Last week, San Diego County moved to the high, or orange, COVID-19 tier due to increasing disease numbers and hospitalizations. That quickly prompted an indoor mask mandate for San Diego Unified Schools District. But at the same time as another wave of infections is taking hold in the region, big public events are also returning in San Diego. The PRIDE parade and related events drew thousands last weekend, and Comic-Con returns to downtown San Diego Thursday for its first large in-person gathering since the pandemic began.
Dr. Eric Topol, director of the Scripps Research Translational Institute, joined Midday Edition Wednesday to get the latest on what is known about the now dominant BA.5 coronavirus variant. The interview below has been lightly edited for clarity.
Q: In your most recent article on your blog, you compare our handling of COVID-19 to that of a boiling frog. Why?
Well, the issue is that BA.5, as we discussed last time we got together, was heating up throughout the country, and there's a lack of perception that it's really the worst variant ... even against severe things like hospitalizations. And so we're not feeling it because we have this immunity wall being built ... because of so many infections and vaccinations and boosters. So this lack of perception because it's gradual, all these different variants that have been occurring over the course of two and a half years, we're missing the fact that the latest variant that is now taking over the country, BA.5, and certainly in San Diego, is the worst one, and we're in a denial state. Willing it away isn't going to work.
Q: You maintain that BA.5 is the worst version of this virus we've seen yet, despite the fact that deaths and hospitalizations are not where they once were. So why is BA.5 the worst, in your opinion?
If you look at places that didn't have lots of prior infection, like, just say, Japan, now a record number of cases throughout the whole pandemic, even exceeding BA.1, had we had this variant before BA.1, the omicron, the wave that hit us so hard in January and February, it would have been even worse. So, the point is, that the virus version is substantially different. The so-called distance of the protein or antigen distance, the genetic distance. I mean, it's basically deserves its own Greek letter it's so different than omicron, BA.1. If you look at it from every property you can think of of a virus, this one is clearly the worst since the pandemic began. But because we have so much immunity, we have this optics, this idea that it's not so bad. But actually another attribute that you are seeing is that it's lasting longer. People who are getting infected with BA.5, the time of being positive testing and having symptoms is longer than prior versions of the virus which goes along with it. You don't have to look at deaths and hospitalizations to say that that's an issue, although they're both going up throughout the country, and certainly not nearly what we saw in the worst BA.1-omicron wave. But again, that's just because we've got lots of protection out there.
Q: Can you give us the latest on the COVID situation here in San Diego? What do recent numbers tell us?
Everything's on the way up and this is not a good picture, because we don't know where the peak is going to be. We know that we have weeks to get through BA.5. And so we're starting to see the increase in hospitalizations, fortunately not at the level that in the worst times previously, but they'll continue to go up no less the number of people infected. The critical issue that you know well is that our testing centrally is very minimal. And so the number of people who are actually infected or infectious not even knowing that they're infected is very high. And in the country it's gone up to about 130,000 cases a day. But it's probably at least 700,000 or a million a day. We just don't know because so many people are either not testing or doing rapid tests at home.
Q: The Novavax vaccine was approved yesterday by the CDC. How does this vaccine differ from the Moderna or Pfizer vaccine?
This is a protein based vaccine. So instead of the Moderna or Pfizer, which is a messenger RNA, which once it gets into the cells, it encodes the protein, this is just direct to the protein. It's very similar otherwise. It's basically using the spike, the key portion of the virus to induce our immune response. And the data that was presented this week to the CDC and previously the FDA looked like it's very comparable to the mRNA vaccines. And so hopefully more people will get vaccinated. It also may have use as a booster. That is because it's somewhat different. That whole idea of mixing might have some appeal as we get more data about that.
Q: Currently, people above 50 or those who are high risk are eligible to get the fourth shot of the COVID vaccine. Do you think it's time for eligibility to be expanded to more of the population?
Yes, both that we don't have enough people who are 50 and older getting a four shot. We're at about 27%. That should be 100%. The reason being is the risk of death and hospitalization in people over age 50 is substantially lowered by a four shot. We have four studies to prove that. But then people less than 50, there's many people there, such as health care workers or essential workers who have lots of risk. And that would be great to use those shots because otherwise they're going to get thrown away because they're about to expire. Tens of millions of doses to be thrown away. So we don't have the green light to get these out there, but we should we should have gotten them going some time ago. But the people who have a considerable risk because of their work or because of their medical status with lots of different coexisting conditions, even less than age 50, should give this a consideration.
Q: What is the data telling us about these newer variants? BA.4.and BA.5 and long COVID?
Yeah, well, let's put aside BA.4 because that really got completely outcompeted by BA.5, which is taking over the country in terms of soon to be all the cases. BA.5, it's about 80% right now. So this variant, as I mentioned earlier, is quite problematic. I don't think we're giving you enough respect as to the fact that it's showing attrition of our vaccines, even against severe protection to some extent. So this decoy to our immune system, that is this escape artist, it's a real problem. And the fact is, we may not be done at BA.5. We could see BA.X or even a whole other family like omicron. Hopefully not, but what's in store, unfortunately, is that the virus evolution is accelerated. As we've seen, we've gone from BA.1 to 5 in a matter of months, whereas in the first year of the pandemic, there was no substantive evolution of the virus to change its properties. So we really should plan. That's why we need much better vaccines ... because we may be seeing over the months ahead that the Paxlovid, which is keeping hospitalizations down, and that's important to emphasize, we could develop resistance to it, the mutations in the critical portion of the virus to Paxlovid. So we should get more backup drugs out there and that's something that's not enough effort, along with these better vaccines is not happening right now.
