Coronavirus updates May 2023

[missy]

"

A monumental moment: End of international emergency​

KATELYN JETELINA MAY 5

Today the World Health Organization declared the end of the Public Health Emergency of International Concern (PHEIC). This is a huge moment in our story arc of the fight against COVID-19. Here is what it does and does not mean.

​

What this means​

The WHO Emergency Committee believes three things:

1. COVID-19 is not unusual and unexpected.
2. Cross-border transmission can’t (and won’t) be stopped.
3. COVID-19 does not require a coordinated international response.

A PHEIC is a key legal mechanism within global health security. The hope is that it catalyzes timely action to limit the societal impacts of emerging risks. Since the PHEIC mechanism started in 2005, a PHEIC has ended five (out of seven) times. So this is a fairly new mechanism. But essentially the end of the PHEIC means:

• The end of mobilizing international coordination;
• The end of streamlining international funding;
• The end of accelerating the advancement of the development of vaccines, therapeutics and diagnostics under emergency use authorization.

The WHO now sees COVID-19 as a threat in our regular repertoire of things-trying-to-kill-us. These things will still happen but with less urgency.

What it does not mean​

This doesn’t mean the end of a pandemic. Declaring a PHEIC is not the same thing as declaring the end of a pandemic. “Pandemic” is rhetoric that governments use as a communication tool—it indicates the widespread occurrence of an infectious disease across the globe at a particular time. In theory, the end of a PHEIC comes far before the end of a pandemic.

This doesn’t mean that COVID-19 is gone. SARS-CoV-2 is currently mutating 2 times faster than the flu. We will get future waves, but hopefully these will be “wavelets” given the population-level immunity from vaccines and infections. And wavelets will happen several times a year. The probability of a variant of concern (which would be named Pi) is still ~20% in the next 1.5 years. If one emerges, it would likely cause a tsunami. (We saw something similar happen after the 1918 flu emergency ended.) And we cannot ignore the fact that COVID-19 is a leading cause of death in many countries. This will likely remain for years.

This doesn’t mean that we can go back to pre-pandemic times. This does not mean that some countries (cough, cough U.S.) don’t have serious underlying problems that need to be addressed. It’s beyond time to confront the threats to our individual and collective health so we are not in a constant state of emergency. We cannot keep living in a perpetual cycle of panic and neglect.

Bottom line​

I welcome this decision to end the emergency for the same reasons I thought it was time to end the American national emergency. We now find ourselves in an awkward phase with this virus—somewhere between a full-blown emergency and an endemic state of predictability. (Epidemiologists don’t have a word for this phase.)

Use this time to take a deep breath, cry, reflect, hit a pillow, meditate and/or celebrate surviving (figurately and literally) the past 3.5 years. We deserve all the feelings today, especially for those of us on the front lines who sacrificed so much. Today is a monumental symbol of this life-changing event. But then we need to hold our heads high and continue fighting COVID-19 and improving our systems so we don’t repeat our failures.

The end of an emergency is the beginning of preparedness.

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[missy]

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COVID-19 vaccine appears more effective if received around midday
Originally published on MedicalXpress Breaking News-and-Events

A study from Washington University School of Medicine in St. Louis indicates that the COVID-19 mRNA vaccine may be more effective at preventing infections if doses are given around the middle of the day rather than at other times. The researchers believe circadian rhythm—the natural cycle of physical and other changes our bodies go through in a 24-hour period—may affect the body's response to the vaccine.

Further, they found that the correlation was strongest in children and teenagers, as well as adults over age 50.

The study is published in The Journal of Clinical Investigation.

"This type of information may be critical during a mass vaccination campaign, because if you can target priority groups—such as the young and the elderly, who our data suggest stand to benefit the most from midday COVID-19 vaccines—and vaccinate them during optimal times of day, that should create a significant societal benefit in reducing breakthrough infections," said senior author Jeffrey A. Haspel, MD, Ph.D., an associate professor of medicine in the Division of Pulmonary & Critical Care Medicine.

"Our data is specific to COVID-19 vaccination, but there are some small studies that also suggest vaccination for influenza may be more effective earlier in the day. Since these trends track with a basic biological phenomenon, it is possible this pattern is reflective of vaccinations in general. But we need more research to confirm that."

The study included data from more than 1.5 million people over age 12 who were enrolled in a large, Israeli health insurance plan. Nearly all had received the Pfizer mRNA vaccine. In Israel, the fourth dose (sometimes referred to as the second booster) was only offered to immunocompromised patients and older, healthy adults. For analysis purposes, morning was considered 8 a.m. to noon; afternoon was noon to 4 p.m.; and evening was 4 to 7 p.m.

Among older adults and people who were immunosuppressed, each of whom had received a fourth vaccine dose, more hospitalizations were seen among those who had received the fourth shot after 4 p.m.

Depending on a person's age, the vaccine's effectiveness improved from 8.6% to 25% when given around the middle of the day, compared with when given in the evening. To give an idea of the size of this effect on a population scale, the researchers estimated that moving 18 to 55 people from the least favorable vaccination time frame (4 to 7 p.m.) to the most favorable time frame (10 a.m. to 2 p.m.) would prevent one post-vaccination infection.

"In a pandemic, preventing any infection is desirable, because it slows the spread of the virus," Haspel said. "Over hundreds of millions of people, a benefit the size we estimated can have a huge impact. Based on our large data set, for children and older adults in particular, it can't hurt to try to have them vaccinated in the late morning and early afternoon."

The researchers found this general pattern remained consistent when they controlled for sex and pre-existing conditions. The benefit also was present for adults in the middle of the age range, but the size of the effect was smaller.

Basic research in mice and other organisms, including work in Haspel's lab, has demonstrated that the biological clock regulates how some genes are expressed, dialing them up and down in a wave pattern depending on the time of day. Various components of the immune system show these day-night rhythms, including innate inflammatory responses, the movement of immune cells from the bone marrow to various organs and lymph nodes, and how T cells respond to outside invaders.

"This observational study can't demonstrate whether any of these specific immune system rhythms are responsible for the cycling we see in vaccine effectiveness," Haspel said. "But we're very interested in investigating these questions further."

This article was originally published on MedicalXpress Breaking News-and-Events.
"

 

[Lookinagain]

that's very interesting

 

[missy]

"

Study of Hospitalizations in Canada Quantifies Benefit of COVID-19 Vaccine to Reduce Death, ICU Admissions​

Richard Mark Kirkner
May 08, 2023




A cohort study of more than 1.5 million hospital admissions in Canada through the first 2 years of the COVID-19 pandemic has quantified the benefit of vaccinations. Unvaccinated patients were found to be up to 15 times more likely to die from COVID-19 than fully vaccinated patients.
Investigators analyzed 1.513 million admissions at 155 hospitals across Canada from March 15, 2020, to May 28, 2022. The study included 51,679 adult admissions and 4035 pediatric admissions for COVID-19. Although the share of COVID-19 admissions increased in the fifth and sixth waves, from December 26, 2021, to March 19, 2022 — after the full vaccine rollout — to 7.73% from 2.47% in the previous four waves, the proportion of adults admitted to the intensive care unit (ICU) was significantly lower, at 8.7% vs 21.8% (odds ratio, 0.35; 95% CI, 0.32 – 0.36).

"The good thing about waves five and six was we were able to show the COVID cases tended to be less severe, but on the other hand, because the disease in the community was so much higher, the demands on the healthcare system were much higher than the previous waves," study author Charles Frenette, MD, director of infection prevention and control at McGill University Health Center in Montreal and chair of the study's adult subgroup, told Medscape Medical News. "But here we were able to show the benefit of vaccinations, particularly the boosting dose, in protecting against those severe outcomes."


The study, published April 20 in JAMA Network Open, used the Canadian Nosocomial Infection Surveillance Program (CNISP) database, which collects hospital data across Canada. It was activated in March 2020 to collect details on all COVID-19 admissions, co-author Nisha Thampi, MD, chair of the study's pediatric subgroup, told Medscape.

"We're now over 3 years into the pandemic, and CNISP continues to monitor COVID-19 as well as other pathogens in near real time," said Thampi, an associate professor and infectious disease specialist at Children's Hospital of Eastern Ontario in Ottawa.

"That's a particular strength of this surveillance program as well. We would see this data on a biweekly basis, and that allows for to implement timely protection and action."

Tracing Trends Over Six Waves​

The study tracked COVID-19 hospitalizations during six waves. The first lasted from March 15 to August 31, 2020, and the second lasted from September 1, 2020, to February 28, 2021. The wild-type variant was dominant during both waves. The third wave lasted from March 1 to June 30, 2021, and was marked by the mixed Alpha, Beta, and Gamma variants. The fourth wave lasted from July 1 to December 25, 2021, when the Alpha variant was dominant. The Omicron variant dominated during waves five (December 26, 2021, to March 19, 2022) and six (March 20 to May 28, 2022).

Hospitalizations reached a peak of 14,461 in wave five. ICU admissions, however, peaked at 2164 during wave four, and all-cause deaths peaked at 1663 during wave two.

