Vaccinations are one of the most important public health efforts for preventing serious illness, avoiding hospitalizations and saving lives. During the COVID-19 pandemic, vaccine technology made a huge leap forward with the introduction of messenger RNA (mRNA) vaccines. COVID-19 vaccines developed by BioNTech/Pfizer and Moderna use mRNA instead of weakened viruses or virus fragments to teach the bodys immune system how to respond when presented with an infection.
Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. (See list below.)
In the area of respiratory diseases, the first two vaccines for respiratory syncytial virus (RSV) were approved for older adults and a separate vaccine was approved to prevent RSV infections in infants. RSV is a common respiratory virus that usually causes mild, cold-like symptoms, but it can lead to serious respiratory illness and increased hospitalizations. It results in 14,000 deaths annually among those over the age 65 and about 58,000 hospitalizations of infant younger than 1, according to the National Institute of Allergy and Infectious Disease. GSKs Arexvy, approved for adults in early May 2023, is an adjuvanted vaccine, which means it contains an ingredient to increase immune response. The second adult vaccine was approved a few weeks later. Pfizers Abrysvo is a bivalent RSV prefusion F (preF) vaccine that is composed of two preF proteins selected to optimize protection against RSV A and B strains.The FDA also approved Abrysvo to prevent RSV in infants.
Separately, the FDA approved Sanofi and AstraZenecas Beyfortus (nirsevimab-alip), which prevents RSV in newborns and infants. Beyfortus is the first monoclonal antibody to protect infants through their first RSV season. Although designed to prevent disease like a vaccine, it is not a vaccine because it does not stimulate the immune system.
The FDA also granted accelerated approval in November 2023 to Ixchiq, the first vaccine to prevent the mosquito-borne virus chikungunya. It was approved for use in adults aged 18 years and older. Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions.
It is administered as a single dose injected intramuscularly. The manufacturer, Valneva, has begun a phase 2 trial of the vaccine in children one to seven years of age. Once available, the phase 2 pediatric data are intended to support a phase 3 pivotal study in children to extend the label. A clinical study in adolescents is also ongoing in Brazil.
This year the FDA could approve additional vaccines, including the first self-administered flu vaccine. AstraZenecas has submitted a supplemental biologics license application (sBLA) for a self-administered option for FluMist Quadrivalent, which is a needle-free nasal spray. Researchers said this would provide another option for flu vaccination and potentially increase access and use of flu vaccine,The FDA has set a Prescription Drug User Fee Act (PDUFA) date for a regulatory decision during the first quarter of 2024. If approved, Astra Zeneca has said it to be available for the 2024-2025 flu season.
Regulators are also currently reviewing Mercks BLA for a pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The vaccine was developed using the serotypes responsible for about 80% of pneumococcal disease in those over the age of 65. The PDUFDA action date is June 17, 2024.
Even though advances have been made in the area of vaccines, the question remains whether people in the United States and elsewhere will accept and get these vaccines. Vaccine hesitancy, which ranges from misgiving to outright resistance, took hold during the COVID-19 pandemic because of misinformation about the COVID-19 vaccines, and it has shown staying power. The proportion of U.S. adults who have received COVID-19 vaccines, flu and RSV remains low, according to recent data from the Centers for Disease Control and Prevention. Just 21.4% of adults over the age of 18 have received the COVD-19 vaccine, while 41.5% have gotten a flu vaccine.
Vaccine hesitancy is not just about COVID-19 vaccines. Cases of measles have surged in the Washington, D.C., area, Pennsylvania, New Jersey, Delaware and Washington state, partly because children have not been vaccinated.
In a recent study, researchers from University of Colorado School of Medicine found while the COVID-19 pandemic did not overall impact parent vaccine hesitancy, some misinformation about COVID-19 may be impacting parental trust in childhood vaccines.
In a survey by researchers from University of Michigan School of Public Health found that some parents (12%) believe that childhood vaccines are less important compared with before the pandemic and that some (13%) believe that childhood vaccines are less effective now. They also found that negative beliefs about childhood vaccines were clustered in places with low COVID-19 vaccination rates.
In a another study, researchers from University of Colorado School of Medicine found that misinformation about COVID-19 may be impacting parental trust in childhood vaccines.
