Category: Vaccine

Page 125«..1020..124125126127..130140..»

Effectiveness of the new omicron booster confirmed – Medical Xpress

December 20, 2023

This article has been reviewed according to ScienceX's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility:

fact-checked

peer-reviewed publication

proofread

by Stefan Zorn , Medizinische Hochschule Hannover

close

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

Continue reading here:

Effectiveness of the new omicron booster confirmed - Medical Xpress

‘Incredibly promising:’ Researchers encouraged by early results of breast cancer vaccine – News 5 Cleveland WEWS

December 20, 2023

CLEVELAND, Ohio Researchers think the early results from a trial vaccine could be a breakthrough in the fight against an aggressive and deadly form of breast cancer.

This month, Cleveland Clinic and Anixa Biosciences released positive new data from the first phase in the trial of an unnamed vaccine for triple-negative breast cancer.

According to the Centers for Disease Control, one in eight women will be affected by breast cancer in their lifetime. The Cleveland Clinic says about 15% of those cases are triple-negative breast cancer, which spreads more quickly and can be more difficult to treat than other types of cancer.

Jenni Davis recalled the feeling of dread when she was diagnosed with the disease.

You shift how you live when you think about those things, Davis said.

The mother of three visited her doctor after discovering a lump in her left breast. Within weeks of the diagnosis, she began chemotherapy, the first of 26 rounds of radiation and a double mastectomy.

[There was] not a lot of time to process what was happening, Davis said. I have children and my mom and husband and stepdad, everybody. It was difficult.

A team at the Cleveland Clinic successfully treated the Lisbon, Ohio native. But Davis said the progress was tempered by the thought of the cancer returning.

It was in the front of my mind every day, every single day, she said.

Triple-negative breast cancer (TNBC) survivors face a more than 40% chance of the disease coming back. The second occurrence is often more aggressive and difficult to treat. Davis said the statistics made it an easy decision to take part in a vaccine trial for the disease.

I am beyond grateful that I got to be a part of this trial and I'm excited for where it's heading, she said.

Davis was the first human participant in the study of an unnamed vaccine developed with decades of research at the Cleveland Clinic.

Sixteen patients participated in the first phase of the trial. The women, all TNBC survivors with a high risk of developing the cancer again, received three vaccinations given once every two weeks.

Researchers say the early results are encouraging.

Im making some very bold statements based on the results of 16 women, but the data is incredibly promising and we hope as we go forward that we will have as good or better results in larger numbers of women, said Dr. Amit Kumar, the CEO and chairman of Anixa Biosciences.

The biotechnology company is manufacturing the vaccine in collaboration with the Cleveland Clinic. Results released by Anixa in early December show all of the trial participants experienced some immune response from the vaccine. 75% of the women had especially robust cancer-fighting immune responses.

Dr. Kumar is hopeful expanded study of the vaccine will corroborate the early findings. He believes the research and methods used for the TNBC vaccine could help advance the prevention of other diseases.

It may take a few decades, but one day we may have vaccines for multiple types of cancers, he said.

Trial participants, including Davis, report little to no side effects from the vaccine. Davis said its eased her mind and helped her focus on her family and life, rather than a potential future cancer battle.

I look forward to everyone being able to get it, I look forward to my girls being able to get it one day, she said. Its just something I am so thankful for.

Anixa and the Cleveland Clinic are scaling up the first phase of the vaccine trial to include more participants. A second phase set to begin in mid to late 2024 will include a controlled group receiving the standard of care to compare to the group receiving the vaccine.

We Follow Through

Want us to continue to follow through on a story? Let us know.

Excerpt from:

'Incredibly promising:' Researchers encouraged by early results of breast cancer vaccine - News 5 Cleveland WEWS

New vaccine strategy targets SARS-CoV-2’s stable S2 subunit, offering broad protection against evolving variants – News-Medical.Net

December 20, 2023

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.

See original here:

New vaccine strategy targets SARS-CoV-2's stable S2 subunit, offering broad protection against evolving variants - News-Medical.Net

COVAX winds down with COVID vaccine shift to regular programs – University of Minnesota Twin Cities

December 20, 2023

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.

