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Coronavirus updates August 1, 2021



Hundreds of thousands of college and graduate students at public universities have been given a choice: Get fully vaccinated against Covid-19 or don’t show up to campus in the fall.


More than a dozen students have opted for a third option: Sue their school.


Students have brought federal lawsuits challenging the vaccination requirements at major public university systems in Indiana, Connecticut, California and Massachusetts. The students, in several cases backed by antivaccine groups, are insisting they have a constitutional right to go to college in person and unvaccinated.

The odds against the lawsuits are considerable, public-health law scholars say. Already a federal appeals court has affirmed Indiana University’s vaccine requirement, a decision cited by other school defendants. When balancing public-health interests against individual liberties, courts historically have given state entities much deference.



Still, the antivaccine legal effort represents one of the most significant tests in recent years of the government’s power to press adults to get vaccinated, legal scholars said.

The battle over campus policies has become a flashpoint amid a resurgence of Covid-19 cases in the U.S. and contentious debate about how to lift the national vaccination rate. The threat of viral variants has led growing numbers of private employers to compel their workers to be vaccinated. New York City’s mayor said it would soon require indoor diners and gym customers to show proof of vaccination.

In the public sector, California and New York City officials are now requiring their workers to either be vaccinated or be tested regularly. The public university policies are more stringent for those students who don’t qualify for exceptions.

More than 200 public campuses require their students or employees to be vaccinated, according to a Chronicle of Higher Education database, which shows those schools clustered in regions that lean Democratic.

The university systems facing lawsuits—which also include the University of Connecticut, California State University and the University of Massachusetts—have varying rules and exceptions. Generally, students can get waivers for medical reasons or because of religious objections, but they are subject to more stringent safety measures, including indoor mask-wearing and regular Covid-19 testing. Unexempted students have been barred from attending classes in person or from campus entirely. Most of the universities being sued don’t currently allow full-time degree-seeking students to fulfill all their requirements online.


The lead plaintiff suing the University of Connecticut, Nicole Wade, a 28-year-old college student and orthopedic specialist in the Army Reserve, said she was fearful of adverse reactions to the rapidly developed new vaccines.

“I was always hesitant. It’s just so new,” said Ms. Wade, a mother of two children. “There’s no long-term data, so I just feel more comfortable waiting.” She said it was unfair that faculty and staff are exempted from the requirement.

In a court filing, the school said its measures to encourage vaccination are “one tool among many that UConn has put in place to protect the health and safety of returning students.”

Under the UConn policy, unvaccinated students may not attend on-campus activity in the fall unless granted waivers. The university said that as of July 23, it had granted most of the nonmedical requests for waivers, including ones submitted by two other plaintiffs in the case. Ms. Wade hasn’t sought an exemption because of a “lack of clarity about the policy itself,” said her attorney, Ryan McLane. While the university said it was offering remote courses as an alternative, virtual classes are no substitute for in-person education, he said.

The lawsuits against the universities claim violations of the right to bodily autonomy and assert that the safety risks of vaccination outweigh the public-health benefits. Antivaccine activists have focused on the public institutions, which are bound by constitutional restraints, and have brought lawsuits under the 14th Amendment and its protection of fundamental rights and liberties.


Most plaintiffs are students but not all. A 55-year-old George Mason University law professor is suing his school over its policy of denying merit pay increases to unvaccinated faculty members.

Judicial challenges to governmental vaccination policies have a long history. Just a few years after English physician Edward Jenner discovered the smallpox vaccine in the late 1700s, a Vermont resident went to court in protest of a tax his town levied to help pay to inoculate its residents. By the turn of the 20th century, state courts had upheld compulsory vaccination in public schools.


But it was Jacobson v. Massachusetts, a 1905 U.S. Supreme Court case, that set the most influential precedent.


The dispute centered on a Massachusetts law enacted after a major smallpox outbreak authorizing local health boards to require adults to get vaccinated or pay a $5 fine. A Swedish Lutheran pastor named Henning Jacobson from Cambridge was jailed after he refused to get the shot or pay the fine. He argued that the smallpox threat had receded, but the Supreme Court upheld the law in a ruling that gave states broad license to combat health threats.


The lawsuits against the universities add new wrinkles. “We haven’t had to confront adult mandates very often,” said Dorit Reiss, a public-health legal scholar at the University of California, Hastings College of the Law. Just how much judicial scrutiny should be applied to vaccination requirements isn’t fully settled, she said.


While higher courts have suggested that people have a constitutional right to refuse lifesaving medical treatment, such freedom has never extended to the right to refuse inoculation.


Judicial hesitancy to second-guess university administrators was underscored in the Indiana University case. Guided by the Jacobson decision, a federal judge last month allowed the university system to impose its requirement, saying he wasn’t persuaded by the student concerns over vaccine safety.



The Chicago-based Seventh U.S. Circuit Court of Appeals affirmed that decision Monday.


