Category: Vaccine

Is it safe to receive a COVID-19 mRNA vaccination during pregnancy? That question has been on the minds of every expectant parent since the vaccines became widely available.

Now, in one of the largest studies of its kind, scientists in Ontario have endeavored to answer this question.

"Many women are understandably nervous about receiving vaccines during pregnancy," the study's lead author, Sarah Jorgensen, a researcher at the University of Toronto, told Newsweek. "Our study hopefully provides them with some reassurance about the safety of the COVID-19 vaccines during pregnancy for newborns and young infants."

Their study, published in the journal JAMA Pediatrics, studied 142,000 live births across Ontario, and 60 percent of the infants had been exposed to one or more COVID-19 vaccine doses while the mother was pregnant.

"We assessed the safety of maternal COVID-19 vaccination during pregnancy for newborns and infants and did not find an increase in adverse outcomes," Jorgensen said. "Some of these outcomes were actually improved in infants of mothers vaccinated during pregnancy."

The study concluded that vaccination during pregnancy was associated with lower risks of severe disease during the first 28 days after birth and neonatal intensive care unit admissions. There was also no association between maternal vaccination during pregnancy and hospital readmission during the first 28 days after birth or after six months.

"These improved outcomes might be because the vaccines protect mothers from severe COVID-19 during pregnancy, which, in turn, is associated with pregnancy complications and harms to the fetus/newborn," Jorgensen said. "Or it could be because women who get the vaccine are generally from higher-income areas and have other health-related behaviors associated with improved newborn and infant outcomes. Most likely both explanations are somewhat responsible."

In a previous study, the team also found that COVID-19 vaccination during pregnancy protected infants from COVID-19 infection during the first few months of their lives.

"Our research has specifically focused on newborn and infant health effects when mothers get vaccinated during pregnancy, but other researchers have found the vaccines protect mothers from COVID-19 with no increase in pregnancy complications," Jorgensen said.

Compared with previous research, this latest study was able to draw from an extensive and diverse pool of health data from across the Canadian province.

"Ontario has universal health insurance and rich health administrative data on the 15 million residents of the province," Jorgensen said. "The availability of these data allowed us to complete one of the largest studies to date that assesses the safety of COVID-19 vaccination during pregnancy for newborns and infants."

She continued: "Our study included a larger proportion of women vaccinated during pregnancy, including all trimesters, than most previous studies assessing infant outcomes. We also assessed a wide range of important infant health effects. And we had data on infants up to 6 months of age, which is the longest follow-up to date."

Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.

Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.

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Effects on Newborns of COVID Vaccine During Pregnancy Shown in Large Study - Newsweek

Over the weekend, as I pondered a volume of forgotten lore it was Emily Wilsons gripping translation of Homers Odyssey, actually my email inbox started filling up with the curious news that a long-discredited and retracted paper claiming that the COVID vaccines had killed nearly 300,000 Americans had been reinstated.

It did not take long to determine that the truth was, no, not really. But the sudden appearance of this claim and its rapid spread across the anti-vaccine ecosystem speak volumes about how bad papers written by antivax ideologues designed to promote a narrative that vaccines are dangerous and/or ineffective ... never die, to quote the veteran pseudoscience debunker David Gorski.

Junk science can often find a home somewhere in the bowels of the literature, but that doesnt stop it being junk science, says John P. Moore, professor of microbiology and immunology at Weill Cornell Medical College, whose experience fighting anti-science quackery dates to the AIDS epidemic of the 1990s.

Bad papers written by antivax ideologues designed to promote a narrative that vaccines are dangerous and/or ineffective...never die.

Pseudoscience debunker David Gorski

In this case, the assertion that a retracted paper by Michigan State University economist Mark Skidmore has been resurrected in the peer-reviewed literature is based on one possibly accurate piece of information, a lie, and a half-truth, Gorski observes.

Lets take a look.

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I wrote about Skidmores paper in April, when it was retracted by its original publisher, the respectable medical journal BMC Infectious Diseases.

Published in January, the paper had started out as a sort of sociological study of what factors might lead people to be more or less amenable to taking a COVID-19 vaccine.

Based on an anonymous database of 2,840 respondents compiled by a third-party survey firm, Skidmore reported that people who knew someone who had a serious bout of COVID illness were more likely to get vaccinated, while knowing someone who appeared to have suffered a post-vaccination injury made them less likely to take the shot.

That was not especially surprising. But Skidmore proceeded to extrapolate from the number of respondents who said they knew someone who had died from the vaccine to conclude that the number of U.S. vaccine-related deaths may be as high as 278,000.

That claim was taken as gospel truth by the anti-vaccine movement, which helped make the paper one of the most-viewed papers in the journals history.

But there was a problem. Skidmore based his estimate of vaccine-related deaths on the opinions of people who had no way of knowing that the illness or death their acquaintances suffered after vaccination had anything to do with the shot.

Another red flag was that he relied on the Vaccine Adverse Events Reporting System, or VAERS, as a benchmark database for COVID vaccine injuries.

VAERS is maintained by the Centers for Disease Control and Prevention, which warns explicitly that its not suitable for that purpose. Thats because its a repository of entirely voluntary reports that can be filed by anyone, including but not limited to doctors, patients and family members, who arent required to document the injury.

VAERS is not designed to determine if a vaccine caused or contributed to an adverse event, the CDC says. A report to VAERS does not mean the vaccine caused the event.

When serious vaccine scientists see VAERS treated in a paper as an authoritative source for injury estimates, they take it as a sign that the paper is sloppy or even willfully dishonest. As it happens, VAERS is a popular source for anti-vaccine claims of all sorts, especially about the COVID shots.

As I observed before, there are few fields in which flawed scientific research has been weaponized as much as in studies of COVID treatments. Worthless nostrums such as hydroxychloroquine and ivermectin have been promoted as COVID treatments based on transparently bogus evidence.

Skidmore disagreed with BMCs retraction notice in April, and still does. He maintains that BMCs retraction violated professional standards, although one rule he cited is that a journal has clear evidence that the findings are unreliable.

Yet BMCs retraction notice cited concerns ... regarding the validity of the conclusions drawn after publication. It said Skidmores methodology in estimating vaccine deaths was inappropriate as it does not prove causal inference of mortality. ... Furthermore, there was no attempt to validate reported fatalities.

My article is one piece of evidence among many that the COVID-19 vaccines have resulted in injury and death, Skidmore told me by email.

Thats what lawyers might call assuming facts not in evidence. For there is no evidence in Skidmores paper that the vaccines have resulted in injury and death to any degree that would make them more dangerous than contracting COVID-19 just unsupported conjectures by acquaintances of people who died at some point after getting vaccinated that their deaths resulted from the shots.

The evidence is overwhelmingly on the other side that the vaccines have saved millions from the dire consequences of the disease.

That brings us to the reported reinstatement. Or as anti-vaccine activist Steve Kirsch put it on his Substack blog, after a 7 month review by his university, Mark Skidmore was exonerated of all charges and his new, improved paper was published in a more credible peer-reviewed journal.

Only 2,032 reports of possible adverse reactions to the COVID bivalent boosters through this spring were serious a tiny percentage of the more than 55 million doses delivered.

