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FDA’s Peter Marks to Congress: Youngest kids vaccine won’t need to hit 50% efficacy mark

The FDA’s top vaccine leader told a congressional committee on Friday afternoon that although the adult vaccines had to meet a 50% threshold for efficacy…

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The FDA’s top vaccine leader told a congressional committee on Friday afternoon that although the adult vaccines had to meet a 50% threshold for efficacy against Covid-19 infections, that same standard will not need to be met for the vaccines for the youngest group of children, for which a vaccine is not yet available.

The agency is currently reviewing data from Moderna’s two-shot vaccine for this youngest group as it awaits further data from Pfizer on its potential three-dose shot. The agency previously scheduled and then canceled an adcomm to review data on two doses of Pfizer’s vaccine for children under the age of 5.

According to a readout of the meeting from the House select subcommittee on the coronavirus crisis, Marks explained that the FDA would not withhold authorization — despite previous guidance — for a pediatric vaccine solely because it did not reach a 50% efficacy threshold at blocking symptomatic infections. All of the other adult and children’s vaccines currently authorized in the US have lost significant amounts of efficacy due to the Omicron variant, but they still remain effective at reducing the risk of severe disease, hospitalization and death.

“If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize,” Marks said.

Jim Clyburn

Meanwhile, Marks directly addressed concerns that the agency might slow-play the Moderna application and wait to review both applications together, saying that the VRBPAC meetings set for next month will be moved up if necessary.

“Obviously if we get through reviews faster, then we will send them to committees sooner,” Marks said, according to Rep. Jim Clyburn’s account of the meeting. Marks also told Clyburn and his staff that VRBPAC members have reserved earlier dates, enabling FDA to potentially “move dates up even by a week for any of these reviews.”

But he also explained that reviewing these vaccines for the youngest children involves more “complexity” than the review of adult vaccines, and the agency’s review process may require more time.

He also said that the emergence of new variants made the process of reviewing vaccines more complex, explaining it “was a little simpler for the original submissions in late 2020 when we didn’t have the variants and tons of immunogenicity data to go through.

“At the end of the day, we want people to have confidence in getting vaccinated,” he said, according to Clyburn. Marks also reiterated the importance of vaccinations to protect children against the coronavirus, stating: “We need to get more kids vaccinated, not just in the younger than 5 age range, but also older than 5.”

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Government

New study: COVID-19 may cause or accelerate neurological diseases

Danish researchers published a study suggesting that COVID-19 increases the risk of neurodegenerative diseases such as Alzheimer’s and Parkinson’s…

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New study: COVID-19 may cause or accelerate neurological diseases

Danish researchers published a study suggesting that COVID-19 increases the risk of neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease.

They presented the research at the European Academy of Neurology (EAN) Congress in Vienna, and the results were published in Frontiers in Neurology.

Specifically, after analyzing data from health records in Denmark, they found that people who tested positive for COVID-19 were more likely to suffer from Alzheimer’s disease, Parkinson’s disease and ischemic stroke.

Courtesy of BioSpace

“COVID-19 has had a disproportionate impact on people with dementia, their carers and their families,” Sara Imarisio, Ph.D., head of research at Alzheimer’s Research UK, said of the study. “The risk of developing Alzheimer’s disease, the leading cause of dementia, is caused by a complex mix of age, genetics and other environmental factors. This research suggests that having COVID-19 is linked to an increased risk of being diagnosed with Alzheimer’s disease, however, this was no stronger than the link to other respiratory diseases like the flu.”

She noted that diseases such as Alzheimer’s develop in the brain over many years, but COVID-19 has only been present outside China since early 2020. “It may be that people in the very early stages of Alzheimer’s are more susceptible to catching diseases like COVID-19,” Imarisio added.

The study analyzed 919,731 people who tested positive for COVID-19. Of them, 43,375 had a 3.5 times increased risk of being diagnosed with Alzheimer’s disease, 2.6 times higher risk of Parkinson’s disease, 2.7 times higher risk of ischemic stroke and 4.8 times higher risk of intracerebral hemorrhage. It’s possible that neuroinflammation increased the development of neurodegenerative disorders. The patients evaluated were in- and outpatients in Denmark between February 2020 and November 2021. It also included influenza patients from the corresponding pre-pandemic period.

