TOPLINE:
"Optimizing vaccination status should be considered a key element in the care of patients with cancer," according to the authors of newly released American of Clinical Oncology (ASCO) guidelines. Optimizing vaccination status includes ensuring patients and household members receive recommended vaccines and adjusting this strategy depending on patients' underlying immune status and their anticancer therapy.
"Enhancing vaccine uptake against preventable illnesses will help the community and improve the quality of care for patients with cancer," the authors said. "Clinicians play a critical role in helping the patient and caregiver to understand the potential benefits and risks of recommended vaccination[s]. In addition, clinicians should provide authoritative resources, such as fact-based vaccine informational handouts and internet sites, to help patients and caregivers learn more about the topic."
Mini Kamboj, MD, with Memorial Sloan Kettering Cancer Center, New York City, and Elise Kohn, MD, with the National Cancer Institute, Rockville, Maryland, served as co-chairs for the expert panel. The guideline was published in March 2024 in the Journal of Clinical Oncology.
The evidence for some vaccines in cancer patients continues to evolve, particularly for new vaccines like COVID-19 vaccines.
This research had no commercial funding. Disclosures for the guideline panel are available with the original article.
During the 2009 H1N1 influenza pandemic, the deployment of pandemic influenza vaccines in importing countries was delayed or disrupted due to the lack of regulatory preparedness. This resulted in WHO developing guidelines for non-vaccine producing countries on the appropriate regulatory approaches to the marketing authorization and lot release of pandemic influenza vaccines in public health emergency conditions. These guidelines were developed in the context of the Pandemic Influenza Preparedness (PIP) Frameworks Partnership Contribution High Level Implementation Plan, covering regulatory capacity-building and strengthening of pandemic preparedness and response.
However, subsequent public health emergencies such as the Ebola epidemic and COVID-19 pandemic further exposed gaps in regulatory preparedness for other types of pandemic vaccines. The role of national regulatory authorities was not acknowledged in national pandemic preparedness plans, thereby hindering their ability to provide appropriate regulatory oversight.
Using lessons learned from these emergencies, stakeholder feedback, as well findings from WHO Global Benchmarking assessments, WHO initiated the revision of the Guidelines on regulatory preparedness for provision of marketing authorization of human pandemic influenza vaccines in non-vaccine-producing countries. The aim was to expand the scope to cover not just influenza but all pandemic vaccines, and to recommend a harmonised, systematic, risk-based approach for regulating vaccines during a pandemic or other public health emergency in importing countries.
The revised Guidelines empower national regulatory authorities to ensure the timely availability of lifesaving, quality-assured vaccines promoting public health. In particular, these guidelines emphasized the implementation of recognition and reliance principles throughout the entire regulatory system .
The process, supported by the PIP Partnership Contribution, began at the end of 2021 with the development of a concept note and approval from the WHO Expert Committee on Biological Standardization (ECBS) to update the guideline. A drafting group of experts was established in June 2022, with the draft guidelines undergoing three rounds of public consultation including a stakeholder workshop held in Turkiye in April 2023. The revised guideline was approved by the ECBS in October 2023 and will soon be published and available for Member States to implement.
March 29, 2024
Sean Valles has a simple approach to those who are reluctant to get vaccinated against flu, Covid-19, and other diseases like measles: listen to them and address their concerns.
A hard sell usually does not work, said Valles, PhD, a professor and director of the College of Human Medicines Center for Bioethics and Social Justice.
People advocating for public health are going to have to change strategies, he said, because right now theyre losing the battle. There are a lot of reasons people are vaccine hesitant. How can we address the root causes?
Vaccine hesitancy includes concern about potential side effects, a false belief that a vaccine can cause the disease it is supposed to protect against, unfounded rumors and distrust of medical science fed by Internet conspiracies, and even a fear of needles. Most vaccine skeptics are not completely opposed to vaccination, Valles said.
For some, the problem is less about fear and more a lack of access, often determined by race, income, and Zip Code. The National Network to Innovate for COVID-19 and Adult Vaccine Equity (NNICE), a partnership that includes MSU, Corewell Health and other organizations, was created to address that problem.
The goal, Valles said, is to find people in the community who can make the case for vaccines. Its hard to scare people into healthy behavior. All you tend to do is make them more afraid.
Of particular concern are recent outbreaks of measles, including in Michigan.
In the case of measles, it is so contagious, far and away more than almost anything else, Valles said, that we dont have room for error.
The mumps/measles/rubella (MMR) vaccine has been available and highly effective in preventing the deadly disease since the early 1970s, lulling some parents into a false sense of security that measles has been eradicated, although, in fact, it never left. Other parents fall prone to a highly politicized climate of misinformation.
Vaccine hesitancy has sort of always been there, Valles said, but its become much more organized.
There are always going to be those people who are going to be a hard no, he added, no matter what you say.
The key, he said, is to find those who remain at least partially open-minded.
Valles comments in WILX news story: "New case of measles reported in Michigan"
This biotechnology company has nearly 90% of its market value in cash and investments but is being shunned by investors even as they gravitate to the sector this year.
The company is BioNTech (Ticker BNTX). It partnered with Pfizer to produce the leading Covid vaccine, Comirnaty, whose original messenger RNA technology was developed by BioNTech. It is rare to find any sizable company with so much cash relative to its market cap.
That could offer an opportunity for investors because investors effectively are ascribing little value to the companys Covid vaccine franchise and a drug pipeline geared toward cancer treatments.
What could go right? A large stock buyback program, a payout of a chunk of that cash to investors, potential activist pressure to rein in expenses or distribute the cash or a sale of the company in what has become a more frothy market for biotech companies.