Q: On the subject of drugs like Paxlovid, how are coronavirus treatments such as that doing against the BA.5 variant? Are they proving to be effective against these newer variants?
Yes. The good thing about Paxlovid is that it really hasn't been a variant specific pill. The problem, however, even though it has a very good track record for reducing hospitalizations and deaths, there is this issue of rebound that's occurred commonly, whereby after five days of treatment of the Blister pack, a couple of days later, symptoms come back and the person does testing and they're still infectious and that can go on for several more days. So rebound is a problem. People are not winding up in the hospital. It's rare after Paxlovid, but the prolonged symptoms and infectiousness is not good. And what we're studying is whether a prolonged course instead of five days rather than ten days to deal with these omicron variants like BA.5 might be better to help avoid the rebound phenomena. The problem is the pills cause a lot of side effects. The taste is really altered and also a lot of gastrointestinal side effects. So you don't want to take it for ten days, but that may wind up being the way to deal with rebound. But it is working well in terms of reducing hospitalizations. And that's another part of this illusion that things aren't too bad when a lot of those people that might have wound up in the hospital were preventing it.
Q: Is anyone eligible to get Paxlovid, or is it being reserved for people who are high risk?
Well, it's supposed to be for high risk, but it's a doctor's prescription, so anybody who is symptomatic, has other conditions that might be in the department of worry that just progressed, they could wind up in the hospital. It's not hard to access Paxlovid. There's a very good supply right now. My biggest concern besides rebound, is it's working well, but how long? And we don't have a backup pill. We really need that. And there's a bunch of candidates, just like with the vaccines that are pan-coronavirus and nasal vaccines, a bunch of candidates for all these things, but we're not doing anything about that yet.
Q: San Diego County reentered the high COVID tier last week. Are you satisfied with the local public health officials' response since that change?
It's disappointing because, as you mentioned, it's only the San Diego Unified School District that has asked for indoor masks to be used routinely. But we don't have that from anyone else. And we know masks help if they're KN95s or N95s, and we're just not using them. People are tired and fed up, and they don't want to mask, but it's a help. It's not a guarantee to avoid BA.5. But the problem is the virus is so hyper-infectious, and we're just playing into its properties by not masking up, particularly indoors, but possibly even outdoors, by not using our tools of ventilation, filtration, and distancing. These things help while we're waiting for better ways to get on top or ahead of the virus with the three biggies: the pan-coronavirus, the nasal vaccines, and better drugs. So we need something to bridge that, and we're ignoring it, largely, and that's unfortunate.
CNN
Injected vaccines against the coronavirus that causes Covid-19 have been hugely successful, saving nearly 20 million lives globally in their first year of use and slashing the pandemics death toll by an estimated 63%, according to a recent study. Yet good as these shots are, they have not stopped the virus from spreading from person to person.
As the SARS-CoV-2 virus spreads, it changes. Thats helped it get past our firewalls, the immunity created by vaccines or left behind after we recover from an infection. Which is why, well into the third year of the pandemic, were in the midst of another wave of Covid-19 caused by the most immune-evasive variant yet, BA.5. And more variants are coming.
Even as vaccine manufacturers race to update the first-generation shots in the hopes of patching up our protection for the fall, other scientists are taking a different approach, making vaccines delivered via nasal sprays or tablets that would deploy more immune defenders to the bodys front lines: the lining of the mouth, nose and throat.
The hope is to shore up the defenses right there in the nose so that the virus cant even replicate in the nose, said Dr. Ellen Foxman, an immunobiologist at the Yale School of Medicine. And then someone who has a really effective mucosal vaccination cant even really support viral replication or make viruses that can infect other people.
That would be like the holy grail, said Foxman, who helped plan the International Congress of Mucosal Immunology meeting this week in Seattle, which is sponsored by pharmaceutical companies Pfizer, Janssen and Merck.
If it works, theres hope that mucosal immunity could slow the development of new coronavirus variants and finally bring the Covid-19 pandemic under control.
Theres a long way to go before that happens, however, and many scientists say the approach needs an injection of funding to accelerate the pace of development, much in the same way the billions of dollars doled out by Operation Warp Speed delivered the first generation of Covid-19 vaccines in record time.
The idea behind vaccinating the mucosa the lining of the tube (as mucosal immunologists refer to it) that runs from our nose and mouths to our lungs and guts isnt new. There are nine existing vaccines that work this way, including oral drops that protect against polio, cholera, salmonella and rotavirus, and a nasal spray, FluMist, that inoculates against the flu.
Most are based on the oldest types of vaccine technologies, using killed or weakened versions of a virus or bacteria to teach the body how to recognize it and fight it off when a real infection gets underway.
Because of those actual pathogens, some people cant use these kind of vaccines. Its risky to expose certain groups including pregnant women and those with weakened immune systems to even weakened viruses.
None has achieved the goal of blocking the transmission of an infection, but that may be because they havent gotten the same kind of investment as injectable vaccines, says Ed Lavelle, an immunologist at Trinity College in Dublin.
What hasnt really happened with mucosal vaccines is kind of huge advances in technology that have happened with injectable vaccines, even before Covid, Lavelle said.
That may be about to change, however.
More than a dozen nasal spray vaccines against Covid-19 are being tested around the world. Many use new kinds of technologies, like delivering instructions for making the spike protein of the coronavirus through harmless Trojan horse viruses. Others aim to deploy the mRNA technology that was so successful in the injectable vaccines in the form of a nasal spray.
One company, Vaxart, has even made a tablet that delivers instructions for making parts of the new coronavirus to the gut, which then builds immunity in the tube.
