FDA Panel Backs Shift Toward One-Dose COVID Shot

Jan. 26, 2023 – A panel of advisers to the FDA unanimously supported an effort today to simplify COVID-19 vaccinations, with the aim of developing a one-dose approach — perhaps annually — for the general population.

The FDA is looking to give clearer direction to vaccine makers about future development of COVID-19 vaccines. The plan is to narrow down the current complex landscape of options for vaccinations, and thus help increase use of these shots. 

COVID remains a serious threat, causing about 4,000 deaths a week recently, according to the CDC. 

The 21 Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously “yes” on a single question posed by the FDA: 

“Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the U.S. to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

In other words, would it be better to have one vaccine potentially combining multiple strains of the virus, instead of multiple vaccines – such as a two-shot primary series then a booster containing different combinations of viral strains.

The FDA will consider the panel’s advice as it outlines new strategies for keeping ahead of the evolving virus.

In explaining their support for the FDA plan, panel members said they hoped that a simpler regime would aid in persuading more people to get COVID vaccines.

Pamela McInnes, DDS, MSc, noted that it’s difficult to explain to many people that the vaccine worked to protect them from more severe illness if they contract COVID after getting vaccinated. 

“That is a real challenge,” said McInness, a retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

“The message that you would have gotten more sick and landed in the hospital resonates with me, but I’m not sure if it resonates with” many people who become infected, she said.

The Plan

In the briefing document for the meeting, the FDA outlined a plan for transitioning from the current complex landscape of COVID-19 vaccines to a single vaccine- composition for the primary series and booster vaccination. 

This would require:

• Harmonizing the strain composition of all COVID-19 vaccines;

• Simplifying the immunization schedule for future vaccination campaigns to administer a two-dose series in certain young children and in older adults and persons with compromised immunity, and only one dose in all other individuals;

• Establishing a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September.

During the discussion, though, questions arose about the June target date. Given the production schedule for some vaccines, that date might need to shift, said Jerry Weir, PhD, director of the division of viral products at FDA’s Center for Biologics Evaluation and Research. 

“We’re all just going to have to maintain flexibility,” Weir said, adding that there is not yet a “good pattern” established for updating these vaccines. 

Increasing Vaccination Rates

There was broad consensus about the need to boost public support for COVID-19 vaccinations. While about 81% of the US population has had at least one dose of this vaccine, only 15.3% have had an updated bivalent booster dose, according to the CDC.

“Anything that results in better public communication would be extremely valuable,” said committee member Henry H. Bernstein, DO, MHCM, of the Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, New York.

But it’s unclear what expectations will be prioritized for the COVID vaccine program, he said. 

“Realistically, I don’t think we can have it all — less infection, less transmission, less severe disease, and less long COVID,” Bernstein said. “And that seems to be a major challenge for public messaging.” 

Panelists Press for More Data 

Other committee members also pressed for clearer targets in evaluating the goals for COVID vaccines, and for more robust data. 

Like his fellow VRBPAC members, Cody Meissner, MD, of Dartmouth’s Geisel School of Medicine, supported a move toward harmonizing the strains used in different companies’ vaccines. But he added that it wasn’t clear yet how frequently they should be administered. 

“We need to see what happens with disease burden,” Meissner said, “We may or may not need annual vaccination. It’s just awfully early, it seems to me, in this process to answer that question.”

Among those serving on VRBPAC Thursday was one of the FDA’s more vocal critics on these points, Paul A. Offit, MD, a vaccine expert from Children’s Hospital of Philadelphia. Offit, for example, joined former FDA officials in writing a November opinion article for the Washington Post, arguing that the evidence for boosters for healthy younger adults was not strong.

At Thursday’s meeting, he supported the drive toward simplification of COVID vaccine schedules, while arguing for more data about how well these products are working.

“This virus is going to be with us for years, if not decades, and there will always be vulnerable groups who are going to be hospitalized and killed by the virus,” Offit said.

The CDC needs to provide more information about the characteristics of people being hospitalized with COVID infections, including their ages and comorbidities as well as details about their vaccine history, he said. In addition, academic researchers should provide a clearer picture of what immunological predictors are at play in increasing people’s risk from COVID.

“Then and only then can we really best make the decision about who gets vaccinated with what and when,” Offit said. 

VRBPAC member Ofer Levy, MD, PhD, also urged the FDA to press for a collection of more robust and detailed information about the immune response to COVID-19 vaccinations, such as a deeper look at what’s happening with antibodies.

“I hope FDA will continue to reflect on how to best take this information forward, and encourage –or require —sponsors to gather more information in a standardized way across these different arms of the human immune system,” Levy said. “So we keep learning and keep doing this better.”

In recapping the panel’s suggestions at the end of the meeting, Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research, addressed the requests made during the day’s meeting about better data on how the vaccines work.