(Centers for Disease Control and Prevention)

Following Gorskis formulation, well start with the one possibly accurate piece of information. That piece is a ruling by Michigan States Institutional Review Board, which oversees the ethics of research involving human subjects. On Sept. 13, the board informed Skidmore that it had found no noncompliance with its protocols.

That may be understandable. Skidmores defense against accusations of unethical treatment of human subjects that his critics had brought to the IRB was that he had based his paper on an anonymized third-party database, so he had no direct clinical contact with any human subjects and the research thus posed little risk to human respondents, according to Liberty Counsel, the conservative legal group that represented him in discussions with the IRB.

But that doesnt get to the core problem of the paper. The lie, as Gorski describes it, is Skidmores claim that COVID-19 vaccines might have killed well over a quarter million people by the end of 2021.

There are simply no data to support that assertion. Skidmores calculation is a wild extrapolation from unreliable reports. It flies in the face of more solid evidence, which validates the CDC and Food and Drug Administration findings that the vaccines are safe. A 2022 FDA study, covering COVID vaccinations through mid-November 2021, found that death reports on VAERS were actually lower than all-cause death rates.

The most recent CDC statistics showed that of the 26,331 VAERS reports of problems from the bivalent boosters developed by Moderna and Pfizer authorized by the FDA in August 2022 and delivered through last spring, 2,032 were serious, a category that presumably includes death.

Because 55.2 million doses of the boosters had been delivered since then, the rate of serious complications came to less than four-thousandths of a percent of doses. And that figure was probably exaggerated, since the VAERS reports are, by their nature, unsubstantiated.

Finally, theres the half-truth. Thats the assertion that Skidmores study has been restored to the peer-reviewed literature.

First of all, its still retracted by BMC, and there are no indications that the journal will backtrack, since its retraction was the result of extended negotiations with the journal editors, ending with Skidmores acknowledgment that he had no way of knowing whether the study subjects perceptions about their acquaintances vaccine-related injuries were accurate.

Validating reported fatalities is not possible with an anonymous survey, Skidmore told the editors. Kirsch asserted on Substack that Skidmores new, improved paper was published in a more credible peer-reviewed journal. Is that so?

There are barely any differences between the original paper and the new version, which has been published in a journal called Science, Public Health Policy, and the Law, issued by the Institute for Pure and Applied Knowledge. The institute is a repository and publisher of anti-vaccination reports, including the long-discredited claim that autism is a consequence of childhood vaccinations.

As for the journal, its editorial board is composed 100% of vaccine skeptics, outright anti-vaxxers and dispensers of medically and scientifically unsupported treatments. Among its most recent articles is one that, amazingly, continues to push the antimalarial medication hydroxychloroquine as a treatment for COVID-19, despite overwhelming evidence that its useless for the purpose. (That papers co-author is Mark Skidmore.)

To assert, as Kirsch does, that this journal is more credible than BMC Infectious Diseases, which is associated with the Nature publishing group, must be some sort of a gag. Its true that questions have been raised about how BMC came to publish Skidmores paper in the first place, but at least the journal retracted it after critics pointed out its flaws.

The political landscape of COVID remains infected with misinformation on a pandemic scale. The Skidmore case underscores an observation seen in science, business and politics: Bad information always prevails over good information, unless the truth fights back, constantly and vigorously.

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Hiltzik: Bad science gets perpetuated by the right wing - Los Angeles Times

Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.

Compared with infants who were not exposed to the COVID vaccine, those who were exposed to one or more doses in utero had lower risks of:

There were no associations between maternal vaccination during pregnancy and neonatal readmission (5.5% vs 5.1%; adjusted HR 1.03, 95% CI 0.98-1.09) or 6-month hospital admission (8.4% vs 8.1%; aHR 1.01, 95% CI 0.96-1.05), reported Jeffrey Kwong, MD, MSc, of the University of Toronto, and colleagues in JAMA Pediatrics.

The study "provides further reassurance on the safety of maternal mRNA COVID-19 vaccination during all trimesters of pregnancy for newborns and infants," the authors wrote, noting that "uncertainty about vaccine safety for the infant is one of the most frequently reported reasons for lack of intent to get vaccinated during pregnancy."

"Lower risks of adverse neonatal outcomes among infants of vaccinated mothers would be consistent with the well-documented association between severe COVID-19 during pregnancy and increased neonatal morbidity, together with evidence suggesting that COVID-19 vaccination reduces the risk of severe COVID-19 in pregnant populations," they continued.

In an accompanying editorial, Catherine Mary Healy, MD, of Baylor College of Medicine in Houston, and Laura Riley, MD, of Weill Cornell Medicine in New York City, noted that the findings paint a compelling picture of the benefits of maternal vaccination, especially when combined with data on maternal immunization against respiratory syncytial virus (RSV) and influenza.

"Safe and effective vaccines such as the COVID-19 vaccine should provide confidence in the maternal vaccination program where maternal vaccines provide protection for mothers and neonates against potentially devastating infections," they wrote. "At the same time, concerns about vaccine adverse effects such as birth defects, spontaneous abortion, preterm labor, and other adverse pregnancy outcomes are not observed."

The challenge, Healy and Riley stressed, is getting pregnant women vaccinated.

"Although influenza vaccine has been recommended to protect pregnant persons and their newborns against influenza for decades, vaccination rates in pregnancy hover at approximately 50%," the editorialists pointed out. "Reasons for these poor vaccination rates include safety concerns despite years of safety data, lack of awareness of risk for severe morbidity and mortality associated with influenza in pregnancy, and lack of knowledge that maternal vaccination protects the newborn when the newborn is most vulnerable before vaccination at 6 months of age."

"Recent data show that maternal vaccination uptake is low for all recommended vaccines, suggesting that greater efforts are needed to provide education about the harmful effect of these diseases on pregnancy specifically as well as to broadly message the safety data that emerges from real-world use," they added.

"Studies consistently demonstrate ... that the single most important factor in vaccination uptake in all populations is receiving a strong recommendation from a trusted health care professional, and for pregnant women, this patient-clinician relationship is particularly strong," they wrote. "When this recommendation is combined with easy access, preferably on-site but at least convenient for uptake during a visit, vaccine administration in pregnancy is most likely to occur."

For this study, Kwong and colleagues used multiple linked health administrative databases in Ontario, Canada, looking at singleton live births with an expected delivery date between May 1, 2021, and Sept. 2, 2022.

In total, 142,006 infants (mean gestational age at birth 38.7 weeks, 51% boys) were included, and 60% were exposed in utero to at least one mRNA COVID vaccine dose. Mean age of mothers was 31.7.

Among the vaccinated mothers, 48.6% had received one dose, 49.6% had received two doses, and 1.8% had received three doses. About a third had received at least one dose during the first trimester, 53.6% received at least one dose during the second trimester, and 44.5% received at least one dose during the third trimester.

Of these women, 68% received the Pfizer/BioNTech (Comirnaty) vaccine for all doses.