“More than two years after the onset of the COVID-19 pandemic, the precise nature and evolution of the effects of COVID-19 on neurological disorders remained uncharacterized,” Dr. Pardis Zarifkar, M.D., lead author, department of neurology, Rigshospitalet, Copenhagen, Denmark, explained. “Previous studies have established an association with neurological syndromes, but until now it is unknown whether COVID-19 also influences the incidence of specific neurological diseases and whether it differs from other respiratory infections.”

The risk of most neurological diseases was no higher in COVID-19 patients than in people diagnosed with the flu or other respiratory diseases, although COVID-19 patients over 80 had 1.7 times higher risk of ischemic stroke compared to influenza and bacterial pneumonia. The researchers found no increase in other neurodegenerative diseases like multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome and narcolepsy for any of the viral diseases.

Zarifkar added, “We found support for an increased risk of being diagnosed with neurodegenerative and cerebrovascular disorders in COVID-19 positive compared to COVID-negative patients, which must be confirmed or refuted by large registry studies in the near future. Reassuringly, apart from ischemic stroke, most neurological disorders do not appear to be more frequent after COVID-19 than after influenza or community-acquired bacterial pneumonia.”

A 2021 study described a potential link between COVID-19 and the onset of Parkinson’s disease. The study out of the University of Twente in The Netherlands showed in laboratory assays that the SARS-CoV-2 N-protein interacts with alpha-synuclein, a protein in the brain, and increases the speed of the formation of amyloid fibrils, which is a defining feature of Parkinson’s disease. Interestingly, one of the predominant features of both early Parkinson’s disease and COVID-19 infection is the loss of sense of smell.

It has been clear for some time that COVID-19 is more than a respiratory disease, with a broad range of symptoms including “brain fog,” blood clots and strokes, possible gastrointestinal and other issues. In addition to links to neurological diseases, an increase in new-onset diabetes has been tied to COVID-19 infections.

Recent research from Osaka University in Japan suggests the association has to do with the insulin/IGF signaling pathway, a key pathway in energy metabolism regulation and cell survival. COVID-19 infection appears to impair insulin/IGF signaling by increasing IRF1 expression, which disrupts blood sugar metabolism.

In light of these discoveries, researchers will likely dig deeper to discover how and why COVID-19 is associated with a higher risk of other seemingly unrelated diseases. 

Source: BioSpace

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Economics

#CannesLions2022: Pharma and health marketers lose spotlight at creativity ad fest, but does it matter?

Pharma advertising has long been considered second-tier when compared to the rest of the advertising industry. And there are some legitimate reasons why….

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Pharma advertising has long been considered second-tier when compared to the rest of the advertising industry. And there are some legitimate reasons why. Nike sneakers and Coca-Cola soda ads will likely always be more entertaining or exciting than regulated campaigns for diabetes and heart disease.

Still, the Cannes Lions advertising festival of creativity was pharma and healthcare advertising’s annual chance to shine. For the past eight years, pharma agencies and clients stood side by side with consumer companies and agency hotshots on the biggest advertising award stage in the world at the Palais in Cannes, France.

However, something changed this year. While the awards for pharma and health and wellness were handed out to widespread applause on the first night of the show, for much of the rest of the time, healthcare marketing was relegated to the back of the room and mostly off the main stages.

The pharma and health and wellness category award finalists, for instance, were tucked in the back corner of the basement of the main building. Even people who wanted to see the work complained that they had to search for them. Only three Cannes Lions official sessions this year covered health or pharma advertising topics and were mostly general topics about creativity, diversity or empathy.

There were no pharma and health case study dissections or deep dives into the unique challenges in health and pharma advertising — and, maybe more importantly for the industry, there were no pharma executives on the Cannes stages as they have been in the past. Patricia Corsi was the lone pharma-connected executive; she is the chief marketing officer of Bayer Consumer Health and served as both a speaker and health and wellness jury president.

Patricia Corsi speaks on a judge’s panel (Clara Bui/Endpoints News)

Click on the image to see the full-sized version

Even among this year’s health and wellness award winners, no gold prizes went to pharma companies. Unexpected winners like Heineken and Harley Davidson did, however, take home the gold for their respective vaccination and “Tough Turban” campaigns.

There are two schools of thought about the disappearance of Cannes Lions Health as an official programmed track. On one hand, it signifies the parity of the industry with big consumer brands, but on the other hand, it also meant fewer conversations, less networking opportunities and an overall dimming of the industries’ presences at Cannes Lions.

