Category: Corona Virus Vaccine

Minnesota is one of only five states where COVID-19 isn't measurably increasing right now, but it might only be a matter of time, because Independence Day has been a flash point for viral activity over the last four years.

Family gatherings and holiday celebrations present opportunities for the spread of the coronavirus that causes COVID-19, especially the latest variants that can overcome immunity levels in people with prior infections and vaccinations, said Stephanie Meyer, a supervisor for the COVID epidemiology section at the Minnesota Department of Health.

People who are sick should err on the side of caution and avoid close contact with others, even if they're unsure whether their symptoms are from COVID or common colds or the high grass pollen levels that triggered allergies this week, she said.

"If you're thinking about visiting your grandma in the nursing home, or someone who is immunocompromised, it's a good idea to stay away if you're not feeling 100%," she said, "because that's how outbreaks happen. That is how people transmit disease to people who can't fight it off."

COVID risks are nowhere near what they were during the three years of the global pandemic. Viral levels detected in Minnesota wastewater in late June were slightly higher than they were at this time last year, but they were one-tenth of the viral levels found during the last significant wave of illnesses in February 2023.

Even so, more than 330 Minnesotans with COVID were admitted to hospitals in June, when the infectious disease was linked to at least 16 deaths, mostly in seniors, according to a state update on Wednesday. COVID in the post-pandemic era has remained more severe than influenza. The state reported 165 flu-related deaths from October through mid-May compared with 957 COVID deaths in the same time frame.

COVID levels bottomed out in late June in three of the last four years, but levels increased sharply after Independence Day in 2020 and 2021 and rose gradually after the 2023 holiday.

Holiday gatherings aren't the only explanation, though, especially considering that many occur outdoors where viral transmission risks are lower, Meyer said. COVID cases have historically peaked each winter, and immunity following infection seems to fade in six months, she noted. That leaves people vulnerable once again by midsummer.

Meyer said she expects more infections in the coming weeks, following the case growth reported by the Centers for Disease Control and Prevention in 44 other states. Saliva samples from infected patients in Minnesota are finding more of the so-called FLiRT coronavirus variants that already have been causing problems in southern and western U.S. states.

The CDC in late June encouraged people to seek existing vaccines, which were made to confront other variants but still appear effective at reducing infection-related hospitalizations and deaths from the latest variants. New vaccines are expected in the fall. More than 780,000 Minnesotans are up to date on COVID vaccine recommendations, but that represents only 14% of the eligible population.

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COVID on the rise everywhere else is Minnesota next? - Star Tribune

LB.1 is the latest COVID-19 subvariant to make headlines as it circulates in the United States. The highly contagious strain, which emerged shortly after the "FLiRT" variants, including KP.3 and KP.2, is causing an increasing proportion of infections.

As the U.S. sees an uptick in cases and emergency room visits around the country, some are concerned about a summer wave.

LB.1 is the third-leading COVID-19 variant in the U.S. right now, trailing close behind the dominant KP.3 and KP.2, according to the latest data from the U.S. Centers for Disease Control and Prevention.

As of June 22, KP.3 accounts for an estimated 33% of cases in the U.S. The next most common variant is KP.2, which makes up about 21% of cases, followed by LB.1, which is driving 17.5% of cases.

Since the end of May, the share of cases caused by LB.1 has more than doubled, per CDC data. According to some experts, this new mutated variant may be on track to surpass the FLiRT variants in the coming weeks.

While overall COVID-19 numbers, including hospitalizations and deaths, are relatively low compared to the winter, its clear that the virus is on the rise. Is the country facing a summer surge?

Here's what we know about summer COVID-19 trends and the new LB.1 variant so far.

In recent weeks, cases have been on the rise in most U.S. states, especially in the West. The CDC estimates that as of June 25, COVID-19 cases are growing or likely growing in 44 states, stable or uncertain in 5 states, and declining in one state, Hawaii.

As of now (early July), were not seeing any major nationwide surge in cases, but cases are moving up in some places and steady in others, Andrew Pekosz, Ph.D., virologist at Johns Hopkins University, tells TODAY.com. The country is likely in the beginning of a wave, Pekosz adds, but its still too early to tell how summer COVID-19 trends will unfold.

Test positivity was at 8% as of June 22,per the CDC, up 1.4% from the previous week but lower than a peak of 12% in the winter. A CDC map shows that test positivity is highest in California and the Southwest U.S.

Viral activity in wastewater is low" nationally, whereas it was "high" or "very high" for most of the winter. (The CDC no longer tracks the total number of new COVID-19 cases in the U.S.)

According to Dr. William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center, what were seeing now is more of an expected "bump." Unlike influenza, COVID-19 is not seasonal and continues to spread in the summer, but these bumps are far less substantial than winter surges, Schaffner adds.