The primary endpoint of severe neonatal morbidity was a composite of 15 poor neonatal outcomes, including gestational age less than 32 weeks and low birth weight; respiratory problems; neurological problems; birth trauma; and the need for resuscitation, ventilation, transfusion, and intercostal, central venous, or arterial catheter placement, as well as death.

Disclosures

This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care, in addition to multiple other sources.

Kwong reported grants from the Public Health Agency of Canada and the Canadian Institutes of Health Research. One co-author reported employment by Pfizer. Others reported relationships with the Canadian Immunization Research Network, CERobs, the Public Health Agency of Canada, CANImmunize, and Medicago Moderna.

Healy reported participation in a data safety monitoring committee for a vaccine trial for Emmes Corporation and participation in an advisory board meeting for Moderna, but declined payment for both. She receives stock options from Vapotherm, Quidel Diagnostics, Intuitive, and Dexcom, and writer/contributor fees from UpToDate. Riley reported receiving consultant fees from Pfizer and GSK, writer/contributor fees from UpToDate, lecture fees from Medscape, and participating on the editorial board of the New England Journal of Medicine.

Primary Source

JAMA Pediatrics

Source Reference: Jorgensen SCJ, et al "Newborn and early infant outcomes following maternal COVID-19 vaccination during pregnancy" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2023.4499.

Secondary Source

JAMA Pediatrics

Source Reference: Healy CM, Riley LE "Safety and benefits of COVID-19 vaccination in pregnancy -- implications for the maternal vaccination platform" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2023.4496.

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COVID Vax During Pregnancy Linked to Lower Risk of Poor Neonatal Outcomes - Medpage Today

Data from 27 states were analyzed to characterize the epidemiology of 315 hepatitis A outbreakrelated deaths during August 1, 2016October 31, 2022. Deaths occurred predominantly among males, non-Hispanic White persons, and persons aged 50 years. Nearly two thirds of decedents had at least one documented indication for hepatitis A vaccination, including drug use, homelessness, or coinfection with hepatitis B virus or hepatitis C virus; however, only 12 decedents had evidence of previous hepatitis A vaccination, indicating substantial missed opportunities to prevent hepatitis A deaths. Lack of stable housing and substance use disorder are commonly associated with viral hepatitides (3,4) and interact to increase disease incidence and health disparities. Although hepatitis A is usually a self-limited and preventable disease, it can have lethal consequences when introduced into populations with limited access to preventive care, unstable housing situations, inadequate access to sanitary services, or coexisting liver disease. These findings underscore the importance of integrated, comprehensive services, including vaccination, harm reduction, substance use disorder treatment, and hygiene and sanitation, to improve the health of medically underserved populations.

Among 272 outbreak-related decedents with available death certificate data, hepatitis A was listed as a cause of death or significant condition contributing to death on only 60% of death certificates, suggesting a substantial underestimation of hepatitis A mortality related to the outbreaks associated with person-to-person transmission in U.S. national vital statistics data. The 60% reporting rate for hepatitis A outbreakrelated deaths is substantially higher than reporting rates for hepatitis B and hepatitis C; in previous death certificate analyses of cohorts of patients with chronic hepatitis B and chronic hepatitis C, only 19% of decedents had hepatitis B or hepatitis C reported on their death certificates (8,9).

The findings in this report are subject to at least five limitations. First, states did not use a standardized hepatitis Arelated death definition, which might have resulted in differential classification of deaths as being related to hepatitis A. Second, death from hepatitis A is not a reportable condition and health departments might not have identified all outbreak-related hepatitis A deaths. Third, risk factor data were self-reported and subject to social desirability and recall biases and missingness. Consequently, information about additional decedents with indications for hepatitis A vaccination was unavailable. Fourth, vaccination information was missing for nearly one half of decedents; however, HAV infection after vaccination or appropriately timed postexposure prophylaxis is rare given the documented high immunogenicity of the vaccine (3). Finally, although the analysis captured nearly three quarters of publicly reported outbreak-related deaths, the results might not be generalizable to all outbreak-related deaths in the United States.

Hepatitis A is a vaccine-preventable disease; safe and highly effective vaccines have been available for decades (3). Substantial progress has been made in controlling the recent outbreaks through intensive efforts by health departments, including outreach through mobile vans and foot teams, nontraditional vaccination clinics in jails and homeless shelters, and partnerships with sheriffs associations and other community-based partners to expand vaccination coverage. As of October 2023, 34 states have declared ends to their outbreaks; however, many susceptible adults, particularly among persons who use drugs, persons experiencing homelessness, and persons with chronic liver disease, remain at increased risk for HAV infection or severe disease from HAV infection (5,10). Increased hepatitis A vaccination coverage is critical to maintain the progress that has been made and prevent future hepatitis A deaths.

Original post:

Preventable Deaths During Widespread Community Hepatitis A Outbreaks United States, 20162022 | MMWR - CDC

Study design and execution, patient selection and treatment

The study design comprises a dose escalation part and a dose expansion part with indication-specific cohorts including GCT, EOC and other indications to start when the recommended phase 2 dose (RP2D) obtained with the dedicated phase 2 manufacturing process is defined.

The primary endpoints for the dose escalation part are to characterize the safety and tolerability of CLDN6 CAR-T cellsCARVac and to identify the maximum tolerated dose (MTD)/RP2D. Evaluation of the antitumor activity of CLDN6 CAR-T cellsCARVac per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and characterization of soluble immune factors (cytokines) induced by treatment are the secondary endpoints. An MTD/RP2D was not established, as dose escalation is being repeated with CAR-T cells manufactured with an automated manufacturing process.

The dose expansion part of the study enrolled adults diagnosed with advanced metastatic solid tumors of any type lacking further systemic treatment options, Eastern Cooperative Oncology Group (ECOG) 01 and measurable disease per RECIST 1.1. Patients with new or growing brain or spinal metastases during screening were excluded. Patients for the study were recruited from a CLDN6 prescreening. Additional eligibility criteria are noted in the Methods.

Of 180 patients prescreened for CLDN6 expression with a semiquantitative immunohistochemistry assay between September 2020 and November 2021, 54 (30%) met the inclusion criteria for tumor CLDN6 positivity defined as 50% of tumor cells displaying an intermediate (2+) or strong (3+) membrane staining intensity (Fig. 1a,b and Supplementary Fig. 1). The fraction of patients complying with the CLDN6-positivity threshold was highest for GCT (90%) and EOC (29%) (Fig. 1c). No significant differences in staining intensity were observed according to whether the specimens were obtained recently or were older paraffin-embedded tissue specimens; this was consistent for both primary and metastatic lesions (Supplementary Fig. 2).

a, Phase 1 bifurcated 3+3 dose escalation design. Screened patients were enrolled into either CLDN6 CAR-T monotherapy or a combination with CARVac, receiving a single dose of either 1107 (DL1) or 1108 (DL2) CLDN6 CAR-T cells. CARVac was administered with a starting dose at 25g, followed by 50g doses if tolerated. b, As of 5 November 2021 (enrollment of last patient dosed), 180 patients were prescreened and 54 classified as CLDN6-positive (50% of tumor cells 2+ CLDN6 membrane staining). Eighteen patients dropped out before the screening visit due to death (n=9), worsening of condition (n=7), loss to follow-up (n=1) or refusal of participation (n=1). Twenty-nine patients underwent full screening for trial eligibility, of which four patients did not meet eligibility criteria. Seven patients remained listed to be screened for trial eligibility, but did not consent for full trial eligibility screening, for example, because of decision to undergo other treatment approaches. CAR-T cell products were manufactured for all 25 enrolled patients. Of those, 22 were treated and included in the safety set, while one patient, who received CAR-T cells at