“We heard loud and clear that we need to use a data-driven approach to get to the simplest possible scheme that we can for vaccination,” Marks said. “And it should be as simple as possible but not over simplified, a little bit like they say about Mozart’s music.”

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The FDA Wants an Annual COVID Vaccine: What You Need to Know

Jan. 24, 2023 – Is pivoting to an annual COVID-19 shot a smart move? The FDA, which proposed the change on Monday, says an annual shot vs. periodic boosters could simplify the process to ensure more people stay vaccinated and protected against severe COVID-19 infection. 

A national advisory committee plans to vote on the recommendation Thursday.

If accepted, the vaccine formula would be decided each June and Americans could start getting their annual COVID-19 shot in the fall, like your yearly flu shot.  

Keep in mind: Older Americans and those who are immunocompromised may need more than one dose of the annual COVID-19 shot.

Most Americans are not up to date with their COVID-19 boosters. Only 15% of Americans have gotten the latest booster dose, while a whopping nine out of 10 Americans age 12 or older finished their primary vaccine series. The FDA, in briefing documents for Thursday’s meeting, says problems with getting vaccines into people’s arms makes this a change worth considering. 

Given these complexities, and the available data, a move to a single vaccine composition for primary and booster vaccinations should be considered,” the agency says.

A yearly COVID-19 vaccine could be simpler, but would it be as effective? WebMD asks health experts your most pressing questions about the proposal.

Pros and Cons of an Annual Shot

Having an annual COVID-19 shot, alongside the flu shot, could make it simpler for doctors and health care providers to share vaccination recommendations and reminders, according to Leana Wen, MD, a public health professor at George Washington University and former Baltimore health commissioner.

“It would be easier [for primary care doctors and other health care providers] to encourage our patients to get one set of annual shots, rather than to count the number of boosters or have two separate shots that people have to obtain,” she says.

“Employers, nursing homes, and other facilities could offer the two shots together, and a combined shot may even be possible in the future.”

Despite the greater convenience, not everyone is enthusiastic about the idea of an annual COVID shot. COVID-19 does not behave the same as the flu, says Eric Topol, MD, editor-in-chief of Medscape, WebMD’s sister site for health care professionals.

Trying to mimic flu vaccination and have a year of protection from a single COVID-19 immunization “is not based on science,” he says. 

Carlos del Rio, MD, of Emory University in Atlanta and president of the Infectious Diseases Society of America, agrees. 

“We would like to see something simple and similar like the flu. But I also think we need to have the science to guide us, and I think the science right now is not necessarily there. I’m looking forward to seeing what the advisory committee, VRBAC, debates on Thursday. Based on the information I’ve seen and the data we have, I’m not convinced that this is a strategy that is going to make sense,” he says. 

“One thing we’ve learned from this virus is that it throws curveballs frequently, and when we make a decision, something changes. So, I think we continue doing research, we follow the science, and we make decisions based on science and not what is most convenient.” 

COVID-19 Isn’t Seasonal Like the Flu

“Flu is very seasonal, and you can predict the months when it’s going to strike here,” Topol says. “And as everyone knows, COVID is a year-round problem.” He says it’s less about a particular season and more about times when people are more likely to gather indoors. 

So far, European officials are not considering an annual COVID-19 vaccination schedule, says Annelies Zinkernagel, MD, PhD, of the University of Zurich and president of the European Society of Clinical Microbiology and Infectious Diseases. 

Regarding seasonality, she says, “what we do know is that in closed rooms in the U.S. as well as in Europe, we can have more crowding. And if you’re more indoors or outdoors, that definitely makes a big difference.”

Which Variant(s) Would It Target?

To decide which variants an annual COVID-19 shot will attack, one possibility could be for the FDA to use the same process used for the flu vaccine, Wen says.

“At the beginning of flu season, it’s always an educated guess as to which influenza strains will be dominant,” she says.

“We cannot predict the future of which variants might develop for COVID, but the hope is that a booster would provide broad coverage against a wide array of possible variants.”

Topol agrees it’s difficult to predict. A future with “new viral variants, perhaps a whole new family beyond Omicron, is uncertain.”

Reading the FDA briefing document “to me was depressing, and it’s just basically a retread. There’s no aspiration for doing bold things,” Topol says. “I would much rather see an aggressive push for next-generation vaccines and nasal vaccines.”

To provide the longest protection, “the annual shot should target currently predominant circulating strains, without a long delay before booster administration,” says Jeffrey Townsend, PhD, a professor of biostatistics and ecology and evolutionary biology at Yale School of Public Health. 

“Just like the influenza vaccine, it may be that some years the shot is less useful, and some years the shot is more useful,” he says, depending on how the virus changes over time and which strain(s) the vaccine targets. “On average, yearly updated boosters should provide the protection predicted by our analysis.”