As summer vacation travel peaks and people increasingly gather indoors in the air conditioning to escape heat waves, COVID-19 is expected to keep rising. If it hasnt bumped in your community yet, it probably will after all the July Fourth travel, says Schaffner.

LB.1 is part of the omicron family the newest great grandchild, so to speak, says Schaffner. The LB.1 subvariant is an offshoot of JN.1, which was dominant for most of the winter and spring.

"LB.1 is closely related to the FLiRT variants, but it has a couple of unique mutations in different parts of the spike protein," says Pekosz. These include key mutations that affect LB.1's ability to evade immunity.

"Weve seen mutations like this before with other variants (including JN.1). ... They dont seem to be particularly concerning or a sign that the virus has changed drastically," Pekosz adds.

The emergence of LB.1 continues an ongoing trend, the experts note. The SARS-CoV-2 virus mutates and gives rise to new variants, which are better able to escape immunity and outcompete other strains until a new one emerges.

More than 97% of people in the U.S. have natural or vaccine-induced antibodies against COVID-19, but this fades over time, per the CDC.

A characteristic of omicron subvariants is that they are very transmissible. "LB.1 highly contagious, and it is spreading very readily," says Schaffner.

How does LB.1 compare to other new strains? "It's too soon to tell, but so far, there is no signal that it is more transmissible than the FLiRT variants," Dr. BernardCamins, medical director of infection prevention at Mount Sinai Health System, tells TODAY.com.

"It may be more likely to escape immunity gained from infection or the vaccine, but it hasn't shown that it's more dangerous than previous subvariants," says Camins.

The recent increase in cases appears to be driven by a combination of new variants, including LB.1 and the FLiRT strains. However, decreases in testing and genomic surveillance make it challenging to accurately track the virus. Its becoming harder for us to get a good sense of how quickly a variant is increasing, says Pekosz.

LB.1 does not seem to be causing any distinct or new symptoms and there is no indication that it produces more severe disease, the experts emphasize.

The symptoms of LB.1 are very similar to those caused by the FLiRT variants, which include:

The newer strains appear to be producing generally milder infections, says Schaffner.

"Some people can still experience severe symptoms, enough to hospitalize them," says Camins namely, high risk groups: people age 65 and older, people with underlying medical conditions, and individuals who are immunocompromised.

Emergency room visits have increased by 23% in the past week, but are still relatively low, and hospitalization rates remain at a steady level, per the CDC.

Antivirals such as Paxlovid are effective against LB.1 and other recent strains, Schaffner notes.

"The current vaccine will offer protection against severe disease," says Schaffner. Right now, the updated 20232024 COVID-19 booster targeting the XXB.1.5 strain is still available. The CDC recommends high-risk groups get an additional dose.

The updated 20242025 vaccine to be released this fall is also expected to offer protection, the experts emphasize. "LB.1 is closely related to KP.2, which looks like itll be the strain targeted in the vaccine for this coming fall season," says Pekosz.

"Previous data show that even if the vaccine doesn't exactly match what's circulating, there is cross-reactivity that gives you some protection," says Camins.

The experts encourage everyone who is eligible to get an updated 20242025 COVID-19 vaccine this fall.

If you develop COVID-19 symptoms or have an exposure, get tested, the experts emphasize. Testing is an important tool to protect yourself and prevent the spread of the virus.

PCR and antigen tests will detect LB.1 and other new variants, Camins notes. If you use an antigen test, follow FDA recommendations to avoid a false negative result.

The CDC recommends people who test positive stay home while sick and avoid contact with others. According to the current isolation guidelines, people can return to normal activities only after they have been fever-free (without medication) and symptoms have been improving for at least 24 hours.

"If you're in a high-risk group and you test positive for COVID-19, we would give you Paxlovid to prevent severe illness," says Schaffner.

As COVID-19 cases keep rising this summer, consider taking additional steps to protect yourself and others. The CDC recommends people:

Caroline Kee is a health reporter at TODAY based in New York City.

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LB.1 COVID Variant: What to Know About Symptoms and Transmission - TODAY

Summary

What CDC knows

In the United States, respiratory virus illnesses typically peak during the fall and winter. These peaks are due to several factors, including human behaviors and environmental conditions that can affect the ability of viruses to survive and spread.

Since the start of the COVID-19 pandemic, infections with SARS-CoV-2, the virus that causes COVID-19, have peaked during the winter and also surged at other times of the year. These periodic surges are due in part to the emergence of new variants and decreasing immunity from previous infections and vaccinations. Because the evolution of new variants remains unpredictable, SARS-CoV-2 is not a typical winter respiratory virus.