Following successful prescreening for fulfillment of CLDN6 expression, twenty-nine patients entered screening for the other enrollment criteria of this trial. We manufactured autologous CLDN6 CAR-T cells for 25 patients who met all eligibility criteria, of which 22 were patients treated with CLDN6 CAR-T cells manufactured from autologous leukapheresis material collected between 15 December 2020 and 14 February 2022, with the day of leukapheresis defined as the day of enrollment to this trial (Fig. 1b). The drug products contained both CD4+ and CD8+ T cells, with the CD4+ subset dominating (Supplementary Fig. 3a). Overall, the proportion of nave (TN) and effector memory phenotype (TEM) was similar within the CD4+ T cell population. (Supplementary Fig. 3b). CD8+ T cells had a predominantly TN-like phenotype, followed by an effector memory re-expressing CD45RA (TEMRA) phenotype (Supplementary Fig. 3c).

Dose escalation followed a 3+3 approach with patients receiving CLDN6 CAR-T cells at DL1 (1107) and DL2 (1108)CARVac. Of the 22 treated patients, 13 had GCTs (all testicular cancer with non-seminoma or mixed-type histology), four had EOCs (all serous carcinoma) and one patient each had endometrial carcinoma, serous carcinoma of the fallopian tube, desmoplastic small round cell tumor (DSRCT), gastric adenocarcinoma and cancer of unknown primary (CUP) (Table 1). GCT and EOC patients had the strongest CLDN6 expression, with an average of >80% tumor cells with 2+/3+ (intermediate/strong) staining intensity (Fig. 1d and Supplementary Fig. 1).

All patients (median age of 46 years) were r/r after standard of care treatment and were heavily pretreated with a median of four previous lines of treatment, predominantly platin-based chemotherapy and three had received checkpoint inhibitor therapy. All GCT patients had received high-dose chemotherapy (HDCT) plus autologous stem cell support. The four EOC patients were platinum-refractory. All patients had measurable disease, and eight patients required bridging chemotherapy between leukapheresis and CLDN6 CAR-T cell transfer. Almost half of the patients had lung metastases (including seven of the 13 GCT patients) and about 30% had either liver involvement or peritoneal carcinosis (including three of the four EOC patients). Seven of the 12 patients with two pretreatment computed tomography (CT) scans showed rapidly progressing disease from baseline visit until infusion of the CAR-T cells (5.9 weeks on average; Table 1). Those who did not progress had all been treated with bridging chemotherapy, further underlying the advanced disease status of patients recruited to this trial.

Of the 22 patients (Fig. 1b), 20 received LD (500mgm2 cyclophosphamide plus 30mgm2 fludarabine for three days) before infusion of CLDN6 CAR-T cells at DL1 (n=7, including one patient with non-conformant product with lower yield) or DL2 (n=13, including one patient with 50% reduced LD). Four patients at DL1 and seven patients at DL2 were treated in combination with CARVac. In two patients who were at risk of prolonged cytopenia, we explored omitting LD (Extended Data Tables 1 and 2).

Patients treated at DL1 or with dose-reduced LD received a median of 3.5 doses of CARVac (range 16) starting at day 4 post-adoptive cell transfer (ACT). For patients treated at DL2 with full dose LD, CARVac administration was delayed to reduce the risk of accelerated and high-grade cytokine release syndrome (CRS), with CARVac starting 23 days or more post-ACT with a median of five (range 29) doses. The two patients at DL2 without prior LD were treated with two and four doses of CARVac, respectively. Two patients at DL2 crossed over and received CARVac (3 doses) starting 65 and 79 days post-ACT, respectively. Five patients were redosed at their original DL 190288 days after their first ACT in combination with CARVac starting on day 4 (DL1) or day 1516 (DL2) post redosing, respectively. One patient at DL1 was redosed without prior LD (Extended Data Table 1).

Overall, assessment of CLDN6-positivity followed by manufacturing and administration of CLDN6 CAR-T cellsCARVac was feasible in this population of heavily pretreated patients including individuals with rapidly progressing disease.

All 22 patients treated within the study were included in the safety analysis. The data cutoff date was 6 October 2022, with a median follow-up of five months (range: 29416 days, Extended Data Table 1).

Nineteen of 22 patients had treatment-emergent adverse events (TEAEs) greater than or equal to grade (G) 3 (Extended Data Table 2). Besides pyrexia, the most frequent TEAEs observed in >20% of treated patients were hematologic toxicities related to LD or transaminase/lipase elevations without clinical correlates (Table 2), observed more often in patients experiencing CRS. TEAEs G3 attributed to the CAR-T cell treatment that occurred in >10% patients were neutropenia (23% G4) and leukopenia (5% G3, 14% G4) (Extended Data Table 3).

CRS was seen in ten patients (46%), eight of whom were treated at DL2 (Extended Data Table 2). CRS typically occurred within 410 days post-ACT, was correlated with high IL-6 levels and peak CAR-T cell concentration post-ACT, was predominantly of G12, and was manageable by supportive care with antipyretics and the IL-6 receptor blocking antibody tocilizumab (Extended Data Table 2 and Extended Data Fig. 1). As CRS events were more frequently observed in the DL2 monotherapy cohort (Extended Data Table 2), the safety committee decided to delay CARVac dosing to day 24 in the DL2 combination cohort to avoid the risk of CAR-T cell-amplification related high-grade CRS.

One patient treated at DL1 plus CARVac had symptoms (headache and decreased level of alertness) classified as G1 immune effector cell-associated neurotoxicity syndrome (ICANS) that occurred in conjunction with G2 CRS and resolved spontaneously within 24h (Extended Data Table 2).

Dose-limiting toxicities (DLTs) emerged in two patients treated at DL2, one with monotherapy and one in combination with CARVac (Extended Data Table 2). One event was G4 hemophagocytic lymphohistiocytosis (HLH) observed in an EOC patient, who had the highest CAR-T cell peak expansion (5.8109) observed in this trial. On day 5 post-ACT, the patient developed G2 CRS (treated with tocilizumab) and on day 23 experienced HLH defined by highly elevated ferritin levels and an aplastic bone marrow, which was successfully treated with high-dose steroids. CARVac treatment was postponed to day 51 until all CRS- and HLH-related AEs had resolved without sequelae.

The other DLT was prolonged G4 pancytopenia observed in a heavily pretreated GCT patient reported 21 days post-ACT. The patient was nonresponsive to granulocyte colony-stimulating factor, received an autologous peripheral blood stem cell support on day 32, upon which the patients bone marrow function recovered within 14 days. The patient was redosed with CAR-T cells 41 weeks after the first CAR-T cell administration. This DLT experience led to the decision to consider GCT patients who had recently undergone HDCT as at risk for treatment-related persistent cytopenia. Consequently, we introduced protocol amendments to make the availability of autologous peripheral blood stem cells a prerequisite for treatment of patients with HDCT within the last 12 months or with impaired bone marrow function with the full dose of LD. Alternatively, we allowed dose-reduced LD.