Townsend and colleagues published a prediction study on Jan. 5, in the Journal of Medical Virology. They look at both Moderna and Pfizer  vaccines and how much protection they would offer over 6 years based on people getting regular vaccinations every 6 months, every year, or for longer periods between shots. 

They report that annual boosting with the Moderna vaccine would provide 75% protection against infection and an annual Pfizer vaccine would provide 69% protection. These predictions take into account new variants emerging over time, Townsend says, based on behavior of other coronaviruses.

“These percentages of fending off infection may appear large in reference to the last 2 years of pandemic disease with the massive surges of infection that we experienced,” he says. “Keep in mind, we’re estimating the eventual, endemic risk going forward, not pandemic risk.”

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Evaluating the state of the pandemic: Euronews asks health leaders

This year’s annual World Economic Forum in Davos marks the biggest gathering of world leaders since the Covid-19 pandemic.

It was three years ago when in January 2020, the World Health Organization (WHO) declared a public health emergency of international concern.

Despite efforts to learn lessons from it – and some world leaders declaring the end of it – the pandemic still represents a major health risk and remains far from over.

To evaluate the state of the pandemic, the increase in cases globally, and discuss the consequences on the healthcare system worldwide, Euronews’ Sasha Vakulina spoke to Maria Leptin, President of the European Research Council, Seth Berkley Chief Executive Officer at GAVI, the Vaccine Alliance, Stéphane Bancel Chief Executive Officer at Moderna and Michelle Williams, the Dean of the Faculty at Harvard Chan School of Public Health.

The current state of the pandemic

Michelle Williams: “Advances in therapeutics and vaccines have really allowed us to reopen our society,” said Michelle Williams. “And I think part of the enthusiasm comes from the fact that we are able to have gatherings like this again after a long period of disruption.”

“So, setting the context, we still in the United States have 526 deaths…per day, from Covid. And that’s up since November, October, where we were in the four hundreds. Now, what’s really disappointing is nine out of ten of those deaths could be averted if we took our vaccines and boosters and practiced the other behavioural aspects, ventilation, mask-wearing when appropriate, distance and so on. And so for me, as a public health person, knowing that we could avert nine out of ten of those deaths reminds me of the fact that we have to avoid prematurely talking about this pandemic being over,” she added.

“I also think that… when we talk about context, we must also discuss the more chronic implications of this pandemic. We must discuss the fact that there, in the US alone, over 174,000 Covid infants will have a life course that’s impacted by this pandemic. We also have to consider the fact that long Covid is a reality, and it’s not only going to be impacting individuals and families, but the economic impact of long Covid as quantified by Larry Summers and David Cutler, both of Harvard, is that it’s going to cost us $3.7 trillion (€3.4 trillion). Our healthcare system is still in distress. And what I hope people will understand is the vaccine not only protects individuals from transmission and severity, but it protects our health systems. We’re able to have a functional, or almost functional, health system because we don’t have the kinds of severe disease that we were facing in 2020. And we need to also recognise that our health systems have to recover as well. We have burnout from our healthcare workers and we have case mixes of chronic diseases that are worse now and require more intensive medical intervention than before.”

The Covid-19 vaccine delivery partnership and vaccine delivery in low- and middle-income countries

Seth Berkley: “Three years ago, we sat here in Davos and we didn’t know where this was going to go. There were some political leaders saying, you know, it’s going nowhere. But Stéphane was part of the conversation and Richard Hatchett and I sat down and said, [during] the last pandemic with flu, the developing world got no vaccines. They were all bought up by wealthy countries. So, we knew that was what was going to happen if this turned into a global pandemic. And so, we started this concept of COVAX, which we brought lots of other people into, and the idea was to try to solve that problem.”

“First of all, the science was amazing. 327 days! If you had asked us, we had thought maybe we could get there in 18 months, two years. So [it’s] extraordinary, you know, advancements in the science. But on the policy side as well. We did our first dose in the developing world 39 days after the first dose was done in a wealthy country. Of course, it should be [on] the same day. But that’s… a record. And what we were able to do then was to bring doses to the developing world.”

“Now, it wasn’t smooth. It didn’t go well. But, in the first year, we had put a goal together of 950 million doses, because that’s what we thought we could get for low- and lower-middle-income countries. And we ended up with about 930 million doses. So, we came close to that and we intensified a programme both providing finance and technical assistance. And today there are seven countries with less than 10% coverage. And, as you can imagine, six of those are quite fragile countries with fragile health systems. The problem we have right now is since the beginning of 2022, we’ve had enough vaccines to provide whatever countries want.”

“The challenge has been getting the demand. Part of it is the world says, you know, we’re done with Covid. Of course, the virus is not done with us, as Michelle said. And, what we really need to do is make sure that policymakers understand that we’re continuing to see new variants…So, the best thing we can do is use the prevention methods, but also make sure we vaccinate our high-risk populations so they’re protected against severe disease and death.”

