Tag: Covid Vaccine

Doctor’s Checklist for Treating Long COVID Patients

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April 4, 2023 – Lisa McCorkell had a mild bout of COVID-19 in March 2020. Young and healthy, she assumed that she would bounce back quickly. But when her fatigue, shortness of breath, and brain fog persisted, she realized that she most likely had long COVID. 

“Back then, we as patients basically coined the term,” she said. While her first primary care provider was sympathetic, they were unsure how to treat her. After her insurance changed, she ended up with a second primary care provider who didn’t take her symptoms seriously. “They dismissed my complaints and told me they were all in my head. I didn’t seek care for a while after that.”

McCorkell’s symptoms improved after her first COVID vaccine in the spring of 2021. She also finally found a new primary care doctor she could trust. But as one of the founders of the Patient-Led Research Collaborative, a group of researchers who study long COVID, she says many doctors still don’t know the hallmark symptoms of the condition or how to treat it. 

“There’s still a lack of education on what long COVID is, and the symptoms associated with it,” she said. “Many of the symptoms that occur in long COVID are symptoms of other chronic conditions, such as myalgic encephalomyelitis / chronic fatigue syndrome, that are often dismissed. And even if providers believe patients and send them for a workup, many of the routine blood and imaging tests come back normal.”

The term “long COVID” emerged in May 2020. And though the condition was recognized within a few months of the start of the pandemic, doctors weren’t sure how to screen or treat it. 

While knowledge has developed since then, primary care doctors are still in a tough spot. They’re often the first providers that patients turn to when they have symptoms of long COVID. But with no standard diagnostic tests, treatment guidelines, standard care recommendations, and a large range of symptoms the condition can produce, doctors may not know what to look for, nor how to help patients.

“There’s no clear algorithm to pick up long COVID – there are no definite blood tests or biomarkers, or specific things to look for on a physical exam,” said Lawrence Purpura, MD, an infectious disease specialist and director of the long COVID clinic at Columbia University Medical Center in New York City. “It’s a complicated disease that can impact every organ system of the body.”

Even so, emerging research has identified a checklist of sorts that doctors should consider when a patient seeks care for what appears to be long COVID. Among them:

  • The key systems and organs impacted by the disease
  • The most common symptoms
  • Useful therapeutic options for symptom management that have been found to help people with long COVID
  • The best heathy lifestyle choices that doctors can recommend to help their patients 

Here’s a closer look at each of these aspects, based on research and interviews with experts, patients, and doctors. 

Key Systems, Organs Impacted                                                                                                 

At least 10% of people who are infected with COVID-19 go on to have long COVID, according to a recent study that McCorkell helped co-author. But more than 3 years into the pandemic, much about the condition is still a mystery. 

COVID is a unique virus because it can spread far and wide in a patient’s body. A December 2022 study, published in the journal Nature, autopsied 44 people who died of COVID and found that the virus could spread throughout the body and persist, in one case as long as 230 days after symptoms started. 

“We know that there are dozens of symptoms across multiple organ systems,” said McCorkell. “That makes it harder for a primary care physician to connect the dots and associate it with COVID.”

A paper published last December in Nature Medicine proposed one way to help guide diagnosis. It divided symptoms into four groups: 

  • Cardiac and renal issues such as heart palpitations, chest pain, and kidney damage
  • Sleep and anxiety problems like insomnia, waking up in the middle of the night, and anxiety
  • In the musculoskeletal and nervous systems: musculoskeletal pain, osteoarthritis, and problems with mental skills
  • In the digestive and respiratory systems: trouble breathing, asthma, stomach pain, nausea, and vomiting

There were also specific patterns in these groups. People in the first group were more likely to be older, male, have other conditions and to have been infected during the first wave of the COVID pandemic. People in the second group were over 60% female, and were more likely to have had previous allergies or asthma. The third group was also about 60% female, and many of them already had autoimmune conditions such as rheumatoid arthritis. Members of the fourth group – also 60% female – were the least likely of all the groups to have another condition.

This research is helpful, because it gives doctors a better sense of what conditions might make a patient more likely to get long COVID, as well as specific symptoms to look out for, said Steven Flanagan, MD, a physical medicine and rehabilitation specialist at NYU Langone Medical Center who also specializes in treating patients with long COVID. 

But the “challenge there, though, for health care providers is that not everyone will fall neatly into one of these categories,” he stressed.