No further DLTs were observed after enrollment of three additional patients into each of these two DL2 cohorts. The Safety Review Committee (SRC) determined that the MTD (primary endpoint) was not reached. The recommended phase 2 dose of CLDN6 CAR-T cells was not further pursued as enrollment to the planned DL3 cohorts was canceled per the study protocol amendment to facilitate a repeat of the CAR-T dose escalation component with CAR-T cells manufactured with an automated process, including potential testing of higher dose levels. All eight deaths in the study were classified as disease progression and not attributed to CAR-T cell toxicity.

The safety profile of CARVac was in line with previous reports related to our RNA-LPX cancer vaccine platform16,17 and no unexpected toxicity was seen in combination with CAR-T cells (Extended Data Table 3). CARVac-related TEAEs were primarily of G12 flu-like symptoms occurring around 4h after administration. TEAEs of G3 that occurred with a frequency of 10% and were attributed to CARVac treatment were pyrexia (18% G3) and neutropenia (12% G4), which was also documented as related to LD. While dose reduction was allowed per protocol in the case of CARVac-related AEs, CARVac was generally well tolerated and no dose reductions occurred. After initial hospitalization, patients received CARVac in an outpatient setting and toxicities were managed with paracetamol.

Transient release of IFN and IFN inducible protein 10, peaking 36h post intravenous CARVac administration, was observed in serum cytokine measurements (Extended Data Fig. 2), as previously reported in patients treated with RNA-LPX mRNA cancer vaccines15.

In summary, the safety profile of both dose levels of CLDN6 CAR-T cells as monotherapy or in combination with CARVac was manageable (Table 2 and Extended Data Table 3) and largely in line with previous reports on approved CAR-T cell products18.

Twenty-one of the 22 patients were treated per protocol and qualified for efficacy analysis for the secondary endpoints ORR, disease control rate (DCR) and duration of response (DOR). Partial responses (PRs) in six patients and one complete response (CR) resulted in an unconfirmed ORR of 33% (Fig. 2a). Four patients with a best overall response (BOR) of PR remained in PR in subsequent scan(s), while two patients experienced progressive disease (PD) at the next assessment. We observed deepening of PRs over time, with further reductions in the sum of target lesions observed over repeat assessments. The median DOR for all seven responders was 2.8months (range 1.1 10.5months) (Fig. 2b), with the CR ongoing at data cutoff for 10.5months (Extended Data Fig. 3). Seven patients had stable disease (SD) as the best response, five with quantifiable target lesion shrinkage, resulting in a DCR of 67%. One SD was ongoing at data cutoff 8.7months post-ACT. Five of the seven patients with PD had either received CLDN6 CAR-T cells at DL1 or had not received LD before DL2. The other two patients with PD were treated at DL2 with prior LD; however, they had rapid disease progression at accrual (61% and 86% increase in target sum between screening and ACT; Table 1). Five patients (three PRs, one SD, one PD as BOR to the first dosing) were redosed with CAR-T cells due to PD (Fig. 2b) resulting in one additional PR (Extended Data Fig. 4).

a, Waterfall plot showing best percent change from baseline (screening, ~6 weeks before ACT) in sum of target lesion diameters. Efficacy evaluable population (n=21) contains one patient that did not reach the first CT scan and was classified as PD (confirmed by X-ray). The table below indicates applied treatment, outcome and disease status at ACT (available for 12 patients). Redosing (n=5) occurred after assessment of best response in all patients. b, Swimmer plots for all efficacy evaluable patients (n=21). The patient with dose-reduced LD is marked with an asterisk. Diamonds represent outcome at tumor assessment (CR, PR, SD). Triangles indicate redosing with CAR-T cells at the same DL (orange) or crossover from monotherapy to combination therapy (yellow). Redosing was always performed as a combination treatment. All responses were assessed according to RECIST 1.1. The patient with CR had a residual radiographic abnormality interpreted as scar tissue, as there was no abnormal radiotracer uptake according to Positron Emission Tomography/Computed Tomography (PET-CT) 12 weeks post-ACT (Extended Data Fig. 5). Cancers of other origin other than GCT and EOC were each a single case of DSRCT, GC, serous carcinoma of the fallopian tube, endometrial carcinoma and CUP. NE, non-evaluable; NR, not reached; PFS, progression-free survival.

All objective responses occurred in patients with either EOC (two of four patients with PR) or GCT (four PRs plus one CR in 13 patients; Fig. 3a,c). The five patients with other tumor entities all had SD as BOR (including the patient treated

a, Spider plots indicating response durability in all patients (left, n=21), GCT patients (middle, n=13) and non-GCT patients (right, n=8). Non-GCT patients include four EOC patients and one each of DSRCT, GC, serous carcinoma of the fallopian tube and endometrial carcinoma. Pretreatment CT scans are not included, as scans performed at screening (~6 weeks before ACT) served as baseline. b, Details on ORR and DCR of all patients as well as subgroups of GCT and non-GCT patients according to treatment (dose and LD). c, PFS analysis for n=7 GCT patients treated at DL2 after LD with 95% confidence interval based on a loglog transformation of the survival function (dotted lines). ORR is unconfirmed.

The ORR in the subgroup of GCT patients was 38% and depended on administered CLDN6 CAR-T DL and LD (Fig. 3a,b): 25% at DL1 after LD (one PR in four patients), 57% at DL2 after LD (four PRs in seven patients) and 0% at DL2 without LD (two patients). GCT patients were those with the longest DORs, leading to a PFS (exploratory endpoint) of 42% at six months for those treated with CLDN6 CAR-T cells at DL2 after LD (Fig. 3c). As the DL2 cohort had not reached median overall survival at the time of the data cutoff, and given the heterogeneity of the patients, indications and treatment schedules, we do not report overall survival (a further exploratory endpoint).

Of the eight non-responding GCT patients, five were treated at DL2. Two achieved SD as BOR, two were treated without prior LD and experienced PD, as did the fifth patient, who entered the study with a rapidly progressing tumor (86% increase in target sum from screening to ACT) having only 50% 2+/3+ CLDN6-positive tumor cells. Notably, of the two non-responding EOC patients, one was treated at DL2 and showed rapidly progressing disease (61% increase in target sum from screening to ACT) stabilizing after infusion (19% reduction from ACT to first assessment). Previous lines of treatment for patients are included in Supplementary Table 1.

Tumor responses were primarily observed at DL2. However, the late timing of CARVac dosing at this DL, combined with the diverse, small cohorts, prevented analysis of how CARVac influences the antitumor activity of CLDN6 CAR-T cells.