Vaccine development and adoption in regard to different variants and sub-variants

Stéphane Bancel: “We have plants in the US and in Switzerland. We’ve shown this summer that we are able to adapt to variants very quickly. If you think about it…in the US, Peter Marks told us on 28 June [that] we want for the US to have a BA.5 Omicron booster. And by early September, on Labour Day weekend, it was in US pharmacies. 60 days! Which…in the old world of vaccines would usually be unthinkable. So, we keep on working on technologies to improve that.”

“The other piece that we are working on also – because Seth and I had many, many discussions over the last few years – is how do we build manufacturing capacity around the world? We had a lot of export restrictions during the pandemic, which was really painful for obvious reasons, even from countries who say they will not limit exports. Trust me, they were. And so we’re very excited now that we are building a factory in Canada. We already broke ground in the fall. We’re building a factory in Australia. We are going to start a factory this quarter in the UK and we’re also going to start building a factory in Kenya. We’re talking to a couple more countries because I would really like every continent to have MRNA capacity because the amazing thing about MRNA is you can use the same facility, the same plant, the same machines, to make any vaccine you want.”

The issue of science denial

Maria Leptin: “Perhaps interestingly, two of the countries which were most successful in getting good coverage of vaccination based this not at all on getting their citizens to try and understand the science. One is Bhutan, where they were very successful in preparing a campaign and (they were) involved. They were sensitive to the country’s needs, to the citizens’ needs, involved in informing the religious establishment and in fact, [in] using them in finding the right time and date. And they got fantastic coverage. No science was explained. The other example I know of is Portugal, where the campaign was handed to a retired army general. And the army general just treated the country as his troops and he rallied the troops. He declared it as a war that the country in patriotic passion was going to fight together. And they [were] up there! I think they were leading in Europe, if not the world.”

“The trouble is that many citizens don’t understand uncertainty as part of the scientific method. And if I say today, ‘this is my best belief’ with that uncertainty and somebody else says tomorrow, ‘you didn’t do that experiment right’…That’s the way we are! So we’ve got to go so profoundly into educating citizens about the scientific method if we want better trust in science. And the bad news is, who’s it going to be? It’s not going to be us because we’re the ones who are mistrusted.”

Michelle Williams: “What you have to do if you’re really interested in communicating information that will motivate people to change their behaviour, you have to take the approach of meeting them where they are, explaining it and presenting the information in a way where they will adopt the desirable behaviour and feel good about it. And maybe that was the secret sauce to what happened in Portugal and in Bhutan. Health communicators and scientists worked to communicate the risks and what we understand today… All of us have to begin to realise that we have to stop our professional scientific speak, or engage others who can translate for us and meet people where they are. If we do that, it will be the stepping stone of building trust.”

Seth Berkley: “What you didn’t mention was the intentionality, the politicisation of the process. There were also attacks that were done. There were bots in social media that were putting out misinformation on both sides. And lastly, and this is what’s completely different, is today a rumour spreads literally at the speed of light.”

Health governance: How can it be improved?

Michelle Williams: “There has to be mindset shifting in what it means to engage in multilateral agreements around global health issues. And there have to be real improvements in the infrastructure and the finances and the workforce. And that’s going to take leadership and it’s going to take a commitment to true multilateral engagement. We have to have people who are committed to the exercise of global health diplomacy. And it’s a science and an art, but it also has to be a commitment for all humanity, because we know and we knew this since 2014 with Ebola, that it only takes 8 hours for a threat from over there to be a threat here.”

“And so, we have to realise not just in rhetoric but in practice, the science is really important – I am a molecular biologist and an epidemiologist – but governance has to realise that they have been underfunding science in understanding human behaviour and they have underinvested in the implementation of the scientific knowledge and the tools that we have. So, we have to get to a level where governance is appreciating funding communities, funding regional health officers, equipping them with tools and engaging in creating a safety net that goes from knowledge creation and creation of vaccines and therapeutics to explaining and motivating and cultivating that environment of trust for adopting behaviours that promote health for individuals, communities, families in the world.”

Seth Berkley: “One of the things we learned is there were countries who were supporting us, giving us money, cheering us on, and then going to the countries that were producing the vaccines and buying them for themselves and using them. A national government is supposed to protect its population. That’s its job. And when we said you’re only safe if we’re all safe, what we were talking about is, yes, protect your high-risk populations, but then protect other high-risk populations. And instead, many countries said, well, you know, forget about others, we’re just going to do our own. And then we saw these waves of disease and people realised it is really a global commons.”

Stéphane Bancel: I still believe we can do much better, with a lot of things we’ve learned about also how we scale the companies. And so, one of the things, for example, we are doing… is trying to get into the clinic all the 15 vaccines against the 15 high-priority viruses defined by WHO and CEPI to be able to get clinical data on those. Because if we had known the dose of a vaccine against the coronavirus in January 2020, we might have saved another three months. So, think about the number of lives that could have been saved with a vaccine launched, you know, in August versus, you know, in December.”