Checklist of Symptoms 

Although long COVID can be confusing, doctors say there are several symptoms that appear consistently that primary care providers should look out for, that could flag long COVID. They include:

Post-exertional malaise (PEM). This is different from simply feeling tired. “This term is often conflated with fatigue, but it’s very different,” said David Putrino, PhD, director of rehabilitation innovation at the Mount Sinai Health System in New York City, who says that he sees it in about 90% of patients who come to his long COVID clinic. 

PEM is the worsening of symptoms after physical or mental exertion. This usually occurs a day or two after the activity, but it can last for days, and sometimes weeks. 

“It’s very different from fatigue, which is just a generalized tiredness, and exercise intolerance, where someone complains of not being able to do their usual workout on the treadmill,” he noted. “People with PEM are able to push through and do what they need to do, and then are hit with symptoms anywhere from 12 to 72 hours later.”

Dysautonomia. This is an umbrella term used to describe a dysfunction of the autonomic nervous system, which regulates bodily functions that you can’t control, like your blood pressure, heart rate, and breathing. This can cause symptoms such as heart palpitations, along with orthostatic intolerance, which means you can’t stand up for long without feeling faint or dizzy. 

“In my practice, about 80% of patients meet criteria for dysautonomia,” said Putrino. Other research has found that it’s present in about two-thirds of long COVID patients.

One relatively easy way primary care providers can diagnose dysautonomia is to do the tilt table test. This helps check for postural orthostatic tachycardia syndrome (POTS), one of the most common forms of dysautonomia. During this exam, the patient lies flat on a table. As the head of the table is raised to an almost upright position, their heart rate and blood pressure are measured. Signs of POTS include an abnormal heart rate when you’re upright, as well as a worsening of symptoms.

Exercise intolerance. A 2022 review published in the journal JAMA Network Open analyzed 38 studies on long COVID and exercise and found that patients with the condition had a much harder time doing physical activity. Exercise capacity was reduced to levels that would be expected about a decade later in life, according to study authors. 

“This is especially important because it can’t be explained just by deconditioning,” said Purpura. “Sometimes these patients are encouraged to ramp up exercise as a way to help with symptoms, but in these cases, encouraging them to push through can cause post-exertional malaise, which sets patients back and delays recovery.”

While long COVID can cause dozens of symptoms, a paper McCorkell co-authored zeroed in on some of the most common ones:

  • Chest pain
  • Heart palpitations
  • Coughing
  • Shortness of breath
  • Belly pain
  • Nausea
  • Problems with mental skills
  • Fatigue
  • Disordered sleep
  • Memory loss
  • Ringing in the ears (tinnitus)
  • Erectile dysfunction
  • Irregular menstruation
  • Worsened premenstrual syndrome

While most primary care providers are familiar with some of these long COVID symptoms, they may not be aware of others. 

“COVID itself seems to cause hormonal changes that can lead to erection and menstrual cycle problems,” explained Putrino. “But these may not be picked up in a visit if the patient is complaining of other signs of long COVID.” 

It’s not just what symptoms are, but when they began to occur, he added. 

“Usually, these symptoms either start with the initial COVID infection, or begin sometime within 3 months after the acute COVID infection. That’s why it’s important for people with COVID to take notice of anything unusual that crops up within a month or two after getting sick.”

Can You Prevent Long COVID?

You can reduce your risk by taking preventive measures such as wearing a mask, keeping your distance from others in crowded indoor settings, and getting vaccinated. Getting at least one dose of a COVID vaccine before you test positive for COVID lowers your risk of long COVID by about 35% according to a 2022 study published in Antimicrobial Stewardship & Healthcare Epidemiology. Unvaccinated people who recovered from COVID, and then got a vaccine, lowered their own long COVID risk by 27%. 

In addition, a February study published in JAMA Internal Medicine found that women who were infected with COVID were less likely to go on to get long COVID and/or have less debilitating symptoms if they had a healthy lifestyle, which included the following: 

  • Healthy weight (a BMI between 18.5 and 24.7)
  • Never smoker
  • Moderate alcohol consumption
  • A high-quality diet
  • Seven to 9 hours of sleep a night
  • At least 150 minutes per week of physical activity

But McCorkell noted that she herself had a healthy pre-infection lifestyle but got long COVID anyway, suggesting these approaches don’t work for everyone.

