At a recent Wilson Center event, hosted in partnership with USAIDs MOMENTUM Routine Immunization Transformation and Equity Project, Dr. Folake Olayinka, Immunization Technical Lead of the Global Health Bureau at USAID, described a recent two year period as the largest sustained backsliding of childhood vaccination, citing the fact that between 2019 and 2021, approximately 67 million children missed out on essential lifesaving vaccines.
The recent eventAdvancing Local Solutions and Innovations for Lasting Impact: Applying Strategies from COVID-19 Vaccination to Routine Immunizationprovided an opportunity for participants to share successful strategies for achieving high equitable COVID-19 vaccination coverage, particularly for hard-to-reach priority populations, with a focus on their application to routine immunization. As we brought our attention back to routine immunization this year, we realized that so much of what is needed for immunization is exactly what we did for COVID-19 vaccination, said Grace Chee, Project Director of MOMENTUM Routine Immunization Transformation and Equity Project.
The introduction of new vaccines in early 2021 also brought about several new uncertainties. The use of novel technologies and specific cold chain requirements, coupled with limited global vaccine supply, posed significant challenges. The complex landscape of multiple vaccines, new variants, evolving evidence, and changing health recommendations also made public communication difficult. The result was a decrease in both vaccine demand and confidence in various regions, which was accompanied by a surge in rumors and misconceptions.
Successful vaccination not only entails managing logistics of vaccine delivery, but also building widespread trust in vaccination, including among the health personnel prioritized for vaccination and tasked with providing the service, said Dr. Olayinka.
The MOMENTUM Routine Immunization Transformation and Equity Project brings a unique perspective to these questions. It works in 18 countries to enhance vaccination programs, address emerging challenges, and prepare them for COVID-19 vaccine introduction. The project focuses on identifying priority populations, designing effective service delivery strategies, and leveraging expertise in areas like microplanning, healthcare staff training, demand generation, communication, community partnerships, and supply chain strengthening.
In early 2022, the Imo state in Nigeria had less than 6% COVID-19 vaccination coverage, ranking third to last nationally. Despite strong political will, insufficient partner support was one of the key reasons. So, initiation of the MOMENTUM Routine Immunization Transformation and Equity Project in Imo strengthened the strategic coordination forum in the state, which enabled regular stakeholder meetings and facilitated awareness campaigns across media platforms. The expansion of mobile teams also proved instrumental in ensuring comprehensive coverage.
For hard-to-reach areas and security compromised areas, we employed vaccinating teams and monitors from those areas because they know the terrain, said Dr. Maria Joannes Uzoma, Executive Secretary of Imo State Primary Health Care Development Agency in Nigeria.
These vaccination outreach efforts in Imo were also supplemented by providing routine drugs, including over-the-counter and antimalarial medications. Within a mere five months of the projects initiation, Imo state witnessed a remarkable surge in vaccination coverage, soaring to an impressive 70% coverage, observed Dr. Uzoma.
Reliable data forms the basis for informed decision making by healthcare professionals and policymakers. But in the Democratic Republic of the Congo (DRC), creating a new data system for COVID-19 vaccines posed challenges in terms of technology access and training.
As more people were getting vaccinated, it was becoming clearer that it was really difficult for health workers to keep up with the number of peoples data they needed to enter, said Constant Kingongo, Monitoring and Evaluation Lead of the MOMENTUM Routine Immunization Transformation and Equity Project in the DRC. So instead of proposing a band-aid solution, the Project used the pandemic as an opportunity to strengthen the DRCs overall digital health system by reverting to the system used for routine immunization.
Health workers in Kinshasa found it easier to enter data into the familiar routine immunization system, reducing their workload and improving data completeness, said Kingongo. He added that New technologies should be adapted to each countrys reality. Make sure the solution fits the context, is designed around end user needs, and builds on existing systems and skills.
In Nigeria, new initiatives included mapping through the use of Geographic Information Systems (GIS) to create a microplan and identify hard to reach communities. COVID-19 resources were available for us to go beyond the cardboard paper mapping to identify settlements, taking their geocoordinates, assessing the distance between the serving health facility and the settlements, and identifying natural barriers and obstacles, said Dr. Joel Yakubu Cherima, Nigeria Country Lead, MOMENTUM Routine Immunization Transformation and Equity Project at JSI.
When COVID-19 vaccination was rolled out in Karnataka, India, the state achieved high vaccine coverage rates of nearly 92% for the first dose and 87% for the second dose. Yet Dr. Rajani B.N, Deputy Director and State Immunization Officer of the Karnataka government noted that the persistent challenge in this region is covering the last mile to bring vaccinations to particularly vulnerable and traditionally unreached populations, such as tribal people, migrant laborers, and the elderly. She added that in collaboration with local NGOs already well-rooted in these communities, the state devised culturally tailored strategies and mapping of vulnerable populations to improve the reach to and uptake of vaccinations in these areas.
In Kenya, the Project partnered with the Aging Concern Foundation (ACF), a community organization that advocates for the welfare of elderly people, said Dr. Isaac Mugoya, Kenya Country Lead of MOMENTUM Routine Immunization Transformation and Equity Project at JSI. Since elderly people in Kenya are supported by the government through a monthly welfare stipend, Dr. Mugoya described an initiative to facilitate the vaccination of this demographic in which ACF successfully collaborated with local banks to provide a tent where elderly individuals could collect their stipends and also get vaccinated.
The vaccine has been characterized by a narrative that shows distrust in relation to the safety and efficacy of [COVID-19] vaccines, said Dr. Betuel Sigauque, Mozambique Country Lead of the MOMENTUM Routine Immunization Transformation and Equity Project at JSI. To address the issue comprehensively, the Project utilized social mobilization initiatives and engaged leaders at community and national levels. By combining strategic messaging with support from influential figures, the project aimed to build trust and convey the importance of COVID-19 vaccination in a manner that resonated with diverse communities.
