, Albert Bourla, as well as CFO, Dave Denton, did have to battle a lot of really stern questions from analysts. A lot of doubt and a lot of wariness that has been sort of an overhang on the stock for years.
Even during the pandemic, we had conversations here at Yahoo Finance with Albert Bourla about just that. About how their stock didn't get that boost that a lot of others saw during the pandemic. And he said even earlier this year, in April, saying, quote, "Although I'm not happy, all we can do is to execute on our strategy so that investors will see that this is a good growth opportunity."
And that growth opportunity he's referring to is the two acquisitions last year as well as that huge $43 billion C-Gen which is oncology focused this year. As well as getting 13 launches of new products from the pipeline. So a lot of R&D focus for the company. And still not being rewarded there by the Street.
Lots of doubts, including, for example, in an analyst note from JPM, saying "PFE shares are looking increasingly washed out at current levels, we do not see a clear path for the stock to recover given the ongoing uncertainty about the company's core earnings power."
And basically what they're saying, and what these analysts have been saying, is that even though they have these acquisitions and they have this rich pipeline, there's nothing to really make up for what could be a $17 billion hole from patent expiry at the end of the decade. And so there's no catalyst. There's no blockbuster to take place what they're losing.
And even though there's a lot in the pipeline, there's nothing that's really stand out and enough to really just weigh on-- give up the weight on the stock.
- All right, we'll keep watching. Anjali, thank you so much for that.
Moderna has submitted marketing authorizations globally for mRNA-1345 and continues to prepare for an expected 2024 marketing launch
CAMBRIDGE, MA / ACCESSWIRE / December 15, 2023 / Moderna, Inc. (Nasdaq:MRNA) today announced the publication of positive Phase 3 clinical study results evaluating mRNA-1345, its vaccine candidate for respiratory syncytial virus (RSV), in The New England Journal of Medicine.
The peer-reviewed article summarizes safety and efficacy data from ConquerRSV, the Company's Phase 2-3 trial evaluating mRNA-1345. An accompanying New England Journal of Medicine op-ed discusses these results as an important achievement in the realization of effective RSV vaccines as well as a milestone in the advancement of mRNA vaccines and medicines. Moderna is the only company to have developed an mRNA-based RSV vaccine. Top-line results from this study were previously announced in January 2023.
RSV is a highly contagious virus that causes severe disease across the age spectrum, including older adults. Each year in the U.S., RSV leads to approximately 60,000-160,000 hospitalizations and 6,000-10,000 deaths among older adults. Applications for mRNA-1345 have been submitted to regulators around the world. Moderna is actively preparing for an expected 2024 marketing launch of mRNA-1345 and believes its U.S. COVID-19 market share to date demonstrates the Company's ability to compete in the commercial market. If approved, mRNA-1345 would have a potential best-in-class profile and be the only ready-to-use RSV vaccine available in single-dose prefilled syringes.
About mRNA-1345
mRNA-1345 is an investigational RSV vaccine that consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs) as in the Moderna COVID-19 vaccines. The F glycoprotein is on the surface of the virus and is required for infection by helping the virus to enter host cells. It exists in two states, prefusion and postfusion. The prefusion conformation is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes.
Story continues
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.
Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Moderna Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company's development of a vaccine against RSV (mRNA-1345); the vaccine efficacy of mRNA-1345; the potential timing for regulatory approval of mRNA-1345; the potential for mRNA-1345 to reduce disease burden from RSV; the availability of mRNA-1345 in pre-filled syringes and the mechanism of action for mRNA-1345. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
Elise Meyer Senior Director, Corporate Communications Elise.Meyer@modernatx.com
Investors:
Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View the original press release on accesswire.com
(Adds analyst comment, share changes in paragraphs 2-3)
By Michael Erman and Patrick Wingrove
Dec 14 (Reuters) - An experimental messenger RNA cancer vaccine developed by Moderna and Merck & Co paired with Merck's Keytruda cut the chance of recurrence or death from melanoma by half after three years, showing that benefits demonstrated a year ago have held up over time.