“I think one reason my symptoms weren’t addressed by primary care physicians for so long is because they looked at me and saw that I was young and healthy, so they dismissed my reports as being all in my head,” she explained. “But we know now anyone can get long COVID, regardless of age, health status, or disease severity. That’s why it’s so important that primary care physicians be able to recognize symptoms.”

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Q&A: The Future of COVID-19

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Senior writer Kara Grant co-authored this report.

March 15, 2023 – As we approach the third anniversary of the COVID-19 pandemic, experts and everyday Americans wonder if we are finally at the end of what has been a painful and exhausting ordeal that’s lasted 3 years. With vaccine and booster fatigue, COVID-19 cases leveling out, and a growing body of research that has helped us understand the virus more clearly, many are still asking: How concerned should I be?

 In February, the Biden administration announced that it was the end of the road for the COVID-19 emergency orders, which had been in place since January 2020. That came after a year still fraught with ups and downs, with the U.S. surpassing 1 million COVID-19 deaths and variants continuing to evolve.

 We asked experts their thoughts on the future of COVID-19 and how their perspectives have shifted over the years.

Where Are We Now With COVID-19?

While the Omicron variant is still lingering, we’re in a period of lower rates of COVID-19 transmission.

Vaccinations and boosters have helped. That, along with antiviral treatments and high rates of collective immunity, have kept COVID-19 at bay, but it’s important to remember that this virus isn’t going anywhere, says Ashwin Vasan, MD, the commissioner of the New York City Department of Health and Mental Hygiene.  

“The federal emergency will expire in May, and compared to where we’ve been, we’re not in an emergency today,” he says. “But we will have to use the tools and strategies to really manage whatever COVID-19 throws at us going forward – if it were to change or if it ends up being more of a seasonal virus, like other coronaviruses.”

One thing is for certain: Health care will never be the same, says Jennifer Gil, a registered nurse and a member of the American Nurses Association Board of Directors.

“While cases in our area are steadily declining, patients and health care workers continue to experience the long-lasting effects of the pandemic,” she says. “I witness it every day when I see the long-term impact it has had on patients, access to care, and health care workers’ mental and emotional well-being.”

Is This the End of the Pandemic? 

First, it’s important to understand the difference between a pandemic and an epidemic, Vasan says. An epidemic is the spreading of a disease that outpaces what would be expected within a certain time and location. A pandemic is an epidemic that spreads across various continents and regions of the world.

COVID-19 is a new virus, which makes things tricky. “Before 2020, our baseline was zero because COVID-19 didn’t exist,” says Vasan. “So, the question we can’t really answer from an epidemiologic standpoint is – ‘is it still a pandemic?’ Well, is it circulating beyond what’s to be expected? I think we’re going to have to figure out what those expectations are at baseline.”

Jim Versalovic, MD, pathologist-in-chief at Texas Children’s Hospital, deems this a “post-pandemic” period, since the virus isn’t impacting us as dramatically as it did in 2020 and 2021. This is thanks to the successful efforts “to diagnose, treat, and prevent COVID-19,” along with collective immunity after many being exposed and infected with the virus, he says.

Some experts believe that declaring the pandemic “over” is a long shot. Rather, it’s likely that we are changing to more of an endemic status, according to Natascha Tuznik, DO, an infectious disease specialist at the University of California, Davis. It’s best to view COVID-19 as a “permanently established infection” in both humans and animals, she says. So we should treat it like the seasonal flu and continue to be careful to update vaccinations. 

“Vaccine uptake, overall, is still insufficient,” says Tuznik, “It’s important to not let our guard down and believe the problem no longer exists.”

The impact the pandemic has had on communities of color, frontline workers, and the health care system more broadly is also not to be forgotten, says Gil. “While the number of COVID-19 cases is subsiding, the invisible impact of the pandemic will continue to emerge in the coming years,” she says. 

What Worries You Now About COVID-19? 

Complacency can be an issue with any viral infection, says Versalovic, and it’s critical to continue to treat COVID-19 with extreme caution. For example, the U.S. will always need to track COVID-19 trends.

“It has become one of our major respiratory viruses affecting mankind around the globe,” he says. “Certainly, in the medical profession, we’re going to have to do our best to communicate and emphasize to everyone that these viruses aren’t going to disappear, and we need to continue to be aware and vigilant.”

Don’t forget that people still die from this virus every day, says Tuznik. “COVID-19 has killed over 1 million Americans and over 6.8 million people globally,” she says. “While the rates of death have declined, they have not stopped.”