Read more:

COVAX winds down with COVID vaccine shift to regular programs - University of Minnesota Twin Cities

Vaccines reduce the risk of long COVID in children – Nature.com

December 20, 2023

Uptake of COVID-19 vaccinations for children in the United States has been low, even when compared with the rates of influenza vaccination in this age group.Credit: Jeff Kowalsky/AFP via Getty

Vaccinated children are less likely than unvaccinated children to develop long COVID, the myriad of symptoms that can last for months to years following a SARS-CoV-2 infection, according to a forthcoming US study1.

This is really important data, says Jessica Snowden, a paediatric infectious-disease specialist at the University of Arkansas for Medical Sciences in Little Rock. She says that in the United States, COVID-19 vaccines are recommended for children as young as 6 months old. But uptake has been low. This will demonstrate to families how important it is that we protect our kids, not just from acute COVID, but from the longer-term impacts of COVID as well.

For the study, Anna Yousaf, a medical officer at the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, and her colleagues enrolled 1,600 children and collected weekly nasal swabs from them for more than a year to check for the SARS-CoV-2 virus. The team narrowed the study to 622 participants aged 5 to 17 years who caught COVID-19; 28 went on to develop long COVID. The researchers then calculated the odds of vaccinated and unvaccinated children experiencing ongoing symptoms.

The results, presented in October at the annual health-care conference IDWeek in Boston, Massachusetts, and due to be published in the coming months, demonstrated that vaccination reduced the likelihood of developing at least one long COVID symptom by 34% and of developing two or more symptoms by 48%. Yousaf says that this is likely to be an underestimate, because the study only looked at children who had an infection; it did not consider that the vaccine can reduce the chances of developing the infection, which also decreases the likelihood of long COVID.

Danilo Buonsenso, a paediatric infectious-disease specialist at the Gemelli University Hospital in Rome, says that the study design was rigorous but points out that it defined long COVID as the persistence of symptoms after one month, whereas the World Health Organization describes long COVID as symptoms that last for at least two months. He says the study also relied on self-reporting of long COVID and not a clinical diagnosis a problem because long COVID includes several broadly defined symptoms that children might experience on a regular basis. Both issues will make it hard to calculate the real incidence of long COVID in children, but Buonsenso says the comparison between vaccinated and unvaccinated children is still statistically robust. It confirms that vaccinations can reduce the burden of long COVID, but not eliminate it, he says.

The findings line up with several recent studies suggesting that vaccines reduce the incidence of long COVID in adults (see, for example, ref. 2). However, paediatric data are limited a major issue because children are not little adults, Snowden says. Their bodies and immune systems are growing and therefore respond to infection and vaccination differently from adults. As such, it was never a guarantee that the vaccine would have the same protective benefit against long COVID. Studies like this show that kids are worth looking at in and of themselves, Snowden says.

These data are another argument in favour of vaccination, Buonsenso says, particularly for newborns who have not yet been exposed to COVID-19. Some European countries do not recommend the vaccine for younger children, in part because so many have already been exposed to the virus and thus have some immunity.

Even in the United States, where the vaccine is recommended as an annual booster for children as young as 6 months, vaccination remains uncommon. As of mid-December, 7.8% of US children had received their autumn COVID-19 vaccine, well below the rate of influenza vaccination, at 43.3%. Yousaf thinks that this is because the Omicron variant of SARS-CoV-2 is often thought of as a milder strain causing light colds that dont necessarily lead to long COVID. Indeed, a recent US household survey found that the rate of long COVID in children was merely 1.3% in 2022, but that still translates to thousands of kids whose health is affected, meaning they might not be able to run around, play or go to school. If you read the individual stories, the impact of long COVID on a childs life can be very severe, Yousaf says.

COVID is not going away, Snowden says. We are fortunate that so far, the variants are less severe as weve gone forward. But thats not a guarantee. And so anything we can do to protect our children from the long-term impact of COVID is critical.

Follow this link:

Vaccines reduce the risk of long COVID in children - Nature.com

Why Is COVID-19 Vaccine Player CureVac Stock Plummeting Today? – Yahoo Finance

December 20, 2023

A German court has invalidated a patent central toCureVac N.V's(NASDAQ: CVAC) lawsuit againstBioNTech SE(NASDAQ: BNTX) related to seeking fair compensation for infringement of a portfolio of CureVac's intellectual property rights utilized in Comirnaty, BioNTech, andPfizer Inc's(NYSE: PFE)mRNA COVID-19 vaccine.