The investigators also analyzed how unvaccinated patients fared in comparison with the fully vaccinated and the fully vaccinated-plus (that is, patients with one or more additional doses). During waves five and six, unvaccinated patients were 4.3 times more likely to end up in the ICU than fully vaccinated patients and were 12.2 times more likely than fully vaccinated-plus patients. Likewise, the rate for all-cause in-hospital death for unvaccinated patients was 3.9 times greater than that for fully vaccinated patients and 15.1 times greater than that for fully vaccinated-plus patients.

The effect of vaccines emerged in waves three and four, said Frenette. "We started to see really, really significant protection and benefit from the vaccine, not only in incidence of admission but also in the incidence of complications of ICU care, ventilation, and mortality."

Results for pediatric patients were similar to those for adults, Thampi noted. During waves five and six, overall admissions peaked, but the share of ICU admissions decreased to 9.4% from 18.1%, which was the rate during the previous four waves (OR, 0.47).

"What's important is how pediatric hospitalizations changed over the course of the various waves," said Thampi.


"Where we saw the highest admissions during the early Omicron dominance, we actually had the lowest numbers of hospitalizations with death and admissions into ICUs."

Doing More With the Data​

Commenting on the study for Medscape, David Fisman, MD, MPH, a professor of epidemiology at the University of Toronto, said, "This is a study that shows us how tremendously dramatic the effects of the COVID-19 vaccine were in terms of saving lives during the pandemic." Fisman was not involved in the study.

But CNISP, which receives funding from Public Health Agency of Canada, could do more with the data it collects to better protect the public from COVID-19 and other nosocomial infections, Fisman said.


"The first problematic thing about this paper is that Canadians are paying for a surveillance system that looks at risks of acquiring infections, including COVID-19 infections, in the hospital, but that data is not fed back to the people paying for its production," he said.


"So, Canadians don't have the ability to really understand in real time how much risk they're experiencing via going to the hospital for some other reason."


The study was independently supported. Frenette and Thampi report no relevant financial relationships. Fisman has disclosed financial relationships with Pfizer, AstraZeneca, Sanofi, Seqirus, Merck, the Ontario Nurses Association and the Elementary Teachers' Federation of Ontario.


JAMA Netw Open.




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[dk168]

Covid is still alive and kicking, and I personally know of a HCP having gone down with it for the 3rd time.

DK

 

[missy]

Covid is still alive and kicking, and I personally know of a HCP having gone down with it for the 3rd time.

DK

Yup. We saw our cardiologist yesterday. He warned us to continue wearing masks because Covid is still here and still strong

 

[missy]

"

Unwinding the US public health emergency​

In January 2020, then-Health Secretary Alex Azar declared a public health emergency. This special designation expanded access to health care for millions of people in the US and eased or waived requirements around how it’s delivered. More than three years later, this declaration was finally rolled back. That will impact the way you interact with the US health system moving forward. Here’s what you need to know: How will access to Covid vaccines and treatments change?Throughout the pandemic, the US government purchased supplies of Covid vaccines and treatments, which, for the most part, have been offered to people without out-of-pocket costs. For now, there’s sufficient government-procured supply that access to vaccines and treatments “will not be affected in the months to come,” the White House said on May 9. When supply runs dry, most Americans will get products through private health insurance plans or federal health programs — such as Medicaid and Medicare — as they already do with annual flu shots. Covid vaccines will continue to be provided to older Americans via Medicare Part B without cost sharing, and Medicaid will cover all vaccines and treatments without cost sharing through Sept. 30, 2024. The Department of Health and Human Services will provide the uninsured access to vaccines and treatments through 2024. Will I still be able to get free Covid tests? Probably not. At the end of the month, free Covid tests will no longer be available at COVIDTests.gov, according to the White House. For those with employer-sponsored health insurance, test cost is likely to depend on your plan. The Department of Health and Human Services has encouraged employer health plan sponsors and private insurers to continue covering Covid tests without any out-of-pocket costs, but that’s all it is: encouragement. If you previously got free, rapid over-the-counter Covid tests through Medicare, that’s now come to an end, too, unless the tests are ordered by a health provider. Medicaid, meanwhile, will continue to cover at-home and PCR tests until September 2024, after which coverage will vary from state to state. Will I still be able to get ADHD or anxiety medication via telehealth? At the outset of the public health emergency, the Drug Enforcement Administration allowed telehealth providers to prescribe certain controlled substances virtually without an in-person medical exam. On May 9, the DEA and HHS said that providers can continue to prescribe controlled substances like Adderall or Xanax online through Nov. 11, 2023. Practitioners who establish relationships with patients on or prior to that date can continue to prescribe controlled substances for an additional year. Will I still be able to learn about Covid levels in my community? US laboratories will no longer be required to report Covid test results to the Centers for Disease Control and Prevention. Instead, the CDC will turn its attention to tracking severe Covid illness via hospital admissions, deaths and emergency room visits, while continuing to analyze wastewater and tests of international travelers to determine how the virus is spreading and evolving. For more information on how the end of the US public health emergency will impact everything from Medicaid enrollment to immigration policy, we’ve answered your most frequently asked questions here. —Riley Griffin

The big story​

As US drug shortages hit a five-year high and concerns mount about the safety of medicines, the Biden administration has quietly assembled a team to address chronic problems hurting America’s drug supply. Since the beginning of the year, a group of White House officials led by Domestic Policy Advisor Susan Rice has been meeting to increase the availability and quality of medications. The effort has intensified as Americans struggle to find common drugs like antibiotics and amid high-profile safety lapses like deadly eye drops. Riley Griffin, Anna Edney, Ike Swetlitz have the scoop on the White House effort.

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[missy]

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What Will Change Now That the Public Health Emergency Is Ending? Experts Weigh In​

— Medicaid and telehealth are among the big areas to watch​

by Joyce Frieden, Washington Editor, MedPage Today May 10, 2023


WASHINGTON -- As practically everyone has heard by now, Thursday marks the end of the COVID-19 public health emergency (PHE) in the U.S. What does that mean for physicians and their patients?

The PHE was originally declared for several reasons, Mario Ramirez, MD, an emergency physician and managing director of Opportunity Labs, said on a webinar sponsored by the COVID-19 Vaccine Education and Equity Project (CVEEP). For one thing, "it grants broad authority to the [HHS] secretary to enter into contracts that are non-traditional and are really designed to decrease and remove some of the bureaucratic hurdles that exist" -- for example, no-bid or single-source contracts. In addition, funds made available during the PHE "can be used to directly treat patients and it can be used to mobilize the private sector to produce vaccines or other therapeutics."



The other big pot of money that the PHE unlocks "comes from CDC, and that is the infectious disease emergency response plan. So those funds are not usable unless there's a public health emergency in place," he added. "It can also sort of unlock some of the telehealth flexibilities which folks may be more familiar with, and allows providers to treat patients in their homes so that we're not necessarily pulling people together in hospitals or other large settings."

Effect on Medicaid

Medicaid is one area that has gotten a lot of attention. Part of the PHE's end includes the end of a provision that required states to keep everyone who was on Medicaid during the pandemic on the Medicaid rolls if the state wanted to receive a 6.2% bump in their Medicaid matching funds from the federal government.

That provision ended on March 31, and states began a 1-year "unwinding" period during which they can assess Medicaid patients for possible disenrollment, Tesch West, JD, an associate at the Morgan Lewis law firm here, explained during a phone call at which a public relations person was present.



"Obviously there are concerns that people will lose coverage as a result of the unwinding," she said. "HHS itself has estimated about 15 million people will lose coverage based on the new screening, and they expect 6.8 million of those individuals will still be eligible for Medicaid but will lose their enrollment anyway, and that's largely because the Medicaid agencies do not have updated contact information for individuals. In addition to that, they're worried about folks that have limited English proficiency, people who have moved, and people who have disabilities" who may not be able to fill out the necessary forms to retain their coverage.

Another element in play will be PHE-era waivers for Medicaid plans to cover home- and community-based services (HCBS), West continued. Many of these waivers, especially those provided through a regulation called 1915(c), "have to do with individuals with intellectual disabilities, and they allow those individuals to have services [provided] in their home or in a non-institutional setting, which has been a very welcome service."



The 1915(c) waivers have a little bit of extra time, "but they'll expire on Dec. 11," she said. "Some states want to finalize and allow those new payment allowances to continue beyond the PHE, some states are not sure, and some don't want them to continue." There are about 330 HCBS waivers across the U.S., with some states using multiple waivers to target different populations, West said.

One positive Medicaid move has been that Congress has required states to wait until at least Sept. 30, 2024, before they can consider requiring cost-sharing for Medicaid patients' COVID-19 vaccines and treatments, Anand Parekh, MD, chief medical advisor of the Bipartisan Policy Center here, said on a phone call. "I think that that helps for that vulnerable population."

In a press release on Tuesday,opens in a new tab or window HHS emphasized that even after the PHE ends, Americans will continue to be able to access COVID-19 vaccines and treatments free of charge, but that "once the federal government is no longer purchasing or distributing COVID-19 vaccines and treatments, payment, coverage, and access may change."