Vaccine Approvals in 2023
This article originally appeared on Managed Healthcare Executive.
NEW YORK -- A New York midwife who gave nearly 1,500 children homeopathic pellets instead of required vaccinations has been fined $300,000, the state's health department announced this week.
Jeanette Breen, who operates Baldwin Midwifery on Long Island, administered the pellets as an alternative to vaccinations and then falsified their immunization records, the agency said Wednesday.
The scheme, which goes back least to the 2019-2020 school year, involved families throughout the state, but the majority reside on suburban Long Island. In 2019, New York ended a religious exemption to vaccine requirements for schoolchildren.
The health department said immunization records of the children who received the falsified records have been voided, and their families must now prove the students are up-to-date with their required shots or at least in the process of getting them before they can return to school.
"Misrepresenting or falsifying vaccine records puts lives in jeopardy and undermines the system that exists to protect public health," State Health Commissioner James McDonald said in a statement.
Breen, a state-licensed healthcare provider, supplied patients with the "Real Immunity Homeoprophylaxis Program," a series of oral pellets that are marketed as an alternative to vaccination but are not recognized or approved by state or federal regulators as valid immunizations, according to the health department.
She administered 12,449 of the fake immunizations to roughly 1,500 school-aged patients before submitting information to the state's immunization database claiming the children had received their required vaccinations against measles, mumps, rubella, polio, chickenpox, diphtheria, tetanus, pertussis, hepatitis B and a host of other diseases, the department said.
"Suffice it to say, Ms. Breen has provided excellent midwifery services for many years to many families, especially on Long Island. She is now toward the end of her career," David Eskew wrote in an emailed statement. "From her perspective, this matter is over, done with, and closed and she is now moving on with her life."
As part of the settlement, Breen has paid $150,000 of the $300,000 penalty, with the remainder suspended contingent upon her complying with state health laws and never again administering any immunization that must be reported to the state, according to the health department. She's also permanently banned from accessing the state's immunization records system.
Erin Clary, a health department spokesperson, said Thursday that while parents and legal guardians had sought out and paid Breen for her services, they weren't the focus of the agency's investigation.
State health officials say they're now in the process of notifying hundreds of affected school districts.
A Long Island midwife is accused of falsifying the vaccination of more than 1,000 New York state schoolchildren, most of whom are from the New York City metropolitan area, the state health department said on Wednesday.
The state alleged that midwife Jeannette Breen falsified the immunization records for about 1,500 children statewide at the beginning of the 2019-2020 school year. Breen was penalized $300,000 and permanently barred from administering vaccines reportable to the state, officials said.
The New York state Department of Health takes this issue seriously and will investigate and use all enforcement tools at its disposal against those who have been found to have committed such violations, said James McDonald, the state's health commissioner, in a statement.
Though the health department declined to specify which schools were affected due to privacy concerns, 300 schools statewide were notified on Wednesday morning with most of those children being from Long Island, New York City and the lower Hudson Valley, state health officials said. Most of the affected students from New York City were in Queens and Brooklyn, the state said. Students in Erie County located about 400 miles from Breens practice on Long Island were also among those who were affected.
By intentionally falsifying immunization records for students, this licensed health care professional not only endangered the health and safety of our school communities but also undermined public trust, said Betty Rosa, the state's education commissioner, in a statement.
The state said the fabrications included records of vaccines for polio, chickenpox, measles, mumps and rubella, but excluded COVID-19 vaccinations. Students must prove theyve received the missing vaccines or are in the process of obtaining them before they can return to school.
City and state officials did not immediately say how many schoolchildren were affected in New York City, and whether or not they attended public schools.
Breen did not immediately respond to a request for comment.
School vaccinations have been a flashpoint in New York state in recent years. The state eliminated non-medical religious exemptions to required school immunizations in 2019, prompting an outcry from anti-vaccine activists and some parents.
Parents of the affected schoolchildren allegedly sought out and paid Breen to evade state vaccination requirements shortly after religious exemptions ended, according to the health department.
Breen, who lacked the necessary federal approvals and authorizations, is also accused of giving the students an oral substance in the form of pellets, improperly marketed as vaccination alternatives.
