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Theres been a lot of chatter about mpox online right now, so its understandable to have questions. As you might remember, mpox (formerly known as monkeypox) was a big concern in 2022 when it began spreading in the United States and other parts of the world. But that outbreak was contained with the help of the mpox vaccine, and the viral infection has since remained at low levels in the country.
While thats still the case, the
Given that its only been a few years since we lived through the COVID-19 pandemic, it makes sense to have concerns. Heres what you need to know, according to an infectious disease doctor.
Meet the expert: Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York.
Mpox is a disease caused by the monkeypox virus. It causes similar symptoms to smallpox, but they tend to be less severe, per the WHO.
Mpox was practically unheard of in the United States before 2022, but the outbreak that happened in the country two years ago led to thousands of cases here. Since then, mpox has circulated in very low levels in the U.S. (around six to seven cases a day), according to data from the Centers for Disease Control and Prevention (CDC).
While mpox is pretty rare in the U.S., its more common in central and west Africa, per the WHO. Two clades (types) of mpox have emerged: clade I and clade II. Clade II is the type responsible for the 2022 outbreak, but it tends to cause less severe illness than clade I, which is the type behind the current outbreak in Africa.
As for why the WHO declared a global health emergency, its to limit the spread beyond Africa and help those currently infected on the continent.
The emergence of a new clade of mpox, its rapid spread in eastern DRC, and the reporting of cases in several neighboring countries are very worrying, said WHO Director-General Tedros Adhanom Ghebreyesus, PhD, in a statement. On top of outbreaks of other mpox clades in DRC and other countries in Africa, its clear that a coordinated international response is needed to stop these outbreaks and save lives.
Currently, this is "an opportunity to curtail the spread of this disease to continents outside of Africa," Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, tells Women's Health. As of now, theres just been one reported case in Sweden, and public health officials are hoping to keep it that way.
Certainly, if we pool our resources as a world to help countries that are overwhelmed with these cases, it will hopefully curtail the spread, Russo says.
Russo is not concerned with this turning into another COVID-19-style pandemic. Mpox is not as readily transmissible as agents capable of causing a pandemic, he says.
Mpox is usually transmitted through close contact, including skin-to-skin contact and sexual contact, he points out. In the U.S., those at high risk of mpox have been identified as men who have sex with men; some people in this group were already vaccinated against mpox during the 2022 outbreak, which can also help to limit the spread, Russo says.
Russo does not expect mpox to cause another lockdown. While there is some data to suggest that mpox can be airborne, its certainly not the main driver of spread, Russo says.
Overall, Russo recommends that people not panic over mpox just yet. The world is still suffering from post-traumatic COVID pandemic syndrome, he adds.
Korin Miller is a freelance writer specializing in general wellness, sexual health and relationships, and lifestyle trends, with work appearing in Mens Health, Womens Health, Self, Glamour, and more. She has a masters degree from American University, lives by the beach, and hopes to own a teacup pig and taco truck one day.
WASHINGTON (TND) A new mRNA vaccine is being tested on cows and dairy workers in an attempt to deal with the global bird flu outbreak.
FLCCC Alliance Senior Fellow Dr. Brooke Miller says that research into how these vaccines affect food sources and agricultural practices has been very opaque and more needs to be done to see how a consumer may be affected.
For more on how Miller is calling for transparent review before these vaccines go into livestock, watch the video player above or visit The National Desks YouTube channel for his full interview.
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Pfizer and BioNTech have announced that a Phase III trial studying their investigational combination mRNA vaccine for the treatment of influenza and Covid-19 has failed to meet one of its two primary endpoints.
While the vaccine demonstrated a trend of higher responses in neutralising the influenza A strain compared to a licensed influenza vaccine, it failed to demonstrate non-inferiority against the influenza B strain in geometric mean titers (GMT) and seroconversion, as per a 16 August press release. Additionally, data indicated that the combination vaccine showed comparable responses for SARS-CoV-2 when compared to Pfizers licensed approved Covid-19 vaccine, Comirnaty (tozinameran).