Parekh also praised the way the CDC is handling the disappearance -- starting Thursday -- of its reporting on COVID cases and hospitalizations. "They've made [the reporting] like [they do for] flu, and I think that's good," he said. "They're using existing systems, and I think it's very sound and it's logical. But this virus compared to flu is even more transmissible and it is continuing to mutate very quickly. So ensuring that we have surveillance systems that can catch and provide early warning, I think, is going to be important."

Telehealth Flexibilities Extended

Telehealth is another area to watch, Jake Harper, JD, partner at Morgan Lewis, said on the Morgan Lewis call. "So luckily, the Consolidated Appropriations Act extended most of the telehealth flexibilities to the end of 2024," he said. "So now we're sort of in this interim period where there's additional data being collected, and within the course of the next year, I suspect that we will receive further congressional guidance on what a permanent telehealth solution will look like."



A big flexibility in that area has been the decision by the Drug Enforcement Administration (DEA) to let clinicians prescribe controlled substances -- everything from buprenorphine to attention-deficit/hyperactivity disorder medications -- via telehealth during the PHE, Harper said.

After issuing a proposed ruleopens in a new tab or window in March regarding what would change following the end of the PHE -- a rule that drew many critical comments -- DEA on Monday "released a temporary ruleopens in a new tab or window to keep everything status quo for 6 months," Harper said. "So we will get, over the next month or two, a final rule from DEA that will provide more clarity on what they perceive at the expectations for teleprescribing controlled substances ... If this hadn't come out, there was going to be chaos on Friday."

Similarly, the HHS Office for Civil Rights (OCR) has said it will allow a 90-day "transition period" for winding down its PHE-era policy of enforcement discretion regarding HIPAA violations. "OCR issued a very public policy at the start of the PHE that said they were going to have a policy of enforcement discretion for certain kinds of non-compliance," he said. For example, "if you were a physician and communicating with your patient via FaceTime or Skype or some other method that wasn't necessarily fully encrypted, OCR was not going to make an issue of that." So giving this 90-day grace period "is sort of like kicking the can down the road a little bit" to help providers ease back into the old rules, he said.



Learning From the Past

One lesson to be learned from the pandemic is that "the cycle of panic and neglect is not the best way to be prepared for public health emergency," Brent Ewig, MSPH, chief policy and government relations officer for the Association of Immunization Managers, said on the CVEEP call. "I don't want to be flip about that. But I think the idea that having a system in place to deliver a vaccine to broad amounts of the population -- if we could do that every day, then we'd be prepared to do that in the next emergency."

Instead, however, although the number of the country's public vaccine providers increased from 44,000 in the Vaccines for Children program to over 400,000 COVID vaccine providers, "when that funding dries up for the pharmacy program, we're going to snap back to our prior system. And it just doesn't make sense," he said. "It was like you you built up a bunch of Navy battleships to go out and win this one battle against COVID, and now we're going to bring them back to port and dismantle them and mothball them, only to have to rebuild them in the next emergency."



"It's been clear for months now that most Americans have already moved on and they think that we may be done with COVID," Ewig added. "But COVID may not be done with us. If we've learned anything, it's to expect the unexpected ... Just remaining vigilant and doing surveillance is going to be key."

One thing clinicians should look out for in the coming months is possible audits and "lookbacks" from the federal government to make sure federal rules were being complied with during the PHE, Harper said. "It's sort of the old saying, 'No good deed goes unpunished,' and those providers that are trying to do the best they can to take care of patients [during a PHE] -- oftentimes they don't get a lot of credit on the back end. To the extent that there's not compliance or there was an inappropriate relationship, remuneration, or a billing error that occurred, regulatory agencies are going to look back at what providers did."

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[missy]

"

As the COVID PHE Ends, Here's What Doctors Are Carrying Forward​

— Responses range the spectrum, from asking patients to mask, to not changing a thing​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today May 10, 2023

The end of the COVID-19 public health emergency in the U.S. may mark as close to an "end" to the pandemic as one could get, but that doesn't mean the lessons of the last 3 years have been forgotten. MedPage Today reached out to about a dozen clinicians to get their take on the way the pandemic has changed them and their practice -- and which alterations will carry on into the future.

Their responses are below, and some have been lightly edited.
Nina Agrawal, MD, NewYork-Presbyterian Hospital, New York City
As a pediatrician, I have definitely modified my practice. Let me count the ways! Before the patient comes into the room, I wipe down the exam table in between patients. I make sure to have my mask on when I go into the waiting room to call a patient. When the patient is in the room and I'm taking a history from my desk, I try to maintain as much eye contact as possible.
Oftentimes, teens do not wear a mask, I ask them to put one on. When patients have cold symptoms and even nonspecific symptoms, like a headache, I always keep COVID in the back of my mind as a differential diagnosis.
If they are flu-positive or have strep throat, I don't test for COVID as it won't change precautions for staying out of school and it's an extra cost as well as time in waiting for the test result, since we don't have rapid tests in the office. I ask patients to do rapid testing at home. Prior to the pandemic, I don't remember ever asking a patient to do a test at home for an infectious condition.

John Moore, PhD, Weill Cornell Medicine, New York City
I do not intend to change any facet of my personal or professional life as a result of the pandemic. There are, however, some adjustments that are "imposed by external forces," such as the now very common use of Zoom or similar platforms for holding work-related meetings, rather than in-person get-togethers (or phone-only conference calls). That's sometimes a good change (convenience), sometimes not (there can be value in in-person discussions).
On a more philosophical level, the spread of disinformation/misinformation and outright lies during the pandemic has greatly annoyed and disturbed me, although it's not altered how I conduct my life in a direct way.
Leana Wen, MD, George Washington University, Washington, D.C.
COVID-19 has made both clinicians and patients much more aware of the impact of infectious diseases.
Those more vulnerable to severe illness are continuing mitigation measures, which were not common before the pandemic, even for higher-risk individuals. Now, I routinely advise patients with immunocompromise or who are elderly with serious underlying medical conditions to take precautions, such as continuing to mask while in indoor crowded settings. That protects them not only against COVID, but also against other infections that could result in them being hospitalized.

The pandemic has also made telemedicine much more of a regular part of medical practice, especially for treatment of behavioral health conditions. And I also think that it was shown how social determinants of health, like housing, food access, and geography, can affect health outcomes. I hope that this will translate into tangible change in how medicine is practiced on a systemic level.
Robert Wachter, MD, University of California San Francisco
Our hospital is still requiring that clinicians wear masks in patient-care areas. I'm not sure how long that will last, but it seems reasonable to me. Patients are not required to mask, and most do not.
We haven't changed the ventilation in patient rooms; I've added a filter to my office. As for the next pandemic, we'll have more personal protective equipment (PPE) and ventilators available, and we will be more prepared in terms of our organizational and workforce responses.

Sen Pei, PhD, Columbia University's Mailman School of Public Health, New York City
I would wear a mask in high-risk settings such as subway trains and crowded indoor spaces, especially in high-transmission seasons with prevalent respiratory illnesses. I would also check local levels of infections to get a better sense of community prevalence of respiratory viruses. Overall, my vigilance against respiratory infections has been improved.
Research and work are resuming to the pre-pandemic period (including in-person conference and meetings) but now I only come in to the office 3 days a week. The use of Zoom has increased the number of meetings I need to attend, which is a downside effect.
Stephen Morse, PhD, Columbia University's Mailman School of Public Health, New York City
For me, a number of big lessons, mostly in four categories:

• Better appreciating the importance of respiratory viruses and their challenges, we can't dismiss them as trivial anymore.
• Keeping up on vaccines (especially modifications as new variants arise) and the nonpharmaceutical interventions.
• The importance of good communications.
• The critical role of strong public health surveillance. A good systematic surveillance system would have allowed us to target preventive measures and not lockdown everywhere at once.

Our risk assessment has improved (it still changes as new variants appear), and we have a better understanding of individual risk tolerance for different people. Everyone still needs to be careful, however, not to infect others. New variants continue to appear, meaning that vaccines will still need to be tweaked. At the same time, it should underscore the importance of the annual influenza vaccines as good for reducing illness and death from flu. I'll be anticipating getting the new vaccines (including my flu vaccine) at least annually for the foreseeable future, but most of all plan to keep up on developments.
We now know poorly ventilated and crowded indoor spaces can be especially risky. Building managers should keep making sure ventilation is good and the spaces not too crowded. Since I can't easily test or control indoor ventilation in most places, I'll continue to wear PPE indoors. Except when I'm eating or drinking, of course -- a calculated risk (but try to calculate carefully).

I'm still wearing a mask (N95 or equivalent for me), as new variants continue circulating. I'll probably be wearing PPE again in winter ("flu season"). People seem to have become understandably bored with masks, but wearing them regularly during the winter has cut down on infection by many respiratory infections. We saw a massive drop in flu last year because of the "COVID" precautions. Would be a good idea if people could do this at least during "flu" season. In the spring and summer, it would help with pollen allergies and air pollution. That may be asking too much, but it would help keep people healthier.
Anita Gupta, DO, PharmD, Johns Hopkins Medicine, Baltimore
One of the most important advances in healthcare from the pandemic was the acceleration of virtual care in all areas of health, from urgent care to virtual clinical trials for drug development to assessing individuals' yearly preventive care visits. Virtual care provides improved healthcare access to many individuals who otherwise may not have access to physicians and specialists to gain general advice or to rapidly advance new treatment options through virtual clinical trials.