Breen has paid half of the monetary penalty from the state and will be relieved from remaining payments if she complies with all terms of the agreement, which state officials have not made public.
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Depending on your age, you may not have gotten an HPV vaccine when you were younger. Thats because the vaccine wasnt available in the U.S. until 2006. Since that time, there has been a dramatic drop in the incidence of cancers caused by the human papillomavirus (HPV), as well as genital and anal warts, due to the vaccine.
There has been an 88 percent drop in infections among teen girls with HPV types that cause most HPV cancers and genital warts since the introduction of the vaccine in 2006, according to the Centers for Disease Control and Prevention (CDC). Among young adult women, the drop in these infections is about 81 percent. Additionally, among all vaccinated women, pre-cancers caused by HPV types most often linked to cervical cancer has dropped by 40 percent.
The HPV vaccine currently used in the U.S. is Gardasil 9. It has been shown to create an antibody response in more than 98 percent of recipients within one month of completing the full vaccination series. Some people may have already been exposed to one or more types of HPV prior to vaccination, but the vaccine is still effective against other types included in the vaccine (the vaccine protects against nine HPV types) so it is suggested that people still get vaccinated even if they have already been exposed to the virus.
It is recommended that all children (females and males) get vaccinated against HPV at age 11 or 12, although vaccination can be given as young as age 9. Older kids, teens and young adults up to age 26 who have not yet been vaccinated should also get the vaccine. The vaccine is given in either two or three doses, depending on the age of the person when initially vaccinated.
HPV vaccination is not generally recommended for people over age 26 because it provides less benefit, primarily because more people have already been exposed to HPV in this age range. However, it may be worth a discussion with your healthcare provider if you are between the ages of 27 and 45 and have not previously been vaccinated to determine if HPV vaccination is right for you.
You may be wondering why boys need HPV vaccination if HPV is primarily associated with cervical cancer, but the fact is that boys can get some types of cancer that are also caused by HPV, including cancers of the head and neck, as well as cancers of the anal and genital area. They can also get genital and anal warts caused by HPV.
More than 135 million doses of HPV vaccines have been given in the U.S., according to the CDC. The vaccines have been shown to be safe and effective. The most common side effects include:
Any side effects experienced tend to be mild and get better within a day or two.
January 18, 2024
2 min read
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COVID-19 vaccination reduces the risk for long COVID in children, according to findings from a study of more than 1 million children published in Pediatrics.
Although research has shown that many children experience persistent symptoms that last months after a SARS-CoV-2 infection, physicians have said that awareness of long COVID in children is lacking.
When we think about how to prevent long COVID, obviously, one of the first things that we think about is vaccine effectiveness, Hanieh Razzaghi, PhD, MPH, a data scientist at The Childrens Hospital of Philadelphia (CHOP), told Healio. There are a lot of data specifically clinical trial data that look at vaccine efficacy, but the question about long COVID still remained unanswered. So, we were very motivated to undertake this.
There was urgency to the investigation, another
We're still just scratching the surface of what might treat long COVID, Charles Bailey, MD, PhD, attending physician in the cancer center and academic investigator at CHOP, told Healio. Most of the access to those is for adults, so there actually aren't a lot of treatment options available for children, and that makes prevention even more important.
Razzaghi, Bailey and colleagues studied data from 17 health systems to assess vaccine effectiveness against long COVID in two groups of patients aged between 5 and 11 years and 12 and 17 years and the time period. The vaccination rate was 67% in the cohort of 1,037,936 children.
According to the researchers, the incidence of probable long COVID in the cohort was 4.5% and the incidence of diagnosed long COVID was 0.7%. They estimated that vaccine effectiveness within 12 months against long COVID was 35.4% among children with probable long COVID and 41.7% among children diagnosed with long COVID.
Estimated vaccine effectiveness was higher in the older age group (50.3%) compared with younger children (23.8%), and higher at 6 months (61.4%) than at 18 months (10.6%).
Children vaccinated after recovering from COVID-19 who endured a subsequent case of the illness also appeared to benefit, with a calculated vaccine effectiveness of 46% against probable long COVID.