Rich Levy

“I would be lying if I didn’t say that I was disappointed so far,” said Rich Levy, chief creative officer of Klick Health on the first day of the show. “When you’re talking about a multibillion dollar industry in the US, I thought that 31 short list for pharma was remarkably small … I don’t think it’s an accurate view of the work that the industry is doing.”

Pharma and health and wellness entries both were way down this year. Total pharma entries dropped to 298, down from 509 last year with 11 total Lion awards given out. In health and wellness, there were 1,213 entries, down from 1,300 last year. There were Grand Prix awards given in both categories, but this was the first year it was required — in the past, judges could pass over a category for the top award if they thought it didn’t rise to the level of Grand Prix.

For the second year in a row, the Grand Prix in the pharma category went to a non-pharma company. Dell Technologies and Intel snagged the top prize for their voice app for people with motor neuron disease. The entry — created by VMLY&R New York and called “I Will Always Be Me” — helps people with MND bank a digital copy of their voice by reading a story book.

In the health and wellness category, Maxx Flash’s mosquito repellent campaign “The Killer Pack” took the top prize. The repellent is designed to address India’s mosquito problem, with a biodegradable packaging that kills mosquitoes outside while a nontoxic coil fights them inside.

Other health creatives and executives agreed with Levy’s award assessment, but also expressed concern about the limited health content. The health and pharma panels and award deep dives that were presented got solid reviews, but there were scant few in the official program, along with a handful of unofficial ones outside the main venues.

Several health agency networks set up off-site slates of healthcare and pharma programming — WPP Health and IPG Health both offered multiple panels and discussions at their own sites. CMI Media Group hosted a panel at the Pandora Beach pavilion on audio branding, while other agency creatives like Levy and Bernardo Romero, along with Ogilvy Health’s Adam Hessel and both panels of judges for pharma and health and wellness, attended sessions and networked with others in the health community.

Still, there just weren’t as many health and pharma people on the ground as there typically have been in the past as agencies cut back rosters of attendees and didn’t invite as many clients. That’s likely in part due to the Covid-19 pandemic recovery year of Cannes Lions this year as well as budget considerations in general.

Dana Maiman

Dana Maiman, CEO of IPG Health and a long-time Cannes Lions attendee said, “I’m hoping the changes honestly are just temporary. Because I remember when I first started coming here — I think this may be my 10th one or so — but back then it was consolidated. It was really liberating when it was focused and broken out, even though clearly there’s a lot of crossovers and all of that. But I think there is something very special about celebrating the creativity in our world because we can all agree it is more challenging.”

Hessel, chief creative officer at Ogilvy Health, said one reason for fewer entries was heavier curation down to just a few this year, but added that no matter the numbers, Cannes and other marketing award shows still are important for the industry.

“Just celebrating great work in any category is what the industry really needs and also maybe to pull back a bit — everybody’s looking for that one crown jewel, but there’s so much great work out there that should be celebrated,” he said, adding, “When clients see great work, they want that too, so that’s the bar.”

Corsi, meanwhile, said she wants to see more creativity from pharma marketers. She finds that creatives in the pharma industry are often trained to be more conservative, because if you cross the line, you face regulators — but she would like that to change.

“We really believe that there is a great opportunity for us to raise the bar in this category,” she said. “Work in health and wellness consistently across the years has not been the most inspiring.”

That doesn’t necessarily mean the work should be more complicated. According to Corsi, sometimes the simplest idea is the best. What she wants to see, though, is more outside-the-box thinking.

A handful of execs, including Corsi, noted that the Covid-19 pandemic has served as a wake-up call for pharma companies discovering what their role should be with patients. Pharma advertising is becoming more of a conversation as opposed to a one-off encounter, Corsi said. Even companies like Walgreens — which facilitated the vaccination of more than 30 million Americans — are taking a new approach to advertising.

Mel Routhier

“The pandemic, there’s no going back. You can’t unhear the bell, right? The bell’s been rung,” said Mel Routhier, chief creative officer of the WPP Walgreens team. “It’s a good thing for us to take stock and say we can have more purpose as a brand.”

One thing that hasn’t changed this year? The level of passion that pharma creatives are bringing to the conference.