The rulingrepresentsthe first decision on validity in ongoing patent litigation between CureVac and BioNTech in Germany, involving eight CureVac intellectual property rights.

Proceedings continue regarding the seven remaining rights, for which validity, infringement, and potential damages will be decided individually.

Following the decision, a ruling on infringement of the German part of EP 1 857 122 B1, scheduled for December 28, 2023, before the Regional Court Dsseldorf, will likely be postponed.

The stakes remain high for CureVac in this legal conflict, Reuters highlighted, citing analysts, the potential transformation of its financial status if even a fraction of the revenues were awarded.

Earlier, a regional German court halted a separate patent infringement trial brought by CureVac against BioNTech, awaiting decisions from German and European patent offices regarding the validity of CureVac's intellectual property rights, indicating the complexities and delays in the legal proceedings.

CureVac and Pfizer/BioNTech are in alegal tussleover the vaccine patent in the U.S. as well.

In May, CureVac was granted to transfer the ongoing patent litigation filed by Pfizer/BioNTech in the federal district court of Massachusetts to the Eastern District of Virginia. The transfer is expected to significantly accelerate the progress of the litigation, allowing for a likely 2024 trial date.

Last month,Acuitas Therapeuticsfiled a lawsuit in Virginia federal court against Germany-based CureVac, accusing it of failing to credit Acuitas on patents relatedto COVID-19 vaccines.

Story continues

Price Action:CVAC shares are down 33.9% at $3.848, and BNTX stock is up 2.69% at $106.36 on the last check Tuesday.

"ACTIVE INVESTORS' SECRET WEAPON" Supercharge Your Stock Market Game with the #1 "news & everything else" trading tool: Benzinga Pro - Click here to start Your 14-Day Trial Now!

This article Why Is COVID-19 Vaccine Player CureVac Stock Plummeting Today? originally appeared on Benzinga.com

2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Read the original here:

Why Is COVID-19 Vaccine Player CureVac Stock Plummeting Today? - Yahoo Finance

Maternal Flu Shot Protects Infants Against Severe Disease – Medpage Today

December 20, 2023

Maternal influenza vaccination was effective at protecting infants under 6 months against severe disease, a case-control study showed.

While overall effectiveness was 34% (95% CI 12-50) against markers of severe disease -- hospitalizations and emergency department (ED) visits combined -- effectiveness was significant for hospitalizations (39%, 95% CI 12-58) but not for ED visits in secondary analyses, according to Leila Sahni, PhD, MPH, of Baylor College of Medicine and Texas Children's Hospital in Houston, and colleagues.

Effectiveness was also greater for infants less than 3 months of age (53%, 95% CI 30-68) and when mom was vaccinated during the third trimester (52%, 95% CI 30-68), they reported in JAMA Pediatrics, though they noted that secondary analyses should be considered exploratory.

"Infants younger than 6 months are at high risk of influenza-associated complications but are not eligible for vaccination given the absence of licensed influenza vaccines for this age group," Sahni and colleagues wrote. "Maternal influenza vaccination is safe, immunogenic, and can prevent laboratory-confirmed influenza and its complications in both mothers and infants."

However, "recent evidence, particularly from the U.S. after the H1N1 pandemic and data on maternal effectiveness by timing during pregnancy are limited," they added. "Updated data are needed on maternal vaccine effectiveness and data to determine optimal timing of vaccination to benefit the pregnant person and their infant."

Further results from secondary analyses showed that effectiveness of maternal influenza vaccination wasn't significant when mothers were vaccinated during their first or second trimesters.

"These findings, particularly the timing of maternal vaccination, weren't surprising to us," Sahni told MedPage Today in an email. "However, this speaks to the complexity of maternal vaccination timing, and the need to balance benefit to the mother who should ideally be vaccinated before influenza season begins, which may occur early in pregnancy, against benefit to the infant, which we found was greatest when vaccination occurs later in pregnancy."

"Additional studies should investigate the timing of vaccination during pregnancy and the benefit to the mother and infant," Sahni added.

Vaccine effectiveness was 47% against influenza B (95% CI 13-68) but it wasn't significant against influenza A, the researchers found; nor was it effective against influenza A subtypes H1N1 or H3N2 in those secondary endpoint analyses.