In animal tests, hamsters vaccinated in the nose or mouth have been less likely to spread a SARS-CoV-2 infection to uninfected animals that are in separate cages but share the same air.
What we found is that if you did an oral immunization, you inhibited the ability for that breakthrough to infect other animals, said Sean Tucker, chief scientific officer for Vaxart.
The Vaxart tablet, which is about the size and shape of an aspirin, uses an adenovirus the same delivery system utilized by the Johnson & Johnson and AstraZeneca Covid vaccines to ferry instructions for making parts of the SARS-CoV-2 spike protein into cells in the gut, which stimulates the release of antibodies in the nose and mouth.
In an early trial that included 35 participants, 46% had an increase of antibodies in their nose after taking the tablet vaccine. Those who did seemed to create a broad spectrum of immunity to a number of types of coronaviruses, and they appeared to hold on to that protection for about a year. That may be a bit longer than injectable vaccines, though more research is needed to confirm those results.
Tucker is presenting these early results Monday at the Seattle conference. He says theyll also be published as a preprint study in the coming days.
A phase 2 trial of a tablet with a slightly different formulation, involving almost 900 participants, is also underway, Tucker says. It is scheduled to be completed next summer.
Most of the mucosal vaccines under development are designed to be delivered as a squirt of liquid or mist up the nose, and many are intended to be used as boosters in people whove had a complete primary series of Covid-19 vaccines.
I dont think of them as nasal vaccines. I think of them as nasal boosts, said Jennifer Gommerman, an immunologist at the University of Toronto who specializes in tissue-specific immunity.
Thats important, Gommerman says, because nasal vaccines like FluMist havent really worked all that well.
The next generation of inoculations will be something different, she says. They will build on the body-wide immunity that was created by shots; theyll just redeploy it to the nose and throat where it is needed most, she says.
But here, were actually talking about something else, where were talking about building on the systemic immunity that was induced by a vaccine to a three shots of mRNA and then training that systemic immunity to go to the upper respiratory tract by boosting through the nose, Gommerman says.
One such approach was recently tested by Akiko Iwasaki, an immunobiologist at Yale University. According to their preprint study, Iwasaki and her team inoculated mice with a low dose of Pfizers Comirnaty mRNA vaccine and followed up two weeks later with a boost of mRNA vaccine delivered via a nasal spray. The low dose of the injected vaccine was meant to simulate waning immunity. Other groups of mice got only an injection or only a dose of vaccine in the nose.
Only the group that got the injection followed by the nasal spray developed robust immunity against the Covid-19 virus.
That approach we have shown in the mouse model to be 100% protective against lethal dose of SARS-CoV-2 infection, and it dramatically reduces the viral load in the nose and in the lung, Iwasaki said.
Mucosal vaccines also target a slightly different part of the immune system than shots.
Injections trigger the body to make antibodies against the virus that causes Covid-19. Most of these are Y-shaped proteins called IgG antibodies that are programmed to recognized and block specific parts of the SARS-CoV-2 virus along its spikes, the parts of the virus that latch onto and infect our cells.
A much smaller portion of these are IgA antibodies, and they look like two Ys joined together at their tails and turned sideways so it looks more like a dog bone, Gommerman says.
Like bouncers at a bar, IgA antibodies are the primary immune molecules on guard in the mucosa.
These molecules are beefier than IgG antibodies. They have four arms instead of two, and theyre special because theyre less picky about what they grab onto than IgG antibodies.
They might be a little more promiscuous in the way they recognize different variants. And thats obviously a plus, Gommerman said.
Shots increase IgA antibodies in the nose for a short time, but the hope is that mucosal vaccines will really ramp up the population of these sentries and help them stay active for longer.
Whether theyll be able to confer complete sterilizing immunity, thats a very tall order, Gommerman said. But we should be now working on ways to slow down person-to-person transmission, because this virus continues to mutate and then fools our immune system and gets past that mucosal layer.
This is now a very contagious virus, she said.
Iwasaki says she would love to move her vaccine out of animal studies and into clinical trials in people.
Were still at the stage where were kind of struggling to raise money, even make the vaccine for human use, because it takes millions of dollars, and we are not sitting on that kind of money for research lab, she said, so not yet.
July 18, 2022
The Oswego County Health Department reported that 174 residents tested positive for the COVID-19 virus from Monday, July 11 through Sunday, July 17. This includes both lab-confirmed and at-home tests.
The New York State Department of Health also reported another COVID-19-related death in Oswego County in the last week, bringing the total to 201.
Our heartfelt condolences go out to the family and friends of this person, Oswego County Deputy Public Health Director Vera Dunsmoor. Of course, we never want to see these reports as we strive to come out of the pandemic. In order to move forward, we must all continue working together to reduce the spread of COVID-19 and reverse the number of new positive cases of the virus.
The following report reflects data collected from Monday, July 11 through Sunday, July 17:
An additional four Oswego County residents were hospitalized due to COVID-19 between Sunday, July 10 and Saturday, July 16, according to the hospitalization report received by the Oswego County Health Department. New hospitalization numbers are not part of a running total of hospitalizations. For hospitalization details such as age groups and vaccination status, go to the Oswego County COVID-19 Dashboard at https://oswegogis.maps.arcgis.com/apps/dashboards/3fd162cd12264b418dc03bdebd7f5300.
The Oswego County Health Department continues to hold weekly vaccination clinics. COVID-19 vaccines are available for children aged 6 months and over as well as adults. The clinics run every Tuesday afternoon from 12:30 to 3:30 p.m. by appointment only. An additional clinic runs from 9 to 11 a.m. and 1 to 3 p.m. on the second Wednesday of the month. Walk-ins are accepted on Wednesdays, but residents are strongly encouraged to go to health.oswegocounty.com/vaccines to make an appointment to avoid wait times.