“Few people want to return to remote education,” wrote Circuit Judge Frank Easterbrook, a President Ronald Reagan appointee, denying an injunction. “[W]e do not think that the Constitution forces the distance-learning approach on a university that believes vaccination…will make in-person operations safe enough.”
 


Drugmakers are crafting Covid-19 vaccines that would target more than one strain of the virus, hoping to strengthen the immunization campaign against the pathogen as it evolves.


Researchers at Moderna Inc., MRNA -0.67% Novavax Inc. NVAX 5.54% and the University of Oxford are designing the shots, known as multivalent vaccines, to protect not only against the form of the virus commonly circulating globally but also potentially contagious strains that have emerged or might in the future.


The work belongs to a range of efforts vaccine makers and drug researchers are undertaking to get ahead of variants like the one identified in the United Kingdom, South Africa and Brazil.

Research indicates some vaccines currently in use generate weaker immune responses against the strain found in South Africa in particular, though there isn’t evidence indicating that current vaccines don’t protect against variants.



To be safe, companies are exploring strengthening the protection conferred by existing shots by adding doses, updating the shots or crafting a booster. A multivalent shot is another approach in the works.

Testing multivalent vaccine candidates in people hasn’t started yet. Some companies hope to begin in the spring so that shots can be available for use as early as the summer.


Health experts say the broad-acting shots could make a difference in the pandemic fight by stymieing mutations to the coronavirus that could help it evade existing vaccines before widespread herd immunity is achieved.


“If there are two or three predominant world-wide strains, and infection or immunity to one doesn’t protect against the others, then we may need multivalent vaccines,” said Buddy Creech, director of Vanderbilt University’s vaccine research program.


Multivalent vaccines are a widely used weapon against other viruses, such as measles, mumps and rubella. Some pneumonia vaccines target as many as 23 strains, while most flu shots target four different influenza strains.


‘Nobody wants to be in a position where a variant is suddenly infecting everybody all over again.’
— University of Pennsylvania immunologist Drew Weissman

To defeat a variety of variants, the vaccines essentially blend together a number of different shots. So long as researchers pick the right combinations, the vaccines should work, though not if the mixture spreads protection too thin, vaccine experts say.


Multivalent vaccines would be especially useful against Covid-19, virologists and vaccine experts say, if scientists are able to predict which mutations might spread, as is done with influenza each year.


“The real question is what’s the virus going to evolve to, and if we knew the answer to that, then we could stop it,” said Dr. Sean Whelan, a virologist at Washington University in St. Louis whose lab is trying to predict important mutations.


Companies began pursuing multivalent Covid-19 vaccines in recent months as research suggested emerging variants could escape protection from the vaccines currently available.


The companies may prefer to make multivalent Covid-19 vaccines, rather than tailoring shots to various regions of the world with different variants.


Yet multivalent vaccines are more complex to research and manufacture, which can increase company costs and the time it takes to make them, vaccine experts say.


The world-wide market for Covid-19 vaccines would be worth more than $15 billion if annual shots are needed to address waning protection over time and multivalent vaccines are required to head off variants, Bernstein Research estimates.

Moderna, which is developing a vaccine targeting the strain identified in South Africa specifically, is also pursuing a candidate that would combine the variant-focused shot with the company’s vaccine currently in use.


The combination “might ultimately be the best approach,” Moderna President Stephen Hoge said during an earnings call last month. Moderna hasn’t specified when a study would begin for the multivalent candidate.


Novavax, which has a Covid-19 vaccine targeting the original version of the virus in late-stage U.S. testing, plans midyear to begin testing a bivalent vaccine that targets the original version of the virus as well as the variant first identified in South Africa, Dr. Gregory Glenn, the company’s R&D chief, said on a conference call this month.


It settled on this approach after analyzing data from its clinical testing in the U.K., indicating targeting the South African variant would offer protection against other strains, a Novavax spokeswoman said.



University of Oxford researchers are pursuing a multivalent approach that includes targeting strains first identified in Brazil and South Africa, according to AstraZeneca AZN 1.92% PLC, which licensed the shot to distribute.


Trials could begin this spring with the shot available in the summer, Dr. Mene Pangalos, an AstraZeneca R&D executive, said on a conference call with analysts last month.


Drew Weissman, an immunologist at the University of Pennsylvania whose research contributed to the mRNA technology used by BioNTech SE BNTX -2.30% and Moderna, said his team is working on a multivalent vaccine to cover all current and future variants.

“Nobody wants to be in a position where a variant is suddenly infecting everybody all over again, so people want to have their vaccines ready to go. We haven’t hit that point. So we’ve got time to do this right,” he said in an interview.


Johnson & Johnson JNJ 0.19% has said it is preparing an antigen—the substance that a vaccine relies upon to generate an immune response—that would target the variant that spread in South Africa.


The company, which has a newly authorized Covid-19 vaccine, hasn’t committed to a multivalent shot, but would develop one if a variant escaped protection from the vaccine.