One of the things that was very interesting was that the effectiveness did wane over time, Razzaghi said. It was most effective within 6 months of the vaccine. Within a year, and then at 18 months, we were still seeing a protective effect, but it was reduced.
Bailey noted that protection for teenagers looked significantly better than for younger children.
I suspect that a lot of what's happening there is that we're better at spotting long COVID in teenagers, who can talk to us about how they're feeling, Bailey said. It gave me some pause because I think it tells me that we need to keep learning about what long COVID looks like in younger children.
COVID-19 vaccine reduces long COVID in children. https://www.chop.edu/news/covid-19-vaccine-reduces-long-covid-children. Published Jan. 16, 2024. Accessed Jan. 17, 2024.
Razzaghi H, et al. Pediatrics. 2023;doi:10.1542/peds.2023-064446.
Ziyad Al-Aly, MD
This is an interesting and well-done study. The news is welcome and supports the growing body of evidence that vaccines work they don't only reduce the risk for severe disease (hospitalization and death) in the acute phase but also reduce the risk for long COVID. The evidence base is less well developed in children than in adults. This study is certainly a welcome addition to the literature. I do hope it motivates better uptake of vaccination among children.
The study also shows that although vaccines work (in reducing the risk for long COVID), they are not a perfect shield. To achieve maximum risk reduction, additional layers of prevention measures are needed.
Ziyad Al-Aly, MD
Chief of research and development
VA St. Louis Health Care System
Disclosures: Al-Aly reports no relevant financial disclosures.
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Disclosures: Bailey and Razzaghi report no relevant financial disclosures. Please see the study for all other authors relevant financial disclosures.
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Cervical cancer should be almost nonexistent, as it's one of the most treatable and preventable cancers. However, women in the United States are still dying at alarming rates.
In 2009, the US Congress established January as Cervical Cancer Awareness Month. This month serves as a public health campaign to educate people who have a cervix about how to take care of it. This includes noticing signs of cervical cancer, getting a vaccination, and checking in with a gynecologist.
Most forms of cervical cancer are caused by human papillomavirus (HPV). The two strands of HPV that cause 75 percent of cervical cancers can be prevented through the HPV vaccine a series of shots administered to people between the ages of 9 and 45. With such an effective solution, one might think cervical cancer was nothing to worry about and that our advocacy efforts should focus elsewhere.
US states like Georgia, Alabama, and Mississippi, where rates are especially high, prove otherwise. Also, because of legacies of anti-Blackness, systemic racism, discrimination, and inequitable healthcare services, Black people are disproportionately impacted by cervical cancer rates and deaths across the US.
Ensuring that healthcare is accessible and affordable including the HPV vaccination plays a pivotal role in addressing racial inequities around cervical cancer, including in who gets sick and who dies. But new risks need to be faced, too. This includes state lawmakers attacks on and the growing anti-vaccination movement.
Some states want to end public school vaccination mandates. Although HPV vaccination is not among those required before children can enroll in public schools, raising awareness about the HPV vaccine is a key part of the advocacy around cervical cancer prevention. The anti-vax movement has the potential to set this work back.
If young people can't receive sexual health education and vaccine information in schools, and if school mandates for vaccines are removed, the impact on cervical cancer rates could be devastating. This is why campaigns like Georgias Adolescent Power and Potential which call for legislation that would mandate sexual education and vaccination information in schools need our attention. Cervical cancer is highly preventable, and we should not allow lawmakers to strip these healthcare decisions from young people, including Black girls and youth.
In a recent article published in TheLancet, researchersexamined the association between under-vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and severe coronavirus disease 2019 (COVID-19) outcomes across the United Kingdom (UK).
Study:Undervaccination and severe COVID-19 outcomes: meta-analysis of national cohort studies in England, Northern Ireland, Scotland, and Wales. Image Credit:solarseven/Shutterstock.com
Previous studies have examined vaccine uptake in the UK; however, population-level studies examining the risk of severe COVID-19 outcomes in under-vaccinated people are lacking.
The UK COVID-19 vaccination programme started on December 8, 2020. The Joint Committee on Vaccination and Immunisation (JCVI) recommended one COVID-19 vaccine dose for children aged five to 11 years, two for 1215-year-olds, and three and four for people aged 1674 and 75+.