What CDC is doing

CDC continues to monitor seasonal trends of COVID-19 and the factors driving these trends, including the emergence of new variants, and to collaborate with state and local health departments, commercial laboratories, and global partners. On June 27, the Advisory Committee on Immunization Practices (ACIP), an independent advisory group to CDC, recommended that persons 6 months of age receive the 20242025 COVID-19 vaccines when they become available this fall.

Many respiratory viruses have increased circulation during the winter. Factors that drive these seasonal patterns fall into a few broad categories:

COVID-19 activity tends to fluctuate with the seasons, meaning it has some seasonal patterns. Data from four years of COVID-19 cases, hospitalizations, and deaths show that COVID-19 has winter peaks (most recently in late December 2023 and early January 2024), but also summer peaks (most recently in July and August of 2023). There is no distinct COVID-19 season like there is for influenza (flu) and respiratory syncytial virus (RSV). While flu and RSV have a generally defined fall/winter seasonality and circulate at low levels in most parts of the United States in the summer, meaningful COVID-19 activity occurs at other times of the year.

Understanding when COVID-19 tends to peak helps to better tailor public health prevention strategies and recommendations, prepare our healthcare system, and allocate resources. That's especially important because the winter peak tends to overlap with those for flu, RSV, and many other viruses. Getting an updated COVID-19 vaccine in the fall can help better protect you through the winter peak. People who might benefit from additional doses of COVID-19 vaccine this summerinclude those who are:

CDC's Advisory Committee on Immunization Practices (ACIP) met on June 27 and recommended that persons 6 months of age receive the 20242025 COVID-19 vaccines when they become available this fall. The U.S. Food and Drug Administration recently selected strains for the vaccine based on currently circulating variants.

The emergence of new SARS-CoV-2 variants has been associated with COVID-19 surges, including an increase in the magnitude of winter peaks and additional peaks at other times of the year. Peaks in COVID-19 activity often, but not exclusively, occur in winter (blue bar in chart, below) and in summer (pink bar in chart). New variants, such as Delta and Omicron, contributed to several peaks.

Although the future pace of SARS-CoV-2 evolution is unpredictable, surges outside the winter season will likely continue as long as new variants emerge and immunity from previous infections and vaccinations decreases over time.

CDC continues to track the emergence of new variants through genomic sequencing, in collaboration with state and local health departments, commercial laboratories, and global partners. CDC also continues to monitor trends in COVID-19 to inform vaccine recommendations, and to publish weekly data so that the public can make informed decisions regarding their individual risk throughout the year.

This past winter, COVID-19 peaked in early January, declined rapidly in February and March, and by May 2024 was lower than at any point since March 2020. Over the past few weeks, some surveillance systems have shown small national increases in COVID-19; widespread as well as local surges are possible over the summer months. Although COVID-19 is not the threat it once was, it is still associated with thousands of hospitalizations and hundreds of deaths each week in the United States, and can lead to Long COVID.

During the summer and throughout the year, you can use many effective tools to prevent spreading COVID-19 or becoming seriously ill. CDCs Respiratory Virus Guidance provides recommendations and information that can help people lower their risk from many common respiratory viral illnesses. These actions can help protect yourself and others from health risks caused by these viruses.

COVID-19 is here to stay, but taking simple actions will help protect you and your loved ones from infection and serious illness.

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COVID-19 can surge throughout the year | NCIRD - CDC

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COVID-19 and flu vaccines are recommended by CDC amid uptick in cases - IndyStar

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A Johns Hopkins Medicine study finds booster doses of bivalent mRNA COVID-19 vaccines given every three to six months helps maintain a persons ability to neutralize multiple SARS-CoV-2 strains, including XBB.1.5.

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FOR IMMEDIATE RELEASE

People who have received solid organ transplants and take immunosuppressant medications to prevent rejection are among those most susceptible to the damaging effects of COVID-19, including breakthrough infections, severe illness, hospitalization and death. Particularly dangerous for them has been the XBB.1.5 subvariant of the omicron strain of SARS-CoV-2, the virus that causes COVID-19. Thats because XBB.1.5 possesses a genetic mutation that enables it to more effectively bind with cells it attacks, and therefore, make it more transmissible than earlier SARS-CoV-2 strains.

In a study published today in the journal Clinical Infectious Diseases, a Johns Hopkins Medicine research team reports that for XBB.1.5, there is good news for solid organ transplant recipients (SOTRs) and other immunocompromised people who receive regular booster doses of a messenger RNA (mRNA) bivalent vaccine (a vaccine designed to enhance immunity to a variety of SARS-CoV-2 strains).

We found that a SOTRs ability to neutralize XBB.1.5 wanes at about three months following the first bivalent booster shot, but improves with a second booster to about the previous level, says study senior author Andrew Karaba, M.D., Ph.D., assistant professor of medicine at the Johns Hopkins University School of Medicine and an infectious diseases expert with the Johns Hopkins Transplant Research Center. This indicates that repeated boosting within six months may play a role in reducing infections, particularly among populations at highest risk, such as SOTRs.