Pfizer Inc., PFE -0.29% which developed with partner BioNTech the first Covid-19 vaccine authorized in the U.S., is only working on a vaccine targeting the South African variant. Pfizer believes it is sufficient to target just the one strain because it is crowding out other variants, so a multivalent vaccine attacking multiple strains isn’t necessary, said Phil Dormitzer, the drugmaker’s chief scientific officer of viral vaccines.


Yet Dr. Ofer Levy, director of the vaccine program at Boston Children’s Hospital, said multiple variants may circulate simultaneously until one becomes the dominant strain.


 

"

Should You Recommend a COVID Booster to Patients?

— Certain at-risk groups need to consider extra protection now

by Robert Colton, MD August 5, 2021


A syringe draws from a vial labeled: BOOSTER SHOT

Fully vaccinated patients are constantly inquiring about getting a COVID-19 vaccine booster. Some are already panicking, breaking the rules, and getting a third shot. While most first world countries have a centralized public health record, we do not. The states track vaccine administration, not the CDC. This means people are easily evading the system.
This begs the questions of how the U.S. should approach boosters and what providers should recommend to patients who ask about boosters.

What's the Current Booster Landscape?
Several studies offer preliminary evidence on the benefits of boosters, especially for certain populations. A recent French study in JAMA showed that about 50% of 159 kidney transplant patients with low or no measurable antibodies after two doses of an mRNA vaccine mounted a response with a third shot, and with no serious side effects or rejection episodes. A study in the Annals of Internal Medicinealso showed the benefits of a third dose in solid organ transplant patients. Pfizer data (that has not yet been peer reviewed) show antibody levels rise 11-fold in patients ages 65 to 75 after a booster.
Around the world, some countries and localities have gotten an early start on boosting. Boosters are being offered to patients over 60 years old in Israel. France is giving a booster dose to the severely immunocompromised 4 weeks after the second dose, and Hungary, Turkey, Thailand, Bahrain, and the United Arab Emirates are starting booster programs. The Mississippi Health Department is now recommending physicians consider boosters for the immunocompromised.

Who Should Get a Booster Now?
We are dealing with two segments of the population.
According to a presentation at a recent meeting of CDC's Advisory Committee on Immunization Practices, just shy of 3% of the adult population is considered immunosuppressed. This includes people with:

  • Cancer
  • Organ or stem cell transplants
  • HIV
  • Severe primary immunodeficiencies
  • Asplenia
  • Advanced chronic kidney disease
  • Conditions requiring immunosuppressive medications such as chemotherapy, tumor necrosis factor (TNF) blockers, certain biologics such as rituximab, and high-dose corticosteroids
These patients may have poor antibody responses to vaccination. Even though they represent about 3% of the adult population, they account for 44% of breakthrough infections requiring hospitalizations, according to one U.S. study. Here, vaccines were 59% protective against hospitalization for this group versus 91% for those without immunosuppression.
For the 97% of people who are not immunosuppressed, the initial two doses of the mRNA vaccines are highly protective for most. While some people are getting breakthrough infections, most just suffer minor symptoms. Moderna and Pfizer are also studying new formulations of the vaccines to better protect against Delta and other variants. For these reasons, there is no pressing reason to offer these patients a booster now, and measuring spike protein antibody levels in this population would only sow confusion.

There are some exceptions, however. Evidence suggests the Johnson & Johnson vaccine may be less effective against the variants, and certain localities, like San Francisco, are allowing people to boost if they received J&J. Those who received the J&J shot may want to consider getting an mRNA booster at this time and should discuss it with their doctor.
For the immunocompromised 3%, the situation is quite different. Multiple studies show these patients can mount a significant antibody response to a booster. Will this translate to a lower risk of severe infection? While we will not know for certain until outcome studies are complete, antibody titers correlate well with susceptibility to infection. An elegant New England Journal of Medicine article in July demonstrated that COVID-19 breakthrough infections in Israeli healthcare workers were less common among those with higher neutralizing and anti-spike protein antibody levels.

With the current Delta surge, we do not have the luxury of waiting for definitive studies. Until such studies determine whether boosters are effective in preventing disease in this population, we have two choices: One is to offer everyone in the immunocompromised group a booster. The World Health Organization just called for a halt on booster shots through September to "make up for a shortfall of vaccine supplies to poor countries." The immunocompromised group, however, remains at significant disease risk despite two mRNA vaccines. A recent studyshowed the rate of infection in transplant patients was 82 times the general vaccinated public and the rate of serious illness was 485 times higher. A booster moratorium clearly should not apply to this group. Furthermore, the White House just announced the U.S. can both provide boosters if necessary and donate the excess supplies to poorer countries.
The second option is to measure quantitative spike protein antibodies and vaccinate those with low or undetectable antibodies. However, the FDA currently does not recommend measuring antibodies except as part of a clinical study. Although it does not measure T-cell immunity, these antibody levels are currently our best proxy and an easily measured determinant of infection risk. Patients appreciate information. If they see their antibody levels are low, they might more readily accept a booster shot now, even though a third dose is not currently authorized. Furthermore, patients with normal antibody levels can be reassured they likely have healthy humoral immunity and might opt to wait for the newer vaccines that have been bioengineered to induce a stronger immune response to the variants. We cannot simply wait around -- either boosting or measuring antibodies in this at-risk population is a must.