“What I worry about now is a lot of countries are forgetting the pandemic is still ongoing. Still, a lot of people are dying every day, but a lot of governments have moved to other things. And that’s a problem because we need investments in public health infrastructure, in healthcare workers, in genomic surveillance. There are so many pieces that need to happen.”

How can we be better prepared for future pandemics?

Maria Leptin: My plea is: keep investing in the basic science. Let’s not forget that. The next pandemic may be different. We don’t even know. Nature can come up with anything. We’re prepared in many ways. I want to say: don’t restrict funding to the fundamental sciences in their full breadth. You never know what we’ll need for the next outbreak.

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Can ‘Radical Rest’ Help With Long COVID Symptoms?

Jan. 18, 2023 – On March 18, 2020, Megan Fitzgerald was lying on the floor of her Philadelphia home after COVID-19 hit her like a ton of bricks. She had a fever, severe digestive issues, and she couldn’t stand on her own. Yet there she was, splayed out in the bathroom, trying both to respond to work emails and entertain her 3-year-old son, who was attempting to entice her by passing his toys through the door. 

She and her husband, both medical researchers, were working from home early in the pandemic with no child care for their toddler. Her husband had a grant application due, so it was all-hands-on-deck for the couple, even when she got sick. 

“My husband would help me up and down stairs because I couldn’t stand,” Fitzgerald says.

So, she put a mask on and tried to take care of her son, telling him, “Mommy’s sleeping on the floor again.” She regrets pushing so hard, having since discovered there may have been consequences. She often wonders: If she’d rested more during that time, would she have prevented the years of decline and disability that followed? 

There’s growing evidence that overexertion and not getting enough rest in that acute phase of COVID-19 infection can make longer-term symptoms worse. 

“The concept that I would be too sick to work was very alien to me,” Fitzgerald says. “It didn’t occur to me that an illness and acute virus could be long-term debilitating.” 

Her story is common among long COVID-19 patients, not just for those who get severely ill but also those who only have moderate symptoms. It’s why many medical experts and researchers who specialize in long COVID rehabilitation recommend what’s known as radical rest – a term popularized by journalist and long COVID advocate Fiona Lowenstein – right after infection as well as a way of coping with the debilitating fatigue and crashes of energy that many have in the weeks, months, and years after getting sick.

These sustained periods of rest and “pacing” – a strategy for moderating and balancing activity– have long been promoted by people with post-viral illnesses such as myalgic encephalomyelitis, or chronic fatigue syndrome (ME/CFS), which share many symptoms with long COVID.

That’s why researchers and health care providers who have spent years trying to help patients with ME/CFS and, more recently, long COVID, recommend they rest as much as possible for at least 2 weeks after viral infection to help their immune systems. They also advise spreading out activities to avoid post-exertional malaise (PEM), a phenomenon where even minor physical or mental effort can trigger a flare-up of symptoms, including severe fatigue, headaches, and brain fog.

An international study, done with the help of the U.S. Patient-Led Research Collaborative and published in The Lancet in 2021, found that out of nearly 1,800 long COVID patients who tried pacing, more than 40% said it helped them manage symptoms.

Burden on Women and Mothers

In another survey published last year, British researchers asked 2,550 long COVID patients about their symptoms and found that not getting enough rest in the first 2 weeks of illness, along with other things like lower income, younger age, and being female, were associated with more severe long COVID symptoms.

It’s also not lost on many investigators and patients that COVID’s prolonged symptoms disproportionately affect women – many of whom don’t have disability benefits or a choice about whether they can afford to rest after getting sick. 

“I don’t think it’s a coincidence, particularly in America, that women of reproductive age have been hit the hardest with long COVID,” says Fitzgerald. “We work outside the home, and we do a tremendous amount of unpaid labor in the home as well.”

How Does Lack of Rest Affect People With COVID?

Experts are still trying to understand the many symptoms and mechanisms behind long COVID. But until the science is settled, both rest and pacing are two of the most solid pieces of advice they can offer, says David Putrino, PhD, a neuroscientist and physical therapist who has worked with thousands of long COVID patients at Mount Sinai Hospital in New York. “These things are currently the best defense we have against uncontrolled disease progression,” he says.

There are many recommended guides for rest and pacing for those living with long COVID, but ultimately, patients need to carefully develop their own personal strategies that work for them, says Putrino. He calls for research to better understand what’s going wrong with each patient and why they may respond differently to similar strategies. 

There are several theories on how long COVID infection triggers fatigue. One is that inflammatory molecules called cytokines, which are higher in long COVID patients, may injure the mitochondria that fuel the body’s cells, making them less able to use oxygen. 