Sensitivity analyses excluding infants with positive test results for A/H3N2 and mothers with prior season vaccination yielded vaccine effectiveness of 43% (95% CI 17-60) and 42% (95% CI 20-58), respectively, the researchers added.

The study "strengthens the evidence that infants benefit when persons receive the quadrivalent-inactivated influenza vaccine during pregnancy," Katherine Poehling, MD, MPH, of Atrium Health Wake Forest Baptist, in Winston-Salem, North Carolina, and colleagues wrote in an accompanying editorial, noting that guidelines from the CDC and the American College of Obstetricians and Gynecologists recommend that pregnant patients receive the inactivated influenza vaccination during the flu season. "With only half of pregnant persons receiving the influenza vaccine in this study and nationally, there is a huge opportunity to improve vaccine coverage and health outcomes for all pregnant persons and newborns."

Opportunities to optimize the health of mothers and their babies include expanding vaccine registries from children to persons of all ages, having all clinicians who see pregnant persons strongly recommend flu vaccination during pregnancy, and having obstetric and pediatric clinicians collaborate on approaches to improve access to, confidence in, and coverage of vaccines and preventive care, they added.

"These data are very encouraging and provide us with updated evidence supporting the benefit of influenza vaccination during pregnancy to protect both the pregnant person and their infant from serious influenza illness," Samantha Olson, MPH, co-first author of the study and epidemiologist with the CDC's Influenza Division, told MedPage Today in an email.

For this prospective, test-negative case-control study, Sahni and colleagues used data from the CDC's New Vaccine Surveillance Network from the 2016/2017 through the 2019/2020 influenza seasons. Infants younger than 6 months of age with an ED visit or hospitalization for acute respiratory illness were included from seven pediatric medical centers in the U.S. Infants with an influenza-negative molecular test were included as controls.

Among 3,764 infants included in the study, 53% were born to vaccinated mothers, including 94 of 223 (42%) infants with influenza and 1,913 of 3,541 (54%) control infants. Among the 2,007 vaccinated mothers, 54% had vaccination verified by immunization information systems or medical records and 46% had self-reported vaccination with timing.

Study limitations included that information about maternal influenza infection during or after pregnancy was not included, nor were data on influenza vaccination prior to conception or postpartum.

Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.

Disclosures

The study was supported in part by the CDC.

Authors reported relationships with the NIH, Sanofi, Quidel, Merck, AstraZeneca, Pfizer, GSK, Cepheid, Viracor, AbbVie, Ark Biopharma, Meissa, Moderna, and Shionogi.

Editorialists reported relationships with Optum, Organon Nexplanon, and DynaMed EBSCO Industries.

Primary Source

JAMA Pediatrics

Source Reference: Sahni LC, et al "Maternal vaccine effectiveness against influenza-associated hospitalizations and emergency department visits in infants" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2023.5639.

Secondary Source

JAMA Pediatrics

Source Reference: Zuber MJ, et al "Influenza vaccination in pregnancy -- rolling up sleeves for pregnant persons and infants" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2023.5630.

Read the original here:

Maternal Flu Shot Protects Infants Against Severe Disease - Medpage Today

Hiltzik: The coming toll in vaccine-preventable diseases – Los Angeles Times

December 20, 2023

Forecasting the future is difficult. But heres an easy prediction: The anti-vaccination movement in the U.S. and globally is going to result in the deaths of more children.

This grim portent comes to us courtesy of UNICEF, which is reporting that 30,601 confirmed cases of measles have been reported in Europe and Central Asia this year through Dec. 5.

Thats up from 909 cases in those regions in 2022, or an increase of 3,266%.

There is no clearer sign of a breakdown in immunization coverage than an increase in cases of measles.

Regina De Dominicis, UNICEF

UNICEF expects the final annual tally to be considerably higher, because the measles rate nearly doubled in October and November, marking a longer-term surge.

There is no clearer sign of a breakdown in immunization coverage than an increase in cases of measles, says Regina De Dominicis, UNICEFs regional director for Europe and Central Asia.

Newsletter

Get the latest from Michael Hiltzik

Commentary on economics and more from a Pulitzer Prize winner.

Enter email address

Sign Me Up

You may occasionally receive promotional content from the Los Angeles Times.