Sabrina Assoumou, MD, MPH, Boston University
We have learned a lot during this pandemic and some of the measures that we adopted have helped us better care for our patients. Here are a few notable ones.
I take care of many patients with a weakened immune system, so I plan to continue masking in clinical settings, especially during times of the year when respiratory infections are more common.
We also learned that bringing resources to the community, such as vaccines, could help with increasing access. We publishedopens in a new tab or window on our experience with partnering with community leaders, community health centers, and local and state health departments to increase access to COVID vaccines. As a healthcare system, we hope to continue to build on those partnerships, build trust, and address other healthcare conditions such as diabetes.
Telehealth was expanded significantly during the pandemic. Some challenges exist with using telehealth, but with the right support it has the potential to continue to improve care. It would, however, be important to ensure that individuals living in less resourced communities can also have access to high-quality care through telehealth.

Katherine Baumgarten, MD, Ochsner Health, New Orleans
At Ochsner Health, we have been preparing for and have been tested by crises of many kind -- weather-related disasters like Hurricanes Katrina and Ida; infectious disease outbreaks like H1N1 in 2009; and more recently, COVID-19.
The H1N1 outbreak is when we began to focus on risk mitigation and processes that have helped us navigate other infection-related crises. Since COVID, we have even more rigor for our crisis playbook and we're always preparing for the next big challenge.
From COVID, we learned to focus inward on capabilities we can expand so that we're not as reliant on others. For example, we expanded our lab capabilities to allow for rapid and streamlined testing in-house rather than sending out to commercial or state labs. This was done quickly and is certainly something we can ramp up for any future needs.

Additionally, we entered a partnership to develop a new venture for manufacturing our own PPE. During a time when PPE was difficult to source, our teams thought creatively about how to secure our supply chain for the future. Safe Source Direct is now manufacturing FDA-approved nitrile gloves and supplying our own hospitals with vital PPE.
Albert Wu, MD, Johns Hopkins Medicine, Baltimore
At the start of the pandemic, to increase our ability to support the resilience and well-being of our workforce, the various existing support services at Johns Hopkins collaborated to create a more integrated model that came to be known by the acronym MESH -- Mental, Emotional, and Spiritual Health.
This new collaborative team of expert resources was organized by the Office of Well-Being for Johns Hopkins Medicine and included a range of programs, including the Healthy at Hopkins wellness offerings, employee assistance, spiritual care and chaplaincy, psychiatry, and our RISE peer support program. This collaborative has continued to meet to coordinate and provide better emotional support now and in the future.
Cheryl Clark, Michael DePeau-Wilson, Jennifer Henderson, Sophie Putka, and Rachael Robertson contributed reporting to this story.



"

 

[missy]

"

Why Is One Dose Suddenly Enough for the mRNA COVID Vaccines?​

— FDA and CDC have made yet another questionable decision​

by John P. Moore, PhD May 2, 2023

The FDA and CDC recently announcedopens in a new tab or window that previously unvaccinated Americans can now receive only a single dose of the bivalent Moderna or Pfizer mRNA vaccines. To be clear, this is not saying they can choose to have one or two doses and be considered fully vaccinated either way -- only one dose is available to them. The CDC made a related decision in respect to international travelers who fly into the U.S. Theyopens in a new tab or window "will now be considered fully vaccinatedopens in a new tab or window 2 weeks after getting a single dose of either the Pfizer or Moderna mRNA vaccine any time after August 16, 2022, when bivalent formulations first became available." However, a more recent decision from the White House made this announcement moot by eliminatingopens in a new tab or window any vaccination requirements for arriving travelers.

In practice, these policy changes will probably not affect many people. The approximately 30%opens in a new tab or window of Americans who have refused all COVID-19 vaccines for over 2 years -- often for political reasons and because of widespread misinformation -- are unlikely to change their attitudes merely because they are now limited to receiving only a single bivalent vaccine dose. And there would have been few international travelers, particularly foreigners, whose only vaccine experience would have been a single bivalent mRNA vaccine. Even so, it's worth exploring what lies behind what just happened.
Since the mRNA vaccines were first rolled out in late 2020, the standard primary series always has been two doses, which remains the legal definition of "fully vaccinated." Indeed, CDC recommends that Americans receive multiple mRNA vaccine doses, either three or four depending on age and health statusopens in a new tab or window. Why, then, do FDA and CDC suddenly consider one dose of the bivalent vaccines to be sufficient for unvaccinated people? What data underlie the decisions, and how were those decisions made? The simplest answers are: None and who really knows?

FDA official Peter Marks, MD, PhD, has referred to "simplifyingopens in a new tab or window" vaccine administration as being the driver for the recent change and "believes" that allowing unvaccinated people to receive only a single dose will "help encourage future vaccination." Given the reasons behind vaccine refusalopens in a new tab or window, that belief seems quite naïve. Marks also refers to how "most of the U.S. population" has been either infected by the virus, already vaccinated, or both. The unstated implication is that an unvaccinated person now needs only a single vaccine dose to boost immunity conferred by prior infection. Indeed, several science reporters have told me that's what FDA officials are saying in private briefings. While there is solid science behind the hybrid immunityopens in a new tab or window argument, there are also ethical concerns.
I will say again that few unvaccinated Americans will now change their minds -- but some might. However, not all of those mind-changers will have been previously infected, so some will lack any prior immunity. It's not possible to estimate the number of people that fall into this category, but it won't be zero. After all, the FDA is still seeking, rightly, to "encourage future vaccination."

There is literally no data on how well a single dose of a bivalent mRNA vaccine will protect anyone. But we have known for over 2 years that a single dose of the original vaccines was not good enoughopens in a new tab or window. The human immune system has not suddenly changed -- I think that giving only a single vaccine dose, of whatever composition, to immunologically naïve people (i.e., no prior infection or vaccination) will leave them perilously under-vaccinated, and hence at future risk of COVID-19. It's particularly problematic if those people believe they are now "fully protected" and increase their exposure to infection. The new one-dose policy is letting these people down.
A better, more humane policy would be to continue to allow every previously unvaccinated person access to two bivalent vaccine doses. Their own knowledge and input from their physicians could guide them as to whether they prefer one dose or two. But they should have the choice -- it's the ethical option.

When flawed policy changes like this one are made, we must ask whether it's appropriate for FDA officials to have that kind of decision-making capacity. In my opinion, FDA has botched several aspectsopens in a new tab or window of COVID-19 vaccine policyopens in a new tab or window over the past year. It's time for a shake-up at the agency, particularly with the winding down of any oversight from the White Houseopens in a new tab or window. "Follow the science" has always been the Biden administration's guiding principle on COVID-19 topics. It should remain so.
John P. Moore, PhD, is a professor of microbiology and immunology at Weill Cornell Medicine in New York City.

"

 

[Karl_K]

Some friends of ours who avoided covid up until now, caught it a week ago.
All vaccinations up to date for their age group.
They didn't have severe symptoms thankfully!

 

[missy]

"
Medscape Medical News > Conference News > AAN 2023

Even Mild COVID Is Hard on the Brain​

Megan Brooks

Even mild cases of COVID-19 can affect the function and structure of the brain, early research suggests.

Dr Clarissa Yasuda
"Our results suggest a severe pattern of changes in how the brain communicates as well as its structure, mainly in people with anxiety and depression with long COVID syndrome, which affects so many people," study investigator Clarissa Yasuda, MD, PhD, from University of Campinas, São Paulo, Brazil, said in a news release.

"The magnitude of these changes suggests that they could lead to problems with memory and thinking skills, so we need to be exploring holistic treatments even for people mildly affected by COVID-19," Yasuda added.
The study was released early, ahead of presentation at the upcoming American Academy of Neurology (AAN) 2023 Annual Meeting in April.

Brain Shrinkage​

Some studies have shown a high prevalence of symptoms of anxiety and depression in COVID-19 survivors, but few have investigated the associated cerebral changes, Yasuda told Medscape Medical News.

The study included 254 adults (177 women, 77 men, median age 41 years) who had mild COVID-19 a median of 82 days earlier. A total of 102 had symptoms of both anxiety and depression and 152 had no such symptoms.
On brain imaging, those with COVID-19 and anxiety and depression had atrophy in the limbic area of the brain, which plays a role in memory and emotional processing.
No shrinkage in this area was evident in people who had COVID-19 without anxiety and depression or in a healthy control group of individuals without COVID-19.

The researchers also observed a "severe" pattern of abnormal cerebral functional connectivity in those with COVID-19 and anxiety and depression.


In this functional connectivity analysis, individuals with COVID-19 and anxiety and depression had widespread functional changes in each of the 12 networks assessed, while those with COVID-19 but without symptoms of anxiety and depression showed changes in only 5 networks.