Over 90% of the UK population above 12 years received the first dose of a COVID-19 vaccine within a few months; however, its uptake declined as more doses were offered, especially among Black ethnicities, those older than 50 years, and those inhabiting more deprived or urban areas.
Clinical trials and observational epidemiological studies have shown the association of COVID-19 vaccine doses with COVID-19 outcomes, such as hospitalizations and deaths.
Researchers conducted separate cohort studies in England, Scotland, Northern Ireland, and Wales using anonymized, harmonized electronic health record (EHR) data from national trusted research environments (TREs).
All four study cohorts included individuals at least five years of age, further stratified into groups: 511, 1215, 1674, and 75 years.
The outcomes of interest were the adjusted odds ratios (aORs) for under-vaccination against SARS-CoV-2 as of June 1, 2022, and severe COVID-19 outcomes between June 1 and September 30, 2022.
Undervaccination, i.e., non-receipt of the standard age-stratified JCVI recommended vaccine schedule, was assessed in each nation for several clinical and demographic groups and cumulatively.
The statistical analysis included these covariates: age group, gender, ethnicity, urban or rural residence, deprivation index, and QCOVID risk groups, derived primarily from general practitioner data, and its availability for some UK nations was limited.
For instance, ethnicity and public practitioner data were not available for Northern Ireland.
The team analyzed time to severe COVID-19 outcomes in different age groups separately for each nation using Cox proportional hazard models, where vaccine deficit was a time-dependent exposure.
Likewise, they fitted in logistic regressions across age groups to analyze under-vaccination as the dependent variable.
Additional tests helped the researchers assess collinearity and model performance, etc., where they used more covariates, such as COVID-19 test results, number of tests taken, health board, shielding status, size of household, and hospitalizations, including COVID-19-unrelated hospitalizations.
Finally, the researchers conducted a UK-wide meta-analysis of nation-specific analyses. In this study, they compared the estimates of the decrease in severe COVID-19 outcomes associated with under vaccination with a counterfactual scenario, where the UK population was fully vaccinated for COVID-19 by June 1, 2022.
As of June 1, 2022, the number of people under-vaccinated in England, Northern Ireland, Scotland, and Wales was 26,985,570,938,420, 1,709,786, and 773,850.
These numbers corresponded to 458%, 498%, 342%, and 444% of the initial cohort size of each nation.
The effect size estimates for the number of risk groups varied across countries in the analysis where undervaccination was the outcome.
For instance, aORs for under vaccination were higher in individuals aged 8084 years and 85+ in Scotland compared with other nations.
It reflected different data availability for QCOVID risk groups and residual confounding from the number of risk groups.
Further, the study results suggested that younger individuals, those from more deprived regions, and of non-White ethnicity, or those with fewer comorbidities were more likely to be under-vaccinated for COVID-19.
Accordingly, of 40,393 severe COVID-19 outcomes across cohorts, 14,156 occurred in unvaccinated participants.
Reductions in severe COVID-19 outcomes over four months of follow-up varied for age groups; these were 210, 1,544, and 5,426 for 515, 1674, and 75+ years age groups, respectively.
In the meta-analysis for the 75-year-olds, aHRs for severe COVID-19 outcomes were 2.70, 3.13, 3.61, and 3.08 for one, two, three, and four dose(s) fewer than recommended.
Moreover, males in this age group showed higher aHR of severe COVID-19 outcomes than females.
The present study furnished precise estimates for the association between full vs. under vaccination and higher risk of severe COVID-19 outcomes for the four UK countries.
Results indicated that under-vaccination rates against COVID-19 in these UK countries ranged from 328%-498% among individuals aged five years or more.
Further analysis showed that had been the vaccine uptake higher, it would have resulted in a considerable reduction in severe COVID-19 outcomes, especially among at-risk subpopulations in the UK. This data could inform policy, public health, and research.
More importantly, the study highlights the significance of analyses on harmonized health datasets across the UK as it could be beneficial in understanding population health outcomes to help design better future health interventions.