The Oswego County Office for the Aging can help people aged 60 and older who need help navigating the internet to make appointments. Call 315-349-3484.
Vaccines are also available at local pharmacies and health care provider offices. Face masks are required at all clinics and at-home COVID-19 test kits will be distributed to those getting vaccinated at a county clinic while supplies last.
Free transportation is provided to residents to go to COVID-19 testing and vaccination sites through a partnership between Oswego County and Oswego County Opportunities, Inc. Rides are available between 6 a.m. and 7 p.m. Monday through Friday. Call 315-598-1514 to schedule a ride in advance.
Oswego County developed a portal for residents to report positive at-home COVID-19 test results, exposure to the virus and get the necessary isolation/quarantine paperwork for schools and employers. Go to https://health.oswegocounty.com/COVID-19 and click on the appropriate link.
Test results received from doctors offices, pharmacies and other testing sites DO NOT need to be self-reported. However, if isolation orders are needed for school, employers or other reasons, people can request these documents using the portals Report a Positive (Laboratory) Test option.
The health department encourages residents who test positive to immediately notify any close contacts. The close contact should then go to the States website at https://coronavirus.health.ny.gov/new-york-state-contact-tracing to find out if they meet the criteria for quarantine. If they do, they should report the exposure on the County Health Departments online portal.
Residents are urged to continue taking precautions to prevent the spread of COVID-19 including:
For more information, go to the Oswego County Health Departments COVID-19 page at https://health.oswegocounty.com/COVID-19 or call its COVID-19 Hotline at 315-349-3330. Callers may need to leave a message and a staff member will return the call.
Residents should contact their medical providers directly for personal medical advice about COVID-19 and vaccinations or booster shots.
For information about emotional supports, visit the Oswego County Department of Social Services Division of Mental Hygiene at www.oswegocounty.com/mentalhygiene.
Under New York State Public Health Law, the Oswego County Health Department is the local public health authority regarding the COVID-19 pandemic response within the County of Oswego. The Oswego County Health Department works closely with New York State Department of Health regarding COVID-19 monitoring, response, and reporting.
The nation is experiencing a COVID-19 tsunami.Yet, peoples behavior suggests that no one is noticing. Are the surge and the behavior related?
The Centers for Disease Control and Prevention (CDC)provides weekly updates on every countys COVID-19 status. As of July 14, over 75 percent of counties are at the medium or high levels. Givenhow these levels are defined, this means that COVID-19 hospital admissions in these counties are sufficient to impact hospital bed availability.
With more people usingat-home tests, case counts have become a meaningless measure for assessing COVID-19 community risk, sincepositive test results rarely get reported to public health agencies. Hospitalizations, both new COVID-19 admissions and current occupancy, provide the most informative risk metrics.
NewCOVID-19 hospital admissionscontinue to increase, with theBA.5 omicron subvariantgaining a foothold in the population and itscontagiousness driving widespread infection spread.
The majority of Americans appear unfazed by the current risk environment.
Restaurants and entertainment venues continue to enjoy robust activity and the travel industry is enjoying a returning vibrance. Air travel continues to be robust, as measured by the daily number of people the Transportation Security Administration (TSA) are screening at airport security checkpoints, which has consistently beenover 2 million travelerssince early June. Given thatseat capacity is just below those levels available in 2019, air travel has essentially returned to pre-pandemic levels.
In the spring of 2021, one year into the COVID-19 pandemic, people were asking what thenew normalwould look like. We can now answer this question.
The new normal is an ongoing stream of new variants and subvariants, each with their own set of characteristics and risks. The ebb and flow of infections will continue. The much hoped for environment that prior infections would be protective has not panned out. The vaccines, including boosters, have continued to provide a fortress of protection against severe disease, albeit weakening over time. Treatments likePaxlovidare invaluable despite limitations such asdrug interactions.
The good news so far is thatdeaths have not surged in lockstep with infections, though at around 300 per day, they are not negligible. The not-so-good news is thathospitalizations continue to climb, which may lead to more deaths in the coming weeks.
Is this new normal acceptable? Will the public health environment continue to erode, or will it heal with time?
The CDC has done a great disservice to the nation. It has placed a tremendous burden on every person to assess what they should do to protect themselves, and most importantly, protect our societys well-being. Opaque guidance on social distancing, masking and ventilation has been lost in the cacophony of freedom to choose jubilation and an insensitivity spawned from a stream of worst-case warnings that have been communicated in the past.
This lack of trust in the CDC means that the public is no longer listening. The recentWhite House briefing, which contained useful information and advice, fell on deaf ears.
Many hoped, or wished, that after over two years of restrictions and constraints, the pandemic would be in the rearview mirror. We can keep our heads in the sand and believe that it has, but the data says otherwise.
Does that mean that people have to lock down again and return to a state of hibernation? Definitely not. That did not work very well, as the implemented social disruptions led tonon-COVID-19 excess deathsthat were unexpected and unpredictable.
What our nation needs is a regained trust in the CDC and the data that can guide us through the BA.5 surge and other new variants that are likely to emerge in the future. The seeds of trust can be found in what is messaged and how it is messaged.
Blanket mask mandates are ineffective. Credible, targeted masking guidance gives people more control over their situation. Ongoing transparent communication on the state of the nation is needed. Worst-case scenarios have been ineffective and even harmful, as people tune out the message, no matter how informative its substance.