Mechanisms Unclear​

"Unfortunately, the underpinning mechanisms associated with brain changes and neuropsychiatric dysfunction after COVID-19 infection are unclear," Yasuda told Medscape Medical News.


"Some studies have demonstrated an association between symptoms of anxiety and depression with inflammation. However, we hypothesize that these cerebral alterations may result from a more complex interaction of social, psychological, and systemic stressors, including inflammation. It is indeed intriguing that such alterations are present in individuals who presented mild acute infection," Yasuda added.


"Symptoms of anxiety and depression are frequently observed after COVID-19 and are part of long-COVID syndrome for some individuals. These symptoms require adequate treatment to improve the quality of life, cognition, and work capacity," she said.


Treating these symptoms may induce "brain plasticity, which may result in some degree of gray matter increase and eventually prevent further structural and functional damage," Yasuda said.


A limitation of the study was that symptoms of anxiety and depression were self-reported, meaning people may have misjudged or misreported symptoms.


Commenting on the findings for Medscape Medical News, Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, Missouri, said the idea that COVID-19 is bad for the brain isn't new.


As previously reported by Medscape Medical News, early in the pandemic, Raji and colleagues published a paper detailing COVID-19’s effects on the brain and Raji followed it up with a TED talk on the subject. (Raji wasn't involved with Yasuda's team for this current study.)


"Within the growing framework of what we already know about COVID-19 infection and its adverse effects on the brain, this work incrementally adds to this knowledge by identifying functional and structural neuroimaging abnormalities related to anxiety and depression in persons suffering from COVID-19 infection," Raji said.


The study was supported by the São Paulo Research Foundation. The authors have no relevant disclosures. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution LLC.

"

​

 

[missy]

COVID Emergency Over, but Hundreds Are Still Dying Weekly​

Claire Sibonney
May 17, 2023

COVID Emergency Over, but Hundreds Are Still Dying Weekly

Just 6 months after President Joe Biden declared that the pandemic is over, Debbie's death was a painful reminder to Traci and her family that COVID hasn't actually gone anywhere.

www.medscape.com

"

Traci Sikes's older sister Debbie had survived several health setbacks in life — a heart attack, a cancer diagnosis, and a couple of botched surgeries for a bad back. But by early 2023, the 68-year-old from Brownwood, TX, was in remission from lymphoma, feeling stronger, and celebrating a birthday for one of her 11 beloved grandchildren.

Then Debbie caught COVID-19. Less than 2 months later, in March, she died of severe lung damage caused by the coronavirus.

Traci was able to make the trip from her home in Washington state to Texas to be with Debbie before she died. She was grateful that she arrived while her sister was still lucid and to hear her sister's last word -- "love" -- spoken to one of her grandchildren before she took her final breath.


"My sister was wonderful," Sikes said. "And she shouldn't be gone."






The prevailing attitude that we need to learn to live with the current level of risk feels like a "slap in the face," for COVID grievers who have already paid the price," said Sabila Khan, who co-founded a Facebook group for COVID loss support, which now has more than 14,000 members.


It also minimizes the continuing loss of life and that so many people are still dying traumatic and unnecessary deaths, she said.

"It feels like it's been brushed aside," she said. "Like, 'It's business as usual. It's over. Take off your mask.' My family and I are still masked, and we're probably the only ones masked in any given room."

The abandoning of protective measures also fails to recognize the ongoing and catastrophic risks of long COVID and the experiences of an estimated 26 million people in the U.S. living with long COVID.

"It's been drummed into us that death is the only serious outcome [of the virus] and we still haven't made enough space for the idea that long COVID is a very serious outcome," said David Putrino, PhD, director of rehabilitation innovation for the Mount Sinai Health System in New York City, who has helped care for thousands of patients with long COVID.

Historic Drop in Life Expectancy​

More than 1.1 million Americans have died from COVID over the past 3 years, and experts say the official numbers are likely underestimated due to errors in death certificate reporting. Although deaths have waned from earlier in the pandemic, the disease has become the fourth leading cause of death in the U.S. after heart disease, cancer, and "unintentional injury" such as drug overdoses.


What makes these deaths all the more tragic is that COVID is a preventable disease, said Carla Sevin, MD, a critical care doctor and director of the Pulmonary Patient Care Center at Vanderbilt University Medical Center in Nashville. Masking, available vaccines, and social distancing have all been shown to significantly lower the risk of spreading and catching the virus. New drugs have also made it possible for infected people to survive COVID.


"It's possible to not spread COVID," she said. "It's possible to protect yourself against COVID. It's possible to treat COVID. And we're doing all of those things imperfectly."


By the end of 2021, Americans overall were dying 3 years sooner, on average, than they were before the pandemic, with life expectancy dropping from 79 years to 76 years, the largest decline in a century.


Globally, the COVID death toll is nearing 7 million. Across all ages, on average, each person who died passed away 10 years younger than they otherwise would have. That's tens of millions of years wiped away.


As U.S. surgeon and health researcher Atul Gawande, MD, put it in a New York Times essay about the pandemic response: "Human development has been pushed into reverse."

What Is an Acceptable Threshold of Death?​

In the U.S., more than 80% of deaths from the disease have been in people age 65 and older. Underlying medical conditions and disabilities also raise the risk of severe illness and dying from COVID.


The virus is also disproportionately killing Black, Hispanic, and Indigenous people and those with less access to health care. Racialized groups are dying from COVID at younger ages. COVID advocates and Americans who've lost loved ones to the disease say our willingness to accept these facts and the current mortality rate amounts to health-based discrimination.


"Would politicians be approaching this differently had it mostly affected rich white people?" Khan said.


Khan's dad, Shafqat, was an advocate and community organizer for Pakistani immigrants. After contracting COVID, he was rushed to a hospital near his daughter's Jersey City, NJ, home from a rehab facility where he was being treated for an aggressive form of Parkinson's disease. For the 8 days her father was in the hospital, she and other family members couldn't visit him and he wasn't even well enough to talk on the phone. He died from COVID in April 2020.


"My father was an extraordinary person who did so much good and he died alone, terrified in a hospital," she said. "I can't even wrap my head around that and how he deserved more. No one deserves that."

At Vanderbilt University Medical Center, where she works as a critical care doctor, COVID deaths are now different from those in the early days of the pandemic, Sevin said. Most patients now in the intensive care unit are older and immunocompromised — and they tend to blend in more with others in the intensive care unit. That makes the impact of COVID even more hidden and easily ignored.

"It's easy not to value somebody who's an invisible number you don't know," she said. "You don't see them writing their will and talking to their best friend. You don't see the tears rolling down their face because they know what's going to happen to them and they're going to asphyxiate to death."


One COVID patient who died recently in Sevin's ICU ward was an older woman who had no living relatives. "She was very, very lonely and we would always stand outside the door on rounds and she would motion for us to come in, but we had to then all gown up," Sevin said. "It just breaks your heart that people are still having to go through it."


Sevin finds it frustrating that so many of the measures that public health officials fought so hard for over the last 3 years — including masking guidelines, government-funded vaccine clinics, and access to potentially life-saving antiviral medications — are now going away because of the lifting of the pandemic emergency declaration.


What makes matters worse, she said, is that public consciousness about taking precautions to protect others is starting to disappear in favor of an "all or nothing attitude" about the continued risks.


"Like either I'm going to stay home and be a hermit or I'm going to just throw caution to the wind and go to bars and let people yell in my face," she said. "We learned some hard lessons and I wish we could hold onto those."


Americans like Traci Sikes who've lost loved ones and health care workers on the front lines say it is particularly frustrating that so many people are framing the current response to the risks of COVID as "personal choice" over responsibility to others, as well as a sense of fatalism and lack of urgent care.


"Why does nobody seem to be angry about this?" Sikes said. "People talk about COVID like it's just another thing to die from. But my sister didn't have to die from it at all."

Sources​

Traci Sikes, Vancouver, WA.

Sabila Khan, co-founder, Covid-19 Loss Support for Family & Friends Facebook group.

Carla Sevin, MD, director, Pulmonary Patient Care Center, Vanderbilt University Medical Center, Nashville.

David Putrino, PhD, director, rehabilitation innovation, Mount Sinai Health System, New York, N.Y.

NPR: "Joe Biden says the COVID-19 pandemic is over. This is what the data tells us."

CDC: "Covid Data Tracker."

PNAS: "Tracking the reach of COVID-19 kin loss with a bereavement multiplier applied to the United States."

CDC: "Life Expectancy in the U.S. Dropped for the Second Year in a Row in 2021," "COVID-19: People With Certain Medical Conditions."

WHO: "Coronavirus (COVID-19) Dashboard."

Journal of Public Health: "Years of life lost associated with COVID-19 deaths in the USA during the first year of the pandemic."

The New York Times: "The Aftermath of a Pandemic Requires as Much Focus as the Start," "My Patients Will Not Be the Same. None of Us Will."

JAMA Network Open: "Variation in COVID-19 Mortality in the US by Race and Ethnicity and Educational Attainment."

PLOS Medicine: "Variation in racial/ethnic disparities in COVID-19 mortality by age in the United States: A cross-sectional study."