Vasan poses another critical question: “What pieces are in place to ensure that we have a strong health system prepared to respond to COVID-19 changes or if another epidemic or pandemic illness arrives?” 

Examples could include ensuring tests, vaccines, and treatments are deployed in a quick, strategic manner, and building a public health system that can make that happen, without failing to support health care workers, he says.

Challenges like staffing shortages and hazardous work conditions have resulted in mental health-related issues and burnout among health care workers, Gil says. Many have reported skyrocketing rates of PTSD, anxiety, depression, and stress. Some have chosen to leave the health care workforce entirely.

“Investing in our health care workforce by providing mental health and wellness resources is essential,” says Gil. “We must also equally address the underlying issues by enforcing safe staffing standards and investing in long-term solutions that aim to improve the work environment.”

Has the Pandemic Changed Your Relationship to Medicine? 

The COVID-19 crisis has altered the health care world, likely for posterity. For many, like Vasan, the last 3 years have been a shining example of how fragile our health care system is. 

“We continually spend on things that don’t deliver on health,” he says, referring specifically to the $4 trillion spent on health care, with only a small fraction of that dedicated to disease prevention efforts. “Had we spent more on prevention, fewer would have died from COVID. We need to have a reckoning in this country about whether we are willing not to design for health care and medicine, but to design for health.” 

And while COVID-19 certainly brought to light the major – and minor – flaws in the health care system, the knowledge we’ve learned along the way is a silver lining for many doctors. Versalovic says that the chaos and anxiety forced those in medicine to rapidly refine their approaches to diagnostics, from in-hospital testing to drive-thru and at-home testing. Along the way, he says, there has also been a renewed gratitude for treatments like monoclonal antibodies and the preventive powers of RNA vaccines. 

But for Tuznik, the pandemic has given her an entirely newfound appreciation for her career path. 

“The infectious diseases community really came together as a tour de force during the pandemic, and it was humbling to be a part of such a mass effort and collaboration,” she says. 

What Have the Last 3 Years Taught You?

COVID-19 has forced us all to learn new and often difficult lessons about ourselves, our relationships, and how we each fit into the world. 

It’s a line we’ve heard over and over again: These are unprecedented times. A large part of that has been the extreme politicization of science and the growing divisiveness across the country. But despite what feels like unyielding friction in the medical community and beyond, people were still able to come together and tackle the pandemic’s challenges. 

Vasan says that our ability to work together on life-saving treatments and prevention strategies is “a testament to human endeavor, ingenuity, collaboration, in the face of an existential threat.”

For nurses, the pandemic brought about pervasive burnout and fatigue. But that’s not the end of the story. 

“Personally, it has driven me to go back to school to gain the research and analytical skills necessary to develop evidence-based policies and programs that aim to improve health care delivery,” says Gil. “Now, more than ever, nurses are key stakeholders at the policy and decision-making table.”

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COVID at 3 Years: Where Are We Headed?

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March 15, 2023 – Three years after COVID-19 rocked the world, the pandemic has evolved into a steady state of commonplace infections, less frequent hospitalization and death, and continued anxiety and isolation for older people and those with weakened immune systems.

After about 2½ years of requiring masks in health care settings,  the CDC lifted its recommendation for universal, mandatory masking in hospitals in September 2022.

Some statistics tell the story of how far we have come. COVID-19 weekly cases dropped to nearly 171,000 on March 8, a huge dip from the 5.6 million weekly cases reported in January 2022. COVID-19 deaths, which peaked in January 2021 at more than 23,000 a week, stood at 1,862 per week on March 8.

Where We Are Now

Since Omicron is so infectious, “we believe that most people have been infected with Omicron in the world,” says Christopher J.L. Murray, MD, a professor and chair of health metrics sciences at the University of Washington and director of the Institute for Health Metrics and Evaluation in Seattle. Sero-prevalence surveys — or the percentage of people in a population who have antibodies for an infectious disease, or the Omicron variant in this case — support this rationale, he says.

“Vaccination was higher in the developed world but we see in the data that Omicron infected most individuals in low income countries,” says Murray. For now, he says, the pandemic has entered a “steady state.”

At New York University Langone Health System, clinical testing is all trending downward, and hospitalizations are low, says Michael S. Phillips, MD, an infectious disease doctor and chief epidemiologist at the health system. 

In New York City, there has been a shift from pandemic to “respiratory viral season/surge,” he says. 