Thinking beyond immunocompromised patients, other medical conditions -- to varying degrees -- pose an increased risk of hospitalization and death from COVID-19: obesity, sickle cell anemia, liver disease, advanced age, chronic lung disease, diabetes, heart conditions, stroke, and substance use disorder. Guidelines for boosters will need to be developed for each of these groups.
"
 

“President Biden may make it more difficult to be an unvaccinated American. Though the discussions are still early, his administration is debating the use federal powers or the threat of withholding funds to increase vaccinations. One penalty under consideration is the restriction of Medicare money to nursing home facilities that do not require their employees to be vaccinated. These talks are a possible sign of harder stances on vaccines to come – a shift from carrot to stick.

It's expected that within the upcoming two weeks the Food and Drug Administration will review data from the Centers for Disease Control and Prevention that support additional vaccine doses for those with compromised immune systems. If that information is persuasive, the FDA may authorize extra shots for the roughly 7 million immunocompromised people in the United States, a group that includes recipients of transplant organs and cancer patients. “It is extremely important for us to move to get those individuals their boosters, and we are now working on that,” the nation's top infectious-disease expert, Anthony S. Fauci, said Thursday at a news briefing.

The outbreak in Provincetown, Mass., put vaccines to the test: There were multiple venues of transmission, at crowded dance parties, bars and Airbnbs. Health officials say that, contrary to what it may seem, the vaccines worked well to protect people from the worst of covid-19 at Provincetown. The vast majority of the 1,000-plus cases at the outbreak, which included a mix of vaccinated and unvaccinated people, resulted in mild cases or cases without symptoms. There have been no deaths. (For more on breakthroughs, be sure to read today's Q&A below.)

Florida Gov. Ron DeSantis (R) continues to oppose mask mandates and other precautions even as covid-19 hospitalizations in Florida exceeded 12,000, once again surpassing the state's previous record. Instead, DeSantis has claimed the surge is expected and railed against shutdowns, saying that Florida residents are “free to choose to make their own decisions.” The state accounts for a fifth of the new infections across the country.

Workers at U.S. hospitals are so exhausted and burned out that some are literally walking off the job. The strain is acute in states such as Arkansas, where an influx of covid-19 patients is burdening already taxed clinicians. “We have had people walk off their shift, in the middle of their shift as distressing as that is because they could not take it anymore," the chancellor of the University of Arkansas for Medical Sciences told CNN.

Nursing home operators are starting to announce vaccine mandates for their staff. The largest nonprofit long-term-care chain in the nation, Good Samaritan, said mandatory vaccinations will go into effect in November. A July outbreak at one of its nursing homes was a catalyst, as is the threat of the delta variant. Some companies, though, are reluctant to force employees to get immunized, fearing labor shortages.
 

White House pushes student vaccinations as hospital admissions, deaths rise about 40 percent in a week​


"
Daily new cases, hospitalizations and deaths from the delta variant of the coronavirus are all surging as millions of Americans remain unvaccinated, federal health officials warned Thursday.
“Across the board, we are seeing increases in cases and hospitalizations in all age groups,” Centers for Disease Control and Prevention Director Rochelle Walensky said at a White House coronavirus briefing where she and other health leaders reiterated pleas for people to get immunized.

The latest slew of stark statistics: Daily cases passing 100,000 — numbers not seen since February. A seven-day average of hospital admissions up by more than 40 percent from the week before and deaths trending up by roughly the same rate.

There is a bright spot, officials said — a significant boost in the numbers of Americans getting vaccinated. They cited a 90 percent jump in first shots in Tennessee over the last two weeks; an 82 percent increase in Oklahoma and a 66 percent rise in Georgia, among other hopeful signs. Nearly 650 colleges and universities are now requiring shots for students and staff on campus, and more than 100 health care systems are embracing similar mandates, they said.

Also Thursday, the Biden administration announced a new push to vaccinate young people as they head back to school, backing initiatives such as hosting pop-up clinics on campus; sending pediatricians to back-to-school nights to discuss the shots with parents; and incorporating vaccination against covid-19 into physicals for student athletes.
The United States has been vaccinating children as young as 12 since May, but that group remains less likely than adults to have their shots.

“The resources are there and the urgency is there,” Secretary of Education Miguel Cardona said at a news briefing where he said the administration is partnering with groups such as the American Academy of Pediatrics and the National Parent Teacher Association. “Now is the time to get our students back into the classroom, not to be complacent or let politics get in front of what is best for our students across the country.”