The Associated Press: "Biden ends COVID national emergency after Congress acts."

​

​

 

[missy]

"

Moderna beats Pfizer among two-dose COVID vaccine recipients aged 60 and over, study shows
Published May 15, 2023 | Originally published on MedicalXpress Breaking News-and-Events

The mRNA COVID-19 vaccines developed by Pfizer and Moderna continue to save lives. But a new paper published in the journal Vaccines provides evidence that the two vaccines are not equivalent when it comes to protecting older adults against death.

For people ages 60+ who received only the initial two doses, and no booster dose, the risk of death from COVID for Pfizer vaccinees was roughly 2.5 times higher than the risk for Moderna vaccinees. Higher risk was seen throughout the study period, from April 2021 through June 2022. There were no differences in vaccine effectiveness in the 60+ group after a booster dose, and no differences in two-dose effectiveness for younger people.

"We need more refined messaging around boosters that explains who stands to benefit the most, and targets those people," said senior author Bernard Black, a professor of law at Northwestern's Pritzker School of Law who specializes in health policy research. He added, "Boosters are crucially important for Pfizer vaccinees. That message needs to be delivered. Our public health agencies should not continue to act as if all COVID vaccines are about the same."

The study, which measured vaccine protection against death (not hospitalization or other outcomes), also highlights important selection effects: People who got vaccinated were healthier than people who remained unvaccinated. As a group, they were less likely to die for other reasons, and thus less likely to die of COVID even had they not been vaccinated. Moreover, among people who were vaccinated, Pfizer vaccinees aged 60+ were healthier than Moderna vaccinees.

Controlling for these selection effects, both vaccines still significantly reduced mortality, but in the omicron period, the remaining mortality risk relative to unvaccinated people was 57% for two-dose Pfizer vaccinees age 60+, while only 23% for Moderna vaccinees.

For example, if an unvaccinated person aged 60+ had a 1% risk of dying of COVID-19 (based on their age, gender, health and other personal characteristics), a similar person who received two Pfizer doses would have an 0.57% chance of death (43% reduction in risk), while a similar person who received two Moderna doses would have a 0.23% chance of dying from COVID (77% reduction in risk).

A booster dose would reduce remaining risk to about 0.1% for both vaccines. Moreover, the difference in effectiveness between Pfizer and Moderna disappeared for booster recipients.

Thus, boosters are important for all people age 60+, but are especially important for Pfizer vaccinees. A possible reason for this difference between vaccines is that the Moderna dose is much higher than the Pfizer dose (100 μg versus 30 μg). Older bodies may need the bigger kick from the larger Moderna dose to prime their immune systems.

For persons aged 18-49, there were almost no deaths among two-dose vaccinees. For persons aged 50-59, there were a meaningful number of deaths, so a booster dose is important, but no evidence of a difference in effectiveness between Pfizer and Moderna.

In sum, booster protection is highly valuable for older people aged 60+, especially Pfizer vaccines; has substantial value for people in their 50s, but has limited value for younger persons, for whom the initial two doses retain strong protective value against death.

In addition to Black, the team included other researchers affiliated with Northwestern University, the Medical College of Wisconsin, and William and Mary. The authors used a dataset of linked mortality and vaccination records for all adults in Milwaukee County, Wisconsin, (adult population 722,000) from Jan. 1, 2021, to June 30, 2022, to conduct their analysis.

Their study is the first to control for the tendency of the people who received the Pfizer vaccine to be healthier than those who received the Moderna vaccine (at least in Milwaukee, the area that the authors studied).

The key metric that the authors studied was how vaccination affects the COVID Excess Mortality Percentage (CEMP)—the percentage increase in mortality risk due to COVID, relative to the risk from other natural causes. CEMP is measured by dividing COVID-19 mortality for a given group by mortality from non-COVID natural causes for the same group.

This article was originally published on MedicalXpress Breaking News-and-Events.

"

 

[missy]

"

Catch up quick: COVID-19​

KATELYN JETELINA MAY 25

Surveillance​

SARS-CoV-2 is nosediving across all metrics in all regions of the U.S.: hospitalizations, deaths, emergency room departments, and wastewater. Wastewater is still higher than in 2020 and 2021, though.

​

We’ve been hitting new lows in death counts, too. In fact, excess deaths are hovering at only ~1% above pre-pandemic rates (at the height of the pandemic we were at 47%). In other words, things are looking good right now.

It will be interesting to watch what happens this summer, as the South has consistently faced a COVID-19 wave. Most scientists (including me) are betting that we will continue to see wavelets, at least until winter.

Virologists continue to identify “cryptic lineages” in wastewater, though. These are highly mutated COVID-19 variants that randomly pop up on our radar. The latest (right below) was detected ~12 hours ago. None have taken off yet, but are a lingering reminder that a variant of concern could be brewing in the background. We still have many unanswered questions about cryptic lineages: What is the health status of the person? Do they have long COVID? Where in the body is the virus replicating?

​

SARS-CoV-2 cryptic lineage examples from Marc Johnson @SolidEvidence

Noteworthy COVID-19 news​

• Indoor air quality. Up until now, the CDC recommended that we “improve ventilation” to reduce transmission. But by how much?Well, for the first time, CDC set minimum ventilation targets for indoor spaces: 5 air changes per hour. This may sound like boring news, but it’s huge for public health. Not just for viruses but health overall. While this standard isn’t mandatory, you should follow up with your business, school, place of worship, etc. to ensure it’s being met now.
  
• Fall boosters. The WHO officially recommends a monovalent (one strain) booster that targets XBB—an Omicron subvariant—this fall. Countries don’t have to follow suit. (The U.S. chose a different vaccine formula than WHO recommended last year, for example.) A big FDA meeting is coming in June to discuss the U.S. plan.
• Mask usage. Polling on May 6-9 found 46% of respondents wore a mask at least some of the time in the past 7 days. Just looking outside, I was surprised about this statistic, but probably because I’m white and in the suburbs, two groups with the lowest rates. We really need to improve masking among older adults, especially in times of high transmission.

​

• Potential relief for immunocompromised. AstraZeneca is on trackfor an Evushield replacement. Their Phase III clinical trial is showing promising results. An emergency use authorization “could be here by the second half of this year.”

Interesting science updates​

• Changes in transmission. The risk of household transmission is increasing as Omicron continues to mutate. In addition, expect to get infected ~1 day quicker than before (average 4 days). Infection risk continues to be higher among unvaccinated versus vaccinated people.

​

• Missed opportunity. COVID-19 vaccinations rates among children are abysmal. One study found that if we reached flu vaccine coverage levels over this past winter, we could have prevented 10,019 pediatric hospitalizations and 5,448,694 days of school absence for COVID-19. Better luck next year?
• Risk of long COVID after second infection. Risk of long COVID decreases after second infections, but is not zero. A new preprint found the risk of long COVID after a second infection is 1 in 40 for those over 16 years old and 1 in 165 for those under 16 years old. (As a comparison, the annual risk of getting into a car accident is 1 in 30 and the annual risk of permanent impairment is 1 in 700.)

What’s next?​

We are in for a few quiet weeks (or months? who knows). In June, we should have clarity on the fall COVID-19 vaccine plan in the States. Stay tuned.



"

 

[missy]

"

FDA Approves First Oral Antiviral Drug for COVID-19​

— After widespread use for more than a year, Paxlovid gains full agency blessing​

by Ian Ingram, Managing Editor, MedPage Today May 25, 2023

The FDA has granted full approvalopens in a new tab or window to nirmatrelvir-ritonavir (Paxlovid) for treating adult outpatients with mild to moderate COVID-19 who are at risk for severe disease, the agency announced on Thursday.
"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity," Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Approval of the antiviral -- which helps ward off hospitalization and death in high-risk patients -- follows an endorsementopens in a new tab or window from the agency's Antimicrobial Drugs Advisory Committee and was largely anticipated, despite some concerns about reboundopens in a new tab or window casesopens in a new tab or window and a host of drug-drug interactionsopens in a new tab or window, which garnered the drug a boxed warning on its labelopens in a new tab or window and fact sheetopens in a new tab or window for healthcare providers.
"Prescribers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines that a patient may be taking require a dose adjustment, interruption and/or additional monitoring," according to the FDA. "Prescribers should consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed."
Nirmatrelvir-ritonavir was a critical component of President Biden's test-to-treat strategy during the pandemic. Given that the antiviral is indicated for use within 5 days of symptom onset, the program aimed to get it into the hands of patients testing positive quickly, and even allowed pharmacists to prescribeopens in a new tab or window the drug directly to patients.

Millions of people with COVID-19, including Bidenopens in a new tab or window, have already taken the drug since its emergency use authorization (EUA)opens in a new tab or window in late 2021, and multiple studiesopens in a new tab or window have confirmed the drug's benefit in high-risk groups, with studies in lower-risk groups typically showing little to no benefit.
In its approval notice, the agency said that previous packages distributed under the EUA will remain available for use. High-risk kids ages 12 and up will also continue to be eligible for the drug under the EUA, though the approval does not cover this group.
The agency further stipulated that nirmatrelvir-ritonavir is not intended for use as a preventive therapy either pre- or post-exposure to COVID (i.e., patients should have symptoms and a confirmed case before use).
Primary support for approval came from the final results of the EPIC-HRopens in a new tab or window trial, which demonstrated an 86% reduction in the risk for hospitalization or death at 28 days versus placebo. Patients enrolled in the study included unvaccinated adults 18 and over with a medical condition(s) placing them at high risk for severe disease, or adults 60 and older with or without a chronic condition.