Here are the numbers: The German biotech reported its fourth-quarter results last Wednesday and said it ended the fourth quarter with $19.3 billion of cash and investments, against a current market value of $22.1 billion. It has minimal borrowings and a book value of $22 billion with only $1 billion of intangible assets.
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BioNTech shares rose 1.3% Monday at $93 and trade near a 52-week low. The stock is off nearly 30% in the past year, versus an 10% gain for the iShares Biotechnology ETF (IBB). Its down 80% from its 2021 high of $441.
Wall Street is lukewarm on BioNTech despite the big cash position because of waning sales of Covid vaccines and a cancer-focused drug pipeline without any potential blockbusters that may not deliver its first commercial product until 2026. TD Cowen analyst Yaron Werber wrote recently that the clinical/commercial outlook for each of the oncology drugs is unclear now, making it tough to include them in valuation models. Then there is the risk that the company spends a big chunk of the cash on a questionable acquisition.
We think BNTXs emerging pipeline beyond COVID has upside potential long-term. However, we continue to think investor focus for shares remains on COVID, where we continue to have limited long-term visibility and think uncertainty could create a headwind for shares, particularly in the context of increasing investments spend, wrote UBS analyst Eliana Merle in a client note. She has a Neutral rating and price target of $110.
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BioNTechs founders, Ugur Sahin, the CEO, and his wife, Ozlem Tureci, the chief medical officer, are cancer experts and have researched the disease for decades. BioNTech is developing treatments for lung and other cancers.
The company is upbeat on the oncology pipeline, noting 10 Phase 2 and 3 trials under way and a goal of 10 indication approvals by 2030.
The companys 2023 sales were below the Street estimate and its 2024 revenue projection of about $3 billion (nearly all Covid related) was $300 million below the consensus projection.
The FactSet
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That projected loss, while not great, is much better than many biotechs with high burn rates and no approved drugs.
The company effectively trades for just one times sales, based on its enterprise value (market value less net cash), a low valuation for a drug company. And BioNTech does offer optionality, or the ability to capitalize on a Covid resurgence that would boost vaccine demand.
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Management has indicated that it intends to focus on building out a pipeline of about a dozen drugs, mostly oncology related. The company said in its earnings press release that it will continue to evaluate appropriate corporate development opportunities to help drive growth and create.
But BioNTech has also said that it plans to husband its cash. On its second-quarter earnings conference call last year, Ryan Richardson, the chief strategy officer, said we think its an immense asset to the company to have a strong balance sheet.
The company plans to spend about $2.7 billion on research and development this year, nearly equal to its projected revenues. Thats a hefty amount and could become the focus on investors if the stock continues to languish.
Barrons has written favorably on BioNTech and the stock has proven a disappointment. At current levels, investors are paying little for its core business given all the cash. That could be a good setup for the rest of 2024.
Write to Andrew Bary at andrew.bary@barrons.com
In a recent study published in the journal Vaccine, a team of researchers evaluated whether the measles, mumps, and rubella (MMR) vaccine administered to children below the age of two after three doses of diphtheria-tetanus-acellular pertussis (DTaP) vaccine provided any non-specific beneficial effects in reducing the overall number of antibiotic treatments.
Study: Is vaccination against measles, mumps, and rubella associated with reduced rates of antibiotic treatments among children below the age of 2years? Nationwide register-based study from Denmark, Finland, Norway, and Sweden. Image Credit:Rohane Hamilton/ Shutterstock
The MMR vaccine against measles, mumps, and rubella is a live vaccine, which generally consists of attenuated forms of the viruses causing the three diseases. This vaccine is administered to children as early as nine months and is known to provide non-specific protective effects against infections other than these three diseases. Studies from high-income countries have reported that the MMR vaccine has decreased the rate of hospitalizations due to infections not targeted by the vaccine.
Compared to non-live vaccines, such as the ones used to vaccinate against diphtheria, tetanus, and pertussis, the MMR vaccine seems to be more effective at preventing hospitalizations due to non-target diseases. However, most studies investigating the non-specific benefits of the MMR vaccine have focused on diseases or infections severe enough to require hospitalization.
Given that common non-severe infections during childhood are often treated with antibiotics without the need for hospitalization, and lowering the non-vital use of antibiotics is beneficial in decreasing the risk of antibiotic resistance, it is vital to understand the efficacy of the MMR vaccine in decreasing antibiotic treatment rates associated with non-specific infections.
The present study investigated whether the administration of the MMR vaccine after three doses of the DTaP vaccine was more effective in lowering the antibiotic treatment rates among children below the age of two years as compared to administering just three doses of the DTaP vaccine. This study was conducted in Denmark, Finland, Norway, and Sweden. It included birth cohorts with registered data on children up to the age of two, indicating the inclusion of pneumococcal conjugate and DTaP vaccine in the immunization programs.
The data was obtained from a project that covered sociodemographic and health data from nationwide registries of these Nordic countries. The vaccination data included the date of immunization and the type of vaccine. The information on antibiotic treatments was gathered from prescription records. Furthermore, factors such as birth weight, season of birth, delivery mode, whether the mother smoked during the pregnancy, maternal age, singleton birth, household income, education level of mother, and single parenthood were considered as covariates.
The study followed the children from the age of the recommended MMR vaccine to the age of two years. Furthermore, age was used as the underlying timescale, while vaccination status was considered the time-varying exposure in calculating the hazard ratios of antibiotic treatments.
The results showed that administration of the MMR vaccine after the third dose of the DTaP vaccine lowered the antibiotic treatment rate by 11% on average across the four Nordic countries. Norway showed the highest (16%) reduction in antibiotic use after the administration of the MMR vaccine in children below two years of age with three DTaP vaccine doses. Finland and Denmark reported a reduction of 8%, while Sweden saw a 13% reduction in antibiotic use.