Starting Saturday, a White House news release said, a “week of action” will enlist school districts, celebrities, businesses and others to “kick off the school year by encouraging young people to get vaccinated and offering accessible ways to do it in their community.”
The administration continues to focus on communities with low vaccination rates, which officials say are driving the pandemic. White House coronavirus coordinator Jeff Zients pointed to seven Southern states — Florida, Texas, Missouri, Arkansas, Louisiana, Alabama and Mississippi — as accounting for about half of all new infections and hospitalizations over the past week, even as these states represent less than a quarter of the American population."
 

Coronavirus booster shots for the immunocompromised expected to be authorized soon​

Federal officials could act within days or weeks.​


"
Federal health officials are racing to ensure that millions of Americans with weakened immune systems can get additional shots of coronavirus vaccines to protect them against the highly contagious delta variant.

The extra shots are expected to be authorized within days or weeks, according to federal officials who spoke on the condition of anonymity because the plan has not been announced.
The stepped-up activity reflects increased urgency by the Biden administration to shield some of the nation’s most vulnerable adults as coronavirus cases rise sharply. The pressure has also grown as other countries have taken steps to get additional shots to people who are immunocompromised or older — and as some Americans pursue such shots on their own.

In the next week or two, the Food and Drug Administration is expected to review data from the Centers for Disease Control and Prevention supporting the use of additional vaccine doses for the immunocompromised. If officials are persuaded, they will amend the emergency use authorizations for the vaccines to permit the extra inoculations. Advisers to the CDC and the agency, in turn, will urge people with certain medical conditions to talk to their doctors or pharmacists about getting the shots.



Immunocompromised patients represent about 7 million adults in the United States, including those who have received organ transplants, patients on cancer treatments and those with rheumatologic conditions and HIV, according to the CDC. They are more likely to become seriously ill from covid-19, the disease caused by thecoronavirus, and might more frequently spread the virus to others, experts say.
“It is extremely important for us to move to get those individuals their boosters, and we are now working on that,” Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said Thursday at a White House briefing. He said many immunosuppressed people did not have a vaccine response “that we feel would be adequately protective.”
For Ileana Benitez of Kensington, Md., the change cannot come soon enough. Benitez, 41, had a kidney transplant in her 20s. Her husband, Jeremy Young, 43, was the donor. Even after getting the Johnson & Johnson vaccine in March, the couple avoids grocery stores and restaurants. And with school starting soon, they fear their 8-year-old daughter might bring the coronavirus home. “It would be such a difference,” Benitez said.

The focus on the immunocompromised comes as officials scramble to develop a more comprehensive strategy for vaccine boosters for others, including older people, as first reported by the Wall Street Journal. But those plans will not be completed until September, when additional data is collected, and would be put into effect only if officials conclude that boosters are needed more broadly because of waning immunity. Those shots would probably not be rolled out until October, they said.



Both the Pfizer-BioNTech and Moderna vaccines are now authorized for a two-dose regimen and Johnson & Johnson for one shot. The goal is to permit extra doses of all three vaccines, but officials said that decision would depend on the data. They also are unsure what the data will show about mixing and matching — using a Pfizer or Moderna vaccine, for example, to bolster Johnson & Johnson’s shot.
Israel is already offering a third dose of the Pfizer-BioNTech coronavirus vaccine to severely immunocompromised adults. Germany said it also would start offering boosters to the elderly, the immunocompromised and those who got the AstraZeneca or Johnson & Johnson shots, because studies suggest they may be less effective than other vaccines.
France also plans to make certain groups of people, including residents of nursing homes, those over age 75 and people with severe health conditions eligible for additional doses in September. Britain has announced a plan for additional doses to begin in September, targeted first to people who are immunocompromised, but is awaiting guidance from an expert panel before firming up plans.

While the World Health Organization called Wednesday for rich countries to halt booster shots through at least September, as developing countries struggle to get doses, agency officials said they do not necessarily oppose giving extra doses to those who failed to respond.
Last month, Camille Kotton, a transplant-medicine physician at Massachusetts General Hospital and a member of the CDC’s Advisory Committee on Immunization Practices, said many immunocompromised patients have “taken matters into their own hands, and many are proceeding with additional doses of vaccine as they see fit.”
She said at a meeting of the advisory committee that she was concerned about patients getting extra shots in an unsupervised fashion.

If regulators authorize the extra shots, that would give doctors and providers liability protection for administering them to certain groups, officials said. Authorizing an extra dose of the Pfizer-BioNTech vaccine for the immunocompromised is less critical because that product is likely to get full FDA approval in the next two to four weeks. Once that happens, doctors are permitted to use the vaccine as they see fit, as long as it is reasonable.


While some health officials use the word “booster” in discussing an extra shot for the immunocompromised, others argue that technically that is not a booster. Instead, they say, such a shot should be seen as part of the primary vaccine regimen for people who have failed to respond fully or at all to previous shots.
A booster in effect “reinvigorates the immune response by giving it another stimulus,” said William Schaffner, an infectious-disease physician at Vanderbilt University and a liaison member to the CDC advisory panel. “Whereas in an immunocompromised person, they never achieved that appropriate immune response, so people are beginning to think of it as a three-dose regimen for immunocompromised people.”