Bivalent mRNA vaccines, such as the ones used in this study, introduce the bodys immune system to spike proteins found in different strains of SARS-CoV-2. Found on the surface of the virus, the spike protein enables the virus to latch onto healthy cells and infect them. Antibodies, produced by the immune system in response to spike proteins in a bivalent vaccine, neutralize the virus particles. This, in turn, prevents infection or, at least, reduces the severity of the disease.

Previous studies have shown that for immunocompromised populations such as SOTRs taking immunosuppressant medications to lower the risk of organ rejection a single bivalent vaccine boosted virus neutralization, but the duration of that boost was unknown, says study co-author William Werbel, M.D., Ph.D., also an assistant professor of medicine at the Johns Hopkins University School of Medicine and an infectious diseases expert with the Johns Hopkins Transplant Research Center. What we wanted to learn was how long the boost lasted and if a second booster would build that immunity back up.

The researchers studied 76 SOTRs who had received a minimum of three doses of a primary monovalent (active against just the original SARS-CoV-2 strain) mRNA vaccine, reported receiving either one or two bivalent mRNA vaccine boosters (containing both the original strain and the omicron BA.5 variant), and provided two or more blood samples that were obtained pre- and post-bivalent booster in one of three groups: 59 paired samples taken before and after the first booster, 31 paired samples taken before and after the second booster, and 14 paired samples taken before and after both boosters.

The study participants were generally middle age, more than five years post-transplant, and were kidney and/or liver transplant recipients. Fourteen had evidence of COVID-19 before the first booster, while 16 developed COVID-19 between the first booster and one month past the second.

The researchers found that the amount of circulating antibody and, in turn, virus neutralization, significantly increased by one month after the first bivalent booster for both the BA.5 and XBB.1.5 strains of SARS-CoV-2. However, this dropped sharply to nearly the pre-booster levels at three months, and even more so at six months.

Following a second bivalent booster, many SOTRs regained the ability to neutralize both virus strains; yet 42% did not have any detectable immunity to XBB.1.5. The researchers found that those SOTRs were more likely to be receiving corticosteroids as part of a three-drug immunosuppression regimen. They also discovered that, at nearly all times post-vaccinations (monovalent plus bivalent boosters), SOTRs with no prior SARS-CoV-2 infection showed poor XBB.1.5 neutralization, and at levels far below those who had hybrid (infection and vaccination) immunity.

Our findings indicate that repeat boosting with omicron-containing vaccines may improve protection against COVID-19 among SOTRs, but more frequent boosting every three to six months appears necessary to maintain neutralizing ability against the more recent omicron subvariants, such as BA.5 and XBB.1.5, says Karaba. We believe this is especially important for SOTRs and other immunocompromised groups, and particularly for those who do not have hybrid immunity.

Werbel adds that this practice is already showing benefit for another population at higher risk of SARS-CoV-2 infection, people age 65 or older.

Our recommendation for immunocompromised groups is concordant with recent guidelines from the U.S. Centers for Disease Control and Prevention stating that people in this age group should get an additional updated vaccine at four months or longer from their last dose, he says.

Along with Karaba and Werbel, the members of the study team from Johns Hopkins Medicine are Aura Abedon, Jennifer Alejo, Andrea Cox, Yolanda Eby, Snigdha Panda and Aaron Tobian, and study lead authors Camille Hage and Scott Johnston. The team also includes former Johns Hopkins Medicine transplant surgeon Dorry Segev, now with the NYU Grossman School of Medicine.

The work was supported by National Institute of Diabetes and Digestive and Kidney Diseases grant 5T32DK007713; National Institute of Allergy and Infectious Diseases grants K24AI144954, U01AI138897, 3U01AI138897, K08AI156021 and K23AI157893; the Ben-Dov family and the Trokhan Patterson family.

Werbel has received consulting and/or speaking fees from AstraZeneca, GlobalData, the China Medical Tribune and the Medical Learning Institute, and advisory board fees from AstraZeneca and Novavax. Karaba has received consulting fees from Hologic Inc. and speaking fees from PRIME Education. Segev reports receiving consulting and/or speaking honoraria from Sanofi, Novartis, Veloxis, Mallinckrodt, Jazz Pharmaceuticals, CSL Behring, Thermo Fisher Scientific, Caredx, Transmedics, Kamada, MediGO, Regeneron, AstraZeneca, Takeda/Shire, Novavax and Bridge to Life.

The other study authors do not have financial or conflict-of-interest disclosures.