The results did not vary according to the child's sex. However, the adjusted hazard ratios were found to vary significantly with time, with the non-specific beneficial effects of the MMR vaccine being higher towards the beginning of the follow-up and decreasing towards the end. The study also found that the third dose of the DTaP vaccine decreased the antibiotic treatment rates more than the second dose.
The researchers found that the difference in the results between Norway and Sweden, on the one hand, and Finland and Denmark, on the other hand, was because Norway and Sweden reported more timely and higher rates of MMR vaccinations than the other two countries.
The study also discussed potential mechanisms through which the MMR vaccine provided non-specific protection against non-severe infections. The researchers believe that the long-term reprogramming of functional immunity that occurs due to the stimulation of the innate immune system by the live viruses also triggers immune responses against other antigens or stimuli.
Overall, the findings reported that administration of the MMR vaccine in children below two years of age, after immunization with the third dose of the DTaP vaccine, significantly lowered antibiotic use by protecting against non-specific, non-severe infections. However, comparable results were observed in children who received three doses of the DTaP vaccine alone, indicating the need for further studies to better understand the non-specific effects of MMR vaccines.
Journal reference:
Rohan Thomson/Getty Images
It seems reasonable to expect that just about anything can and will go wrong with a full-size replica of a cruise ship that famously sank on its maiden voyage, killing more than 1,500 people aboard. But Titanic II, Australian mining billionaire Clive Palmers proposed heir to the original RMS Titanic, hasnt faced a disaster so far because over the decade and change that Palmer has been pitching it, nothing has been built.
First announced in 2012 for the 100th anniversary of the Titanics fateful voyage, Palmer envisions the Titanic II, operated by his company Blue Star Line, as a historically accurate tribute to its namesake, right down to the cramped steerage cabins. Of course, there will be some tweaks to ensure it reaches its destination this time: Palmer wants the ship to have cutting-edge navigation equipment, safety systems, and plenty of lifeboats. Throughout the many snags in the project including payment disputes and scrapped plans to build in a Chinese shipyard very little of this core idea has changed, with Palmer brushing off skeptics by reminding them that he has the money and determination to see it through.
What has changed somewhat is how Palmer, who in the past decade has served in Australian parliament and chaired a right-wing political party he founded, describes the symbolism of the Titanic(s). In a March 13 press conference at the Sydney Opera House to announce his recommitment to reconstructing the doomed ocean liner, Palmer said it would be a beacon of hope amid war in Ukraine and Gaza, bring people together after the era of Covid lockdowns, and embody traditional values as opposed to woke politics. Here, he talks with Rolling Stone about what he thinks Titanic II crossing the Atlantic into New York Habor would mean to the world.
This has been in the works for a long time, but how did you originally get interested in the Titanic? Its very topical. I originally got interested because we know how to make war see whats happening in Ukraine and Gaza. Its much more difficult to make peace in the world. And the Titanic is an international symbol. Its a symbol of love and peace, really. I mean, the movie, everyone knows the Jack and Rose story. All of us have a Jack and Rose story of our own. So I thought itd be good to do something to promote those aspects in life. Secondly, we need to remember the people of the Titanic, and some of the values that we question in society today disappearing, such as courage and self-sacrifice. You remember the musicians on the Titanic that stood there at their station, playing Nearer My God to Thee? They were more concerned about the people that were with than themselves. Were running our culture into a self-centered society, so we want to refocus on those things. We thought we could design the whole ship and have it ready in three to four years construction. But it took about five to six years to design. Originally, the challenge was much greater because we had to incorporate all the safety provisions and still keep the design of the ship the same that was a lot harder than we thought. And we know what happened with cruise shipping and Covid, we had to stop and pause and see what was happening, but today shipping has come back. It gives us the time to pull those plans off the shelf and to get the project moving.
With all these delays you had, how did you get back on track? Well, Ive got a lot of money. And at my age, at 70, I should try to do something with it thats positive for the world. But its not unusual that people my age build the boat, sail the world, climb a mountain, do something like that. I did promise the people of New York [in 2012], we launched it on the [USS] Intrepid, One day youll be able to say that you were there where it all began. The Titanic sailed up the Hudson River into New York Harbor, completed the journey. A lot of the original descendants of people who died on the Titanic, some of the best-known names in New York, wanted to buy their tickets and they offered millions of dollars. Surprisingly, we had an enormous number of people wanting to go a third class. One of the big things we found in the plans as we tried to build Titanic was a big square, going down five decks we didnt know what it was for, but we discovered a flooring that had one word: Potatoes. That was the food store for all the third class: you could have sauted potatoes, fried potatoes, potatoes, mashed potatoes, but all you had was potatoes in third class. A lot of people saying they wanted tickets at that time were New York stockbrokers stuck in a dingy office all day, talking to other people about nothing, I guess, wanting to get back to some reality, some sort of human nature. Because we will have Irish dancing, we will have one-to-one contact in the cabin, the two of you sharing together and 30 of you sharing a bathroom. Thats part of the experience that part of the Titanic. Its not the luxury part.
Some billionaires are really focused on the future space travel, advanced AI. But it sounds like you really want to look to the past. I want to look to the present and the future. Look, Im saying these things are important, you know, to touch someone, to give them a hug. Doesnt matter whether youre on the moon or youre going to Mars, right? You still meet people, you still need to respect them. You still need to value that sort of human relationship. I think one of our problems in our society that we dont value that sense. We want to challenge the whole concept that whats important is money for the sake of money without any reasonable purpose. Then, of course, weve got to remember the Titanic has played an enormous role in safety in shipping. So many people would have perished if those changes werent put into place, lifeboats and bulkheads and things like that. So weve got to recognize that from a disaster, we learn how we can make our lives better.