In the United States, measles has remained more or less under control since the 2019 spike to 1,274 cases: 41 cases reported so far this year, down from 121 in 2022.

The 2019 surge was attributed to pockets of unvaccinated people spreading the virus. A spike also appeared in 2014, when more than half the 667 cases were attributed to unvaccinated Amish communities in Ohio.

That epidemiological pattern is what should give you qualms about what lies ahead for the U.S. Thats because the anti-vaccine movement is in full cry across the country, fueled by right-wing ideology and the presidential campaign, such as it is, of prominent anti-vaccine agitator Robert F. Kennedy Jr.

This 2014 map showed the surging incidence across the world of measles (red), whooping cough (green), mumps (brown), rubella (blue), polio (orange) and other (yellow). In the developed world, the cause was anti-vaccine sentiment; in the Third World, it was the unavailability of vaccines.

(Council on Foreign Relations)

A key factor spurring the spread of anti-vaccine propaganda is the politicization of the COVID-19 vaccines. One leading public health advocate has called that phenomenon an accelerant for the anti-vaccine movement, which likens it to a can of gasoline in the hands of an arsonist.

For anti-vaxxers, it has been only a short step from opposition to COVID vaccine mandates to opposition to all childhood immunization mandates. This has often proceeded under the banner of health freedom, the idea being that individuals should have the untrammeled right to decide for themselves what to put or not put in their bodies.

That may be marginally defensible when it concerns individuals decisions to eat or drink themselves to death, but obviously vaccination is in a different category: A vaccine defends not only patients themselves, but everyone around them fellow pupils, teachers, family members, strangers with whom they come into contact.

Vaccination works best when it reaches coverage of about 95% of a population, producing what is sometimes described as herd immunity, in which a disease is so well suppressed that even the few unvaccinated members are protected.

It doesnt take a very large decline in vaccine coverage to spur a surge in disease incidence. Consider the record in Britain. Through 1997, about 91% of British schoolchildren had received the measles/mumps/rubella (MMR) vaccine.

In 1998, the Lancet, a then-respected British medical journal, published a notorious article claiming a link between the MMR vaccine and autism, and by 2004 the vaccine uptake had fallen to 80%. Measles cases soon surged from an average of about 100 a year through 2005 to 1,280 in 2008 and 1,920 in 2012. By then the vaccination rate had begun to recover, but as of last year it was still below 90%.

That article, by the way, was fully retracted by the Lancet in 2010 and its principal author, Andrew Wakefield, stripped of his medical license. He has since surfaced in the U.S. as a star of the domestic anti-vaccine movement, rubbing shoulders with Kennedy and his gang.

Kennedys entry into the political fray poses a particular peril to public health because political reporters, who may be tasked with interviewing him on policy, may be ill-equipped to challenge the fire hose of misinformation and disinformation he dispenses with cocksure certainty.

When a reporter gets it right, compliments are warranted, so lets examine an interview that CNNs Kasie Hunt conducted with Kennedy on Dec. 15. Hunt came armed. When she quoted Kennedy as saying, There is no vaccine that is, you know, safe and effective, he responded, I never said that.

Hunt cut Kennedy off on the spot and ran a clip from an interview in which he said, yep: There is no vaccine that is, you know, safe and effective.

Kennedy mumbled and bumbled for a moment or two, then confessed to a bad choice of words and eventually retreated to his oft-repeated assertion that none of the vaccines currently recommended for children have ever been tested in a pre-licensing safety study.

Unfortunately, at that point, Kennedy had Hunt at a disadvantage. His assertion was carefully phrased to sound as though the Food and Drug Administration waved through all the childhood vaccines without a second thought. In other statements, Kennedy has made clear that he means that the vaccines have not been subjected to placebo-controlled randomized, double-blinded trials. This is the core of Kennedys claim that hes not anti-vaccine, but merely an advocate for vaccine safety.

As Ive written before, this is misleading to the point of being a flagrant lie.

The truth is that the FDA doesnt allow vaccines on the market unless theyve been safety-tested. When a vaccine is introduced as a treatment for a disease for which no safe and effective vaccine exists, its subjected to one of those randomized, placebo-controlled trials.

Once its approved, however, that standard for later generations of the same vaccine is different. As explained by vaccine specialist Paul Offit of Childrens Hospital of Philadelphia, subjecting those vaccines to placebo-controlled testing, say by injecting them with water or a saline solution instead of the vaccine, would be unethical, because it would require depriving half of the subjects of a known treatment.