In India, similar efforts identified faith-based leaders who could disseminate correct messaging about COVID-19 vaccination and combat the spread of misinformation among religious communities, said Dr. Gopal Krishna Soni, India Country Lead of the MOMENTUM Routine Immunization Transformation and Equity Project at JSI.
In Ethiopia, the MOMENTUM Routine Immunization Transformation and Equity Project worked with the Ministry of Health in Addis Ababa City Health Bureau to integrate COVID-19 vaccination with a mass measles vaccination campaign. In one of the vaccination sites, we helped the vaccination team to rearrange the service station so that the COVID-19 information and vaccination was stationed in the middle of the vaccination post, said Tewodros Alemayehu, Ethiopia Immunization Project Director of the MOMENTUM Routine Immunization Transformation and Equity Project at JSI. This rearrangement helped each vaccination team to provide clear information to every client on COVID-19 vaccination.
New programs and initiatives from the COVID-19 era especially those that build on existing best practices will play a pivotal role in helping navigate a growing vaccination crisis. Nida Parks, COVID-19 Response Coordinator of Global Health Bureau at USAID, noted that not only can these innovations support our primary health care systems now, but that they might also prepare global health systems for the next major crisis.
Sources: American Hospital Association (AHA), Centers for Disease Control and Prevention (CDC), United Nations Childrens Fund (UNICEF).
Photo credit: Woman receives vaccination in Mozambique., used with permission courtesy of Neide Guesela, MOMENTUM Routine Immunization Transformation and Equity/Mozambique.
Particles of SARS-CoV-2 (yellow; artificially coloured) infect cells in the lining of the nasal passage.Credit: National Institute of Allergy and Infectious Diseases/National Institutes of Health/SPL
Delivery of COVID vaccines directly to the lungs and nose can stop SARS-CoV-2 infections in their tracks, according to a trio of new studies in monkeys. The research offers a boost to the wave of mucosal COVID-19 vaccines now in development and provides clues about how they might be improved.
Until now, there has been little evidence that mucosal vaccines, which are taken by nose or mouth, shield people against infection any better than existing COVID-19 jabs do. Even so, some countries have already approved such vaccines, and key trials are under way in the United States, with others set to start.
Together, the studies show that how and where vaccines are delivered can have a profound effect on the immunity generated and the protection conferred. The latest results also raise hopes that mucosal vaccines that offer sterilising immunity complete blockage of infection could become a reality.
These studies are showing you can get near sterilising immunity, says Akiko Iwasaki, an immunologist at the Yale School of Medicine in New Haven, Connecticut. "Its not complete science fiction to think about developing vaccines that would stop transmission and infection.
COVID-19 jabs saved millions of lives during the pandemic and continue to do a good job of keeping at-risk individuals out of hospital. But even updated versions of existing injected vaccines offer scant and short-lived protection against infection, scientists say.
Researchers think this is because injected intramuscular vaccines do a good job of stopping SARS-CoV-2s spread deep in the lungs, but are much less effective in the rest of the airway, where infections probably begin. Mucosal COVID-19 vaccines aim to trigger the production of antibodies and other immune players in the mucous membranes, or mucosa, that line the nose and the rest of the respiratory tract, in the hope that this will boost protection there.
Dozens of mucosal COVID-19 vaccines are in development (see High hopes) and several have been approved in countries including China and India. But according to an 8 December report by the London-based data and analytics firm Airfinity, the efficacy of existing mucosal COVID-19 vaccines has been disappointing and the available data suggest that they do not offer a meaningful increase in protection against infection.
Source: Airfinity
However, the latest studies in monkeys and other laboratory animals offer hints on how these vaccines might be improved. A team led by Dan Barouch, a vaccine scientist at Beth Israel Deaconess Medical Center in Boston, Massachusetts, tried two approaches in monkeys that had previously received COVID-19 jabs: squirting a liquid vaccine into the animals noses, or applying it directly to their tracheae1.
Only the trachea-delivered vaccine substantially boosted mucosal immunity and protection against SARS-CoV-2 infection. We think that the problem with intranasal delivery is that most of the vaccine is either swallowed or sneezed out, Barouch says. The results were published in Nature 14 December.
Biochemical engineer Wei Wei at the University of Chinese Academy of Sciences in Beijing and his colleagues created a nanoparticle vaccine that includes a fragment of a SARS-CoV-2 protein, and delivered it as an aerosol into the lungs of mice, hamsters and monkeys. This triggered a strong mucosal immune response and stymied the spread of SARS-CoV-2 in vaccinated hamsters housed in cages next to one another, the researchers reported in Nature2 on 13 December. Both this study and that from Barouchs team hint that vaccines applied more deeply to the respiratory system outperform nasal sprays.
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In a third study, a team led by Robert Seder, a vaccinologist at the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, reached a slightly different conclusion. His group used devices approved to deliver other medicines to give monkeys a booster dose of mucosal COVID-19 vaccine either by way of the nose or as an inhaled aerosol delivered through the mouth and nose. Then they exposed the animals to SARS-CoV-2.
Monkeys that had received a booster dose with either device developed much lower levels of the virus in their upper airways than did monkeys that had received a booster jab, even though the animals were exposed to the virus five months after the booster. Such durability, Seder says, is striking. The results were posted on the preprint server bioRxiv on 8 November and have not yet been peer reviewed.