The randomised, parallel assignment Phase III study (NCT06178991) enrolled over 8,000 adults aged 18 to 64 years old to evaluate the safety, tolerability, and immunogenicity of a single dose of the combined vaccine for protection against influenza and Covid-19. No new safety signals were found in the Phase III study.
Todays results provide insight and direction towards achieving this goal, and we remain optimistic about our combination Covid-19 and influenza program, for which we are evaluating the next steps, said Annaliesa Anderson, PhD, Senior Vice President and Head, Vaccine Research and Development at Pfizer.
Comirnaty, which gained full approval from the US Food and Drug Administration (FDA) in August 2021, is indicated for use in individuals aged 12 years and older for protection against Covid-19. The vaccine achieved peak sales of $42.4bn in 2022. However, there has been a decline in Covid-19 revenues in recent times, with pharma scrambling to make up the deficits.
In May, Pfizer announced a cost reduction programme to combat declining Covid-19 revenues, which was expected to save the company approximately $1.5bn by 2027. This measure came after the company announced in October 2023 that it would implement a $3.5bn cost-saving programme to combat a $5.5bn non-cash charge after the US government returned nearly eight million courses of the companys Covid-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir).
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However, mRNA Covid-19 vaccines could continue to be in the news as the FDAs Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to update the existing Covid-19 vaccines, including Comirnaty, to target the JN.1 variant. Aside from Pfizers Comirnaty, the FDA has granted traditional approval to Modernas SpikeVax (elasomeran).
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A recent study found that the Fluad MF59-adjuvanted influenzavaccine (aTIV) was more effective than the high-dose flu vaccine (HD-TIV) at preventing severe respiratory complications in older adults with risk factors.
Published inOpen Forum Infectious Diseases on August 16, 2024, the study included 1,115,725 aTIV and 2,561,718 HD-TIV recipients. For the primary outcome, the analysis found comparable effectiveness between aTIV and HD-TIV (rVE [95% CI]: 5.2% [-5.915.1]) among those with 0 risk factors, whereas aTIV was more effective than HD-TIV among patients with 1, 12, or 3 risk factors (12.5% (10.015.0), 18.4% (13.722.9), and 10.4% (7.413.3), respectively).
The same trends were observed for the secondary outcomes.
Previous studies have found the two vaccines to be similar in effectiveness in older adults.
The Fluad vaccinehas an extensiveclinical legacy and has been licensed in 30 countries since its first approvalin 1997. Fluad is available at most pharmacies in the U.S. for the 2024-2025 flu season.
Jeremy Faust is editor-in-chief of MedPage Today, an emergency medicine physician at Brigham and Women's Hospital in Boston, and a public health researcher. He is author of the Substack column Inside Medicine. Follow
Emily Hutto is an Associate Video Producer & Editor for MedPage Today. She is based in Manhattan.
In part 2 of this Instagram Live discussion, MedPage Today editor-in-chief Jeremy Faust, MD, Katelyn Jetelina, PhD, MPH, and Katrine Wallace, PhD, talk about the science and anxiety surrounding a potential H5N1, or avian flu, pandemic.
Jetelina is the author of "Your Local Epidemiologist" newsletter. Wallace is with the School of Public Health at the University of Illinois at Chicago.
Watch part 1 of this interview here, where they discuss the recent rise in measles cases in the U.S.
The following is a transcript of their remarks:
Faust: I do want to move on to threat number two, H5N1 -- bird flu, avian influenza.
Just to let everyone know if they haven't gone to virology camp, seasonal flu is one thing. Year to year, there can be changes in the genetic code -- that's called antigenic drift -- but then if you have a complete swap out of a big, huge chunk of the genetic material, that's called shift.
And that usually happens and that does happen when you combine maybe one part of a flu from a bird with maybe a human flu virus, and they intermingle and out comes a new version of this virus, which we don't have any sort of immune memory to. And so H5N1 could be one of these highly pathogenic avian influenzas. That's the setup.
Again, I'll start with Dr. Wallace. What do we know about this virus, this H5N1?