We observed encouraging signs of efficacy and disease control in a heterogenous cohort of hard-to-treat solid tumor patients, indicating GCT and EOC patients in particular as future target populations. In parallel, we developed an automated manufacturing process to scale up CAR-T production and increase the robustness of the manufacturing process. Recruitment of patients to a planned DL3 with CAR-T cells manufactured with the manual manufacturing process was therefore canceled by protocol amendment, and we have initiated a repeat of dose escalation with CAR-T cells produced with the automated manufacturing process, introducing further dose levels for both CAR-T cells and CARVac.

Identification of predictive biomarkers was an exploratory endpoint. All responding patients had tumors with >80% of tumor cells expressing 2+/3+ CLDN6 at prescreening (Fig. 4a), suggesting that CLDN6 expression level may be predictive of outcome. Four patients had PD despite high CLND6 expression, three of which entered the trial with progressing disease (61%, 99% and 105% increase in target sum from start of screening to ACT). The fourth patient did not receive LD and experienced poor CAR-T cell engraftment. A positive correlation between CLDN6 CAR-T expansion and clinical response was detected for both peak expansion (CAR-T cell Cmax) and area under curve (AUC) from ACT to first staging with CT (Fig. 4b).

a, Correlation of clinical outcome and CLDN6 expression of the corresponding tumor according to indication and treatment (dose and LD). b, Correlation analysis of CAR-T cell peak concentration (Cmax) (left) and AUC up to day 42 post-ACT (first tumor assessment) (right) with outcome. Cancers of other origin other than GCT and EOC were single cases of DSRCT, GC, serous carcinoma of the fallopian tube and endometrial carcinoma. Box plots show median and upper and lower quartiles, with whiskers indicating 1.5 the interquartile range. Individual data points are overlaid.

Characterization of the pharmacokinetics of CLDN6 CAR-T cells was an exploratory endpoint. For lymphodepleted patients at DL1 and DL2, CAR-T cell peak expansion (Cmax) detected in peripheral blood was reached on average within 18 days (range 1724) and within 15.6 days (range 824), respectively, with higher peak engraftment seen at DL2 (Extended Data Fig. 5). The two patients treated at DL2 with CARVac but without LD displayed poor engraftment, and this cohort was therefore closed (Extended Data Fig. 6). Two patients treated at DL1 (29%) and six patients treated at DL2 (46%) showed CAR-T cell persistence for 100days post-ACT, with CAR-T cells in one patient treated once at DL2 detectable for >1year (Extended Data Fig. 3). Four patients (two at DL1, two at DL2) with decrease of CAR-T cells over time were preconditioned again and redosed with CAR-T cells in combination with CARVac 190288 days after their initial ACT (exemplified by a patient at DL1+CARVac in Extended Data Fig. 6). Robust engraftment with almost phenocopied kinetics of their first ACT was achieved in three patients; all three had detectable CAR-T cells at their last follow-up. One patient preconditioned with LD before their first ACT was redosed at DL1 without LD and reached a lower Cmax compared to their first ACT.

CARVac was administered to 11 patients who had received CLDN6 CAR-T cells after LD and two patients who received CAR-T cells without prior LD (Extended Data Fig. 6). Within this group, four patients were given CARVac following CAR-T cells at DL1. A trend for greater expansion of CAR-T cells was observed at DL1 in patients receiving CARVac compared with patients receiving CLDN6 CAR-T cells alone (Extended Data Fig. 5). Notably, the patient who received CAR-T cells at

Given the limited sample size, the heterogeneity of patients and unequal initial engraftment within the subgroups at DL2, the impact of CARVac on persistence of CAR-T cells cannot be statistically evaluated with the data available at this initial cutoff. However, we noted a transient increase in CAR-T cells immediately following CARVac administration in some patients (Extended Data Fig. 4c). In two patients treated with CAR-T cells at DL2 who commenced CARVac at a later stage, CARVac appeared to halt an ongoing decline in CAR-T cell frequency (Extended Data Fig. 6, bottom left). A further four patients in monotherapy cohorts crossed over to combination therapy, two after redosing with CAR-T cells at DL1 and two (indicated with a circle in Extended Data Fig. 6) at DL2 that experienced PD before crossover. No conclusions can be reached from this heterologous group that had differing CARVac vaccination schemes.

Further analysis with a larger patient cohort treated with CARVac at an earlier time point is planned to provide a more conclusive understanding of the impact of CARVac on CAR-T cell dynamics.

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CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211 ... - Nature.com

The manufacturer for the new vaccine to help protect infants from RSV, or respiratory syncytial virus, revealed that they are limiting availability of the drug due to its inability to keep up with the unprecedented demand.

Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100 mg doses used primarily for babies born before the RSV season, has been higher than anticipated, drugmaker Sanofi said in a statement.

The RSV vaccine nirsevimab, which is sold as Beyfortus, is not currently listed as being in shortage by the FDA.

Due to the high demand and limited supply, the Centers for Disease Control and Prevention announced Monday that doctors should prioritize doses of Beyfortus for infants under 6 months old and infants with underlying health conditions that put them at a higher risk for severe infection.

"RSV season is here," Dr. Buddy Creech, pediatrician at Vanderbilt University Medical Center and president of the Pediatric Infectious Disease Society, told NBC. "We are seeing a substantial increase in the amount of RSV such that in many areas, it has become the most commonly identified respiratory virus causing disease in children.

"This is one of the reasons why there's probably a lot of scrambling going on," he said, "to identify those babies at highest risk and to try to prioritize them, since it's such a limited resource right now."

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The CDC also recommended that doctors now stop providing Beyfortus to infants 8-19 months old. Instead, the agency said healthcare providers can offer palivizumab, or Synagis, which is approved only for children at high risk of severe disease with RSV due to serious lung or heart conditions. Synagis is also only available during RSV season.

We are going to protect some children from RSV this year. Were not going to be able to protect as many as wed hoped, and thats frustrating, Creech added, CNN reports.

RSV infections, which are the most common cause of bronchitis and pneumonia in children under the age of one in the U.S., typically occur in the fall and winter during flu season. These infections "primarily spread via respiratory droplets when a person coughs or sneezes, and through direct contact with a contaminated surface," according to the CDC.

Each year, the virus leads to nearly 80,000 hospitalizations and as many as 300 fatalities in the U.S. among this age demographic. Notably, an estimated 80% of children under the of age two who are hospitalized due to RSV have no pre-existing medical issues.

The CDC says in infants younger than six months, "RSV infection may result in symptoms of irritability, poor feeding, lethargy, and/or apnea with or without fever." Beyond managing the symptoms, there is currently no specific treatment for RSV infection.

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RSV Vaccine for Infants in Short Supply Due to 'Unprecedented Demand' - PEOPLE

A new COVID-19 variant, HV.1, is being monitored by health authorities.

Omicron has mutated many times since it burst onto the scene in December 2021, and its new subvariant, HV.1, could become the next dominant strain this fall and winter.

The Centers for Disease Control and Prevention estimates that the strain currently makes up almost one in five cases in the United States; it's closer to one in four in the mid-Atlantic and some Midwestern states.

HV.1s growth has been quickit made up just 0.5% of cases in late July and has now nearly overtaken EG.5, the dominant subvariant in the U.S. since mid-August.