The CDC’s vaccine advisory panel is scheduled to meet next Friday to hear presentations on additional data about doses for the immunocompromised in anticipation of changes in FDA regulatory authorization, according to a federal health official. That way, once the FDA takes action, the advisory panel could move quickly to recommend how they should be used.

Panel members have spoken of the urgent need to give people with fragile immune systems additional doses amid concerns about waning immunity and surging delta infections.
At one point, the CDC explored making additional doses possible through an FDA program that gives severely ill people access to drugs that have not yet been approved. But officials concluded that it would be more straightforward to amend the emergency use authorizations.

At last month’s meeting, CDC vaccine expert Sara Oliver said evidence is needed regarding the safety and strength of the immune response from a mixed-dose approach in immunocompromised people. She noted studies from Europe about mixed doses, including a large United Kingdom study in the general adult population, found that the response to one dose of AstraZeneca and one dose of Pfizer-BioNTech would be equivalent to two doses of AstraZeneca.


In small studies, people’s side effect from a third dose of mRNA vaccines was similar to prior doses, according to CDC.
Determining eligibility is another major issue. “How do you define immunocompromised?” Schaffner said. “And how do you make that clear to the public and the medical professions and how do you implement it in practice?”
To date, however, oversight of the shots has been minimal. Some people who have sought and gotten extra does say they have not been asked whether they are already vaccinated. Others who already gotten vaccinated have told providers they wanted their first shots and gone unchallenged.
“Basically we have an honor system,” an official said. “But that’s okay. This isn’t fentanyl.”

"
 
I’m finding this website very helpful..I want to know the risk in different counties…My county is moderate..but all of the surrounding counties are substantial. I’m staying closer to home….My husband is working in a substantial risk area..so that‘s worrisome..

 
FYI I am having covid like symptoms and have for the last 3 days. Early this morning I woke up with wicked cough. did not contact the research center until today. I have an appt to get covid tested on monday, so I'll know probably tuesday/wednesday.

As y'all know, I mask everywhere, I wash hands, etc. I'm vaccinated. However, my other half who I love dearly, and who happens to be vaccinated, is not as careful as I am. he goes out to dinner with friends and colleagues. he still has in person meetings with people and he still volunteers with military personnel.

The problem is, either of us could have been in contact with someone with covid and brought it into the home. I have not yet lost sense of smell but its diminished. I have heavy cough, chest pain, diarrhea, tiredness, headache, stuffy/runny nose. feels more like a heavy ass cold.

But because I'm asthmatic, I can't take too many chances. Plus, with these types of symptoms this is why you get tested.

Lets hope its nothing more than a funky cold. He's not having symptoms aside from a runny nose and a cough.
 
@Arcadian , I’m sorry you are sick. Are their Covid test sites you can just drive up to In Florida that give quick results. The only reason I ask is I think the sooner you find out the better. This really could be just a normal bug that we all get from time to time and nothing to be concerned with. Can you also call your doctor and ask what they recommend you doing now for your symptoms. Sending lots of healing dust and prayers your way.

I had a covid test yesterday at the hospital and I knew the results within a half hour.
 
@Arcadian so sorry to hear that you are not feeling well. If you would feel better knowing sooner, rather than later, could you get to somewhere like a CVS where they have drive through testing? I believe where I am it's not the rapid test but you do get the results within 24-48 hours.
 
Today/tomorrow, nothing in my vicinity for 20+ miles is available for testing. The first thing I did was look at the drugstores to see what was available....nada today. I'm near 10 of them! The ones closest to me won't have appts until Thursday. If I drive further out 30+ miles I'm still looking at Monday.

They've even reopened up the big gov testing centers here. no appts available for any of them on the weekends.

If I get any worse, like if I end up with a fever, and/or can't breathe, I'm to go to a hospital and have someone call them. The hospitals will do it if you're part of a study down here, but normally they want you to have a fever before they actually test you. I keep my study info in my handbag on a card as a JIC.

To take the edge off I'm trying to put together this cabinet from Ikea.... :oops2: :oops2::lol:
 
@Arcadian, It's terribly distressing to hear this has happened to you and all my digits are crossed that you recover quickly and with no lasting effects. Ikea cabinet assembling is not good for one's blood pressure.
 
@Arcadian, Please keep us posted on how you are doing if you are able to. You have a lot of people here who genuinely care about you.
 
The problem is, either of us could have been in contact with someone with covid and brought it into the home. I have not yet lost sense of smell but its diminished. I have heavy cough, chest pain, diarrhea, tiredness, headache, stuffy/runny nose. feels more like a heavy ass cold.
Hope it is a common cold. No fever is good news. Take care.
 