Gena Pemberton

“What I’m taking away now, that I guess maybe I didn’t really expect, is how much passion people have in the work that they’re doing,” said first-time attendee Gena Pemberton, Omnicom Health Group’s diversity, equity and inclusion director. “[It’s] really impactful to be able to talk with people in different areas, understand a little bit more about the work they’ve done, and just seeing how excited everybody is to be together again.”

In the end, the questions remain. Does Cannes Lions need a separate pharma and health track? Or vice versa, does pharma and healthcare advertising need that spotlight at Cannes? The debate won’t be easily settled.

Franklin Williams, director of experience design at Area 23 and a pharma judge, said, “It doesn’t really matter who’s doing the work as long as the targets are being hit. So I think that’s what you’re starting to see almost as a trend and a theme. It doesn’t have to be, we did pharma because we’re pharma. We did pharma because we wanted to do good.”

The danger, of course, is that without broader inclusion, specific content and more awards, pharma may lose interest in Cannes.

“It becomes a self-fulfilling prophecy. And what I mean by that is fewer winners every year mean fewer entries the following year. And fewer entries mean fewer winners,” Levy said.

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Science

Long COVID: female sex, older age and existing health problems increase risk – new research

A new study has analysed UK data from long-term health surveys and electronic health records to understand how common long COVID is, and who might be at…

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shurkin_son/Shutterstock

About 2 million people in the UK currently have long COVID, according to the latest data from the Office for National Statistics.

In the UK, long COVID is defined as “signs and symptoms that continue or develop after acute COVID-19”. This definition is further split into people who have symptoms between four to 12 weeks after infection (ongoing symptomatic COVID-19) and for 12 weeks or more (post-COVID syndrome).

Symptoms can include fatigue, breathlessness, difficulty concentrating and many more – but the precise nature of the symptoms is not well understood. There are also gaps in our knowledge when it comes to the frequency of long COVID, and whether there are particular factors that put people at higher risk of developing the condition.

All of this is partly because the symptoms used to define long COVID often vary between studies, and these studies tend to be based on relatively few people. So the results may not apply to the wider population.

In a new study published in the journal Nature Communications, my colleagues and I looked at data from ten UK-based long-term studies, alongside 1.1 million anonymised electronic health records from English general practices. Based on this data, we investigated whether the burden of long COVID (how common it is) differs by demographic and health characteristics, such as age, sex and existing medical conditions.

The studies were established before the pandemic, and have tracked participants over many years. From these surveys, we used data from 6,907 people who self-reported they’d had COVID-19. Comparing this with the data from the electronic health records of people diagnosed with COVID allowed us to examine the frequency of long COVID in those who have seen their GP about it and those who haven’t.


Read more: Long COVID: a public health expert’s campaign to understand the disease


We found that of the people who self-reported having COVID in the studies, the proportion who reported symptoms for longer than 12 weeks ranged between 7.8% and 17%, while 1.2% to 4.8% reported “debilitating” symptoms.

In the electronic health records, we found that only 0.4% of people with a COVID diagnosis were subsequently recorded as having long COVID. This low proportion of diagnoses by GPs may be partly because formal logging of long COVID was only introduced for doctors in November 2020.

COVID-19 National Core Study, Author provided

The proportion of people who reported symptoms for more than 12 weeks varied by age. There was also a lot of variation depending on which definition each study used to capture long COVID. But overall, we found evidence to suggest an increased risk of long COVID was associated with increasing age up to age 70.

The studies include participants across a range of ages, from an average age of 20 to 63. Using a strict definition of symptoms affecting day-to-day function, we found that the proportion of people with symptoms for 12 or more weeks generally rose with increasing age, ranging from 1.2% for 20-year-olds to 4.8% for those aged 63.

We also found that a range of other factors is associated with a heightened risk of developing long COVID. For instance, being female, poorer pre-pandemic mental health and overall health, obesity and having asthma were also identified as risk factors in both the long-term studies and electronic health records.

These findings are broadly consistent with other emerging evidence on long COVID. For example, a recent international review study concluded that women are 22% more likely than men to experience long COVID.


Read more: COVID: long-lasting symptoms rarer in children than in adults – new research


It will be important to understand why these links exist, which is beyond the scope of our research. But identifying who may be at higher risk of long COVID is important, and as we continue to learn more, this could inform public health prevention and treatment strategies.

Ellen Thompson does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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