Clinical Infectious Diseases

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Study suggests regular vaccine boosts may help people who are immunocompromised fight Covid-19 - EurekAlert

ED Visits for Heat Illness Spike

The CDC has reported an unusually high number of heat-related illnesses across the US, even in areas that aren't accustomed to extreme heat, according to CNN Health. This is mainly due to a lack of air conditioning in homes and bodies unable to handle high temperatures. As a results, physicians are seeing a rise in heat exhaustion and heat stroke cases, especially among outdoor workers, older adults without air conditioning, and people with underlying health conditions. Climate change is increasing the frequency and intensity of heat waves, making it a serious public health threat that Americans are still learning to deal with. The CDC has a new heat risk tool that allows people to see a heat forecast and safety recommendations for their area.

The CDC is recommending that individuals 6 months or older receive an updated COVID-19 vaccine for the 2024-2025 immunization campaign, regardless if they were previously vaccinated, according to Reuters. This recommendation will take effect as soon as new vaccines from Moderna, Novavax, and Pfizer are available later this year. The FDA requested the vaccine manufacturers update the shots to attack the KP.2 variant rather than the JN.1 lineage. Moderna and Novavax submitted their applications to the FDA for updating the fall 2024 season shots targeting the JN.1 strain, and Novavax says it is planning to update the vaccine once the season begins and the FDA officially authorizes the decision. Earlier this year, the US had an estimated 4.4% of JN.1 variant cases, dominating over a 2 week period, ending June 22. Recently, however, the KP.3 strain has become the most dominant strain in the US (33.1%) followed by the KP.2 strain (20.8%). Pfizer advises that is is hosting global discussions with regulators, especially the FDA, to discuss the future of its COVID-19 vaccine formulas, Pfizer and BioNTech assure they will be ready to supply their updated vaccines upon arrival, and Moderna says it will be ready with its updated shot in time for the fall vaccination season.

According to NBC News, US health officials are arguing for a stronger endorsement for the respiratory syncytial virus (RSV) vaccine for people aged 75 or older, with a more narrow recommendation for people aged 60 to 74 years. In 2023, the same advisory group suggested people aged 60 or older should speak with their doctors about whether they should receive the shot. Physicians have commented that the lenient recommendations can be confusing to patients, and is potentially why less than 25% of older Americans have received the shot. Also during this time, vaccine advisors turned away from recommending older adults receive the shots based on questions about potential adverse effects and the duration of protection. Panel members declined the request by vaccine manufacturers to enforce stricter shot recommendations for all Americans aged 60 or older. These patients are considered at high risk of severe illness if they have chronic heart disease, advanced-stage kidney disease, chronic lung illnesses, severe obesity, live in nursing homes, and are classified as frail.

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What We're Reading: Heat-Related Illness Spike; CDC Updates COVID-19 Vaccine Recommendations; New RSV ... - AJMC.com Managed Markets Network

News Release

Monday, July 1, 2024

Candidate vaccine could provide enhanced breadth of protection against emerging SARS-CoV-2 variants.

A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIHs National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.

The rapid development of safe and effective COVID-19 vaccines was a triumph of science, and their use greatly mitigated the toll of the pandemic, said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease. With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission.

The study aims to enroll 60 adult participants, ages 18 to 64 years old, who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine. The trial sites are Baylor College of Medicine, Houston; The Hope Clinic of Emory University, Decatur, Georgia; and New York University, Long Island. Hana M. El Sahly, M.D., at the Baylor College of Medicine Vaccine Research Center, is leading the study.

Study volunteers will be divided into three cohorts. Those in the first cohort will receive one dose of the investigational vaccine delivered in a nasal spray at the lowest dosage, with enrollees in the next two cohorts receiving progressively higher doses. During seven follow-up visits over about one year, scientists will measure how well the vaccine candidate is tolerated, and if it generates an immune response in the blood and in the nose.

The investigational vaccine, MPV/S-2P, uses murine pneumonia virus (MPV) as a vector to deliver a version of the SARS-CoV-2 spike protein (S-2P) stabilized in its prefusion conformation. MPV does not cause disease in humans or non-human primates but does have an affinity for epithelial cells that line the respiratory tract and may be effective in delivering vaccine to the places where natural coronavirus infections begin.

In pre-clinical non-human primate studies, MPV/S-2P was safe and well tolerated. It produced robust systemic immune responses, including SARS-CoV-2-directed antibodies, as well as local immunity in cells in the mucosal tissues lining the nose and respiratory tract. Studies in humans and animals suggest that mucosal immunity is more effective than systemic immunity in controlling replication of respiratory viruses.

This is the first NIAID clinical trial to be conducted as part of the U.S. Department of Health and Human Services (HHS) Project NextGen. Led by the Biomedical Advanced Research and Development Authority, part of the HHS Administration for Strategic Preparedness and Response, and NIAID, Project NextGen is a coordinated effort between the federal government and the private sector to broaden the pipeline of new, innovative vaccines and therapeutics. Through Project NextGen, NIAID plans to facilitate clinical development of promising next-generation COVID-19 vaccines in Phase 1 and 2 trials.