Delivering aerosolized vaccines to the lungs might be the best strategy for mucosal COVID-19 vaccines, says Zhou Xing, a vaccine immunologist at McMaster University in Hamilton, Canada. But he adds that simple, hand-held delivery devices might need to be developed for such vaccines to be widely deployed.
There is also a need to optimize the vaccines themselves, says Seder. Many of the current injectable vaccines contain SARS-CoV-2 RNA, but Seders team has found that the RNA formulations used in those vaccines arent effective when inhaled.
The vaccines that Seders and Barouchs teams tested, as well as the mucosal vaccines approved in China and India, are based instead on bioengineered adenoviruses that carry snippets of genetic material from SARS-CoV-2. The US government is supporting trials of mucosal vaccines based on other viruses: one that harnesses Newcastle disease virus, which infects birds, and a second based on a strain of SARS-CoV-2 that has been altered to replicate too slowly to cause disease.
China and India approve nasal COVID vaccines are they a game changer?
The protein-based vaccine that Weis team developed has the advantage that it can be stored at room temperature in a powdered form, reducing storage and transportation costs, Wei says.
Showing that mucosal vaccines actually work and work better than existing jabs do is another challenge facing the field. One possibility for testing these products is a human challenge trial, in which participants are intentionally infected with a virus. Seder expects it to take at least another two or three years to develop successful mucosal vaccines for COVID-19.
But the burst of interest in these vaccines has wider relevance, say scientists. If we can learn how to trigger mucosal immunity against SARS-CoV-2, it should be possible to do the same for influenza, respiratory syncytial virus and infections we might not yet know about. Its a worthy goal, says Hyon-Xhi Tan, an immunologist at the University of Melbourne, Australia, especially for respiratory viruses that may pop up in the future with pandemic potential.
The U.S. Centers for Disease Control and Prevention (CDC) says there is an urgent need for vaccinations to fight respiratory illnesses this winter.
Earlier this week, the organization issued a health alert to doctors across the United States, calling on them to encourage their patients toget shotsto protect them from COVID, the flu and Respiratory Syncytial Virus (RSV) for the remainder of the season.
Low vaccination rates, coupled with ongoing increases in national and international respiratory disease activity caused by multiple pathogens, including influenza viruses, SARS-CoV-2 (the virus that causes COVID-19) and RSV, could lead to more severe disease and increased healthcare capacity strain in the coming weeks, the CDC said.
"Healthcare providers should administer influenza, COVID-19 and RSV immunizations now to patients, if recommended. Healthcare providers should recommend antiviral medications for influenza and COVID-19 for all eligible patients, especially patients at high-risk of progression to severe disease such as older adults and people with certain underlying medical conditions," the organization added.
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According to the CDC, there has been an increase in hospitalizations among groups of all ages within the past four weeks tied to respiratory illnesses.
There has been a 200% increase in hospitalizations for the flu, a 51% jump for COVID and a 60% rise for RSV, per the organization.
"Currently, the highest respiratory disease activity in the United States is occurring across the southern half of the country, with increasing activity in northern states," the CDC said.
There have also been 12 reported pediatric influenza deaths and 30 reports of MIS-C, a rare complication that typically occurs a month after a COVID infection, the organization added.
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According to CDC data through Nov. 18, about 36% of both adults and children have received their flu vaccine this year. Compared to 2022, about 7 million fewer adults have gotten the shot in 2023, the health organization said.
As for COVID shots, 17% of adults and about 8% of children have received the latest round, according to CDC data through Dec. 2.
Meanwhile, only about 16% of adults ages 60 and up have gotten the new RSV vaccine, the CDC found.
Key reasons for low vaccination, the CDC said, citing a national survey, include a lack of provider recommendations, concerns tied to side effects and a lack of time or forgetting to get vaccinated.
Multiple large-scale studies have found that vaccines are safe. There is no scientific link between vaccines and autism, according to the Centers for Disease Control.
With the holidays in full swing, the U.S. is seeing high rates of respiratory virus activity, but concerningly low levels of vaccination against COVID, influenza (flu), and respiratory syncytial virus (RSV), the Centers for Disease Control and Prevention (CDC) said.
In a health alert published Thursday, the agency warned healthcare providers that the combination of high virus circulation and low vaccination uptake could lead to more severe disease and increased healthcare capacity strain in the coming weeks.
Within the last month, the CDC reported that among all ages, hospitalizations have gone up by 200% for flu, 51% for COVID, and 60% for RSV.
The CDC recommended that healthcare professionals continue to vaccinate their patients, if eligible, and should recommend antiviral treatments for COVID and flu for those who are at risk ofserious disease.
We wanted to make sure our providers know that it is not too late to get folks vaccinated, Mandy Cohen, MD, MPH, director of the Centers for Disease Control and Prevention, told Health.
In addition to data on current virus activity and vaccination rates, the health alert also features a conversation guide for healthcare providers with information on talking people through vaccine concerns.
Importantly, we wanted to give folks tools on how to have those conversations, and to flag some new data that we have, Cohen added.
Junior Asiama/500px/Getty Images
According to the CDCs health alert, vaccinations arent where they should be for all age groups.
The agency found that as of mid-November, there were 7.4 million fewer influenza vaccine doses administered to adults in pharmacies and physician offices compared with the 20222023 influenza season.
By November 11, 36.1% of adults had gotten a flu shot, including just 58.6% of people over the age of 65. Thats down from 38.4% and 61.3%, respectively, in 2022.
Its worth noting that, according to CDC data from December 15, an estimated 42.2% of adults had gotten their flu shot, including 69.3% of seniors.
In general, flu shot uptake declined during the pandemic and has not yet returned to pre-pandemic levels.
This is the first season that the RSV vaccine has been widely available, meaning theres no comparative data. However, as of December 2, about 16% of adults over 60 reported getting the vaccine.