The new Covid-19 sub-variant JN.1 started a new scare among the masses with growing numbers of cases all around the world. The scare was so much that in some parts of the world, people were reminded of old pandemic days.
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The latest figures show that Englands current Covid wave is less likely to get people sick enough to be hospitalised, as compared to previous waves.
It means, people who are infected by Covid-19 recently have less to worry about than at any other time during the pandemic, Paul Hunter at the University of East Anglia in the UK told the NewScientist.
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JN.1 subvariant which was first detected in August in Luxembourg was another version of the deadly Omicron variant. It then spread across many European countries quickly and by November it became quite evident by genetic sequencing that JN.1 was rapidly taking over.
These observations led to concerns over JN.1 that it might start a new Covid wave that would be even deadlier than the previous ones. At this time, hospitals in Europe have already been facing a high turnout of patients with seasonal respiratory viruses. This encouraged hospitals in Europe to take preventive measures way before it was established whether JN.1 is as deadly as Omicron.
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Fortunately, data later suggested that the fear of a bigger wave because of JN.1 variant is not true.
To put things into perspective, the number of Covid-19 infected people in England amid the current wave seems to have peaked in late December, at about 4.5 per cent of the population, as per a large, regular survey by the Office for National Statistics and the UK Health Security Agency. This is similar to that seen during the Covid-19 wave that peaked in December 2022.
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Yet the number of Covid-19 infected people being admitted to hospitals in England seems to have peaked this winter at just over a third of the equivalent figure from 2022. The number was 3300 a year ago in early January, while during the same time in 2024, only 1300 people were hospitalised.
It is unclear whether the fall in severity is because JN.1 is milder than other variants or if people just have more immunity to Covid-19 now due to past infections and vaccinations, I think immunity is probably playing a big role, but it may be that the latest variant is also less virulent, says Hunter.
(With inputs from agencies)
Research on COVID-19 misinformation conducted by Dr. Nitin Agarwal, Maulden-Entergy Chair and Distinguished Professor of Information Science and founding director of the Collaboration for Social Media and Online Behavioral Studies (COSMOS) Research Center at the University of Arkansas at Little Rock, has been highlighted as a success story by the U.S. Army Research Office.
The story, Developing Research Infrastructure to Strengthen Socio-Cognitive Security for Combating Misinformation and Deviant Collective Behavior, was featured in the U.S. Army Research Offices year-in-review magazine.
In this research, funded and recognized by the ARO, Dr. Agarwal and his team at the COSMOS research center applied their expertise to study COVID-19related cross-media misinformation campaigns and scams. They put the research in practice by deploying the research-driven solution in collaboration with Arkansas Attorney Generals office to raise awareness and combat misinformation and scams in the state of Arkansas.
This groundbreaking work has garnered recognition from the World Health Organization (WHO), acknowledging its potential as a critical technological innovation in the fight against COVID-19. COSMOS worked closely with the Arkansas Attorney Generals office to understand their need during an intensive barrage of COVID-19related scams and misinformation and delivered effectively for proactive policymaking. Findings from this collaboration were published in the book entitled Coronavirus and Disinformation A Whole of Society Perspective under the auspices of NATO Research and Technology Group (RTG HFM-293).
Our inclusion in the U.S. Army Research Offices year-in-review magazine marks not just a milestone for our team but a beacon of commitment to truth and building community resilience against the tide of misinformation by working closely with our policymakers, Agarwal said. As the digital landscape evolves, so does our dedication to fortifying our socio-cognitive security. The journey continues, and each discovery strengthens the foundation of our collective pursuit.
The funding and recognition of the Army Research Office not only speaks to the importance of such research pursuits, but also to how COSMOS has taken academic theories, such as those on deviant collective behaviors, and applied them with computing algorithms in such a way that government and military officials can now look to such research for practical solutions.
This demonstrates COSMOSs ability to bridge science, society, and policy-making through research, technology, and innovation, Agarwal said. We demonstrated how modern coordinated cognitive threats can be modeled, and its consequences can be mitigated through proactive policy-making supported by research-driven solutions. The recognition puts us at par with research centers and labs at top-tier institutions across the nation working to advance foundational research competencies to enable crucial future Army technologies and capabilities.