Has anyone tried to talk you out of this? My wife, but thats purely for selfish reasons, so Id spend more time with her and the kids. I just think Ive got the money. Ive got a limited lifespan. Unlike Rupert Murdoch, I cant live to 150. I might as well spend the money Ive got doing something positive. We can certainly fund this without any problems, its no strain on me at all. All Ive got to do is write the check. Well, I want to do more than that. I want to be a bit of an inspiration to people and say, This is what you can do. I think its a great, a great project, and its so popular.
I know youre not worried about profit, but how much of your own money have you already spent? Were allocating at the moment a couple of hundred million dollars. And certainly theres more available. But youve got to remember the Titanic is a 60,000-ton vessel. Well, it was actually 48,000 originally, but one of the problems we had with the Titanic is that you have to make it safe. Youll remember, in the movie you had the guy in the crows nest saying Iceberg! That was because from the from the bridge, you couldnt see over the bow. We cant do that today. So we had to put a whole new deck in the Titanic. And its got a lot of the modern conveniences that you want. Were going to make sure that in every room therell be a little panel that will tell you the history of the person who occupied your cabin. Did they survive, did they prevail? Everyone will get a costume so that they can come up to dinner, and it will be a real experience for them. One of the worst experiences, of course, on the Titanic was delousing. They took the third class up on deck and sprayed them in their underpants and bras. So depending on the weather, well have delousing for our third class, too.
Are you interested in getting any outside financing, or do you just want to be in complete control? I dont really want to be in control so much, Im not that sort of person. But Ive got too much money. So I dont need any other money. We dont need to raise any funds. We dont need to take mums and dads money, if anyone loses any money, its [me], and Im happy to lose money at this age. We can make instant decisions about what we want to do without worrying about the consequences. We havent got to have a committee sits here and says, Oh, should we do this? What will the SEC say? Itll be a Covid vaccine-free environment.
Vaccine-free how? We wont have any. We dont believe people should be compelled. You might be aware of it, but I recently funded a case in Queensland where we had the vaccines declared unlawful because we believe that impeded on individual choice and freedom. And the courts agreed with us as well, the superior court so its the first in the world. That was another controversial thing. [Palmer put $2.5-$3 million toward a successful legal challenge brought by police and ambulance service workers who said they faced disciplinary action up to termination for refusing to comply with a vaccine mandate.]
But will vaccinated people be allowed on the ship? Yeah, weve got to extend our hand in love and friendship for people being vaccinated despite the side effects. We have to look after them. And theyre all good people. Were all the same really, like white, green, yellow, whatever it is to embrace each other.
This gets to something you said in your recent press conference, which is that the Titanic reflects traditional values instead of woke values. So can you explain what that means? Theres been a concept in society that you can cancel people. I think you know what I mean by canceled people, and we think thats a terrible concept. The United States was founded on the rights of men to be different. The diversity that weve had in our economy, in our intellectual development has really meant thats developed our society to a higher level. Im talking about Western society in general. So the French Revolution, the American Revolution, all those things were brought about by individuals [claiming] their rights to express an opinion or view. I mean, you should have the right to be wrong.
In that same press conference, it seems like you were also ready to argue with some of the journalists, or that you take issue with people who are skeptical of the project. Do the naysayers get you down? Doesnt get me down. I think the press are not relevant to me from that context. A lot of people go out to the press because they want to raise money or public support. Youve got to admire the journalist, because a journalists job is to create a bit of controversy. I dont need to have any bad feelings towards that, theyre just doing their job. If this was a project where public money was going into it, [there would be] a greater justification for journalists to be skeptical.
There are people who view the Titanic as a symbol of mankinds hubris. What would you say to that kind of thinking? Its up to everybody to decide for themselves, will they buy tickets, where they travel, whether its got value to them and their family. People really dont get a unified position on hardly anything. If you go to a communist regime, were supposed to have that, I guess. That might be enforced, not by free will. We want people and journalists to be free. I mean, look at New Zealand, all the television stations there are closing, theyll maybe have one government service. So its getting more and more like a Stalin situation. So thats not good. [Newshub, one of two free TV news stations in the country, will be shuttered in the coming months by owner Warner Bros. Discovery.] We need to respect and cherish all opinions, and society should benefit by that and get to the right decision. Thats how I look at it. Im not frightened of controversy.
No, I didnt get that impression. Youve said a lot of people are interested in this maiden voyage. Is there anyone you can share whos expressed an interest? James Cameron, maybe? He hasnt expressed an interest, I can tell you that. We previously had the great-granddaughter of the Unsinkable Molly Brown, who was on the Titanic and went around rescuing people in the lifeboats in the first World War, the U.S. Navy christened a ship after her. Weve had Bruce Ismay, who owned the White Star Line, his great-great grandson wants to be involved in the project and has given us support. Its a funny project. To go back into the past to appreciate it, to learn from it and realize that diversity is a good thing. And were slowly evolving as a race. We dont necessarily need to go to Mars to be happy. The pursuit of happiness is what we should be working for as a human civilization. That should be our top bar. And hopefully the Titanic will make a lot of people happy.
I understand what youre saying about wanting this project to be uplifting for the entire world. Has anyone ever made the argument to you that you could be spending this money in ways that more directly benefit people who are poor, unhoused, suffering in war zones? We do spend money on that. I spend millions of dollars on that more than I think you do. But one thing that you cannot take from anyone is the human spirit. And in one of these war zones, when youre down and out, youre up against it, you need to have a spirit that drives you on, something youre looking at [that shows] life can get better. That makes life worth living on this planet. The Titanic reinforces some of those values for all the world. Same as human thought, freedom of thought and things that stimulate the heart and soul are important. I dont know if that answers it. But its just as important as food. I realize Im contentious in the U.S. context.