Our new normal need not be as bleak as it appears. It can be changed, with a willingness for people to recognize where we are, and a willingness to take actions that are in everyones best interest, even their own.
Without trust, our new normal will continue to on its current trajectory that serves no ones interests.
Sheldon H. Jacobson, Ph.D., is a professor in computer science and the Carle Illinois College of Medicine at the University of Illinois Urbana-Champaign. A data scientist, he applies his expertise in data-driven risk-based decision-making to evaluate and inform public policy.
Mike Stucka USA TODAY NETWORK| Deming Headlight
New coronavirus cases increased 8.5% in New Mexico in the week ending Sunday as the state added 6,717 cases. The previous week had 6,188 new cases of the virus that causes COVID-19.
New Mexico ranked seventh among the states where coronavirus was spreading the fastest on a per-person basis, a USA TODAY Network analysis of Johns Hopkins University data shows. In the latest week coronavirus cases in the United States increased 29% from the week before, with 947,862 cases reported. With 0.63% of the country's population, New Mexico had 0.71% of the country's cases in the last week. Across the country, 42 states had more cases in the latest week than they did in the week before.
The Fourth of July holiday disrupted who got tested, when people got tested and when both test results and deaths were reported. This may significantly skew week-to-week comparisons.
Luna County reported 56 cases and two deaths in the latest week. A week earlier, it had reported 69 cases and zero deaths. Throughout the pandemic it has reported 7,194 cases and 135 deaths.
Within New Mexico, the worst weekly outbreaks on a per-person basis were in Grant County with 511 cases per 100,000 per week; Lincoln County with 450; and San Juan County with 419. The Centers for Disease Control says high levels of community transmission begin at 100 cases per 100,000 per week.
Adding the most new cases overall were Bernalillo County, with 2,216 cases; Doa Ana County, with 703 cases; and San Juan County, with 520. Weekly case counts rose in 19 counties from the previous week. The worst increases from the prior week's pace were in Bernalillo, Doa Ana and Sandoval counties.
>> See how your community has fared with recent coronavirus cases
Across New Mexico, cases fell in 12 counties, with the best declines in Los Alamos County, with 70 cases from 132 a week earlier; in San Juan County, with 520 cases from 572; and in Valencia County, with 205 cases from 245.
In New Mexico, 93 people were reported dead of COVID-19 in the week ending Sunday. In the week before that, 17 people were reported dead.
A total of 577,583 people in New Mexico have tested positive for the coronavirus since the pandemic began, and 8,056 people have died from the disease, Johns Hopkins University data shows. In the United States 89,542,107 people have tested positive and 1,023,799 people have died.
>> Track coronavirus cases across the United States
USA TODAY analyzed federal hospital data as of Sunday, July 17. Likely COVID patients admitted in the state:
Likely COVID patients admitted in the nation:
Hospitals in 36 states reported more COVID-19 patients than a week earlier, while hospitals in 27 states had more COVID-19 patients in intensive-care beds. Hospitals in 40 states admitted more COVID-19 patients in the latest week than a week prior, the USA TODAY analysis of U.S. Health and Human Services data shows.
The USA TODAY Network is publishing localized versions of this story on its news sites across the country, generated with data from Johns Hopkins University and the Centers for Disease Control. If you have questions about the data or the story, contact Mike Stucka at mstucka@gannett.com.
INTERVIEW HIGHLIGHTS:
Surprising aspects of BA.4 and BA.5
What really has gotten our attention about BA.4 and particularly BA.5 is that the virus is evolving to become more evasive or able to better escape our immune protection from the vaccines and from prior infection, as well as increasingly easily spread or transmissible to other people.
They spread faster?
Probably about 20% to 30% faster than the original Omicron variant or some of the earlier subvariants we saw back in the early spring.
Some interesting data suggests the way BA.5, in particular, is more efficient at entering into cells and leads to higher spikes of the viral load we're seeing in the upper airways, which probably explains at least part of the reason why it's more easily spread.
Are the vaccines and the one or two boosters we've had effective against four and five?
They're not as effective against four and five at preventing any infection. And so we are seeing an increase in what we would call reinfection, meaning people who've had COVID before, including people who had Omicron only a few short months ago. We're seeing those individuals getting reinfected with BA.4 and BA.5. We're also seeing individuals who are fully up to date getting infected as well.
Now, prior infection and being fully vaccinated are still largely providing protection against severe disease. And so we haven't seen a significant increase in deaths from BA.4 and BA.5, but we are starting to see a slight uptick in hospitalizations just due to really to the large number of individuals who are getting infected or reinfected.
Will new boosters expected this fall offer more protection against four and five?
The FDA has come out and said all boosters the companies are planning for this fall should be what we call a bivalent vaccine, meaning they have a part of the vaccine-specific to target BA.4 and BA.5. And there is preliminary data that those do provide added protection. You know, I think that it will certainly help.
The question I think that's lingering in many people's minds is if we have to wait till October or November for these new boosters, will they still provide a substantial benefit then, or will the virus have further changed or mutated itself before we get there?
Is this worse than what I would have gotten from some previous variant?
We have not seen evidence that BA.4 and BA.5 are causing more severe disease. Now, we don't know if that's just the virus itself intrinsically doesn't cause more severe disease or if it's infecting individuals who already have that partial wall of immunity from prior infection and vaccines.
Fortunately, we aren't seeing trends of significantly more serious disease. But that's something we're going to have to monitor closely because we're these are still relatively new subvariants that we're learning a lot more about their clinical behavior when they infect people.
How do existing treatments for COVID stand up against BA.4 and BA.5?
We still have oral antivirals, and the main one people have been using is Paxlovid, a product that still works well if started early in high-risk individuals who get infected with BA.4 and BA.5.