Of the 1,966 patients in the final analysis without SARS-CoV-2 antibodies at baseline, 0.9% of those who received nirmatrelvir-ritonavir and 6.5% of those on placebo were hospitalized due to COVID-19 or died through 28 days. Some benefit against hospitalization or death was also seen in that trial among people with prior immunity to the virus that causes COVID-19 as well (0.2% vs 1.7%, respectively).
And in the negative EPIC-SR studyopens in a new tab or window, which enrolled vaccinated patients with at least one risk factor for progression, a non-significant risk reduction in hospitalization and death was observed in the nirmatrelvir-ritonavir arm.
Data in those trials suggested that COVID-19 rebound cases occurred in a similar proportion of nirmatrelvir-ritonavir and placebo patients, leading the agency to conclude that "there is not a clear association" with the available evidence.
Beyond that, the FDA noted impaired sense of taste and diarrhea as the most common side effects with treatment.

"

 

[missy]

"

Long COVID Now Has a Framework to Define It​

— 12 key symptoms identify the disorder, U.S. researchers say​

by Judy George, Deputy Managing Editor, MedPage Today May 25, 2023

Long COVID now has a working case definition in the U.S.
Twelve key symptoms of long COVID include postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements, said Andrea Foulkes, ScD, of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues from the NIH's RECOVERopens in a new tab or windowconsortium.

Survey data from nearly 10,000 people were used to define the 12 signature symptoms, the researchers reported in JAMAopens in a new tab or window. The findings also included a symptom-based scoring system to help clinicians and researchers better identify long COVID and investigate treatments.
"One of the big takeaways from this study is the heterogeneity of long COVID: long COVID is not just one syndrome; it's a syndrome of syndromes," Foulkes said in a statement. "Understanding this idea is a really important step for doing more research and ultimately administering informed interventions."
"Now that we're able to identify people with long COVID, we can begin doing more in-depth studies to understand the biological mechanisms at play," she added.
Since 2020, researchers have documented a wide range of symptomsopens in a new tab or window that emerge after acute SARS-CoV-2 infection. Many studies have been limited by retrospective design, reliance on electronic health record data, or lack of a control group, which has led to disagreement about how common long COVID is, how severe certain symptoms may be, and what patterns define long COVID.

Incorrect case definitions can delay diagnoses, decrease the chance of finding underlying mechanisms, and lead to misdirected, ineffective treatments for long COVID (also known as post-acute sequelae of SARS-CoV-2 infection, or PASC), observed Robert Gross, MD, MSCE, and Vincent Lo Re III, MD, MSCE, both of the University of Pennsylvania in Philadelphia, in an accompanying editorialopens in a new tab or window.
Before developing a case definition for long COVID, it's important to "consider whether these sequelae represent a single pathophysiologic process or rather multiple different conditions triggered by antecedent SARS-CoV-2 infection," Gross and Lo Re wrote.
"In addition, it is important to know whether they are direct sequelae of infection itself or are mediated by specific organ injury and dysfunction," the editorialists continued. "For example, severe SARS-CoV-2 infection that requires intensive care unit admission can result in a well-described post-intensive care syndrome with many features that overlap with post-acute sequelae."

To classify long COVID, Foulkes and colleagues analyzed data from a symptoms survey distributed at 85 hospitals, health centers, and community organizations in 33 states, Washington, D.C., and Puerto Rico. Participants enrolled in the RECOVER adult cohort before April 2023 and completed a survey 6 months or more after acute symptom onset or test date.
A total of 9,764 participants met selection criteria. Of these, 8,646 people were infected with SARS-CoV-2 and 1,118 were uninfected controls.
Most participants (71%) were female and most were white; 16% were Hispanic or Latino, and 15% were Black. Median age was 47. More than half (58%) of participants were fully vaccinated at the index date. Uninfected participants were more likely to be fully vaccinated (77% vs 55%).
Overall, 37 symptoms had a frequency of 2.5% or greater and an adjusted odds ratio that was 1.5 or greater for infected versus uninfected participants. Symptoms with more than 15% absolute difference in frequencies between infected and uninfected participants included postexertional malaise (28% vs 7%), fatigue (38% vs 17%), dizziness (23% vs 7%), brain fog (20% vs 4%), and gastrointestinal symptoms (25% vs 10%).

Statistical analyses identified 12 hallmark symptoms. The researchers assigned points to each of the 12 symptoms and gave participants a PASC score based on symptom combinations. The proportion with a qualifying PASC score in the full cohort (subject to selection bias) was 23% of infected participants and 3.7% of uninfected participants.
Certain symptoms occurred together, allowing some study participants to be clustered into one of four subgroups. Cluster 1 was characterized by loss of or change in smell or taste; cluster 2 by postexertional malaise and fatigue; cluster 3 by brain fog, postexertional malaise, and fatigue; and cluster 4 by fatigue, postexertional malaise, dizziness, brain fog, gastrointestinal symptoms, and palpitations.
Long COVID was more common and had more severe manifestations in people infected before Omicron. In a subset of 2,231 patients with initial infection on or after Dec. 1, 2021 (when Omicron was circulating), 10% were positive for long COVID at 6 months.
Survey results are not final and will be validatedopens in a new tab or window against lab tests and imaging, according to the NIH. The PASC score is operational and needs further refinement, the researchers added. Selection bias in the cohort was likely, they acknowledged, and all symptoms were self-reported.


"

 

[Daisys and Diamonds]

some good news
SIr Dr AShley Bloomfield KNZM who was the director general of health through the dark days of the pandemic got his well deserved knighthod today

from a jewelry perspective (granted not usual on this thread) the governer general (the Queen's represenatative in NZ) Dame Cindy KIro has nice earrings on and you can clearly see the insigna awarded in the short video in the link below

Stuff

www.stuff.co.nz

 

[Brigid]

I have not contracted COVID-19, I have had four vaccinations along with my husband & 2 children, we will all get our fifth vaccination next week.

I stopped wearing a mask long ago after research & our Government advising that it was up to the individual and their circumstances eg: being immunocompromised.

As I have not had COVID-19 while being exposed to it on at least 3 occasions I’m taking part in a medical study, I’m interested to hear the results.

 

[missy]

I have not contracted COVID-19, I have had four vaccinations along with my husband & 2 children, we will all get our fifth vaccination next week.

I stopped wearing a mask long ago after research & our Government advising that it was up to the individual and their circumstances eg: being immunocompromised.

As I have not had COVID-19 while being exposed to it on at least 3 occasions I’m taking part in a medical study, I’m interested to hear the results.

Glad you appear to be Covid immune and it is very interesting you are part of a medical study. Thank you for sharing. Please let us know the results when the study is finished.

My husband and I are still wearing masks despite the fact no one else is here (even the physicians for the most part have stopped wearing masks though always politely ask if we would prefer they wear theirs when they see we are wearing ours). The hospitals here are no longer requiring masks either. It's as if OK the official government Covid emergency is over so all of a sudden we are safe. NOT. Our cardiologist is still wearing a mask (only one besides us who is) and he cautioned us not to stop wearing them but we are older and we have underlying medical conditions so I feel comfortable continuing to wear my mask.

 

[missy]

"

COVID Outbreak at CDC Meeting Grows; 14 Cancer Drugs in Shortage; Human Organ Sales​

— Health news and commentary from around the Web gathered by MedPage Today staff​

by Jennifer Henderson, Enterprise & Investigative Writer, MedPage Today May 30, 2023

Tally of covid-19 cases after CDC conference climbs to 181


The Centers for Disease Control and Prevention is advising people attending a June agency event to wear their “own high-quality masks and, if possible, also carry covid-19 rapid tests with them.” (Tami Chappell/Reuters)


The tally of people infected with the coronavirus after attending a high-profile Centers for Disease Control and Prevention conference in April has risen to at least 181, the agency reported Friday. No one was hospitalized.
The CDC’s Epidemic Intelligence Service officers and alumni — the disease detectives deployed to identify and fight outbreaks — met April 24-27 at an Atlanta hotel. The conference drew 1,800 in-person attendees, the first in-person Epidemic Intelligence Service gathering in four years. Like many conferences, it was crowded, with much face-to-face contact, many events held in small rooms and lots of socializing, according to attendees. About 70 percent of participants who responded to a CDC survey said they did not wear masks at the event.
The outbreak of covid-19 cases at the conference underscores the persistence of an evolving and highly infectious virus.