“When a virus infects your body, it starts to hijack your mitochondria and steal energy from your own cells,” says Putrino. Attempts to exercise through that can significantly increase the energy demands on the body, which damages the mitochondria, and also creates waste products from burning that fuel, kind of like exhaust fumes, he explains. It drives oxidative stress, which can damage the body.

“The more we look objectively, the more we see physiological changes that are associated with long COVID,” he says. “There is a clear organic pathobiology that is causing the fatigue and post-exertional malaise.”

To better understand what’s going on with infection associated with complex chronic illnesses such as long COVID and ME/CFS, Putrino’s lab is looking at things like mitochondrial dysfunction and blood biomarkers such as microclots

He also points to research by pulmonologist David Systrom, MD, director of the Advanced Cardiopulmonary Exercise Testing Program at Brigham and Women’s Hospital and Harvard Medical School. Systrom has done invasive exercise testing experiments that show that people with long COVID have a different physiology than people who have had COVID and recovered. His studies suggest that the problem doesn’t lie with the functioning of the heart or lungs, but with blood vessels that aren’t getting enough blood and oxygen to the heart, brain, and muscles.

Why these blood vessel problems occur is not yet known, but one study led by Systrom’s colleague, neurologist Peter Novak, MD, PhD, suggests that the small nerve fibers in people with long COVID are missing or damaged. As a result, the fibers fail to properly squeeze the big veins (in the legs and belly, for instance) that lead to the heart and brain, causing symptoms such as fatigue, PEM, and brain fog. Systrom has seen similar evidence of dysfunctional or missing nerves in people with other chronic illnesses such as ME/CFS, fibromyalgia, and postural orthostatic tachycardia syndrome (POTS).

“It’s been incredibly rewarding to help patients understand what ails them and it’s not in their head and it’s not simple detraining or deconditioning,” says Systrom, referring to misguided advice from some doctors who tell patients to simply exercise their way out of persistent fatigue. 

These findings are also helping to shape specialized rehab for long COVID at places like Mount Sinai and Brigham and Women’s hospitals, whose programs also include things like increasing fluids and electrolytes, wearing compression clothing, and making diet changes. And while different types of exercise therapies have long been shown to do serious damage to people with ME/CFS symptoms, both Putrino and Systrom say that skilled rehabilitation can still involve small amounts of exercise when cautiously prescribed and paired with rest to avoid pushing patients to the point of crashing. In some cases, the exercise can be paired with medication.

In a small clinical trial published in November, Systrom and his research team found that patients with ME/CFS and long COVID were able to increase their exercise threshold with the help of a POTS drug, Mestinon, known generically as pyridostigmine, taken off label.

As is the case of many people with long COVID, Fitzgerald’s recovery has had ups and downs. She now has more help with child care and a research job with the disability-friendly Patient-Led Research Collaborative. While she hasn’t gotten into a long COVID rehab group, she’s been teaching herself pacing and breathwork. In fact, the only therapeutic referral she got from her doctor was for cognitive behavioral therapy, which has been helpful for the toll the condition has taken emotionally. “But it doesn’t help any of the physical symptoms,” Fitzgerald says.

She’s not the only one who finds that a problem.

“We need to continue to call out people who are trying to psychologize the illness as opposed to understanding the physiology that is leading to these symptoms,” says Putrino. “We need to make sure that patients actually get care as opposed to gaslighting.”



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China’s emergency rooms ‘overwhelmed’ as COVID-19 wave sweeps country

As China grapples with its first-ever national COVID-19 wave, emergency wards in small cities and towns southwest of Beijing are stunned as they attempt to reel with the massive influx of critical cases.

Emergency rooms are turning away ambulances, relatives of sick people are searching for open beds, and patients are slumped on benches in hospital corridors and lying on floors for lack of beds.

In more than three decades of emergency medicine, Beijing-based doctor Howard Bernstein said, he has never seen anything like this.

Patients are arriving at his hospital in ever-increasing numbers; almost all are elderly, and many are very unwell with COVID and pneumonia symptoms, he said.

Bernstein’s account reflects similar testimony from medical staff across China who are scrambling to cope after China’s abrupt U-turn on its previously strict COVID policies this month was followed by a nationwide wave of infections.

It is by far the country’s biggest outbreak since the pandemic began in the central city of Wuhan three years ago.

Beijing government hospitals and crematoriums also have been struggling this month amid heavy demand.

“The hospital is just overwhelmed from top to bottom,” Bernstein told Reuters at the end of a “stressful” shift at the privately owned Beijing United Family Hospital in the east of the capital.

“The ICU is full,” as are the emergency department, the fever clinic and other wards, he said.

“A lot of them got admitted to the hospital. They’re not getting better in a day or two, so there’s no flow, and therefore people keep coming to the ER, but they can’t go upstairs into hospital rooms,” he said. “They’re stuck in the ER for days.”