There's one treatment, the monoclonal antibody bebtelovimab, that does still work against the subvariants. And so that is available and out there.
And there is also the preventative monoclonal for those that are very high-risk, such as immunocompromised individuals. And that does still appear to provide some protection.
What's important is anybody who's over the age of 50 or has other high-risk features have a treatment action plan in place where they can access testing quickly and then contact their physician to see what treatment options would be best for them, given their other medical conditions, and other medications that they may be taking.
RESOURCES:
What You Need to Know About Variants
Texas COVID-19 Data
Covid Data Tracker
COVID-19 Current State Analysis and Forecasting for the DFW Region
Five things weve learned about the BA.4 and BA.5 Omicron variants
BA.5, now dominant U.S. variant, may pose the biggest threat to immune protection yet
Tracking Coronavirus in Texas: Latest Map and Case Count
Interview highlights were lightly edited for clarity.
Got a tip? Email Sam Baker at sbaker@kera.org. You can follow Sam on Twitter @srbkera.
KERA News is made possible through the generosity of our members. If you find this reporting valuable, consider making a tax-deductible gift today. Thank you.
In a recent study published in the Lancet Regional Health Europe, researchers evaluated the efficacy of the fourth dose of coronavirus disease 2019 (COVID-19) vaccine in residents of long-term care facilities (LTCFs).
Previous studies have barely investigated the COVID-19-related all-cause mortality beyond two months of receiving the fourth dose of an mRNA-based COVID-19 vaccine in individuals over 80 years. The authors extensively searched PubMed and medRXiv servers. They found only one study from Israel which reported high relative effectiveness of the fourth compared to the third dose of an m-RNA-based vaccine, between 75 to 80%, against COVID-19-related mortality in the elderly (60+ years) during one to two months of receiving a vaccine. It was critical to obtain evidence on the effects of vaccination in LTCFs as they are frailer and because the transmission in LTCFs has been high.
In the present study, researchers used cox regression models to estimate hazard ratios for all-cause mortality in recipients of a four-dose mRNA-based vaccine vis-a-vis recipients of a three-dose regimen. They computed relative vaccine effectiveness (VE) as one minus the hazard ratio. They enrolled residents of LTCFs who received a fourth dose of an mRNA vaccine from 1 January 2022 onwards. Next, they made a 1:1 matched cohort of Swedish individuals who received at least a third dose. The team also made another 1:1 matched cohort comprising 80+ individuals who had received a fourth dose and Swedish individuals who received at least a third dose.
The primary study outcome was all-cause mortality from seven days after baseline until 27 May 2022. The team used the Kaplan-Meier method to illustrate cumulative mortality. They also created a product term between vaccination status and dosing interval between the third and fourth dose; likewise, a product term between vaccination status and vaccine type among fourth dose recipients. Finally, the team performed interaction analyses using product terms, which they added to the final Cox model.
Over 98% of study participants had received BNT162b2 for primary-series vaccination, of which 80% also received a third dose of BNT162b2. Among four-dose recipients, ~60% received BNT162b2, and the remaining received mRNA-1273. The median age of the study cohort with 80+ individuals was 85.2 years. Of these, roughly 58% were women, and ~7% lived in an LTCF. More four-dose recipients lived in LTCFs compared to three-dose recipients (86% vs. 54%).
The fourth dose of an mRNA-based COVID-19 vaccine reduced all-cause mortality by about 40% during the first two months in LTCF residents. Previously, a Canadian study reported a 40% reduction in COVID-19-related hospitalization or death in LTCF residents from the fourth dose compared to the third dose.
The authors followed up with LTCFs on average for 77 days, and a maximum of 126 days. During days 7 to 60, 1119 residents died, and the observed VE against all-cause mortality was 39% among LTCFs, with no effect of dose interval in fourth-dose recipients. Likewise, the time since the first booster dose and vaccine type had no effect. During subsequent follow-up, from day 61 to 126 days, VE declined to 27%, and there were 259 deaths reported.
In individuals 80 years or older, the average follow-up time was 73 days, with maximum follow-up reaching 143 days. During days 7 to 60, 5753 elderly died, and the observed VE against all-cause mortality was 71%, with a slight effect of living conditions in fourth-dose recipients. Accordingly, the authors observed a VE of 73% for individuals living in their own homes. Although the dosing interval had no impact, the time since the first booster dose changed VEs. The VE of the fourth dose increased to 79% when more than four months had passed since vaccination. During subsequent follow-up, from day 61 to 143 days, VE declined to 54%, and there were 1054 deaths reported.
The current study, executed during the era of the predominance of new SARS-CoV-2 variant of concern Omicron in Sweden, showed that compared to the first booster, a second booster dose substantially decreased the short-term risk of all-cause mortality in LTCF residents and the oldest. However, the conferred protection declined slightly after two months, indicating limited durability of protection from the third dose in the oldest and the frailest. Thus, vaccination timing is crucial for protecting this high-risk population via vaccination.
More-viscous blood, which increases the propensity for clotting, is a sign that patients hospitalized for COVID-19 are more likely to do worse over the short term, according to data from a New York City health system.
The risk of in-hospital all-cause mortality increased along with rising estimates of blood viscosity, with patients with the highest estimates of high-shear and low-shear blood viscosity having 53% and 36% greater relative risks, respectively, compared with their counterparts with the least-viscous blood.
If you have elevated blood viscosity, high shear or low shear, those individuals are in an accelerated pathway for death, senior author Robert Rosenson, MD (Icahn School of Medicine at Mount Sinai, New York, NY), told TCTMD, noting that the relationship held true even after adjustment for many of the biomarkers that have been used to stratify risk in the setting of COVID-19.