Have you ever taken a submersible down to see the wreck of the Titanic? I wouldnt do it. No. Because from my point of view, I think thats a graveyard. And we dont want to exploit people who have died. I dont think it gets us anywhere, really. What were trying to do is to talk about life today, about people living now. Because its a pivotal time in history. I believe weve got to learn from how history repeats itself, time and again. Theres a time when humans were tested. They prevailed.
Youre talking about history repeating itself. We had this [OceanGate] submersible that went down last year, with everyone dying. Do you see a lesson in that, in trying to return to the past so directly? One thing about the Titanic was that it didnt have the safety controls that it should have. And you look at submersible, the same was true, that it didnt have the safety or certification it needed. I think its a message for all of us, that when we go into the unexpected, if were going to challenge nature, we need to do it in a responsible manner. We need to have our authorities checking these sort of things out. Their design wasnt what it should have been. If you look at James Cameron and other people who dive on the Titanic, theyre going in very safe submersibles. And, of course, why was that? [OceanGate] were trying to cut the budget and make more profit for the company. And thats the wrong thing to do.
Ive been noticing this painting over your shoulder. Can I ask what that boat is in the picture? Thats the Titanics sister ship, the Olympic. It became a hospital ship in World War II and was sunk by the Germans off the coast of Ireland. [The Olympic, originally a commercial vessel that served as a troop ship during WWI, was decommissioned in 1935. The Britannic, another sister vessel, served as a hospital ship in WWI and sank in 1916 off the coast of Greece after striking a German mine. Neither served in WWII.]
Is that story meaningful to you as well, the hospital ship? Again, its one of self-service. As I said, today youve got a lot of concerns, its going to be about the war in Ukraine, how its straining the U.S. economy. Same thing is happening in Gaza, people have a lot to be concerned about, and certainly what happened to Israel wasnt very good either. The message is weve got to realize that were all human beings. Weve all got the same needs. And basically, for me, its if youve got someone that loves you, somewhere we can sleep at night, with a good meal, the rest of its an illusion. Thats part of the message that we can send out with the Titanic. And, of course, weve also got a lot of people who make movies about Titanic that were talking to at the moment. This story is going to get bigger from here.
How many times have you seen the James Cameron movie? Ive only seen it twice. Molly Browns great-granddaughter was very grateful to him for reinvigorating it, bringing it to life. So I think hes done a great job. But it shouldnt be a competition between me and James Cameron, or someone else.
Well, I hope when Titanic II is built I can come and see it. Well have it in New York Harbor, so well reserve a position for you when it sails up the Hudson River. You can stand on the top deck and say, Wooo! King of the world!
Update March 28, 12:08am ET: This story has been updated to amend comments about the history of Titanic sister ships Olympic and Britannica.
Earlier this week, Robert F. Kennedy Jr. announced that his 2024 running mate will not be Aaron Rodgers or Jesse Ventura, but Silicon Valley lawyer (and Sergey Brin ex) Nicole Shanahan. What is there to know about Kennedys VP pick? For starters: At a time when in vitro fertilization is under serious threat, shes a major critic of the procedure that has helped millions of people become parents.
Politico reports that Shanahan has for years denounced IVF. In February, she told the Australian Financial Review that IVF is one of the biggest lies thats being told about womens health today. In a 2023 interview with The New Yorker, she told the outlet, Many of the I.V.F. clinics are financially incentivized to offer you egg freezing and I.V.F. and not incentivized to offer you other fertility services. In an essay for People published in 2022, she wrote I believe IVF is sold irresponsibly, and in my own experience with natural childbirth has led me to understand that the fertility industry is deeply flawed. While criticizing IVF, Shanahan has also called for research into things like sunlight exposure to help women have children. Im not sure that there has been a really thorough mitochondrial respiration study on the effects of two hours of morning sunlight on reproductive health. I would love to fund something like that, she said during a 2023 panel with the National Academy of Medicine, a group she had given $100 million. The statement was met with laughs, to which she responded: Yeah, lets do it...I just have an intuition that could be interesting and maybe work.
Elsewhere, it will perhaps not come as a surprise that Kennedys running mate has questions about vaccines, and takes umbrage with the term anti-vaxxer. Speaking to The New York Times earlier this year, she said I do wonder about vaccine injuries. While insisting she is not an anti-vaxxer, she told the outlet I think there needs to be a space to have these conversations. In an interview with Newsweek, she boldly suggested Kennedy is not anti-vaccine, despite the fact that, as CNN notes, Kennedy is among the most prominent vaccine skeptics in the country and, through his role as the head of Childrens Health Defense, has helped spread falsehoods about vaccines, including the claim that they can lead to injuries. In her interview with Newsweek, Shanahan said that she received a Moderna COVID-19 vaccine and a booster and later suffered from significant health issues. I dont know if theyre related, she said, but Id love to know.
Before Shanahan was officially added to the ticket, she was a major source of fundingand creative inputfor the Kennedy campaign ad that ran during the Super Bowl and was condemned by more than one member of the Kennedy family. Tony Lyons, a cochairman of the Kennedy-aligned super PAC that produced the commercialwhich recreated a vintage JFK political ad from 1960told the Times Shanahan was the driving force behind the decision to remake the spot.
Also, this is the one he can make money off of
Published 03-29-24
Submitted by Merck & Co., Inc.
Vaccines are one of the most significant public health achievements in modern history, playing a vital role in helping to prevent certain infectious diseases and protect communities across the globe.