Wallace: Obviously people have probably heard that we've had some human cases, all of which have been people that work directly with either poultry or dairy cattle. So there hasn't been any person-to-person spread of this virus. It doesn't seem like it's very good at spreading between people. It hasn't achieved the kind of mutations it would need to do that, so that's good.
But what I find to be a little surprising is that we're not doing a whole lot of surveillance on cattle unless they're being moved across state lines, which is the law, but we're not really doing a whole lot of active surveillance here. There's been some testing of people, but I think only like 60 people have been tested for it or something like that.
So it makes me a little bit nervous that we don't have a handle, really, on the numbers that we would need to have.
Everybody's worried that it might become like the next pandemic, and you keep seeing headlines like that. I don't think that this virus, on its own, will probably become that.
I could be wrong obviously, but what worries me is, like you're saying, one of these shift situations where a person who's working in one of these farms who has influenza already gets a co-infection with this H5N1 and then has some kind of recombinant virus that can then lead to it being more transmissible in humans.
That's what worries me about it. That's why I feel like we need to be doing a little bit more surveillance to make sure that doesn't happen.
Faust: You said that very clearly, but just to repeat something and add to it -- the way that these major pandemic-potential bugs emerge in flu is just as you said, a co-infection, so that something that's spreading through humans but is causing a normal amount of influenza disease -- which is not a good thing, but nor is it a 1918 situation -- but it's spreading in the way we would see in December and January. Imagine combining that degree of spread with the ability to cause disease that is on a 1918 level or a COVID level, and now you've got a problem.
What's interesting is, as you said, we're not seeing a human-to-human spread, but shots on goal, right? I mean, if this happens during flu season, a co-infection with a highly contagious but otherwise run of the mill flu, it could be a real shit show. I don't usually swear on these things, but I just feel like that's what we're dealing with here.
Dr. Jetelina, you are plugged into a lot of organizations and healthcare leaders that are watching this. What's the mood on the inside?
Jetelina: What's the mood on the inside? I think it depends who you ask. I think there are really two big camps here. One, that they don't believe that this is going to turn into a pandemic. And the other, that is "Let's prepare for the worst and hope for the best."
I think I'm more in the camp of "Let's prepare for the worst and hope for the best." The probability of this turning into a massive pandemic is small, like about 2% to 5% --
Faust: But that sounds big to me! That sounds huge!
Jetelina: But if we catch it, we have some huge implications to that, right? Especially since we think H5N1 is more deadly than COVID-19 or even seasonal flu that we see.
I think there's also a lot of frustration. Just like Dr. Wallace said, we feel like we can be doing more, we should be doing more. The really huge challenge with H5N1 is you have other groups, because this is a one health problem, it has animals and has humans and has a virus. So you have to get all these people talking on the same level.
The challenge is that they have different priorities. They have different legal authority, they have conflicts of interest -- it's election year, and a lot of these outbreaks are happening in swing states. I mean, it's really hard to watch, especially coming off the heels of a COVID pandemic.
So I don't know, I guess we'll see what happens. I am concerned about fall, I'm concerned about these mixing vessels that you guys are talking about. We know that pigs are mixing vessels, but we haven't seen H5 in pigs yet. We don't know if cows are mixing vessels, they certainly could be, because they have both receptors to bird and human. And then there's of course just humans working very closely to cows that could have influenza at the same time they go to work and you get a mixing vessel.
So I don't know how to answer that question other than, there's a lot of mixed feelings right now.
Faust: We had a question just now in the chat from Dr. Marcio Nehab about how long does it take to produce a big amount of vaccines for bird flu? And I think that's a great question to tackle.
First of all, I want to preface this by saying that one of the things that went well in the COVID experience was Operation Warp Speed. That was our effort to get a vaccine out, and there were a couple of things that made that work.
One was to sort of combine phase one and phase two and to get phase three going really quickly.
Another thing that helped -- which was not even a matter of the policy of Operation Warp Speed, but just the situation -- was that a lot of times vaccine trials take a long time because you don't have enough cases. Unfortunately, in the COVID experience, we had plenty of cases, right? So we got data. We usually would've expected it would take 10 years to get as many cases for a pathogen that we're interested in preventing. It took a few months.