Those individuals should be appropriately hydrated to decrease the plasma viscosity, they should receive high-intensity glucocorticoids to decrease the inflammatory response, and they should be monitored much more closely because of the prognostic significance of an elevated blood viscosity, he advised.
Ongoing studies are exploring whether additional interventions can improve the prognosis of patients with COVID-19 and high blood viscosity. In the meantime, Rosenson said that based on the results of a multiplatform trial published last yearfrom the REMAP-CAP, ACTIV-4a, and ATTACC investigatorstherapeutic-dose heparin, which provided a benefit in noncritically ill patients, can be recommended.
The findings of the current study were published online today ahead of the July 26, 2022, issue of the Journal of the American College of Cardiology, with lead authors Daein Choi, MD, and Ori Waksman, MD (both Icahn School of Medicine at Mount Sinai).
Integrating Inflammatory and Thrombotic Markers
COVID-19 is characterized by the presence of diffuse microthrombi, which can lead to organ dysfunction, long-term disability, and death, but what the infection is doing to increase clotting is not clear, Rosenson explained. Prior research has examined markers like D-dimer and fibrinogen to try to understand which patients are most at risk for thrombotic events, he noted.
Theres been a lot of disappointment regarding these biomarkers, and thats because the inflammatory process also results in upregulation of the genes and the pathways that manufacture these acute-phase proteins like fibrinogen, he said.
Blood viscosity is an integrative measure of all of these influences, and a prior study showed that directly assessed viscosity (using centipoise as the unit of measure) was higher in patients hospitalized for COVID-19 than in people without the infection and remained so for 2 months after discharge, Rosenson said. Direct measurement of viscosity can be challenging, however, and a method for estimating itthe Walburn-Schneck model, which incorporates routinely measured lab values like blood count, hematocrit, and globulin levelshas been developed.
Estimates using that method are what was done in the current study, which included 5,621 patients hospitalized for COVID-19 within the Mount Sinai Health System between February 27, 2020, and November 27, 2021.
This is definitely the first time that anyone has shown a prognostic role of estimated blood viscosity in COVID patients. Cheryl Maier
The researchers differentiated between high-shear and low-shear blood viscosity: the former applies to high-flow situations in medium and large arteries and has been associated with endothelial damage, whereas the latter applies to low-flow situations and is associated with the propensity for clotting. Every one-centipoise increase in high-shear and low-shear estimated blood viscosity was associated with a 36.0% and 7.0% increase, respectively, in in-hospital mortality (P < 0.001 for both).
Compared with patients in the lowest quartile of high-shear estimated blood viscosity, those in the highest had an elevated in-hospital mortality risk after adjustment for confounders (adjusted HR 1.53; 95% CI 1.27-1.84). The relationship tended to be stronger in Hispanics, patients with diabetes, and those without any comorbidities.
Similarly, patients with the highest estimated values for low-shear blood viscosity had a greater risk of in-hospital mortality compared with those with the lowest values (adjusted HR 1.36; 95% CI 1.14-1.64).
Other factors associated with a greater risk of mortality were levels of C-reactive protein and interleukin-6, although the relationship between high-shear blood viscosity and death remained significant even after accounting for these inflammatory markers.
As new emerging antiviral agents suggest benefits in patients at high risk of progressing to severe illness, identifying high-risk populations in the earlier stage of the disease becomes crucial, the investigators write. From a translational perspective, the variables to calculate estimated blood viscosity (hematocrit, albumin, and total protein) are readily available to practitioners and are easily obtained from most admission labs, suggesting a possible use of estimated blood viscosity as an efficient and simple risk assessment of patients with COVID-19 to offer proper preventive therapy.
Moreover, they write, further studies investigating the impact of targeted reduction of whole blood viscosity are merited given the association between estimated blood viscosity and mortality.
Potentially Major Implications for Patient Management
Commenting for TCTMD, Cheryl Maier, MD, PhD (Emory University School of Medicine, Atlanta, GA), said this is definitely the first time that anyone has shown a prognostic role of estimated blood viscosity in COVID patients. And its also really helpful to the field that they were able to do this from a calculated measurement, because one of the major limitations in doing [a direct] assessment of viscosity is that most healthcare settings just dont have the ability to do it.
A key question is around the mechanism that links more-viscous blood with mortality in the setting of COVID-19, Maier said. A feature that is unique to COVID-19 is just how high fibrinogen levels rise in response to the acute infection, and this would directly increase blood viscosity, she noted. But the explanation for how that might ultimately lead to the multiorgan microvascular damage seen with COVID-19 is still missing.
The answer to that question, and whether blood viscosity is a marker of disease or is directly mediating the disease course, will influence the clinical implications of these findings, Maier indicated. If its mediating the disease, it absolutely could have impact patient management, because we should have targeted therapies that decrease the viscosity rather than just some of these more-standard approaches that weve already been trying.
A lot of these patients are given anticoagulants, but some still develop thrombotic events, Maier pointed out. If we knew that the viscosity was directly causing those clots . . . then we could target the viscosity itself rather than just using typical anticoagulation. She noted that despite the fact that anticoagulants are commonly called blood thinners, they dont necessarily thin the blood and instead work by stopping the clotting cascade.
Maiers group has conducted a small trial evaluating plasma exchange as a way to lower blood viscosity in the setting of COVID-19, though she said further research would be needed to establish that reducing viscosity will improve patient outcomes before implementing changes to practice.