Another CDC global health meeting is scheduled for the same hotel in early June; about 300 to 400 people are expected to attend in person, said one CDC employee who spoke on the condition of anonymity because they were not authorized to speak.
In a “Know Before You Go” document shared with The Washington Post, CDC organizers encourage attendees at the June conference to wear their “own high-quality masks and, if possible, also carry covid-19 rapid tests with them.” Organizers of the second conference were informed about the covid outbreak at the earlier event, CDC spokeswoman Kristen Nordlund said. The agency will have masks available if employees want to wear one, she said.
With in-person conferences and summer travel underway, infectious-disease experts say the CDC event is a reminder that the coronavirus is not going away.

“This outbreak dramatically illustrates that if the circumstances are right, this virus can really spread to a lot of people,” said William Schaffner, an infectious-disease doctor at the Vanderbilt University School of Medicine. One of his colleagues attended the April CDC conference, and even though the person had a mild illness, like many others at the event, “these were people who were quite discomforted for several days,” Schaffner said.
Covid-19 hospitalizations and deaths have fallen dramatically because of immunity conferred by vaccines and prior infections, public health experts have said. Tracking viral circulation or cases has become problematic because many Americans are testing at home, or not all. The end of the public health emergency on May 11 also meant cases and positive test results stopped being reported to the CDC.
The virus can cause significant illness, primarily in unvaccinated people, older adults, people with underlying health conditions and those with weakened immune systems. Among the 181 who were sickened at the CDC conference, the median age was 38, nearly all were younger than 65 and two-thirds were women, Nordlund said. No severe illnesses were reported.

Jeffrey Duchin, health officer for Seattle and surrounding King County, said four members of his team attended the conference. Two wore high-quality masks reliably, he wrote in an email. Of the two who did not, one was sickened by the virus.
“In my view, [Epidemic Intelligence Service] and other conference organizers should take reasonable steps to decrease the risk to participants by optimizing venue indoor air quality … opting for outdoor venues when possible, minimizing crowding, and providing N95 and KN95 masks for those who want to reduce their risk,” Duchin said.
“At a minimum, I think it would be useful for conference organizers to inform participants of what steps are being taken to reduce the risk for COVID-19 transmission, so that participants can make informed risk assessments about any additional steps they may want to take, like masking.”

At a large travel industry conference that drew nearly 5,000 attendees in San Antonio this week, delegates were told they could choose to wear a face mask. “Please respect the decision of attendees who choose to be masked,” said health and safety guidance that was provided.
Greg Staley, senior vice president for communications at the U.S. Travel Association, the conference organizer, said no cases of covid-19 have been reported.
To unravel the cluster of cases tied to the April CDC conference, the agency conducted a May 5-12 survey of in-person attendees, with more than 80 percent responding. Of those who reported testing positive, 52 percent said they had no known prior coronavirus infection. More than 99 percent of respondents had at least one dose of a coronavirus vaccine. About one-fourth of those who tested positive received antiviral medication.
The risk of infection was 70 percent greater among those who attended three or more days compared with those attending two or fewer days, an agency statement said.
The CDC statement said the findings support data that coronavirus vaccines, antiviral treatments and immunity from previous infection continue to provide people with protection against serious illness. It did not reference masking.


"

 

[Brigid]

@missy I will let you know but so far it appears that I’m COVID immune. The clinical trial is not invasive which is good, just blood testing and medical history.
I did get Staphylococcus aureus after a minor procedure in a small country hospital which I recovered from with a short course of antibiotics, one of the clinicians in the trial is very interested in this, not sure why.

 

[Brigid]

Hi @missy, My report finally came back about why I have not had COVID, the report has very detailed information, so this is my summary.
I have acquired strong B-cells which are a key player in a persons immune response. I also have developed a hormone called Type-1 Interferon, which is one of the key players in our innate immune system and produced by cells to stop viral infection from occurring.

 

[missy]

Hi @missy, My report finally came back about why I have not had COVID, the report has very detailed information, so this is my summary.
I have acquired strong B-cells which are a key player in a persons immune response. I also have developed a hormone called Type-1 Interferon, which is one of the key players in our innate immune system and produced by cells to stop viral infection from occurring.

That is super interesting and thank you for sharing Brigid! I hope they can extrapolate this info to help others. Amazing

A few questions if I may.

Have you been vaccinated against Covid?
How many vaccines and which ones did you receive?
Has anyone in your immediate family had Covid?
Health wise may I ask what viral infections you have had through your life if any?

Thank you

 

[Brigid]

Happy to answer your questions, Missy.
I have had 5 vaccinations, all were Pfizer. My husband, daughter & son have had COVID 3 times (they have had 5 vaccinations), I must say their symptoms each time were very mild, thankfully!
We all live together, our home is spacious so when isolation is necessary there’s still room to move.
I don’t remember the last time I had a viral infection, it was soo long ago. I have never had the flu but I still get the vaccine just to be safe.
Hope this helps!

 

[missy]

Happy to answer your questions, Missy.
I have had 5 vaccinations, all were Pfizer. My husband, daughter & son have had COVID 3 times (they have had 5 vaccinations), I must say their symptoms each time were very mild, thankfully!
We all live together, our home is spacious so when isolation is necessary there’s still room to move.
I don’t remember the last time I had a viral infection, it was soo long ago. I have never had the flu but I still get the vaccine just to be safe.
Hope this helps!

TY. And thank you for taking part in the clinical trial!

 

[missy]

"

Your top 7 questions about fall vaccines answered​

KATELYN JETELINA AUG 29

​

Thank you for all of your questions! You’re keeping us busy here at YLE. Here are answers to the top 7 that I’ve received in my inbox.

When will we know about the COVID-19 vaccine?​

The ACIP meeting is now scheduled for September 12. This will be a huge meeting, as we will find out:

• Who is eligible for a COVID-19 vaccine and why.
• Cost-effectiveness, given this vaccine is now privatized. In other words, we will get an answer to the question: Do the benefits of a vaccine outweigh the costs for all age groups?
• Updated myocarditis data for younger males (I hope).

I will be in attendance and provide cliff notes.
Then, vaccines should be available mid-to-late September.

Can I get the vaccines (flu, RSV, and/or COVID-19) at once?​

There is no combined shot (some companies are working on it, but will not be available for years). This means that, if you’re eligible, you will need three shots to protect against the three viruses this fall.
You can get them all at once. But it may not be ideal. It just depends on your situation and your comfort with unknown risks:

• Benefits to getting all at once: Going to the doctor/pharmacy multiple times can be a pain for many people, including grandparents. Or some people may tend to forget to go. Getting all three at once may be the best option in this situation.
• Benefits to staggering: The optimal timing of vaccines is different for all three viruses. Also, we don’t know the safety risks of getting all three simultaneously. It hasn’t been studied. In other words, there are unknown risks. This is what we do know:
  • COVID-19 and flu vaccines are safe together
  • Older adult RSV and flu vaccines are safe together

Should I wait for the fall COVID-19 vaccine?​

I’m telling my family and friends to wait (as opposed to getting last year’s vaccine formula). Of course, there is some risk to waiting, but there are two benefits, too:

1. While we are in a wave now, we expect a larger wave in winter. Getting it closer to this wave will better prevent infection;
2. Recent preprint shows that two shots of last year’s vaccine formula resulted in imprinting. This isn’t necessarily dangerous, but it means our antibody factory line (i.e. B-cells) wasn’t updated—it doesn’t broaden protection. Getting an updated vaccine formula will be more helpful against currently circulating variants.

Novavax vs. mRNA COVID-19 vaccine?​

Both are great shots. And the data pool to draw on is so narrow I’m uncomfortable saying one is immunologically better than the other. But we’ve had some studies (here, here, here, and here), and they’ve shown many similarities and some subtle differences:
Similarities

• Both provide a solid first line of defense (i.e., neutralizing antibodies).
• Both strengthen a solid second line of defense (i.e., T-cells).

Differences

1. Negative: Novavax produced significantly lower levels of a specific antibody called IgG.
2. Positive: Novavax had a more durable response over time (waned less quickly).
3. Positive: Novavax has fewer side effects, like pain and muscle aches. For this reason alone, I will be getting Novavax this fall.

​

Side effects from varying combinations of COVID-19 vaccines. Figure from the Lancet, with YLE annotations. Original source here.

The new RSV vaccines aren’t covered by insurance?​

Medicare Part D covers the RSV vaccine, but some private health insurance plans don’t. In other words, some older adults must pay ~$330 for their RSV vaccine. This is because of two factors:

1. The adult RSV vaccine is not yet included in the CDC’s annual vaccine schedule, which should be updated in 2024.
2. CDC’s official recommendation for RSV vaccines is that older adults “may” get the vaccine rather than “should.” Private companies use this language as justification not to cover expenses.

Aren’t there neurological side effects to the adult RSV vaccine?​

Clinical trials found a possible safety signal. For more details, see this previous YLE post.
TLDR: Because the number of events was so small, it’s hard to know whether these are coincidental events or reflect a real safety issue. Future data will clarify this, but it will take time for real-world data to accumulate.

When will the maternal RSV vaccine be available?​

It will still be a while. While the FDA has officially approved the vaccine, the CDC is not meeting until October 25-27 to determine policy.

Bottom line​

A lot is going on this fall. Keep sending us your questions. I hope this helps!

"