The shift is also away from universal source control – where every patient encounter in the system involves masking, distancing, and more – to a focus on the most vulnerable patients “to ensure they’re well-protected,” Phillips says. 

Johns Hopkins Hospital in Baltimore has seen a “marked reduction” of the number of people coming to the intensive care unit because of COVID, says Brian Thomas Garibaldi, MD, a critical care doctor and director of the Johns Hopkins Biocontainment Unit.

“That is a testament to the amazing power of vaccines,” he says. 

The respiratory failures that marked many critical cases of COVID in 2020 and 2021 are much rarer now, a shift that Garibaldi calls “refreshing.”

“In the past 4 or 5 weeks, I’ve only seen a handful of COVID patients. In March and April of 2020, our entire intensive care unit – in fact, six intensive care units – were filled with COVID patients.”

Garibaldi sees his own risk differently now as well. 

“I am not now personally worried about getting COVID, getting seriously ill, and dying from it. But if I have an ICU shift coming up next week, I am worried about getting sick, potentially having to miss work, and put that burden on my colleagues. Everyone is really tired now,” says Garibaldi, who is also an associate professor of medicine and physiology in the Division of Pulmonary and Critical Care Medicine at Johns Hopkins University School of Medicine. 

What Keeps Experts Up at Night?

The potential for a stronger SARS-CoV-2 variant to emerge concerns some experts.  

A new Omicron  subvariant could emerge, or a new variant altogether could arise.  

One of the main concerns is not just a variant with a different name, but one that can escape current immune protections. If that happens, the new variant could infect people with immunity against Omicron. 

If we do return to a more severe variant than Omicron, Murray says, “then suddenly we’re in a very different position. 

Keeping an Eye on COVID-19, Other Viral Illnesses

We have better genomic surveillance for circulating strains of SARS-CoV-2 than earlier in the pandemic, Phillips says. More reliable, day-to-day data also helped recently with the respiratory syncytial virus (RSV) outbreak and for tracking flu cases.

 Wastewater surveillance as an early warning system for COVID-19 or other respiratory virus surges can be helpful, but more research is needed, Garibaldi says. And with more people testing at home, test positivity rates are likely an undercount. So, hospitalization rates for COVID and other respiratory illnesses remain one of the more reliable community-based measures, for now, at least. 

One caveat is that sometimes, it is unclear if COVID-19 is the main reason someone is admitted to the hospital vs. someone who comes in for another reason and happens to test positive upon admission. 

Phillips suggests that using more than one measure might be the best approach, especially to reduce the likelihood of bias associated with any single strategy. “You need to look at a whole variety of tests in order for us to get a good sense of how it’s affecting all communities,” he says. In addition, if a consensus emerges among different measures – wastewater surveillance, hospitalization and test positivity all trending up – “that’s clearly a sign that things are afoot and that we would need to modify our approach accordingly.”

Where We Could Be Heading

Murray predicts a steady pace of infection with “no big changes.” But waning immunity remains a concern. 

That means if you have not had a recent infection – in the last 6 to 10 months – you might want to think about getting a booster, Murray says “The most important thing for people, for themselves, for their families, is to really think about keeping their immunity up.” 

Phillips hopes the improved surveillance systems will help public health officials make more precise recommendations based on community levels of respiratory illness. 

When asked to predict what might happen with COVID moving forward, “I can’t tell you how many times I’ve been wrong answering that question,” Garibaldi says.

 Rather than making a prediction, he prefers to focus on hope. 

“We weathered the winter storm we worried about in terms of RSV, flu, and COVID at the same time. Some places were hit harder than others, especially with pediatric RSV cases, but we haven’t seen anywhere near the level we saw last year and before that,” he says. “So, I hope that continues.”

“We’ve come very far in just 3 years. When I think about where we were in March 2020 taking care of our first round of COVID patients in our first unit called a biocontainment unit,” Garibaldi says. 

Murray addresses whether the term “pandemic” still applies at this point. 

“In my mind, the pandemic is over,” he says, because we are no longer in an emergency response phase. But COVID in some form is likely to be around for a long time, if not forever.  

“So, it depends on how you define pandemic. If you mean an emergency response, I think we’re out of it. If you mean the formal definition you know of an infection that goes all over the place, then we’re going to be in it for a very long time.”

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FDA Panel Backs Shift Toward One-Dose COVID Shot

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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

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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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