More information about the trial is available at clinicaltrials.gov using the identifier NCT06441968.

NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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NIH-sponsored trial of nasal COVID-19 vaccine opens - nih.gov

Older people and those who are immunocompromised are strongly encouraged to get their updated COVID-19 and flu vaccines when they come out this fall. Getty Images.

Federal health experts have authorized a new 2024-25 COVID-19 vaccine that they hope will reduce deaths and hospitalizations among the most vulnerable people in the country.

COVID-19 continues to sicken people and still is causing hundreds of deaths every week in the U.S. Its especially dangerous for older adults, many of whom are not up to date on their vaccines.

Thats why medical experts who advise the U.S. Centers for Disease Control and Prevention (CDC) just approved new versions of COVID-19 and flu vaccines and are urging everyone ages 6 months and older to get their annual shots this fall and winter.

The new 2024-25 COVID-19 vaccines will come out in August and September, and health experts hope a much higher percentage of Americans will decide to get an annual COVID-19 vaccine this fall and winter than did last year since vaccines protect well against hospitalization and death.

Our top recommendation for protecting yourself and your loved ones from respiratory illness is to get vaccinated, said Dr. Mandy Cohen, director of the CDC. Make a plan now for you and your family to get both updated flu and COVID vaccines this fall, ahead of the respiratory virus season.

The percentage of people who are up to date on COVID-19 vaccines is relatively low. Heres a snapshot of the data:

To learn more about the newest 2024-25 COVID-19 vaccines, we consulted with Dr. Michelle Barron, UCHealthssenior medical director of infection prevention and control.

COVID-19 is behaving a lot like the flu now. Were seeing increases in cases in the fall and winter months. The severity is usually worse in older people and those who have underlying issues with their immune systems. Thats also true for the flu, and all of these people can get very sick, said Barron, who is alsoa professorat theUniversity of Colorado School of Medicineon theAnschutz Medical Campus.

She strongly encourages older people and those who are immunocompromised to get their updated COVID-19 and flu vaccines when they come out this fall.

She also encourages parents to get their children vaccinated, and younger people can stay up to date on vaccines to protect others and avoid getting sick themselves.

These vaccines are very effective and preventing severe illness, Barron said. And who likes being sick? Not me.

Updated COVID-19 vaccines will be available from Moderna, Novavax, and Pfizer by August or September.

While the worst days of the pandemic are certainly in the rearview mirror, and most Americans have either some natural immunities or have received at least one or two doses of the COVID-19 vaccine, people continue to get sick and immunities wear off. So, people can get infected repeatedly, and some are still getting critically ill.

Heres a snapshot of how COVID-19 and flu are affecting people:

Health experts are encouraging everyone ages 6 months and older to get the new COVID-19 vaccine.

These vaccines are very effective. They keep people out of hospitals. They lessen infections and the severity of disease, Barron said. Even if youre healthy, if you have family members or people around you who are vulnerable, getting an updated vaccine is a great way of keeping them healthy too.

The newest vaccines will protect against the JN strains which are descendants of the Omicron version of the SARS-CoV-2 virus, which causes COVID-19. The newest variants that are circulating and causing infections now are known as the KP variants, and vaccine makers will try to create vaccines that also protect against KP variants.

The newest vaccines are about 40 to 50% effective, which is not perfect. But they help a great deal in protecting against hospitalization and death. Immunities do wane over time.

Due to waning effectiveness, its possible that CDC experts will recommend an additional booster shot for older adults next spring as they did earlier this year.

CDC experts recommend flu shots for everyone ages 6 months or older. There are rare exceptions.

When youre deciding which vaccines you or family members need, its best to consult with your doctor so you can stay up to date on immunizations and avoid getting sick, Barron said.

Yes, its safe to get both your COVID-19 and your flu shots at the same time. In fact, medical experts recommend getting the two vaccines together since thats most convenient for people.

And Barron says vaccine makers are currently testing combined flu and COVID-19 shots. If those prove to be effective, shes looking forward to the day when people can get a single combined annual flu/COVID-19 vaccine.

That would be very cool. Theyre working on it now. Its in clinical trials, she said.

No. The percentage of people who are up to date on COVID-19 has dropped dramatically from 2021 to this year.

The pandemic was a rough time for most people, and Barron thinks many people dont want to think about COVID-19 or dont see it as a major risk, so theyre skipping vaccines.

She strongly encourages people to get vaccinated, but of course, people have the right to make their own medical decisions.

People ages 75 and older are at the greatest risk if they get a COVID-19 infection.

And health experts want to see many, many more of these people getting their updated vaccines this fall or winter.