Warm wishes for a speedy recovery @Arcadian
 
@Arcadian I’m sorry you don’t feel well..I hope it’s just an innocent bug. My daughter-in-law had a Covid test today. She has a horrible sore throat with fever and congestion. It came back negative. She will get a strep test later today. There’s lots of stuff floating around now besides Covid..Fingers and toes crossed. I hope you feel better soon..
 
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@Arcadian I’m sorry you don’t feel well..hope it’s just an no innocent bug.My daughter-in-law had a Covid test today. She has a horrible sore throat with fever and congestion. It came back negative. She will get a strep test later today. There’s lots of stuff floating around now besides Covid..Fingers and toes crossed. I hope you feel better soon..

Indeed. Sad that we have to be hopeful for a freaking cold. But I don't want no 'Rona.

Hopeful that your DIL feels better soon!
 
Fingers crossed for you @Arcadian !

Could you get some at-home tests sonyiu could have an indicator while you wait for the official test?

They are around 5€ where I live and are supposed to be pretty accurate once one has symptoms.
 
@Arcadian I hope you start feeling much better very soon and that it is not Covid.:pray:

@MamaBee hope your DIL also starts feeling much better soon.
 
Very interesting.

"
Find it. Kill it. This is the simple premise behind new biomaterial-based vaccines that experts are designing to fend off future pathogens, or germs that could threaten human health.
As they plan next-generation vaccines, scientists are banking on the idea that the structure of a future pandemic-scale pathogen will be like the ones they already know about.
The new class of vaccines are being developed to supercharge the immune system to help the body quickly respond to a range of pathogens.
The new biomaterial-based vaccines are also shelf-stable, meaning they wouldn’t have to be refrigerated like some the COVID-19 shots. This is encouraging news for faster vaccine rollouts, and it will help poorer countries that lack refrigeration for supplies.

New biomaterial vaccines tap into the body's natural immune response, explains Michael Super, PhD, from the Wyss Institute at Harvard University in Boston, who is first author on a new study exploring what the vaccines can do.
Previous research has shown that scientists can create a depository under the skin that acts like a protective lymph node, or a small bean-shaped structure that works as part of the body's immune system to help fight infection and disease.

Supercharging the Immune System

This opens the possibility that a biomaterial, such as silica, an important trace mineral already in connective tissues of the body, could be used to inject a pathogen to help the body produce antibodies to it and support how the immune system rallies, explains Super.


"We recruit the immune system to that site, and then the dendritic cells pick up the antigen you put in that biomaterial," he says. "That creates a danger signal that activates those dendritic cells in a very natural manner. The immune system doesn't overproduce, but it does respond, and we've found that it responds very quickly. We are essentially recapturing what the immune system normally does."



As cells mature at the deposit site, they learn what signals to send to the rest of the immune system so that it responds to the pathogen targeted by the vaccine. Those cells then travel through the body, stimulating other immune-responsive cells.
In their study, Super and his research team took this process a step further and used their biomaterial vaccine to introduce live attenuated pathogens into the body. This process kept the pathogen viable, but harmless.
This process is different from the recombinant spike protein vaccines used for COVID-19 that use genetically engineered agents to produce antibodies that target the coronavirus.

"We found we could take live pathogens and kill them with an antibiotic or something else and use that directly as part of the vaccine of our choice," says Super. "You don't have to do that complex manufacturing; you can simply take it, capture it, kill it, and mix it with the biomaterial and inject or implant it. We've seen that you've then got these native antigens to fight the pathogen."

The team used this process to target a form of E. coli, a type of bacteria that’s scientifically known as Escherichia coli that is particularly dangerous in livestock. They infected a pig and then gave it an antibiotic to kill the infection. They extracted that dead bacteria from the pig's blood and combined it with a biomaterial, in this case mesoporous silica, to create a vaccine.

After they gave this vaccine to mice, they exposed the mice to a different strain of E. coli, and the mice fought off the infection.

"It's not just the pig-to-mouse aspect that is exciting, it's that we were able to protect against a lethal challenge from a different strain," Super says. Results were similar when they tested the vaccine on mice infected with Staphylococcus aureus, he says.

Most of this study, which focused on immune responses to bacteria, was completed before the COVID-19 pandemic started. But the researchers say the work has important implications for preparing for future pandemics.

Stockpiling for Future Threats

"One of the problems is that, very often, you don't know what the pathogen is that you're dealing with, especially in the case of a biothreat," Super points out. But "we believe the structure of a microbial pathogen will be similar to the native, normal pathogens we already know about."

If that holds true — and the research suggests it will — then a vaccine for a little-studied pathogen could be created using pathogens that target structurally similar but well-studied bacteria.

Biomaterials can be made in bulk at low cost and dried for future use.

"We see this as something that could be made and stored and ready to use whenever it is needed," Super explains.


SOURCES:

Nature Biomedical Engineering: "Biomaterial vaccines capturing pathogen-associated molecular patterns protect against bacterial infections and septic shock."

Michael Super, PhD, lead senior staff scientist, Wyss Institute, Harvard University, Boston.


"
 
Very interesting.