Unfortunately, the COVID-19 pandemic brought forth a new set of challenges in sustaining vaccination efforts for other preventable diseases highlighting existing disparities and inequalities in access to health care and underscoring the urgent need for action.
In two op-eds for Devex, an independent news organization covering global development, Drew Otoo, Pharm.D., president of global vaccines, Merck, and Alfred Saah, M.D., executive director of scientific affairs, Merck, highlighted some of the ways the company is working to address these challenges at the global, national and local levels.
Collaborating to help increase health equity
Otoo said collaboration across sectors is key to building trust, enabling equity and establishing stronger, more resilient vaccination programs.
Now more than ever, we have an opportunity to evaluate and strengthen our approach Together, we can help create a more equitable future where vaccines are available to and accepted by all who can benefit from them.
Drew Otoo, Pharm.D. President of global vaccines, Merck
Otoo shared examples of Merck's work with local and global stakeholders to develop tailored approaches to improve vaccine confidence and supply vaccines for communities that might otherwise be without them:
Combating vaccine hesitancy and building trust
Saah emphasized Merck's commitment to addressing vaccine hesitancy (the reluctance or refusal to vaccinate despite the availability of vaccines) and building confidence at local, national and global levels.
By understanding the knowledge gaps and prioritizing strategies that strengthen how we communicatewe can potentially combat vaccine hesitancy, improve vaccine confidence and make a difference in global public health.
Alfred Saah, M.D. Executive director of scientific affairs, Merck
Despite the well-documented benefits of vaccines, hesitancy is a longstanding public health issue that can result in under-vaccination and global disease outbreaks. The reasons behind vaccine hesitancy are often connected to the 3Cs Model, defined by a World Health Organization strategic advisory group:
Saah shared some of Merck's efforts to improve vaccine confidence, which include:
Continuing to improve vaccine access
Despite the challenges ahead, both Saah and Otoo are optimistic about the future.
Combating vaccine hesitancy is not an easy feat and has been a challenge our global society has faced for centuries, wrote Saah. However, these challenges bring new opportunities to improve our approach and be better advocates for ourselves, our families and our communities.
By going where the need exists and continuing to invest in innovative, strategic and diverse collaborations, I'm confident we'll find new ways to solve complex public health problems.
Drew Otoo
Learn more about how collaborations can help yield stronger vaccination programs.
View original content here.
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Liaw YF. Antiviral therapy of chronic hepatitis B: opportunities and challenges in Asia. J Hepatol. 2009;51:40310.
Article PubMed Google Scholar
Moucari R, Korevaar A, Lada O, Martinot-Peignoux M, Boyer N, Mackiewicz V, Dauvergne A, Cardoso AC, Asselah T, Nicolas-Chanoine MH, et al. High rates of HBsAg seroconversion in HBeAg-positive chronic hepatitis B patients responding to interferon: a long-term follow-up study. J Hepatol. 2009;50:108492.
Article CAS PubMed Google Scholar
Kim GA, Lim YS, An J, Lee D, Shim JH, Kim KM, Lee HC, Chung YH, Lee YS, Suh DJ. HBsAg seroclearance after nucleoside analogue therapy in patients with chronic hepatitis B: clinical outcomes and durability. Gut. 2014;63:132532.
Article CAS PubMed Google Scholar
Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr., Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67:156099.
Article PubMed Google Scholar
EASL. 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol 2017, 67:370398.
Li MH, Yi W, Zhang L, Lu Y, Lu HH, Shen G, Wu SL, Hao HX, Gao YJ, Chang M, et al. Predictors of sustained functional cure in hepatitis B envelope antigen-negative patients achieving hepatitis B surface antigen seroclearance with interferon-alpha-based therapy. J Viral Hepat. 2019;26(Suppl 1):3241.
Article CAS PubMed Google Scholar
Wu Y, Liu Y, Lu J, Cao Z, Jin Y, Ma L, Geng N, Ren S, Zheng Y, Shen C, Chen X. Durability of Interferon-induced Hepatitis B Surface Antigen Seroclearance. Clin Gastroenterol Hepatol. 2020;18:514e516512.
Article PubMed Google Scholar
Huang D, Wu D, Wang P, Wang Y, Yuan W, Hu D, Hu J, Wang Y, Tao R, Xiao F, et al. End-of-treatment HBcrAg and HBsAb levels identify durable functional cure after Peg-IFN-based therapy in patients with CHB. J Hepatol. 2022;77:4254.
Article CAS PubMed Google Scholar
Zeng QL, Yu ZJ, Shang J, Xu GH, Sun CY, Liu N, Li CX, Lv J, Liu YM, Liang HX, et al. Short-term Peginterferon-Induced High Functional Cure Rate in Inactive Chronic Hepatitis B Virus Carriers with Low Surface Antigen levels. Open Forum Infect Dis. 2020;7:ofaa208.
Article PubMed PubMed Central Google Scholar
Wu F, Wang Y, Cui D, Tian Y, Lu R, Liu C, Li M, Li Y, Gao N, Jiang Z et al. Short-term Peg-IFN -2b Re-treatment Induced a high functional cure rate in patients with HBsAg recurrence after stopping Peg-IFN -Based regimens. J Clin Med 2023, 12.
Cao Z, Liu Y, Ma L, Lu J, Jin Y, Ren S, He Z, Shen C, Chen X. A potent hepatitis B surface antigen response in subjects with inactive hepatitis B surface antigen carrier treated with pegylated-interferon alpha. Hepatology. 2017;66:105866.
Article CAS PubMed Google Scholar
Wu YL, Shen CL, Chen XY. Antiviral treatment for chronic hepatitis B: safety, effectiveness, and prognosis. World J Clin Cases. 2019;7:178494.