But the third thing that was so important that gets to this question is that the companies got permission to start making the vaccine before we knew it worked. Meaning [the companies] were going to be made whole, the government was going to pay Moderna, in our case, and then Pfizer. Even if it didn't work, they were going to get paid for that stuff. That way if it did work, we didn't have to build up and spend months and months producing this stuff.
Do we have any idea of how long it would take to get 10,000 doses of a new vaccine, and then a million, and then a hundred million?
Wallace: What I do know is that Moderna has entered into the same type of deal with the NIH to develop a bird flu vaccine here in the U.S. So that's at least being worked on, it's already underway. And I guess they're trying to do it pretty quickly because flu season is coming up.
Faust: I'd forgotten about that. $176 million, right? It's funny how many news cycles ago that was. I forgot! I know. But I actually don't know, and maybe you don't either, whether that money is purely "Just go make the stuff and test it," or is part of that "If it works, make us a couple million doses, then if that works, do that a hundred times."
Wallace: I don't know.
Faust: Yeah. But I think that Warp Speed showed that principle at work, which is that we could get it done in 100 or 150 days.
Jetelina: Yeah. I'll add to that we already are manufacturing vaccines. We'll have 5 million ready in August. Those aren't mRNA vaccines, they're your traditional types of vaccines, but that's a really big difference from COVID is that we're not starting from zero. We actually know a whole lot about H5N1. In fact, we know exactly where it needs to mutate so we start seeing human-to-human transmission. So I think that we're already ahead.
The other thing that we have in place is we already have a massive system in place to manufacture and distribute flu vaccines. So we just need to figure out what's that "oh shit" line where we start integrating it into our full flu vaccine pipeline. That gives me a little hope.
The challenge is that like we just saw with COVID-19, vaccines aren't everything. It's not going to fix it. We actually don't know how well a H5N1 vaccine would work once it mutates to humans. We don't know how much prior immunity to flu will help. We have a lot of unanswered questions.
And so, I urge people not to just say, "Hey, we will have a vaccine. We'll be fine." Because it can turn into quite a disaster quickly.
Faust: There's a good question someone here has. Dr. Jetelina, when you say a 2% to 5% chance of becoming a pandemic, what's the timeframe of that over the next year or the next 20 years?
Jetelina: Every year. So every year we have about a 2% chance of any pandemic hitting. Now, with H5 and it's spreading in cows and we're close to cows and humans are getting infected, that increases the probability a little. So that's why I say 5% to 7%. I haven't done the math, but that's just my back of the napkin guess.
Faust: Right. It's funny you mentioned like the two moods, when people are more hopeful or more measured. But it seems to me like the cautionary principle is often invoked in a weird way that means alarmism. I think this is a good example of the precautionary principle being important.
Like you and me, we don't have to act like there's bird flu in our neighborhood right now, but there are farmers and surveillance workers who do. And so I think the action items aren't for the average person right now. The action items are for public health officials and people working in the cattle and bird space.
Jetelina: Right. And I actually think that's a really important distinction that leaders aren't really making that much clearer. Because there's a time when epidemiologists and virologists freak out, right? That's kind of now. We're like, "This is not great. Red flag, red flag," but that doesn't translate to "red flag, red flag" to the general public because there's no action for them to do. And the problem coming off the heels of COVID is that red flag for epidemiologists was directly translated to red flag for the general public.
But this is a very different situation right now, and I think we could do better communicating that disconnect so people don't feel fear or anxiousness or hopelessness. Because literally, their risk is low and there's nothing that they can do unless they're working on farms.
Faust: Right. And I think that the risk is low thing, that's very much a today thing. That's like the weather forecast. The risk of rain today is low here, but the risk of rain next month is high.
Key Takeaways
Shares of Pfizer (PFE) and American depositary receipts (ADRs) of BioNTech (BNTX) dropped in intraday trading Friday following disappointing results from a late-stage study of the drugmakers' combined COVID-19 and flu vaccine in adults.
The companies reported that just one of two endpoints was reached in a Phase 3 trial of the experimental treatment which used the Pfizer-BioNTech COVID-19 drug and Pfizers flu medicine. While positive responses to COVID-19 and influenza A viruses were seen, they were not for influenza B.