Dr. Oliver Brooks is the chief medical officer for Watts HealthCare Corporation in Los Angeles and is a member of the CDC advisory committee for vaccines.

During a recent meeting of the advisers, Brooks urged health experts to do more to help get all vulnerable people vaccinated, especially older Americans.

One out of 100 (people) ages 75 and older was hospitalized (due to COVID-19), Brooks said.

While older Americans are vaccinated at the highest rates, COVID-19 infections can be very dangerous for these folks, and a higher percentage of them need to get the newest vaccines.

We need them to be at 99%, Brooks said.

COVID-19 can hit older adults hard. Heres a snapshot of the newest data:

Barron said its typical for people ages 65 and older to need more protection both because older people have immune systems that are not as strong as those in younger people and many older adults get exposed to more infections.

Thats the age when grandkids start popping up, Barron said.

Newborns cannot receive COVID-19 vaccines. And babies cant be vaccinated until theyre older than 6 months. The best way to protect newborns is for moms to get vaccinated during pregnancy. Immunities to COVID-19 and other illnesses also can pass through the breastmilk from mom to baby.

Barron encourages everyone to get their vaccines in the fall or early winter.

During past respiratory virus seasons, COVID-19 infections have peaked in the period from January through March. But its very difficult to time a vaccine perfectly. So, Barron advises people to be practical.

Im a big fan of convenience, Barron said. If youre already at your doctors office in mid-November, go ahead and get your flu and COVID-19 vaccines.

She advises people not to overthink the timing. Just get it done.

Everyones busy. Minimize the number of times you need to go see your doctor, Barron said.

Please discuss vaccines with your doctor. People who are immunocompromised may need extra doses. Your doctor may give one dose early and another three to six months later. The timing will depend on what medications people are on, Barron said.

Earlier this year, CDC experts also recommended extra doses of the 2023-24 vaccine for older people because the new variants that were circulating made it less effective. That could happen next spring. So, if people have any questions, they should check with their doctors.

Youll want to get the updated vaccine. But people who have had a recent infection can wait about three months after their illness to get the newest vaccine.

You can get your vaccine about 90 days after your last COVID-19 episode, Barron said.

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New COVID-19 vaccine aims to cut hospitalizations and deaths, especially among older Americans. Everything you ... - UCHealth Today

COVID-19 cases and hospitalizations in El Paso County are on the rise after hitting a low in the spring.

According toEl Paso County Public Health's co-medical director Dr. Bernadette Albanese, COVID cases and hospitalizations decreased throughout March and April after a typical winter season. Around mid-May, numbers started to go back up.

While El Paso County is not seeing as significant of an increase as it did from November to January, the increase is steady.

In January, 120 hospitalizations were reported in El Paso County. February saw 94. A significant decrease happened in March with 39 hospitalization reported. April jumped slightly to 41 and May saw 51. Albanese told The Gazette that it is too soon to tell what those numbers look like for June in El Paso County.

"There's no reason to think that our county would be any different than the combined observations that we are seeing around the state and around the country," Albanese said. "Every region of the country has seen an increase up upwards of 10% from the week prior in test positivity."

The county's public health departmentcontinuously monitors testing for the virus in wastewater and sewer water. Several sewer sheds in Colorado Springs give samples to the state to be tested.

According to Albanese, the amount of COVID found in the water started to see an increase in the middle of May, correlating well with hospitalization numbers.

"We have multiple data points that tell us this is real," Albanese said.

The county's public health department will continue to watch the numbers through July and into August. COVID typically sees an increase during the wintertime, but unlike other seasonal illness like the flu, it also seems to bump up in the summer.

According to Albanese, this is the third summer in a row of this phenomenon.

"It's not unique to Colorado, and it's not unique around the county," Albanese said. "We are seeing a change in COVID activity across in our county, across the state and in the country."

In the state of Colorado, there were 54 deaths in February due to COVID, 36 in both March and April and 19 in May.

"Can people still die from COVID? The answer is yes," Albanese said.

The main strain of COVID continues to be the omicron variant, according to the public health department. Despite subtle difference, most of the variants going around are still falling under the omicron umbrella.

"The type of omicron variant that was circulating back in March is different than the one circulating now and and it's just our sophisticated testing allows us to distinguish that," Albanese said.

An updated vaccine is currently in the works by the Centers for Disease Control and Prevention and the Food and Drug Administration, and will be available in the fall alongside the new flu vaccine. With slight tweaks, the hope is that the updates to the vaccine will allow for a more efficient performance in combating the virus.

El Paso County Public Health wants the community to be aware of the trends so individuals can make informed decisions regarding their health.

The summer travel season is hitting a peak, with lots of visitations happening all over the country to friends and family.