The vaccines currently recommended for children are later-generation versions of shots that were placebo-tested. So are the COVID-19 vaccine boosters on the market today.

Offit points to what may be the most famous randomized trial in history, the 1954 test of Jonas Salks polio vaccine, in which about 200,000 first- and second-graders got the vaccine and 200,000 got salt water. Offit tells us that Salk didnt want to structure the trial that way because polio was paralyzing 50,000 American kids a year and killing 1,500, and he felt it was wrong to deprive 200,000 of protection.

In the event, 16 of the child subjects died of polio during the study, all in the placebo group, and 36 were paralyzed, 34 of them in the placebo group. They gave their lives and health for nothing. Even today, when a clinical trial establishes that a treatment is safe and effective, its often halted early, so the placebo patients can get the treatment without waiting.

Hunt let this claim by Kennedy slide, perhaps because she couldnt be prepared in advance for all the lies he was ready to spin out. But the claim was part of his known arsenal, so perhaps she should have been ready.

With RFK Jr. running for President, says veteran pseudoscience debunker David Gorski, being ready with clips to bring home the evidence are not enough. Reporters on the Kennedy beat must develop a deep knowledge of the antivaccine claims that hes been making since at least 2005 and then using that knowledge every time he tries to deny being antivaccine. By his recknoning, Kasie Hunt did way better than average with RFK Jr., but journalists need to do better still.

Fighting back against the anti-vaccine propaganda spewed out by Kennedy and his cohort has never been as desperately crucial as it is today.

Thanks to the sustained assault on vaccination and science waged by right-wingers devoted to burnishing their own partisan bona fides rather than working in the public interest, vaccine coverage of kindergarten children has been declining since 2019 and remains well below the 95% target, according to the Centers for Disease Control and Prevention.

The share of children with a nonmedical exemption from vaccination, such as a parents purported religious or moral objections, reached 3% in the 2022-23 school year, the highest exemption rate ever reported in the United States, the CDC reports.

In Florida, that hotbed of anti-science folderol purveyed by Republican Gov. Ron DeSantis and his handpicked surgeon general, the anti-vaccine charlatan Joseph Ladapo, school vaccine rates for non-COVID diseases fell in 2022 to the lowest level in 10 years. Its rate fell again this year, by an appalling 0.6 percentage points to 4.5%, the 12th worst in the nation.

States with responsible leaders respond to trends that threaten public health to that degree. After Californias 2010 outbreak of whooping cough (pertussis) 9,120 cases, the most since 1947, the majority among unvaccinated children the Legislature eliminated almost all nonmedical exemptions for childhood immunization. Californias exemption rate of 0.2% in 2022-23 was the third best in the nation, after West Virginia and New York.

Can vaccine resisters be reached with a rational counterargument? One would think so. They tend not to be low-income, low-information residents two of the most-vaccinated states are West Virginia and Mississippi.

Rather, they tend to come from more affluent, educated families, the sort of people who think theyre so smart they can decide healthcare policies for themselves, no matter how complex the issue.

In this respect, however, theyre just being stupid and irresponsible. They should be receptive to reason. Lets hope that it doesnt take outbreaks of dangerous diseases like measles in their school districts to open their eyes.

See more here:

Hiltzik: The coming toll in vaccine-preventable diseases - Los Angeles Times

EU Hoarding Then Dumping COVID Vaccines Highlights Pandemic Accord Equity Challenge – Health Policy Watch

December 20, 2023

Vials of Pfizers COVID-19 vaccine.

Days after government officials took a break from frenetic pandemic accord negotiations, news broke that European countries had destroyed at least 215 million unwanted COVID-19 vaccine doses valued at over 4 billion.

The 19 countries surveyed dumped 0.7 doses per resident with Estonia and Germany being the most wasteful, according to Politico, which broke the story this week.

In 2021, the European Union (EU) bought the equivalent of three doses per resident in secret deals with drug companies hoarding these when African countries did not have access to any vaccines, not even for health workers.

Ending this cycle of waste and want is at the heart of the current pandemic agreement negotiations hosted by the World Health Organization (WHO). The talks are due to conclude in May 2024 with an agreement to govern countries conduct during pandemics but parties seem to have entrenched disagreement about how best to ensure equitable access to vaccines and other medical products in future pandemics.