Moderna shares rose 11% in morning trading after having fallen 50% this year due to waning demand for COVID vaccines and questions about how well its mRNA influenza shot works compared to the current standard and whether the cancer vaccine will be successful. Two analysts said this data was a positive but incremental step.
Merck shares fell by 0.6% to $105.70 in morning trading.
The combination of the personalized cancer vaccine and Merck's blockbuster immunotherapy cut the risk of recurrence or death of the most deadly skin cancer by 49% compared with Keytruda alone in the midstage trial, the companies said.
The results come at a median point of three years into the study involving 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combination or Keytruda alone with the aim of delaying disease recurrence.
A year earlier, the study had shown a 44% reduction of recurrence or death.
"The durability of the responses is really strong, they're essentially rock solid through this time," Moderna President Stephen Hoge said in an interview. "This is a pretty significant improvement, a pretty dramatic improvement over standard of care with just Keytruda alone."
Morningstar analyst Karen Andersen said the new results could help Moderna and Merck make a case to the U.S. Food and Drug Administration for accelerated approval based on its midstage data.
The combination treatment has won U.S. breakthrough therapy and European Medicines Agency PRIME scheme designations, regulatory programs that aim to speed development of innovative treatments. Still, Hoge said that even with the new data it would be some time before the companies can file for approval of the treatment.
Story continues
The vaccine is custom-built based on an analysis of a patient's tumors after surgical removal. The vaccines are designed to train the immune system to recognize and attack specific mutations in cancer cells.
Moderna is currently building a dedicated facility in Massachusetts to produce the vaccine at commercial scale, which it hopes to finish sometime next year.
"We need to make sure that we have that near completion before we could even contemplate asking for approval," Hoge said.
He said the companies are engaging with regulators globally on the pathway for approval for the product.
They have already begun a confirmatory late-stage trial for the combination in melanoma, as well as one in non-small cell lung cancer that is already enrolling patients. (Reporting by Michael Erman; Editing by Bill Berkrot and Mark Porter)
December 14, 2023 4:03 PM | 2 min read
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Moderna, Inc. (NASDAQ:MRNA) CEO Stphane Bancelappeared on CNBC's "Squawk Box" Thursday to discuss the company's promising new cancer vaccine developed in partnership with Merck & Company, Inc. (NYSE: MRK).
What Happened: When combined with Keytruda,Moderna'snew vaccine candidatemRNA-4157 (V940)reduced the risk of relapse or death by 49% in melanoma patients and showed a 62% lower risk of the cancer spreading, the Moderna CEO said.
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"It's a big day for patients, and we are so excited," Bancel said."We think it's a huge impact on melanoma, it's one in two people. Think about the number of lives that can be impacted, and people that can be saved and live a normal life despite a diagnosis of cancer."
Moderna's CEO told CNBCthe treatment may reach some markets in Europe and Asia by 2025 and could enter theU.S. market by 2028.
Why It Matters: Moderna shares are downmore than 50% year-to-date, and shares of rival drug-maker Pfizer, Inc. (NYSE:PFE) are down 49% this year. Someinvestors are concerned that many of thevaccinestocks that roseduring the pandemic will continue to fall alongsidedeclining demand for Covid vaccines.
When asked about the company's future growth, Bancel said, Number one: we are gaining market share in Covid so that is good for sales growth. We are launching RSV in 24 so thats going to be great for sales growth because we have no sales of RSV in 23, and we have seven Phase 3 products in the pipeline.
Related News: Pfizer Issues FY24 Forecast, Joins Target Hospitality, Southwest Airlines And Other Big Stocks Moving Lower On Wednesday
MRNA Price Action: According to data from Benzinga Pro, Moderna shares are up by more than 9% at $85.76 at the time of publication.
Image:Marco Verchfrom Flickr.
Want to become an options master? In his free report, options expert Nic Chahine will give you access to the four bulletproof tips for beginners, the secret to scoring 411% gains with options, and his time-tested "plan" for success. Grab your free copy of Options 101: The Beginner's Guide ASAP.
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