Article PubMed PubMed Central Google Scholar
Pan CQ, Li MH, Yi W, Zhang L, Lu Y, Hao HX, Wan G, Cao WH, Wang XY, Ran CP, et al. Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens. Liver Int. 2021;41:1498508.
Article CAS PubMed Google Scholar
Song A, Wang X, Lu J, Jin Y, Ma L, Hu Z, Zheng Y, Shen C, Chen X. Durability of hepatitis B surface antigen seroclearance and subsequent risk for hepatocellular carcinoma: a meta-analysis. J Viral Hepat. 2021;28:60112.
Article PubMed PubMed Central Google Scholar
Jiang S, Cai M, Zhang Z, Qian C, Wang J, Li Z, Guo Q, Zhou H, Xin H, Cai W et al. The potential effect of HBV vaccination on off-treatment HBsAg reversion after interferon-induced HBsAg clearance. Hum Vaccin Immunother 2023:2161254.
Liu Y, Ren S, Ma L, Lin X, Li H, Lu J et al. Clinical study of hepatitis B vaccine in achieving hepatitis B surface antibody seroconversion in patients with functional cure. Braz J Infect Dis, 2023:103703.
Wu ZQ, Tan L, Gan WQ, Mo ZS, Chen DB, Wang PP, Zhao QY, Xie DY, Gao ZL. The relationship between the clearance of HBsAg and the remodeling of B cell subsets in CHB patients treated with Peg-IFN-. Ann Transl Med. 2021;9:414.
Article CAS PubMed PubMed Central Google Scholar
Xu X, Shang Q, Chen X, Nie W, Zou Z, Huang A, Meng M, Jin L, Xu R, Zhang JY, et al. Reversal of B-cell hyperactivation and functional impairment is associated with HBsAg seroconversion in chronic hepatitis B patients. Cell Mol Immunol. 2015;12:30916.
Article CAS PubMed PubMed Central Google Scholar
Bertoletti A, Ferrari C. Adaptive immunity in HBV infection. J Hepatol. 2016;64:S7183.
Article CAS PubMed Google Scholar
Salimzadeh L, Le Bert N, Dutertre CA, Gill US, Newell EW, Frey C, Hung M, Novikov N, Fletcher S, Kennedy PT, Bertoletti A. PD-1 blockade partially recovers dysfunctional virus-specific B cells in chronic hepatitis B infection. J Clin Invest. 2018;128:457387.
Article PubMed PubMed Central Google Scholar
Wu YC, Kipling D, Leong HS, Martin V, Ademokun AA, Dunn-Walters DK. High-throughput immunoglobulin repertoire analysis distinguishes between human IgM memory and switched memory B-cell populations. Blood. 2010;116:10708.
Article CAS PubMed PubMed Central Google Scholar
Vsquez C, Franco MA, Angel J. Rapid Proliferation and differentiation of a subset of circulating IgM Memory B cells to a CpG/Cytokine stimulus in Vitro. PLoS ONE. 2015;10:e0139718.
Article PubMed PubMed Central Google Scholar
McHeyzer-Williams LJ, Milpied PJ, Okitsu SL, McHeyzer-Williams MG. Class-switched memory B cells remodel BCRs within secondary germinal centers. Nat Immunol. 2015;16:296305.
Article CAS PubMed PubMed Central Google Scholar
Rinaldi S, Pallikkuth S, George VK, de Armas LR, Pahwa R, Sanchez CM, Pallin MF, Pan L, Cotugno N, Dickinson G, et al. Paradoxical aging in HIV: immune senescence of B cells is most prominent in young age. Aging. 2017;9:130725.
Article CAS PubMed PubMed Central Google Scholar
Weinstein JS, Bertino SA, Hernandez SG, Poholek AC, Teplitzky TB, Nowyhed HN, Craft J. B cells in T follicular helper cell development and function: separable roles in delivery of ICOS ligand and antigen. J Immunol. 2014;192:316679.
Article CAS PubMed Google Scholar
Zhang L, Li H, Ren H, Hu P. Circulating PD-1(hi)CXCR5(+)CD4(+) T cells are associated with a decrease in hepatitis B surface antigen levels in patients with chronic hepatitis B who are receiving peginterferon- therapy. Mol Immunol. 2018;103:2708.
Article CAS PubMed Google Scholar
Liu Y, Hu X, Hu X, Yu L, Ji H, Li W, Cai Y, Cheng G, Jiang Y. T follicular helper cells improve the response of patients with chronic hepatitis B to interferon by promoting HBsAb production. J Gastroenterol. 2022;57:3045.
Article CAS PubMed Google Scholar
Bentebibel SE, Khurana S, Schmitt N, Kurup P, Mueller C, Obermoser G, Palucka AK, Albrecht RA, Garcia-Sastre A, Golding H, Ueno H. ICOS(+)PD-1(+)CXCR3(+) T follicular helper cells contribute to the generation of high-avidity antibodies following influenza vaccination. Sci Rep. 2016;6:26494.
Article CAS PubMed PubMed Central Google Scholar
Heit A, Schmitz F, Gerdts S, Flach B, Moore MS, Perkins JA, Robins HS, Aderem A, Spearman P, Tomaras GD, et al. Vaccination establishes clonal relatives of germinal center T cells in the blood of humans. J Exp Med. 2017;214:213952.
Article CAS PubMed PubMed Central Google Scholar
Xing M, Feng Y, Yao J, Lv H, Chen Y, He H, Wang Z, Hu C, Lou X. Induction of peripheral blood T follicular helper cells expressing ICOS correlates with antibody response to hepatitis B vaccination. J Med Virol. 2020;92:6270.