Low rates of vaccination for the updated COVID vaccine is an especially sorry state, Mark Cameron, PhD, associate professor and infectious disease researcher at the Case Western Reserve University School of Medicine, told Health.
So far, just over 17% of adults have gotten the shot, including 36% of those over the age of 65. These numbers are slightly down from those who got last years bivalent COVID shotaccording to data gathered between fall 2022 and spring 2023, just over 20% of all adults got that shot, including just over 43% of older adults.
These lagging vaccination rates are worrisome, especially for seniors, said Cameron.
If you havent been infected for a while or youre exposed at a point thats been months or maybe years away from your last vaccine, that really puts up a risk for more severe illness, he said. We cant become complacent. We have to keep up with boosters.
Alongside low vaccination rates, the U.S. is also seeing increased rates of all three major respiratory viruses, Cohen explained.
We are probably at the peak of RSV season. Flu is definitely increasing right now, but were on the early end of the flu season, she said. [COVID is] elevated and increasing across most of the country, particularly in the Midwest and the Mid-Atlantic regions.
According to respiratory illness data from last week, over 10% of flu tests came back positive, and 4.4% of all visits to healthcare providers were related to respiratory illness.
Health experts are also keeping an eye on COVID, as new Omicron variants are also emerging concurrently with this spike in hospitalizations and virus activity. The HK.3 variant has grown in recent weeks and now makes up an estimated 7.7% of cases. And, having exploded since early November, the JN.1 variant now makes up 1 in 5 COVID cases.
The JN.1 variant luckily doesnt seem to be any more severe than other variants, experts agreed, but it will likely still have an impact in the coming weeks.
Its still going to lead to a lot of infections that will peak over the holidays, and still up our hospitalizations and deaths, said Cameron.
Though vaccinations cant completely stem the tide of infections, they will be an integral part of managing this increase in RSV, COVID, and flu. Unmitigated, these viruses can lead to more hospitalizations and death, Cohen explainedvaccines prevent the worst of what the viruses could bring.
In the face of low vaccination rates, new COVID variants, and increasing case numbers, theres still good news, said Cohen.
While the virus has continued to change and be more transmissible and spread more quickly, our tools continue to be able to work against it, she said.
COVID cases will likely increase over the next few weeks and peak in mid-January, Cohen explained, and the country still has a long flu season ahead of it.
That means its not too late to get those updated vaccines, Cohen said. If people havent yet gotten vaccinated, they should do that before the holidays if possible, she added.
But, with holiday gatherings in full swing, its important to remember that vaccination is just one way to stay safe.
I want folks to enjoy the holidays, but use the tools that we have to protect themselves, said Cohen. If youre sick, stay homeI know thats probably the hardest recommendation to give because no one wants to miss a holiday gathering. But if you are sick, get tested, stay home, get treatment.
Theres no correct way to gather safely, Cohen emphasized. It has more to do with evaluating each persons individual risk, and increasing or decreasing safety measures from there. If someone is visiting an elderly family member or a friend fighting cancer, for example, those may be situations where increased protective measures are necessary.
It could be just opening a window, or it could be gathering outside, or it could be wearing masks, she said. But you want to think about yourself and the risk of the folks you are gathering with. But I want folks to be together [...] We can do that in a safe way using all of these tools as layers of protection.
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Anixa Biosciences CEO Dr. Amit Kumar told FOX Business that the company is working on a "game-changing vaccine" that could prevent the recurrence of the most aggressive form of breast cancer.
It's already being tested on women who were diagnosed with triple-negative breast cancer. Kumar believes that the potentially life-saving vaccine could hit the market within the next five years.
The vaccine was developed at Cleveland Clinic by the late Dr. Vincent Tuohy who died earlier this year. Before his death, Tuohy and his team worked on the development of this vaccine for two decades, Kumar said.
"Various other types of cancer vaccines have been attempted and nothing has been successful," Kumar told FOX Business. "The reason we believe that they failed is because of the mechanism of action that's been utilized to try and destroy cancer cells."
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For the first time, Kumar believes the team may have made a breakthrough with a vaccine administered in a series of three shots that might be able to help more than just breast cancer patients. Eventually, he believes this vaccine could have the power to eliminate various forms of cancer.
After years of animal testing, the team received approval from the Food and Drug Administration (FDA) to begin human testing in 2021. In October 2021, Jennifer Davis was the first woman to undergo the series of shots.
Jennifer Davis receiving treatment for triple-negative breast cancer. (Jennifer Davis)
"A lot of people, physicians, doctors, scientists, nurses, people like myself and others are going to be working on this before this vaccine is approved," Kumar said. "But the people who should really get the credit are people like Jenny and all the patients who let us as scientists try the vaccine out."
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The mother of three was first diagnosed with triple-negative breast cancer in the fall of 2018. She was only 41 years old.
It was a harrowing reality and within a few weeks, she was assigned a team of doctors and nurses at Cleveland Clinic and started an aggressive chemotherapy treatment. She underwent four rounds of a "brutal chemotherapy drug" and was supposed to endure 12 more rounds of another chemotherapy drug afterward.
However, she was forced to stop the second treatment short after suffering from neuropathy, a condition that left her unable to even button her own shirt. If she kept doing the chemotherapy, she could have ended up in a wheelchair for the rest of her life, Davis' doctor warned.
"In my mind, I thought the chemotherapy was what was going to save my life. So it was very difficult for me to finally stop," she said.
In 2019, she underwent a double mastectomy followed by 26 rounds of radiation.
Jennifer Davis holding an image of her receiving treatment for triple-negative breast cancer. (Jennifer Davis)
According to the American Society of Clinical Oncology, as many as 50% of patients diagnosed with early-stage triple-negative breast cancer experience a recurrence.