Despite the fact that HV.1 seems to be highly transmissible, experts agree that the new subvariant shouldnt be a cause for major concern.

All that people know at this point, is that its increasing in representation, Ross Kedl, PhD, professor of immunology and microbiology at University of Colorado Anschutz School of Medicine, told Health. Theres no evidence that its more severe.

Heres how HV.1 relates to the other variants, when COVID mutations could pose a threat to Americans health, and how to stay safe during the expected rise in cases this winter.

Getty Images / Images By Tang Ming Tung

HV.1, despite having mutations that make it different from other subvariants, is fairly similar to the other Omicron strains, Kedl said.

Alongside its sister subvariant HK.3, HV.1 is a mutation of EG.5, which was originally derived from the original XBB strain.

The updated COVID vaccines target XBB.1.5, a sort of uncle to EG.5 and HV.1 on the Omicron family tree.

According to Kedl, the U.S. is still in the early days of dealing with HV.1, so theres a lot of information not yet known.

In terms of symptoms, nobodys noticed anything out of the ordinary, Kedl explained. HV.1 will likely cause the symptoms that come to be associated with an Omicron infection, such as cough, fatigue, congestion, and runny nose.

Ultimately, HV.1 is expected to be about as severe as the other XBB-related subvariants.

To determine how concerning a new subvariant is, U.S. health agencies will see if it's overrepresented in hospitals, Thomas Russo, MD, SUNY distinguished professor and chief of the division of infectious diseases at the Jacobs School of Medicine at the University at Buffalo, told Health.

For example, a new subvariant would be considered more dangerous if a large percentage of hospitalized COVID patients had that particular strain as compared to people who werent hospitalized.

But that doesnt seem to be happening with HV.1, Russo explained.

Where HV.1 seems to deviate from other Omicron subvariants is in its ability to spread around the population.

Its representation is going up, said Kedl. That means that its found a way to bob and weave around a little bit more pre-existing immunity.

Since HV.1 is similar to other, existing Omicron-related subvariants, the U.S.s COVID tools will likely be equally effective against it, experts agreed.

Overall, these newer variants are very closely related to the XBB.1.5 variant thats in the current updated [booster], David Montefiori, PhD, a viral immunologist at the Duke University School of Medicine, told Health.

Thats a good thing, Montefiori said. These variants havent really fallen much farther from the tree, so to speak.

Russo explained that while updated vaccines are imperfect when it comes to preventing infections, that doesnt mean they dont significantly help keep people safe.

Well probably be doing a good job to decrease the likelihood that people develop severe disease, land in the hospital, and have a bad outcome, he said.

COVID tests and antiviral treatments such as Paxlovid should still be functional, too.

Both of these treatments are not based on the spike protein, theyre based on other proteins of the virus, Montefiori explained. And those proteins are mutating, but at a much slower rate.

Mutations in these viral proteins are possible, but for now, thats not a concern.

It is possible that HV.1 could become more or less of a threat as the weeks go onits definitely something experts said they want to keep an eye on.

[For] HV.1 and the HK.3, the unique mutations that they do have havent really been tested yet. Those data will be coming in the following week or two, said Montefiori. But scientists are not expecting the minor changes that are seen in these variants to really have a substantial impact.

Barring a surge in cases or hospitalizations from HV.1, experts agree that theres no need for people to be overly concerned.

At this point, I dont think any of the variants that were experiencing right now require extra [health] measures than what people are already practicing, said Montefiori.

Still, its important to remember that the overall virus itselfregardless of which strainhas some elevated risks for people over the age of 65, said Kedl.

This also goes for people who are immunocompromised or have severe underlying diseases, Russo added.

People at higher risk may want to consider wearing a mask when out, since HV.1 and other future subvariants could lead to more transmission, Russo said.

Those at greatest risk need to be cognizant that COVID is still out there, he said.

The most important thing for all people to do this fall is to get an updated COVID shot, Montefiori said.

Were still learning about this, to be clear, said Russo. At this point, [theres] no grounds for panic. But [its] important to monitor this. If you get the updated vaccine, its in the Omicron family, and its predicted that that will afford good protection.

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What to Know About the New HV.1 Variant - Health.com

Abuja, 24 October 2023 Nigeria today introduced the human papillomavirus (HPV) vaccine into its routine immunisation system, aiming to reach 7.7 million girls. This is the largest number in a single round of HPV vaccination in the African region in a vaccination drive against the virus that causes nearly all cases of cervical cancer.

Girls aged 914 years will receive a single dose of the vaccine, which is highly efficacious in preventing infection with HPV types 16 and 18, which are known to cause at least 70% of cervical cancers.

In Nigeria, cervical cancer is the third most common cancer and the second most frequent cause of cancer deaths among women aged between 15 and 44. In 2020 the latest year for which data is available the country recorded 12,000 new cases and 8,000 deaths from cervical cancer.

The loss of about 8000 Nigerian women yearly from a disease that is preventable is completely unacceptable, says Muhammad Ali Pate, the Coordinating Minister of Health & Social Welfare. Cervical cancer is mostly caused by HPV, and parents can avoid physical and financial pain by protecting their children with a single dose of the vaccine. Saving lives, and producing quality health outcomes and protecting the wellbeing of Nigerians are central to the Renewed Health Agenda of President Bola Ahmed Tinubu. The onset of the vaccination campaign is an opportunity to safeguard our girls from the scourge of cervical cancers many years into the future. As a parent myself, I have four daughters, all of them have had the same HPV vaccine to protect them against cervical cancer. Id like to implore fellow parents to dutifully ensure that this generation of our girls disrupt the preventable loss of lives to cervical cancer in addition to other untold hardship, loss, and pain.

A five-day mass vaccination campaign in schools and communities will be carried out during the inaugural roll-out in 16 states and the Federal Capital Territory. The vaccine will then be incorporated in routine immunisation schedules within health facilities. The second phase of the vaccination introduction is set to start in May 2024 in 21 states.

The vaccine is being provided for free by the Federal Ministry of Health through the National Primary Health Care Development Agency with support from Gavi, the Vaccine Alliance, United Nations Childrens Fund (UNICEF), World Health Organization (WHO) and other partners.

With support from WHO country office in Nigeria and other partners, more than 35,000 health workers have so far been trained in preparation for the campaign and subsequent vaccine delivery in all health facilities. Vaccination sites have been established in all 4,163 wards across the 16 states included in the phase one roll-out, to ensure no eligible girl is left behind. Mobile vaccination units have also been set up to ensure that remote communities can access the vaccine.

This is a pivotal moment in Nigerias efforts to lower the burden of cervical cancer one of the few cancers which can potentially be eliminated through vaccination, says Dr Walter Kazadi Mulombo, WHO Representative in Nigeria. Were committed to supporting the government increase access to the HPV vaccine to protect the health and well-being of the next generation of women.

WHO recommends that HPV vaccination is included in the national immunisation programmes of countries where cervical cancer is a public health priority, where its cost-effective and sustainable implementation is feasible. As such, Nigeria has prioritised the addition of the vaccine to the countrys routine immunisation schedule.