Article CAS PubMed Google Scholar
Chekol Abebe E, Asmamaw Dejenie T, Mengie Ayele T, Dagnew Baye N, Agegnehu Teshome A, Tilahun Muche Z. The Role of Regulatory B Cells in Health and diseases: a systemic review. J Inflamm Res. 2021;14:7584.
Article PubMed PubMed Central Google Scholar
Sanaei MJ, Nahid-Samiei M, Abadi MSS, Arjmand MH, Ferns GA, Bashash D, Rahimian G, Bagheri N. New insights into regulatory B cells biology in viral, bacterial, and parasitic infections. Infect Genet Evol. 2021;89:104753.
Article CAS PubMed Google Scholar
Fu B, Wang D, Shen X, Guo C, Liu Y, Ye Y, Sun R, Li J, Tian Z, Wei H. Immunomodulation Induced during Interferon- therapy impairs the Anti-HBV Immune Response through CD24(+)CD38(hi) B cells. Front Immunol. 2020;11:591269.
Article CAS PubMed PubMed Central Google Scholar
Gong Y, Zhao C, Zhao P, Wang M, Zhou G, Han F, Cui Y, Qian J, Zhang H, Xiong H, et al. Role of IL-10-Producing Regulatory B cells in Chronic Hepatitis B Virus infection. Dig Dis Sci. 2015;60:130814.
Article CAS PubMed Google Scholar
Krber N, Pohl L, Weinberger B, Grubeck-Loebenstein B, Wawer A, Knolle PA, Roggendorf H, Protzer U, Bauer T. Hepatitis B Vaccine Non-responders Show Higher frequencies of CD24(high)CD38(high) Regulatory B cells and lower levels of IL-10 expression compared to responders. Front Immunol. 2021;12:713351.
Article PubMed PubMed Central Google Scholar
Bolther M, Andersen KLD, Tolstrup M, Visvanathan K, Woolley I, Skinner N, Millen R, Warner N, stergaard L, Jensen-Fangel S. Levels of regulatory B cells do not predict serological responses to hepatitis B vaccine. Hum Vaccin Immunother. 2018;14:14838.
Article PubMed PubMed Central Google Scholar
McHeyzer-Williams LJ, McHeyzer-Williams MG. Antigen-specific memory B cell development. Annu Rev Immunol. 2005;23:487513.
Article CAS PubMed Google Scholar
Islam M, Kumar K, Sevak JK, Jindal A, Vyas AK, Ramakrishna G, Kottilil S, Sharma MK, Sarin SK, Trehanpati N. Immune drivers of HBsAg loss in HBeAg-negative CHB patients after stopping nucleotide analog and administration of Peg-IFN. Hepatol Commun 2023, 7.
Doede AM, Kannegieter N, ztrk K, van Loveren H, Janssen R, Buisman AM. Higher numbers of memory B-cells and Th2-cytokine skewing in high responders to hepatitis B vaccination. Vaccine. 2016;34:22819.
Article PubMed Google Scholar
ASCO Updates Vaccination Guidelines for Patients With Cancer
The American Society of Clinical Oncology (ASCO) published an updated guideline, which recommends certain vaccinations for patients with cancerboth solid and hematologic malignanciesto address their increased infection risks.1
For adult patients of all ages, the guideline recommends:
For patients aged 60 or older, the guideline recommends:
We want to document vaccination status at the first patient visit and provide recommended vaccines that might be needed as quickly as possible within the parameters of optimal oncology carerecognizing that we do not want to impede or impinge upon care, said Elise C. Kohn, MD, of the Cancer Therapy Evaluation Program at the National Cancer Institute, and guideline cochair, in a press release.2These vaccinations have very limited if no potential harm, but the potential benefits are significant.
Further, patients aged 19 to 26 are eligible for 3 doses of the HPV vaccine. The guidelines advise shared decision making for patients 27 to 45 when considering the HPV vaccine.1
For patients undergoing chemotherapy, immunotherapy, hormonal treatment, radiation, or surgery, ASCO notes that vaccinations should precede planned cancer treatment by 2 to 4 weeks; however, it is safe for these patients to receive inactivated vaccines during or after treatment.
ASCO has additional recommendations for patients undergoing hematopoietic stem cell transplantation (HSCT), CD19 chimeric antigen receptor (CAR) T-cell therapy, or B-cell depleting therapy.
According to ASCO, patients receiving HSCT should undergo complete revaccination 6 to 12 months following HSCT, and live attenuated vaccines should be delayed for at least 2 years. Patients should only receive live attenuated vaccines if there is no presence of graft-vs-host disease or immunosuppression. COVID-19, influenza, and pneumococcal vaccines can be administered by 3 months posttransplant.
Patients undergoing CAR T-cell therapy can receive influenza and COVID-19 vaccines as early as 3 months after therapy is complete, and inactivated vaccines can be administered 6 months after treatment. However, ASCO notes that the evidence quality for this recommendation is very low, and the recommendation is weak.
Notably, COVID-19 is the only revaccination required for patients undergoing B-cell depletion therapy. It can be administered as early as 6 months after treatment.
ASCO adds that all household members who have close contact with patients with cancer should be fully up to date on vaccinations when feasible.
ASCO recommends that patients who are traveling outside the US follow the CDC standard recommendations for the destination. The organization notes that hepatitis A, intramuscular typhoid, inactivated polio, hepatitis B, rabies, meningococcal, and inactivated Japanese encephalitis vaccines are safe to receive.
Long-term survivors of hematologic malignancies with or without active disease who have B-cell dysfunction, hypogammaglobulinemia, or B-cell lineage malignancies, should still receive the recommended inactivated vaccines; however, ASCO notes that patients responses may be attenuated.
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