"How triple-negative works is once you're done with standard of care, then that's it. There's no pill or anything that I could take that would ensure that this would not come back," Davis said.
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If it does come back, it tends to be much more aggressive and metastatic, meaning it's moved to other parts of the body, Kumar added.
Davis was one of 16 people who were part of the trial, which is still ongoing. Data released last week revealed that all women had an immune response.
"That means that that vaccine taught my body to identify these cancer cells and destroy them before they become a tumor," Davis sporting a tremendous smile said.
Anixa Biosciences CEO Dr. Amit Kumar. (Dr. Amit Kumar / Anixa Biosciences)
Kumar said the team of scientists plans to test a few more women as part of their phase one trial. Starting in 2024, they will initiate a double-blind study with hundreds of women, which will be split into two groups. Both groups will have the standard of care, but one group will get a series of placebo shots.
"The ratio of recurrences within those two groups will tell us how good this vaccine is, even if we can prevent half those recurrences. It's still a game changer," Kumar said.
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Right now, the team is only testing the shots on women who have triple-negative breast cancer because of the high recurrence rate of the type of the disease.
The goal, though, is to eventually test this vaccine on women with other types of breast cancer, Kumar said. Eventually, the team of scientists will test to see if this vaccine can address the prevention of cancer in women who've never had the disease.
Davis and Kumar, both of whom have daughters, have expressed how critical it is to have a vaccine like this for their children.
Kumar said that if the team is successful in this vaccine, "there's no reason why we couldn't develop similar vaccines for other types of cancers," he said.
Meanwhile, researchers from the University of Washington School of Medicine in Seattle published findings in the journal JAMA Oncology last year that said an experimental vaccine against breast cancer safely generated a strong immune response to a key tumor protein. The findings, published in November 2022, might be able to treat different types of breast cancer, according to the university.
The "results should be considered preliminary, but the findings are promising enough that the vaccine will now be evaluated in a larger, randomized clinical trial," lead author Dr. Mary"Nora" L. Disis, said in a statement when the findings were published.
The vaccine has been licensed to Korean biopharmaceutical company Aston Sci. The company has initiated a randomized Phase II study in human growth receptor 2, or HER2, low breast cancer. The study is open and actively enrolling at multiple sites.
The Polk County Health Department is urging people to get updated respiratory shots with an alarmingly low number of doses reported in recent months.According to the Centers for Disease Control and Prevention, hospitalization rates for the flu, COVID-19 and RSV are the highest they've been since March.Paired with those high rates, the number of people getting vaccinated against respiratory diseases is alarmingly low.According to the Iowa Department of Public Health, 12.4% of Polk County residents are up-to-date with the COVID-19 vaccine. It's a staggering drop from the 68.5% of people who were up-to-date as of Aug. 31.The department also says 31.3% of Polk County neighbors got the updated flu shot this year.It's the lowest rate since the department began reporting numbers online in 2017.And, according to the CDC, 17% of adults age 60+ nationally report receiving an RSV vaccine.Madisun VanGundy, of the Polk County Health Department, said no matter how healthy you are, it's important to remember the others you may put at risk."Think about your grandparents. Think about the pregnant mothers in your life. Think about someone who's battling cancer. By getting the updated respiratory shots, you're helping protect their health as well," she said.Des Moines neighbors have various thoughts about why the vaccine rates are coming in lower for this time of year."I think people put priorities at this time of the season on some other things, especially since it seems like COVID-19 concerns have diminished a little bit," Tom Joensen said."I suppose people are just getting complacent. It's been a few years since COVID-19," Tami McLaren said.VanGundy said no matter how many COVID-19 vaccines you've had thus far, you only need the most recent shot to be considered up to date. However, if you haven't gotten one in the last six months, it's time to get another dose.
The Polk County Health Department is urging people to get updated respiratory shots with an alarmingly low number of doses reported in recent months.
According to the Centers for Disease Control and Prevention, hospitalization rates for the flu, COVID-19 and RSV are the highest they've been since March.
Paired with those high rates, the number of people getting vaccinated against respiratory diseases is alarmingly low.
According to the Iowa Department of Public Health, 12.4% of Polk County residents are up-to-date with the COVID-19 vaccine.
It's a staggering drop from the 68.5% of people who were up-to-date as of Aug. 31.
The department also says 31.3% of Polk County neighbors got the updated flu shot this year.
It's the lowest rate since the department began reporting numbers online in 2017.
And, according to the CDC, 17% of adults age 60+ nationally report receiving an RSV vaccine.
Madisun VanGundy, of the Polk County Health Department, said no matter how healthy you are, it's important to remember the others you may put at risk.
"Think about your grandparents. Think about the pregnant mothers in your life. Think about someone who's battling cancer. By getting the updated respiratory shots, you're helping protect their health as well," she said.
Des Moines neighbors have various thoughts about why the vaccine rates are coming in lower for this time of year.
"I think people put priorities at this time of the season on some other things, especially since it seems like COVID-19 concerns have diminished a little bit," Tom Joensen said.
"I suppose people are just getting complacent. It's been a few years since COVID-19," Tami McLaren said.
VanGundy said no matter how many COVID-19 vaccines you've had thus far, you only need the most recent shot to be considered up to date. However, if you haven't gotten one in the last six months, it's time to get another dose.
Health
By Daniella Genovese, Fox Business
Published Dec. 19, 2023, 12:36 p.m. ET
Anixa Biosciences CEO Dr. Amit Kumar told FOX Business that the company is working on a game-changing vaccine that could prevent the recurrence of the most aggressive form of breast cancer.
Its already being tested on women who were diagnosed with triple-negative breast cancer.