In the past month, Bernstein went from never having treated a COVID patient to seeing dozens a day.

“The biggest challenge, honestly, is I think we were just unprepared for this,” he said.

Furnaces at crematoriums ‘burning overtime’

At the Zhuozhou crematorium in the Hebei province bordering Beijing to the north, furnaces are burning overtime as workers struggle to cope with a spike in deaths in the past week, according to one employee.

A funeral shop worker estimated it is burning 20 to 30 bodies a day, up from three to four before COVID-19 measures were loosened.

“There’s been so many people dying,” said Zhao Yongsheng, a worker at a funeral goods shop near a local hospital. “They work day and night, but they can’t burn them all.”

At a crematorium in Gaobeidian, about 20 kilometres south of Zhuozhou, the body of one 82-year-old woman was brought from Beijing, a two-hour drive, because funeral homes in China’s capital were packed, according to the woman’s grandson, Liang.

“They said we’d have to wait for 10 days,” Liang said, giving only his surname because of the sensitivity of the situation.

Liang’s grandmother had been unvaccinated, he added, when she came down with coronavirus symptoms and had spent her final days hooked to a respirator in a Beijing ICU.

Over two hours at the Gaobeidian crematorium on Thursday, AP journalists observed three ambulances and two vans unload bodies.

A hundred or so people huddled in groups, some in traditional white Chinese mourning attire. They burned funeral paper and set off fireworks.

“There’s been a lot!” a worker said when asked about the number of COVID-19 deaths before funeral director Ma Xiaowei stepped in and brought the journalists to meet a local government official.

As the official listened in, Ma confirmed there were more cremations but said he did not know if COVID-19 was involved. He blamed the extra deaths on the arrival of winter.

“Every year during this season, there’s more,” Ma said. “The pandemic hasn’t really shown up” in the death toll, he said, as the official listened and nodded.

Medical staff forced to work even with COVID symptoms

Sonia Jutard-Bourreau, 48, chief medical officer at the private Raffles Hospital in Beijing, said patient numbers are five to six times their normal levels, and patients’ average age has shot up by about 40 years to over 70 in the space of a week.

“It’s always the same profile,” she said. “That is most of the patients have not been vaccinated.”

The patients and their relatives visit Raffles because local hospitals are “overwhelmed”, she said, and because they wish to buy Paxlovid, the Pfizer-made COVID treatment, which many places, including Raffles, are running low on.

“They want the medicine like a replacement of the vaccine, but the medicine does not replace the vaccine,” Jutard-Bourreau said, adding that there are strict criteria for when her team can prescribe it.

Jutard-Bourreau, who, like Bernstein, has been working in China for around a decade, fears that the worst of this wave in Beijing has not arrived yet.

Elsewhere in China, medical staff told Reuters that resources are already stretched to the breaking point in some cases, as COVID and sickness levels amongst staff have been particularly high.

One nurse based in the western city of Xian said 45 of 51 nurses in her department and all staff in the emergency department had caught the virus in recent weeks.

“There are so many positive cases among my colleagues,” said the 22-year-old nurse, surnamed Wang. “Almost all the doctors are down with it.”

Wang and nurses at other hospitals said they had been told to report for duty even if they tested positive and had a mild fever.

Jiang, a 29-year-old nurse on a psychiatric ward at a hospital in Hubei province, said staff attendance has been down more than 50% on her ward, which has stopped accepting new patients.

She said she is working shifts of more than 16 hours with insufficient support.

“I worry that if the patient appears to be agitated, you have to restrain them, but you cannot easily do it alone,” she said. “It’s not a great situation to be in.”

COVID death toll numbers ‘political’

The doctors who spoke to Reuters said they were most worried about the elderly, tens of thousands of whom may die, according to estimates from experts.

More than 5,000 people are probably dying each day from COVID-19 in China, Britain-based health data firm Airfinity estimated, offering a dramatic contrast to official data from Beijing on the country’s current outbreak.

The Chinese government has reported only seven COVID-19 deaths since restrictions were loosened dramatically on 7 December, bringing the country’s total toll to 5,241.

There were no COVID deaths on the mainland for the six days through Sunday, the Chinese Centre for Disease Control and Prevention said on Sunday, even as crematories faced surging demand.

Last Tuesday, a Chinese health official said that China only counts deaths from pneumonia or respiratory failure in its official COVID-19 death toll — a narrow definition that excludes many deaths that would be attributed to the virus in other places.

Experts have forecast between a million and 2 million deaths in China through the end of next year, and a top World Health Organisation official warned that Beijing’s way of counting would “underestimate the true death toll”.

“It’s not medicine, it’s politics,” said Jutard-Bourreau. “If they’re dying now with COVID, it’s because of COVID. The mortality rate now it’s political numbers, not medical.”