The Peoples Vaccine Alliances Piotr Kolczyski said that the EU appears not to have learnt from its COVID mistakes, based on the positions it has taken during the pandemic agreement negotiations.

The EU pumped unprecedented public funding into COVID-19 vaccines with no strings attached to ensure universal access. Yet, instead of learning from its mistakes, public funding conditionalities have been deleted from the draft Pandemic Agreement, and the EU is now trying to remove the remaining transparency and equity measures too, said Kolczyski, who is the EU Health Policy Advisor at Alliance and Oxfam.

Several countries and non-state actors involved in the pandemic agreement negotiations advocate for governments that have invested public money in the development of pandemic products to retain a stake in these via measures such as shares or joint intellectual property (IP) so that private companies do not call the shots during pandemics.

However, the EU and the US have been lukewarm about this proposal.

Meanwhile, the four global co-convenors of the COVID-19 vaccine access platform, COVAX, urged in a joint statement on Tuesday that future global pandemic preparedness and response architecture be informed by COVAX learnings.

Noting that COVAX would close at the end of December, the Coalition for Epidemic Preparedness Innovations (CEPI), vaccine alliance Gavi, UNICEF and the WHO, highlighted three key learnings.

The first is the need to design, invest in and implement an end-to-end solution to equitable access ahead of time that centres on the needs of the most vulnerable.

While vaccine nationalism will persist in future pandemics, they urge mechanisms to mitigate it including by diversifying vaccine manufacturing so all regions have access to supply.

The third lesson is the need to take financial risks to avoid potentially deadly delays to the development, procurement and delivery of medical countermeasures.

Money left over from COVAX will be redirected to implement some of these lessons, including investing $1 billion in the establishment of an African Vaccine Manufacturing Accelerator (AVMA) to support African vaccine manufacturing, a measure announced recently by the Gavi board.

In addition, a First Response Fund will be established to ensure financing for a vaccine response is immediately available in the event of a future pandemic, they note.

Meanwhile, Tuesday also saw the launch of a new South-South partnership, the Health Development Partnership for Africa and the Caribbean (HeDPAC) to strengthen health cooperation between Africa and the Caribbean.

Promoting technology transfer for pharmaceutical manufacturing, building regulatory capacity, and enhancing universal health coverage will be core HeDPAC strategies, according to a statement released via the WHO.

COVID-19 left an indelible scar on our global solidarity and the right of all people to good health, said Prime Minister Mia Mottley of Barbados. It is our shared responsibility to ensure that the inequity of the global response to COVID-19 is not repeated. This is the kind of action that will allow us to help people where they need it most.

HeDPAC will also focus on strengthening the health workforce in the two regions, and sharing innovative solutions in primary health care, with a special emphasis on climate resilience, and maternal and child health.

The seventh meeting of the Intergovernmental Negotiating Body (INB) negotiating the pandemic agreement ended late on 7 December with a rapid and vapid report back likely indicating that the negotiations remain difficult.

While informal inter-sessional meetings are set to continue in early January, the INB meets for the eighth time from 19 February to 1 March 2024.

A ninth meeting is also planned before the World Health Assembly at the end of May at which the pandemic agreement is due to be presented.

Image Credits: Photo by Mat Napo on Unsplash, @CEPI .

Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.

Here is the original post:

EU Hoarding Then Dumping COVID Vaccines Highlights Pandemic Accord Equity Challenge - Health Policy Watch

United Workers’ Job Bias Suit Over Covid Vaccine Mandate Trimmed – Bloomberg Law

December 20, 2023

United Airlines Inc. convinced a federal judge to dismiss several claims from a proposed class lawsuit over the companys handling of workers with religious or medical objections to receiving Covid-19 vaccination.

The ruling Monday by the US District Court for the Northern District of Texas rejected allegations by two of the workers leading the suit that they were denied accommodation for their religious beliefs when they were told to mask up at work and regularly submit Covid tests if they didnt want to be vaccinated. Those allegations failed to plausibly state that the workers experienced an adverse employment action, the ...

See the article here:

United Workers' Job Bias Suit Over Covid Vaccine Mandate Trimmed - Bloomberg Law

Page 125«..1020..124125126127..130140..»