Kumar believes that the potentially life-saving vaccine could hit the market within the next five years.
The vaccine was developed at Cleveland Clinic by the late Dr. Vincent Tuohy who died earlier this year.
Before his death, Tuohy and his team worked on the development of this vaccine for two decades, Kumar said.
Various other types of cancer vaccines have been attempted and nothing has been successful, Kumar told FOX Business. The reason we believe that they failed is because of the mechanism of action thats been utilized to try and destroy cancer cells.
For the first time, Kumar believes the team may have made a breakthrough with a vaccine administered in a series of three shots that might be able to help more than just breast cancer patients. Eventually, he believes this vaccine could have the power to eliminate various forms of cancer.
After years of animal testing, the team received approval from the Food and Drug Administration (FDA) to begin human testing in 2021.
In October 2021, Jennifer Davis was the first woman to undergo the series of shots.
A lot of people, physicians, doctors, scientists, nurses, people like myself and others are going to be working on this before this vaccine is approved, Kumar said. But the people who should really get the credit are people like Jenny and all the patients who let us as scientists try the vaccine out.
The mother of three was first diagnosed with triple-negative breast cancer in the fall of 2018. She was only 41 years old.
It was a harrowing reality and within a few weeks, she was assigned a team of doctors and nurses at Cleveland Clinic and started an aggressive chemotherapy treatment.
She underwent four rounds of a brutal chemotherapy drug and was supposed to endure 12 more rounds of another chemotherapy drug afterward.
However, she was forced to stop the second treatment short after suffering from neuropathy, a condition that left her unable to even button her own shirt.
If she kept doing the chemotherapy, she could have ended up in a wheelchair for the rest of her life, Davis doctor warned.
In my mind, I thought the chemotherapy was what was going to save my life. So it was very difficult for me to finally stop, she said.
In 2019, she underwent a double mastectomy followed by 26 rounds of radiation.
According to the American Society of Clinical Oncology, as many as 50% of patients diagnosed with early-stage triple-negative breast cancer experience a recurrence.
How triple-negative works is once youre done with standard of care, then thats it. Theres no pill or anything that I could take that would ensure that this would not come back, Davis said.
If it does come back, it tends to be much more aggressive and metastatic, meaning its moved to other parts of the body, Kumar added.
Davis was one of 16 people who were part of the trial, which is still ongoing. Data released last week revealed that all women had an immune response.
That means that that vaccine taught my body to identify these cancer cells and destroy them before they become a tumor, Davis sporting a tremendous smile said.
Kumar said the team of scientists plans to test a few more women as part of their phase one trial. Starting in 2024, they will initiate a double-blind study with hundreds of women, which will be split into two groups. Both groups will have the standard of care, but one group will get a series of placebo shots.
The ratio of recurrences within those two groups will tell us how good this vaccine is, even if we can prevent half those recurrences. Its still a game changer, Kumar said.
Right now, the team is only testing the shots on women who have triple-negative breast cancer because of the high recurrence rate of the type of the disease.
The goal, though, is to eventually test this vaccine on women with other types of breast cancer, Kumar said.
Eventually, the team of scientists will test to see if this vaccine can address the prevention of cancer in women whove never had the disease.
Davis and Kumar, both of whom have daughters, have expressed how critical it is to have a vaccine like this for their children.
Kumar said that if the team is successful in this vaccine, theres no reason why we couldnt develop similar vaccines for other types of cancers, he said.
Meanwhile, researchers from the University of Washington School of Medicine in Seattle published findings in the journal JAMA Oncology last year that said an experimental vaccine against breast cancer safely generated a strong immune response to a key tumor protein.
The findings, published in November 2022, might be able to treat different types of breast cancer, according to the university.
The results should be considered preliminary, but the findings are promising enough that the vaccine will now be evaluated in a larger, randomized clinical trial, lead author Dr. Mary Nora L. Disis, said in a statement when the findings were published.
The vaccine has been licensed to Korean biopharmaceutical company Aston Sci.
The company has initiated a randomized Phase II study in human growth receptor 2, or HER2, low breast cancer. The study is open and actively enrolling at multiple sites.
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by Stefan Zorn , Medizinische Hochschule Hannover
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The pandemic is over, but many people in Germany are still infected with the coronavirus. The current omicron variants in particular are highly contagious. The new booster vaccines from BioNTech and Moderna are specially adapted to the omicron subline XBB.1.5. However, the effectiveness of the new boosters has not yet been proven.
A study by the Department of Rheumatology and Immunology at Hannover Medical School (MHH) has now closed this gap. In cooperation with the MHH Institute of Immunology and the German Primate Center Gttingen, the researchers have published the world's first paper on the new XBB.1.5-based vaccine from BioNTech.
As part of the "COVID-19 Contact (CoCo)" study at the MHH, 53 MHH employees who received the vaccine were examined. Their immune response was then measured. The result: after vaccination with the new booster, antibodies against omicron variants increased significantly. The work has been published in The Lancet Infectious Diseases.
"We have not only found a large number of neutralizing antibodies against omicron XBB.1.5, but also against other sub-variants," says senior physician Professor Dr. Alexandra Dopfer-Jablonka, who is leading the immune study together with her clinical colleague Professor Dr. Georg Behrens.
This means that the vaccine not only triggers the immune defense against the currently dominant coronavirus variant XBB.1.5, but also activates the body's own defenses against the currently spreading variants "Pirola" (BA2.86) and "Eris" (EG1.5).
"The B cells that produce antibodies against omicron increased significantly and the T cells were also strengthened by the vaccination," explains the rheumatologist. "The data show that the new booster vaccination achieves its goal and also induces antibodies against new SARS-CoV-2 variants."