The companies said they are "evaluating adjustments to the candidate" and will discuss the results with health officials.
BioNTech Chief Executive Officer (CEO) Dr. Ugur Sahin explained that both firms are "dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases," and that the insights gained from this trial "are highly valuable and will play a crucial role in guiding the further development."
Included in the announcement was an update on a Phase 2 study of Pfizer's experimental second-generation trivalent influenza mRNA vaccine, which the drug maker said "showed encouraging data demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine."
Pfizer shares, which began the day roughly flat for the year, and BioNTech ADRs slipped 1.9% and 2.9%, respectively, as of 1:30 p.m. ET Friday. BioNTech ADRs are down about 20% in 2024.
Dive Brief:
Pfizer and BioNTech are in a race with rival Moderna to develop vaccines that can simultaneously protect against multiple respiratory viruses, hoping the convenience of one shot will spur an uptick in flagging immunizations.
The undertaking has proven difficult, forcing the makers of mRNA shots to search for doses that are potent against multiple pathogens while minimizing side effects. The eventual financial reward is also unclear, as the timing of COVID and flu spikes arent currently lining up, complicating the utility of a single shot at a particular time, Evercore ISI analyst Umer Raffat wrote in a research note.
Both groups have found trouble with influenza B viruses, which are less common than their A counterparts.
For example, Modernas initial flu vaccine struggled against influenza B before adjustments led to the success of a combination shot in a Phase 3 trial earlier this year. Pfizer last year reporteda flu-only shot also failed to generate a sufficient immune response against influenza B, and on Friday reported similar issues with its combination vaccine.
Those stumbles could leave the door open for Sanofi and Novavax, which this year partnered to develop a protein-based combination vaccine. Leerink Partners analyst David Risinger noted that dose optimization is well-characterized with those shots, potentially making their path through testing less complicated.
Still, Pfizer and BioNTechintend to press forward with combination shots. On Friday, executives from both companies claimed theyre committed to pursuing multi-pronged vaccines. Todays results provide insight and direction towards achieving this goal, said Annaliesa Anderson, Pfizers head of vaccine R&D, in the statement.
We are dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases, added BioNTech CEO Ugur Sahin.
Theyre also still working on a vaccine only directed at the flu. A Phase 2 study of a new trivalent shot spurred a meaningful immune response against influenza B. By that measure, it also surpassed an existing shot against influenza A, the companies said.
Pfizer and BioNTech have announced top-line results from a late-stage study of their mRNA-based combination vaccine for influenza and COVID-19.
The partners have been evaluating the candidate against a licensed flu vaccine and their own licensed COVID-19 vaccine given at the same visit in more than 8,000 healthy adults aged 18 to 64 years.
The trial met one of its two primary immunogenicity endpoints, with a single dose of the combination candidate demonstrating comparable responses against SARS-CoV-2 versus the companies COVID-19 vaccine.
Despite eliciting higher influenza A immune responses compared to the standard flu vaccine comparator, the combination candidate showed weaker results against the influenza B strain.
The companies said they are now evaluating adjustments to the vaccine aimed at improving immune responses against influenza B and will discuss next steps with health authorities.
The combined vaccine approach could alleviate the impact of both COVID-19 and flu while offering a combined administration, potentially simplifying immunisation practices for healthcare providers and patients.
Annaliesa Anderson, senior vice president and head, vaccine research and development at Pfizer, said: We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this.
[These] results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza programme, for which we are evaluating the next steps.
Ugur Sahin, chief executive officer and co-founder of BioNTech, added: The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizers and our combination vaccine programme against influenza and COVID-19.
The announcement comes just two months after Moderna shared positive phase 3 results for its own flu/COVID-19 combination vaccine candidate.
The immune responses from a single dose of mRNA-1083 were found to be non-inferior to the flu and COVID-19 vaccine comparators co-administered in the study, with the candidate also demonstrating statistically significantly higher immune responses against three influenza virus strains and against SARS-CoV-2.