"
Find it. Kill it. This is the simple premise behind new biomaterial-based vaccines that experts are designing to fend off future pathogens, or germs that could threaten human health.
As they plan next-generation vaccines, scientists are banking on the idea that the structure of a future pandemic-scale pathogen will be like the ones they already know about.
The new class of vaccines are being developed to supercharge the immune system to help the body quickly respond to a range of pathogens.
The new biomaterial-based vaccines are also shelf-stable, meaning they wouldn’t have to be refrigerated like some the COVID-19 shots. This is encouraging news for faster vaccine rollouts, and it will help poorer countries that lack refrigeration for supplies.

New biomaterial vaccines tap into the body's natural immune response, explains Michael Super, PhD, from the Wyss Institute at Harvard University in Boston, who is first author on a new study exploring what the vaccines can do.
Previous research has shown that scientists can create a depository under the skin that acts like a protective lymph node, or a small bean-shaped structure that works as part of the body's immune system to help fight infection and disease.

Supercharging the Immune System

This opens the possibility that a biomaterial, such as silica, an important trace mineral already in connective tissues of the body, could be used to inject a pathogen to help the body produce antibodies to it and support how the immune system rallies, explains Super.


"We recruit the immune system to that site, and then the dendritic cells pick up the antigen you put in that biomaterial," he says. "That creates a danger signal that activates those dendritic cells in a very natural manner. The immune system doesn't overproduce, but it does respond, and we've found that it responds very quickly. We are essentially recapturing what the immune system normally does."



As cells mature at the deposit site, they learn what signals to send to the rest of the immune system so that it responds to the pathogen targeted by the vaccine. Those cells then travel through the body, stimulating other immune-responsive cells.
In their study, Super and his research team took this process a step further and used their biomaterial vaccine to introduce live attenuated pathogens into the body. This process kept the pathogen viable, but harmless.
This process is different from the recombinant spike protein vaccines used for COVID-19 that use genetically engineered agents to produce antibodies that target the coronavirus.

"We found we could take live pathogens and kill them with an antibiotic or something else and use that directly as part of the vaccine of our choice," says Super. "You don't have to do that complex manufacturing; you can simply take it, capture it, kill it, and mix it with the biomaterial and inject or implant it. We've seen that you've then got these native antigens to fight the pathogen."

The team used this process to target a form of E. coli, a type of bacteria that’s scientifically known as Escherichia coli that is particularly dangerous in livestock. They infected a pig and then gave it an antibiotic to kill the infection. They extracted that dead bacteria from the pig's blood and combined it with a biomaterial, in this case mesoporous silica, to create a vaccine.

After they gave this vaccine to mice, they exposed the mice to a different strain of E. coli, and the mice fought off the infection.

"It's not just the pig-to-mouse aspect that is exciting, it's that we were able to protect against a lethal challenge from a different strain," Super says. Results were similar when they tested the vaccine on mice infected with Staphylococcus aureus, he says.

Most of this study, which focused on immune responses to bacteria, was completed before the COVID-19 pandemic started. But the researchers say the work has important implications for preparing for future pandemics.


Stockpiling for Future Threats

"One of the problems is that, very often, you don't know what the pathogen is that you're dealing with, especially in the case of a biothreat," Super points out. But "we believe the structure of a microbial pathogen will be similar to the native, normal pathogens we already know about."

If that holds true — and the research suggests it will — then a vaccine for a little-studied pathogen could be created using pathogens that target structurally similar but well-studied bacteria.

Biomaterials can be made in bulk at low cost and dried for future use.

"We see this as something that could be made and stored and ready to use whenever it is needed," Super explains.


SOURCES:

Nature Biomedical Engineering: "Biomaterial vaccines capturing pathogen-associated molecular patterns protect against bacterial infections and septic shock."

Michael Super, PhD, lead senior staff scientist, Wyss Institute, Harvard University, Boston.


"

I'll be watching this with great interest. It's akin to homeopathy, but with actual science and no woo!

@Arcadian and @MamaBee I'm sending all the get better vibes!
 
Indeed. Sad that we have to be hopeful for a freaking cold. But I don't want no 'Rona.

Hopeful that your DIL feels better soon!

Thanks @Arcadian We’ll hope you have a bad cold! My daughter-in-law just had her strep test..negative! I’m hoping the same for you!
 
I ordered Pho from my favorite place. I didn't eat it all but it did hit the spot.

Also Lot of school districts in FL have mask "mandates" good for them. Latest is my county.

The governor has threatened to take money away from school districts that mandate masks. Considering the CDC guidelines as they currently stand its going to be hard to do. And mainly counties that are doing this have the money to fight. This shit is serious and its killing the unvaccinated. There's a lot of unvaccinated kids down here.
I hope they don't back down.

 
I don't understand how the "opt out" option for parents works for the kids whose parents want them to be wearing masks to be safe. I guess the kids wearing masks will be somewhat safer than those that don't, but they'd all be safer if it was a mandate. I just don't get it.
 
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