Like the first coronavirus vaccines from BioNTech and Moderna, the new booster is again an mRNA vaccine, i.e., it consists of messenger RNA. The principle: The mRNA contains the genetic information for the blueprint of the so-called spike protein, which is located on the surface of the coronavirus and with the help of which the virus enters the cells. This genetic information is read in the body's cells and the spike protein is produced. The immune system recognizes the protein as foreign to the body, triggers a defense reaction and develops immune protection.
Unlike last season's bivalent vaccines, the new vaccines only contain mRNA of the omicron variant. "The new boosters nevertheless activate a backward and a forward defense," says Professor Dopfer-Jablonka. Only the BioNTech vaccine was analyzed in the study. "However, as the Moderna vaccine is also adapted to XBB.1.5, we expect it to be equally effective." The same applies to the booster vaccine from the manufacturer Novavax, which has also been adapted to XBB.1.5 and authorized by the European Commission.
"The work is once again a great team success and the result of the CoCo study, which is made possible and supported by MHH employees," says Professor Behrens. The CoCo study started in March 2020 and uses blood samples to investigate immune reactions against SARS-CoV2 in employees of the MHH and affiliated institutions. "Our data can also make a significant contribution to better understanding the long-term immune response against SARS-CoV-2 and assessing the success of the vaccination," says the physician.
According to the Standing Committee on Vaccination (Stiko), a booster vaccination with the new, adapted vaccine is recommended for everyone aged 60 or over. In addition, all people who are at particular risk of a severe course of the disease due to an underlying illness should be boosted. The Stiko also recommends the booster vaccination for residents of care homes and for employees in the care and health care sector. The booster vaccination should be repeated annually, preferably in autumn.
More information: Metodi V Stankov et al, Humoral and cellular immune responses following BNT162b2 XBB.1.5 vaccination, The Lancet Infectious Diseases (2023). DOI: 10.1016/S1473-3099(23)00690-4
Journal information: Lancet Infectious Diseases
Provided by Medizinische Hochschule Hannover
A study based on patients in 11 South American countries shows that new daily persistent headache (NDPH) can be a clinical symptom after COVID.
"Persistent headache, with a prevalence ranging from 8 to 15% in the first six months after COVID-19 remission, is a frequent symptom," the authors of the study write. "However, limited knowledge exists regarding the clinical spectrum and predisposing factors."
The study, based on responses to an online survey conducted from April 15 to April 30, 2022, is published in BMC Infectious Diseases. The 421 participants were 18 years or older, had previously tested positive for COVID-19, and had an NDPH for at least 28 days. The survey contained four different sections assessing demographics, medical history, persistent headache characteristics, and COVID-19 vaccination status.
The mean age was 40 years, and most participants were women (81.5%), with university education (76.2%). More than 90% described their COVID-19 infections as mild to moderate.
Among participants, 106 met the diagnostic criteria for NDPH. Persistent headache began during the first 2 weeks of COVID-19 in most participants (68.9%) with NDPH. Compared to those who had a non-NDPH headache, the most predominant clinical characteristics were occipital location (43.4% for NDPH vs. 28.3%), severe/unbearable intensity (70.8% vs. 56.8%), burning character (17% vs. 6.7%, and radiating pain (70.8% vs. 60%).
During the acute phase of COVID-19, patients with persistent headache reported neuropsychological spectrum symptoms more frequently.
Most participants were vaccinated against COVID-19 before developing persistent headache (60.3%), with no differences between the two groups, the authors said.
"During the acute phase of COVID-19, patients with persistent headache reported neuropsychological spectrum symptoms more frequently, such as fatigue, sleep problems, anxiety, and mental fog," the authors wrote. "Notably, during the acute phase of COVID-19, a higher proportion of cranial autonomic symptoms were observed in participants with NDPH. These symptoms include sweating of the face or forehead, drooping of the upper eyelid and/or pupillary constriction, and palpebral edema."
The authors concluded that healthcare workers should take a COVID-19 infection history in patients reporting NDPH.
In a recent study posted to the bioRxiv pre-print* server, a team of researchersdeveloped a broadly reactive and stable severe acute respiratory syndrome coronavirus 2 spike protein subunit 2 (SARS-CoV-2 S2) vaccine capable of eliciting strong antibody responses against various sarbecovirus strains, including rapidly evolving and immune-evasive variants.
Study: A broadly generalizable stabilization strategy for sarbecovirus fusion machinery vaccines. Image Credit: NIAID
*Important notice: bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
In response to the changing SARS-CoV-2, researchers have created a new vaccine targeting its S2 subunit. This strategy focuses on stabilizing the subunit's prefusion state, enhancing the immune response. Maintaining the subunit structure and antigenicity of S2, that vaccine proves effective against different sarbecovirus clades. It elicited robust antibody responses in animal tests, chiefly against difficult-to-resolve variants such as XBB.1.5. While promising, further research is required to confirm its efficacy in humans and its long-term effectiveness against new SARS-CoV-2 variants.
The present study employed various cell lines, including Human Embryonic Kidney 293 cells with SV40 T-antigen (HEK293T), Expi293F, and VeroE6-TMPRSS2. These cells were cultivated in specific media conditions, though not authenticated or tested for mycoplasma contamination. The focus was on producing recombinant S2 antigen proteins. Utilizing Expi293F cells, deoxyribonucleic acid (DNA) transfections were carried out, followed by a precise harvesting process. The proteins were then purified using specialized techniques and equipment, ensuring their quality for further experiments.
HexaPro S glycoproteins of both the SARS-CoV-2 and the SARS-CoV-1 were produced following specific protocols in Expi293F cells. After transfection, the proteins underwent a similar purification technique to maintain their stability and usability.