In an accompanying editorial, Aldo Bonaventura, MD, PhD (Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy), and Nicola Potere, MD (G. dAnnunzio University of Chieti-Pescara, Chieti, Italy), also say that additional studies are needed.
While still requiring adequateboth external and prospectivevalidation, estimated blood viscosity is likely to represent an attractive biomarker, as it was shown to be an early and robust predictor of mortality, and it is widely available and relatively inexpensive, they write. In light of the translational potential associated with [it], further investigation is eagerly warranted to confirm and expand the present findings, in order to advance estimated blood viscosity into the clinical scenario.
OSHA's emergency temporary standard (ETS) requiring healthcare employers to adhere to numerous regulatory requirements addressing COVID-19 was largely withdrawn in December 2021. On June 21, 2022, the U.S. Department of Labor (DOL) published its regulatory agenda forecasting that employers in healthcare settings can anticipate that the Occupational Safety and Health Administration (OSHA) will roll out permanent COVID-19 regulations in September 2022.1 It is expected that many, perhaps most, of the requirements in the ETS will be resurrected in the new final rule. Healthcare employers will be well-served to prepare now to ensure compliance later this year if OSHA, in fact, publishes its new final rule.
One year ago, OSHA issued the 900-page healthcare ETS, which will serve as a starting point for its forthcoming permanent COVID-19 healthcare regulations. The healthcare ETS required employers to develop and implement COVID-19 plans that included paid time off for vaccination, social distancing, personal protective gear, physical barriers, ventilation, patient and employee screening, employee training, recordkeeping and reporting. Although the ETS immediately went into effect, the bulk of the emergency regulation was withdrawn in December 2021 when OSHA was unable to meet the six-month deadline to complete a final standard.2
Nevertheless, OSHA strongly recommended employers continue to adhere to all of the terms of the healthcare ETS and has asserted that doing so will offer protection against citations under the General Duty clause, respiratory standard, and PPE standards as they relate to COVID-19. However, the only healthcare ETS regulations that actually remain in effect are the healthcare ETS's log and reporting requirements, found at 29 CFR 1910.502(q)(2)(ii), (q)(3)(ii)-(iv), and (r).
OSHA opened (and has completed) two comment periods on its proposed final rule and held public hearings on a broad range of topics, including the necessity of permanent standards, compliance with CDC recommendations, and the scope of healthcare workers to be covered. Although it is anticipated that the new permanent regulations will be based upon and have similarities to the healthcare ETS, there are also potential differences. By definition, OSHA can only authorize an ETS in limited circumstances in which workers are in "grave danger." Given that a permanent standard will not have such restrictions, it is possible that the new rule will be applicable (or more clearly applicable) to a broader scope of workers in nonemergency situations, such as home healthcare settings and embedded clinics at non-healthcare workplaces (e.g., a clinic at a manufacturing or processing plant). Additionally, OSHA's requested comments and public hearings suggest that the new, permanent healthcare regulations will not include a mandatory vaccination requirement for employees. OSHA also appears to be contemplating allowing more flexibility in implementing required policies in areas where healthcare employees do not encounter people with COVID-19.
Assuming the new regulations are issued in September, it is likely that legal challenges will ensue targeting specific provisions or the new regulations altogether. DWT will continue to monitor OSHA's progress on these regulations and any potential lawsuits, and provide updates as they occur.
The DOL's regulatory agenda also includes a potential infectious disease regulation for healthcare and other high-risk environments that was initially considered in 2010 and is now scheduled for proposed rulemaking in May 2023. OSHA indicates the prospective rule will address safety standards for COVID-19, among other infectious diseases, in workplace settings that include healthcare, emergency response, correctional facilities, homeless shelters, and drug treatment programs. OSHA would first publish a proposed rule, then allow a period for comments. More will be revealed over the next year.
OSHA's forthcoming healthcare regulations will apply immediately to states in which federal OSHA directly enforces the federal Occupational Safety and Health (OSH) Act and its regulations. But approximately half of U.S. jurisdictions, including California, Washington, Oregon, Alaska, and Virginia have state plans that OSHA has approved and, as such, are administered by local state agencies. Any new OSHA regulations will not immediately be enforceable in these "state plan" states. Subject to OSHA oversight and approval, these state plans must adopt rules within six months of the federal regulation's adoption that are either identical to or more protective of employee safety and health than any new federal regulation. Thus, although any new federal OSHA COVID-19 or infectious disease regulations may not immediately apply to healthcare employers in these state-plan jurisdictions, they or something similar to them (and possibly even more restrictive) may apply in short order.
1 In the ETS, OSHA broadly defined "healthcare setting" to include places where practitioners (e.g., doctors, nurses, and dentists) provided healthcare services and where individuals provided healthcare support services, such as patient intake/admission, patient food services, housekeeping, and medical equipment cleaning. However, the ETS included several exceptions, which limited the application to more traditional healthcare settings (e.g., hospitals). As discussed below, OSHA will have a greater ability to define healthcare setting broadly with a non-emergency regulation than it did with the ETS.2 The OSHA healthcare COVID-19 ETS is not to be confused with OSHA's general industry COVID-19 ETS. The U.S. Supreme Court blocked the enforcement of OSHA's general industry ETS on January 13, 2022, which ruling effectively killed the general industry ETS.
The facts, laws, and regulations regarding COVID-19 are developing rapidly. Since the date of publication, there may be new or additional information not referenced in this advisory. Please consult with your legal counsel for guidance.
DWT will continue to provide up-to-date insights and virtual events regarding COVID-19 concerns. Our most recent insights, as well as information about recorded and upcoming virtual events, are available at www.dwt.com/COVID-19.
[View source.]