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Here’s what the Federal Reserve’s half-point rate hike means for you

The Federal Reserve raised its target federal funds rate by 0.5 percentage points at the end of its two-day meeting Wednesday in a continued effort to cool inflation.

Although this marks a more typical hike compared to the super-size 0.75 percentage point moves at each of the last four meetings, the central bank is far from finished, according to Greg McBride, chief financial analyst at Bankrate.com.

“The months ahead will see the Fed raising interest rates at a more customary pace,” McBride said.

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The latest move is only one part of a rate-hiking cycle, which aims to bring down inflation without tipping the economy into a recession, as some feared would have happened already.

“I thought we would be in the midst of a recession at this point, and we’re not,” said Laura Veldkamp, a professor of finance and economics at Columbia University Business School.

“Every single time since World War II the Federal Reserve has acted to reduce inflation, unemployment has shot up, and we are not seeing that this time, and that’s what stands out,” she said. “I couldn’t really imagine a better scenario.”

Still, the combination of higher rates and inflation has hit household budgets particularly hard.

What the federal funds rate means for you

Pay down high-rate debt

Since most credit cards have a variable interest rate, there’s a direct connection to the Fed’s benchmark, so short-term borrowing rates are already heading higher.

Credit card annual percentage rates are now over 19%, on average, up from 16.3% at the beginning of the year, according to Bankrate.

The cost of existing credit card debt has already increased by at least $22.9 billion due to the Fed’s rate hikes, and it will rise by an additional $3.2 billion with this latest increase, according to a recent analysis by WalletHub.

If you’re carrying a balance, “grab one of the zero-percent or low-rate balance transfer offers,” McBride advised. Cards offering 15, 18 and even 21 months with no interest on transferred balances are still widely available, he said.

“This gives you a tailwind to get the debt paid off and shields you from the effect of additional rate hikes still to come.”

Otherwise, try consolidating and paying off high-interest credit cards with a lower interest home equity loan or personal loan.

Consumers with an adjustable-rate mortgage or home equity lines of credit may also want to switch to a fixed rate.

How to know if we are in a recession

Because longer-term 15-year and 30-year mortgage rates are fixed and tied to Treasury yields and the broader economy, those homeowners won’t be immediately impacted by a rate hike.

However, the average interest rate for a 30-year fixed-rate mortgage is around 6.33% this week — up more than 3 full percentage points from 3.11% a year ago.

“These relatively high rates, combined with persistently high home prices, mean that buying a home is still a challenge for many,” said Jacob Channel, senior economic analyst at LendingTree.

The increase in mortgage rates since the start of 2022 has the same impact on affordability as a 32% increase in home prices, according to McBride’s analysis. “If you had been approved for a $300,000 mortgage in the beginning of the year, that’s the equivalent of less than $204,500 today.”

Anyone planning to finance a new car will also shell out more in the months ahead. Even though auto loans are fixed, payments are similarly getting bigger because interest rates are rising.

The average monthly payment jumped above $700 in November compared to $657 earlier in the year, despite the average amount financed and average loan term lengths staying more or less the same, according to data from Edmunds.

“Just as the industry is starting to see inventory levels get to a better place so that shoppers can actually find the vehicles they’re looking for, interest rates have risen to the point where more consumers are facing monthly payments that they likely cannot afford,” said Ivan Drury, Edmunds’ director of insights.

Federal student loan rates are also fixed, so most borrowers won’t be impacted immediately by a rate hike. However, if you have a private loan, those loans may be fixed or have a variable rate tied to the Libor, prime or T-bill rates — which means that as the Fed raises rates, borrowers will likely pay more in interest, although how much more will vary by the benchmark.

That makes this a particularly good time to identify the loans you have outstanding and see if refinancing makes sense.

the savings account rates at some of the largest retail banks, which were near rock bottom during most of the Covid pandemic, are currently up to 0.24%, on average.

Thanks, in part, to lower overhead expenses, the average online savings account rate is closer to 4%, much higher than the average rate from a traditional, brick-and-mortar bank.

“The good news is savers are seeing the best returns in 14 years, if they are shopping around,” McBride said.

Top-yielding certificates of deposit, which pay between 4% and 5%, are even better than a high-yield savings account.

And yet, because the inflation rate is now higher than all of these rates, any money in savings loses purchasing power over time.

What’s coming next for interest rates

Consumers should prepare for even higher interest rates in the coming months.

Even though the Fed has already raised rates seven times this year, more hikes are on the horizon as the central bank slowly reins in inflation.

Recent data show that these moves are starting to take affect, including a better-than-expected consumer prices report for November. However, inflation remains well above the Fed’s 2% target.

“They will still be raising interest rates now and into 2023,” McBride said. “The ultimate stopping point is unknown, as is how long rates will stay at that eventual destination.”

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Correction: A previous version of this story misstated the extent of previous rate hikes.

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