Monoclonal antibody Enzyme-linked immunosorbent assays (ELISAs) were conducted using carefully prepared proteins and specific protocols to determine EC50 values. Meanwhile, HEK293T cells were used to produce vesicular stomatitis virus (VSV) pseudoviruses expressing various S constructs. This time-consuming process went through several steps to maintain the quality and effectiveness of pseudoviruses.
Serological ELISAs were also carried out, employing a systematic approach to analyze the immunogenicity of various proteins. Additionally, the study utilized negative stain electron microscopy and cryo-electron microscopy for detailed structural analysis, following rigorous preparation and data collection protocols. The immunogenicity aspect was thoroughly examined through experiments on BALB/c mice, following specific guidelines and protocols. This included detailed immunization schedules and serum collection for comprehensive analysis.
Finally, neutralization assays were performed using VeroE6-TMPRSS2 cells and various pseudoviruses. This involved a series of well-orchestrated steps to accurately measure the neutralization capacity of the sera, providing critical insights into the effectiveness of the immunogens. The data from these assays were carefully analyzed to determine ID50 values, contributing to the overall understanding of the vaccine candidates' potential.
The research team previously designed a fusion machinery (S2 subunit) antigen stabilized by introducing specific HexaPro mutations, an inter-protomer disulfide, and an intra-protomer disulfide. This construct, named C-44, exhibited a prefusion tertiary structure but a splayed-open quaternary structure. To achieve a native quaternary structure in the prefusion S2 subunit trimer, they selected mutations from a deep-mutational scanning dataset, focusing on prefusion-stabilizing amino acid substitutions. Individual mutations, namely T961F, D994E, and Q1005R, were introduced into the C-44 background and recombinantly produced. These constructs showed monodispersity and high yields of purified protein.
Electron microscopy (EM) characterization revealed that the T961F mutation (E-31) formed closed S2 trimers, unlike other constructs which adopted various conformations. CryoEM structure determination at 2.7 resolution confirmed the prefusion closed structure of E-31, with the T961F substitution reinforcing interactions at the fusion machinery apex. Although a fraction of E-31 trimers with an open apex was detected, the mutation effectively closed the apex in a prefusion conformation.
A broadly generalizable prefusion-stabilization strategy for sarbecovirus fusion machinery (S2subunit) antigens.A,Ribbon diagrams of superimposed S2subunits of the prefusion SARS-CoV-2 S (PDB 6VXX), SARS-CoV-1 S (PDB 5X58) and PRD-0038 S (PDB 8U29) structures. Prefusion-stabilizing mutations are shown in blue (intra-protomer disulfide bond), purple (VFLIP inter-protomer disulfide bond), red (mutations ported from E-69), and green (subset of proline mutations selected from HexaPro).B-I,Zoomed-in views of superimposed S2subunits of the prefusion SARS-CoV-2, SARS-CoV-1 and PRD-0038 S structures highlighting the local structural conservation of residues mutated in SARS-CoV-2 E-69/F-53. Mutated residues in our designed constructs are underlined. SARS-CoV-2, SARS-CoV-1, and PRD-0038 S are respectively shown in light gray, gold, and pink in panels (A-I).J,Size-exclusion chromatograms of the designed SARS-CoV-1 and PRD-0038 S2constructs, as compared to SARS-CoV-2 F53.K,Purification yields of the designed SARS-CoV-1 and PRD-0038 S2constructs. The yield for the best SARS-CoV-2 S2construct (F53) is included for comparison.L,M,Evaluation of retention of antigenicity for the SARS-CoV-1 (L) and PRD-0038 (M) S2antigens in various storage conditions using binding of the S2P6, 76E1 and RAY53 monoclonal antibodies analyzed by ELISA.N,O,Evaluation of retention of the native prefusion conformation of the negatively stained SARS-CoV-1 (N) and PRD-0038 (O) S2trimers after freeze/thawing. Insets: 2D class averages showing compact prefusion S2trimers. The scale bar represents 50 nm (micrographs) and 200 (2D class averages).
To improve conformational homogeneity, additional constructs with more mutations were designed. The E-60 construct contained nine additional mutations, but its cryoEM structure indicated distortion in an -helix region. A new construct, E-69, was designed with four additional mutations, resulting in a prefusion closed S2 subunit trimer without open apex trimers, as confirmed by a 3 resolution cryoEM structure.
Antigenicity retention was tested under various storage conditions to assess the stability of the E-69 design. ELISA and EM analyses showed that E-69 retained its prefusion conformation and unaltered antigenicity, even after freezing and thawing. This stability suggested validity in the prefusion-stabilization strategy, making E-69 a promising vaccine candidate.
The broad applicability of the S2 subunit prefusion-stabilization strategy was then evaluated across different sarbecovirus clades. Constructs were designed for SARS-CoV-1 S2 and PRD-0038 S2, incorporating mutations from E-69. These constructs showed high yields and stability, retaining their antigenicity and adopting the intended closed prefusion architecture.
The immunogenicity of the E-69 vaccine candidate was tested in BALB/c mice with various vaccination schedules. ELISA analyses showed comparable antibody binding titers against SARS-CoV-2 variants and higher titers against SARS-CoV-1. Neutralizing antibody titers were highest in E-69-vaccinated mice against the XBB.1.5 variant, demonstrating the potential of this vaccine to elicit broadly reactive antibody responses.
Finally, to assess the in vivo protective efficacy, mice were challenged with the XBB.1.5 variant. While none of the vaccines prevented infection, vaccinated mice were protected against weight loss and had comparable viral titers, suggesting the potential of the S2 subunit vaccine to protect against immune evasive SARS-CoV-2 variants.
*Important notice: bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