During Independence Day weekend, in Colorado and across the U.S., people are expected to hit airports and roadways at a pace that hasnt been

"For some people, they may even choose to change travel plans; they may choose to wear a mask as a way for their own personal health and benefits," Albanese said. "This is information for the public to know and to make a decision for themselves and for their loved ones."

For more information regarding current COVID data, check out Colorado's Department of Public Health and Environment's website. For nationwide numbers, visit the CDC's website.

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COVID-19 cases see typical summer increase for third year in a row - Colorado Springs Gazette

Those whove dodged COVID-19 for more than four years may have a newly discovered immune response to thank.

In a study that intentionally infected volunteers with the coronavirus, participants with elevated activity of a little-studied immunity gene called HLA-DQA2 didnt get a sustained infection after exposure to SARS-CoV-2, researchers report June 19 in Nature. The study offers an unprecedentedly detailed look at how the immune system responds to the coronavirus, and how variation in that response could explain why some people get sick while others dont.

The results stem from a challenge trial: At the height of the pandemic in 2021, scientists in the United Kingdom exposed 36 young, healthy unvaccinated volunteers whod never gotten COVID-19 to the virus through their noses (SN: 2/18/21). While the initial goal was to establish how much virus it takes to kick-start an infection, 16 of the participants underwent more extensive testing. Researchers tracked the actions of a wide range of immunological players in the blood and lining of the nose, both before and after exposure, allowing a detailed view of when and where different players spur into action.

But there was a problem: Only six of the 16 participants got sick.

Initially, we were very bummed, like, were wasting all these experiments on people that we didnt actually infect, says Rik Lindeboom, a biologist at the Netherlands Cancer Institute in Amsterdam. But later, he says, he and his colleagues realized theyd stumbled across a unique opportunity to understand how some people who got an infectious dose of the virus managed to fend it off. Its unclear how many people have dodged COVID-19. The most recent estimate from the U.S. Centers for Disease Control and Prevention suggested that by the end of 2022, nearly 1 in 4 Americans hadnt caught the virus.

Challenge trials are controversial, as some experts question the ethics of deliberately infecting people with a pathogen (SN: 5/27/20). But you cant underplay how valuable this kind of information is, says Jill Hollenbach, an immunogeneticist at the University of California, San Francisco who wasnt involved in the research. Its so rare that we get to see a snapshot of whats actually happening in early infection, she says, as researchers in challenge trials can track people from the moment they encounter the pathogen.

Participants who didnt get sick in Lindebooms 2021 trial fell into two buckets. Seven individuals never tested positive for the virus, while three got transient infections in their nose that their bodies quickly shut down, so they never got sick. In the former group, researchers detected widespread, but subtle, changes in immune cells called monocytes and MAIT cells. The transiently infected individuals mounted a robust immune reaction, known as an interferon response, in their noses within a day of exposure. Interferons help signal a viral threat, attracting cells that fight the infection.

By contrast, people who got sick took about five days, on average, to marshal the same interferon response in their noses, giving the virus time to proliferate and spread. The discrepancy suggests that swift, localized activity at the site of infection may help prevent SARS-CoV-2 from getting a foothold, Lindeboom says.

Surprisingly, sick participants blood showed interferon activity before their noses did. Thats the exact opposite of what we had hypothesized, Lindeboom says, given that the virus was delivered via the nose. Your immune system is capable of sensing that something is happening and relaying this to the body before the cells that are actually affected know about it.

Among those who didnt get sick, Lindeboom isnt sure why some got briefly infected and others didnt. But before exposure, both groups exhibited elevated activity the gene HLA-DQA2 in specialized immune cells that help alert the immune system to pathogens, compared with people who developed symptoms. Scientists arent sure exactly what this gene does, though previous research linked it to milder COVID-19 outcomes.

We may be able to predict who is susceptible to infection just by looking at their gene signature for this particular gene, says Akiko Iwasaki, an immunologist at Yale University who wasnt involved in the study but wrote about it in Nature.

Of course, a lot has changed since these challenge trials were conducted in 2021. Virtually everyone has some immunity to SARS-CoV-2 from infection or vaccination, meaning most peoples immune responses would likely differ from those traced here, Iwasaki says. A larger, more diverse study population for instance with people of different ages could show more varied responses, too.

For whatever reason, folks who have this different constellation of immune cells present in the [nose] prior to infection may be able to mount an immune response more quickly, says Hollenbach. Its a lucky break for those people.

In a sense, the study was also a lucky break for researchers. Subsequent challenge trials have struggled to infect volunteers, given virtually everyone has some immunity to COVID-19 now. Thats what makes this study so unique, says Lindeboom. Well hopefully never be in the position to do this kind of study for SARS-CoV-2 again.

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Some people have never gotten COVID-19. An obscure gene may be why - Science News Magazine