Global supply shortages have slowed Gavi-supported vaccine introductions. These supply issues are now easing thanks to years of market shaping efforts to develop a more robust HPV vaccine market, and the single dose recommendation. Recognising this critical opportunity to reach more girlswith higher levels of global HPV vaccine supply and renewed momentum towards accelerating efforts to prevent cervical cancer, the Gavi board approved the revitalisation of its HPV vaccine programme with an investment of more than US$ 600 million by the end of 2025. With the additional funding, Gavi and its partners have set an ambitious goal to reach more than 86 million girls by 2025, aiming to avert more than 1.4 million future deaths from cervical cancer.

Every day, cervical cancer inflicts profound loss and devastation on families across Nigeria. It also disproportionately impacts the lives of women. And yet, it is a disease that can be prevented. With the HPV vaccine now available in Nigeria for eligible adolescent girls at no cost, communities now have the most effective tool to fight cervical cancer, and the nation has an opportunity, collectively, to save millions of lives, says Thabani Maphosa, Managing Director of Country Programmes Delivery at Gavi.

More than 16 million girls could be protected in Nigeria alone by 2025. To support these efforts in Nigeria and in line with its goal to build sustainable immunisation programmes, Gavi is co-financing the cost of the vaccines and providing technical support for the introduction.

UNICEF has procured nearly 15 million HPV vaccines on behalf of the Government of Nigeria. Alongside this, the childrens agency has produced informational materials, including radio and TV jingles in multiple local languages to dispel misinformation and rumours. To further the outreach, UNICEF also supported academia and researchers with two rounds of readiness assessments to understand the populations sentiments on the HPV virus and vaccine. Additionally, UNICEF has facilitated logistical support for vaccination campaigns and distributed cold chain equipment for vaccine preservation.

In our shared quest for a brighter future, the introduction of the HPV vaccine in Nigeria represents a monumental stride towards safeguarding our girls from the grips of cervical cancer. This vaccine doesnt just prevent a disease; it promises a life where our young women can thrive, unburdened by the spectre of this grave health concern. UNICEF, in collaboration with the government and other partners, is proud to be a key partner in this initiative, ensuring that every eligible girl, irrespective of her location or circumstances, has access to this life-saving intervention. Together, we are scripting a narrative of hope, resilience, and a healthier Nigeria." says Cristian Munduate, UNICEF Representative in Nigeria.

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Nigeria to vaccinate 7.7 million girls against leading cause of cervical cancer - Gavi, the Vaccine Alliance

By Leocciano Callao For Dailymail.Com 06:26 25 Oct 2023, updated 06:26 25 Oct 2023

Kansas City Chiefs tight end Travis Kelce denied any friction between him and New York Jets quarterback Aaron Rodgers.

On Tuesday, Kelce appeared on Paper Route and addressed Rodgers' comments from the October 3 episode of the Pat McAfeeShow.

Following the Chiefs' 23-20 win over the Jets on October 1, Rodgers, 39, appeared on the program and referred to Kelce, 34, as 'Mr. Pfizer'. Rodgers also challenged Kelce to a debate over the Covid-19 vaccine.

'To each his own and I think he was just having fun with it,' Kelce said.

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'He has his ways. He has his thoughts how he feels about things,' Kelce added. 'And he has the right to have that. How you feel about certain things is up to you.'

Rodgers made headlines in 2021 as sports were returning from the hiatus caused by the pandemic. The then-Packers quarterback refused to get the Pfizer vaccine due to being allergic to one of the ingredients in the mRNA vaccines.

As for the remaining option, Rodgers did not want to take get the Johnson & Johnson shot after seeing people suffer adverse effects from the vaccine. Rodgers then appealed to enter an immunization protocol but had his petition rejected by the NFL.

In a January episode of the Pat McAfee Show, Rodgers addressed the situation and called out Pfizer, Moderna, and Johnson & Johnson for the negative press.

Rodgers' comments on Kelce were inspired by Kelce's appearance in a Pfizer ad in September.

'Who knew I'd get into vax wars with Aaron Rodgers, man?' Kelce said. 'Mr. Pfizer against the Johnson & Johnson family over there.'

Kelce was seen embracing and laughing with the injured Rodgers on the before their Week 4 showdown with the Jets.

'You're not going to see me up here going in the great debate against Aaron Rodgers over something like that. I think it's all fun and games, at least between us, and I got all the respect for him.'

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Travis Kelce laughs off Aaron Rodgers' 'Mr. Pfizer' jab and challenge to debate Covid-19 vaccines as Taylor Sw - Daily Mail

Johnson is a colonel in the United States Army Reserves Medical Corps with 26 years of service. He is president of the Emory University Medical Alumni Board, president of the Medical Association of Atlanta and vice president of the board of directors for Leadership Empowerment Project, a nonprofit that helps African American men excel in their first years in college.

By Dr. John Johnson

Unfortunately, meningitis B has caused tragedy in Atlanta. I was saddened to read about a case in 2021 at the Marist School where a 17-year-old honors student and dancer died. She fell ill with symptoms mimicking the flu. But within days, she had passed.

Meningitis strikes fear in the hearts of parents, teenagers and young adults. While the disease is relatively rare there are roughly 1,000 meningitis B cases a year in the United States the effects are devastating. Of those who contract it, 10%-15% will die, and 20% of those who survive suffer permanent disabilities such as brain damage, hearing loss, loss of kidney function or limb amputations.

Unlike diseases that primarily afflict elderly or compromised populations, meningitis targets young, otherwise healthy patients. And the initial symptoms present as the flu, delaying lifesaving treatment in far too many cases. That leads to worse outcomes. Symptoms escalate quickly, with death coming within a day or two of first feeling ill.

Thankfully, there are vaccines that protect against meningococcal diseases. However, confusing federal guidance and the complicated nature of the disease itself have caused limited adoption of vaccines.

One key factor is that there are five strains of meningococcal disease: A, B, C, W and Y. One of the vaccines now on the market protects against A, C, W and Y. Another vaccine is needed to protect against the most dangerous B strain.

However, there is good news on the horizon. A new vaccine is expected to hit the market in the coming months that will protect against all five strains of meningitis.

The Advisory Committee on Immunization Practices, an advisory board that is part of the Atlanta-based Centers for Disease Control and Prevention, will meet Wednesday to issue recommendations on the new vaccine. The ACWY vaccine is now recommended, but the B vaccine received a shared clinical decision making recommendation. This means the vaccine is not routinely recommended, but that the decision to vaccinate should be made between physicians and patients based on their individual risk.

The results? According to CDC data in 2021, 89% of adolescents have received at least one dose of the ACWY vaccine, but only 31% have gotten the menB vaccine, the most dangerous variant.

And these low vaccination rates are likely even worse among communities of color and lower socioeconomic groups. Vaccinations are a front-line issue for those concerned with health equity, as I am.

I am pleased that ACIP will have an opportunity to advise patients and doctors on the new vaccine that will protect against all strains. This is not about mandates or requirements, its about giving sound medical advice to doctors, patients and parents, ensuring that we immunize as many people, across all socioeconomic groups, as possible.

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Opinion: New vaccine will protect young people from all meningitis strains - The Atlanta Journal Constitution