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An experimental mRNA vaccine against human cytomegalovirus (CMV), a common virus that can infect babies during pregnancy, elicited some of the most promising immune responses to date of any CMV vaccine candidate, according to a study by Weill Cornell Medicine investigators.

The study, published in the Journal of Infectious Diseases on Feb. 7, provided evidence that the new mRNA vaccine candidate, which is manufactured by Moderna, Inc., may protect adults against CMV. Thus, it could potentially prevent women from passing the harmful infection to their babies during pregnancy. Compared with a previous moderately successful vaccine candidate called gB/MF59, the mRNA vaccine elicited responses that were better at preventing the CMV virus from infecting epithelial cells that line the mouth and nose and provide the first line of defense against viral infection. The mRNA vaccine was also more effective at triggering the immune system to destroy CMV-infected cells.

“We learned that the newer vaccine has the potential to be more effective than a previous CMV vaccine candidate because some of the functional immune responses it elicits are higher in magnitude,” said senior author Dr. Sallie Permar, the chair of the Department of Pediatrics and Nancy C. Paduano Professor in Pediatrics at Weill Cornell Medicine. “An ongoing clinical trial will confirm if those differences lead to greater protection against CMV infection.”

Though healthy adults are largely asymptomatic, one in every 200 newborns worldwide are infected with CMV during their mother’s pregnancy. The virus rarely causes serious illness in healthy adults, but it can cause birth defects and brain damage in newborns infected in utero and deadly infections in immune-compromised adults.

“It is the most common congenital infection worldwide,” explained Dr. Permar, who is also pediatrician-in-chief at NewYork-Presbyterian/Weill Cornell Medical Center and NewYork-Presbyterian Komansky Children’s Hospital.

Co-first authors Dr. Krithika P. Karthigeyan, postdoctoral associate in pediatrics at Weill Cornell Medicine, and Dr. Xintao Hu, who was part of the research team at the time, also contributed to this research.

CMV Vaccine Candidates

Previously, Sanofi and Novartis had developed vaccine candidate gB/MF59, which targeted glycoprotein B (gB), a sugar-laden viral surface protein that works with other proteins to help CMV attach to and enter human cells. It protected about half of vaccinated individuals from CMV infection in a phase 2 clinical trial led by the National Institute of Allergy and Infectious Diseases Vaccine Clinical Trials Network. When the trial ended in 2013, it did not progress to phase 3 clinical trials.

Dr. Permar and her colleagues used the data and patient samples from the gB/MF59 phase 2 trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine. Using the same technology that produced the company’s COVID-19 vaccine, Moderna’s CMV vaccine added a second target—a five-unit protein complex that allows the virus to infect the epithelial cells that line the nose and mouth-in addition to glycoprotein B.

In this study, Dr. Permar and her team compared the immune responses of individuals vaccinated with gB/MF59 in the phase 2 trial with those immunized with Moderna’s mRNA-based CMV vaccine in a phase 1 clinical trial which ended in 2020. Specifically, the team compared the immune responses in people who were protected against CMV infection after receiving the older vaccine.

New Vaccine Triggers Stronger Immune Response

The mRNA vaccine-likely because of the additional second target-did a better job of preventing the CMV virus from infecting healthy epithelial cells. The vaccine triggered immune cells to produce neutralizing antibodies that block the entry of the virus into a cell, which prevents viral replication. Also, the mRNA vaccine induced antibody responses that could destroy infected cells. In contrast, people vaccinated with the gB/MF59 vaccine produced higher levels of antibodies against gB that had low neutralizing activity but had strong ability to engulf and eliminate a virus.

The Moderna vaccine has moved on to the first ever phase 3 clinical study for a CMV vaccine candidate, which will help determine if these differences in immune responses will lead to stronger protection against CMV. “After more than 50 years of research, we are closer than ever to having a licensed CMV vaccine,” Dr. Permar said. “The new mRNA platform has a lot of potential.”

In the meantime, Dr. Permar and her colleagues have developed a preclinical model to test whether similar vaccines protect against fetal CMV transmission during pregnancy.

Reference:

Xintao Hu, Krithika P Karthigeyan, Savannah Herbek, Sarah M Valencia, Jennifer A Jenks, Helen Webster, Itzayana G Miller, Megan Connors, Justin Pollara, Caroline Andy, Linda M Gerber, Emmanuel B Walter, Kathryn M Edwards, David I Bernstein, Jacob Hou, Matthew Koch, Lori Panther, Andrea Carfi, Kai Wu, Sallie R Permar, Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine, The Journal of Infectious Diseases, 2024;, jiad593, https://doi.org/10.1093/infdis/jiad593.

Hyderabad: In response to the suspension of the two on-duty doctors and a nursing staff following an incident where a patient was bitten by rats in the ICU of Kamareddy Government Hospital. The doctors across Telangana protested and demanded the order be revoked. 

After a patient was bitten by rats on his fingers and toes while he was undergoing treatment at the Kamareddy government hospital, two doctors and a nursing staff were suspended on Sunday due to allegations of being negligent towards the patient.

The three employees in the Intensive Care Unit (ICU) at Government Medical College and General Hospital, Kamareddy, faced disciplinary action after an investigation conducted by Vaidya Vidhana Parishad commissioner Ajay Kumar uncovered alleged medical negligence on their part.

The patient was undergoing treatment at the government hospital at Kamareddy district headquarters. According to hospital officials, he had undergone decompressive craniotomy surgery at NIMS, Hyderabad on January 21. He was later admitted to Kamareddy Hospital and was on ventilator support.

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However, the situation turned serious when the patient was bitten by rats on his hands and feet in the ICU on February 9. After noticing the scars on his fingers and toes, the family members filed a complaint to the hospital authorities. 

In response to the complaint, a preliminary investigation was launched and the probe held that these three employees who were on night duty were responsible for the matter asserting that they were negligent in taking care of the patient, reports TOI. 

Kamareddy district collector Jitesh V. Patil ordered the suspension of ICU in-charge general medicine Dr Vasanth Kumar (Associate Professor), ICU in-charge Dr Kavya (Assistant Professor) and nursing officer. The district collector also surrendered the services of the hospital superintendent to the government, IANS reports.

Meanwhile, doctors and hospital employees on Monday staged a protest over the suspension of three colleagues. Wearing black badges, doctors participated in the protest in front of the hospital. Not only this, doctors from government hospitals across the state, including Mancherial, Jangaon, Nirmal, Ramagundam, Mahabubnagar, Wanaparthy and Asifabad, among others also expressed their displeasure with the government’s decision. They demanded that the suspension be revoked and threatened to go on strike if the suspension was not lifted.

Condemning the suspension of the doctors, the Telangana Teaching Government Doctors’ Association (TTGDA) said that the doctors were concerned only till they treated the patients and it was the responsibility of sanitation staff and officials to keep the hospital free from rats, dogs, pigs and insects.

Following this, the association had a meeting with Health Minister Damodar Raja Narasimha on Monday evening. The Minister assured the protesting doctors that the suspension order would be revoked and action would be initiated against appropriate authorities.

Dr Jalagam Thirupathi Rao, the State General Secretary of the Telangana Teaching Government Doctors Association (TTGDA) told TH, “The responsibility for rodent-related issues lies with the sanitation staff and not the doctors. The required action should be directed towards the sanitation agency, not the doctors who have no involvement in sanitation matters. We are staging a black badge protest, urging the DME to revoke the suspensions; otherwise, all doctors in the State will march to the DME office on Tuesday.”

Among those suspended Dr Vasanth Kumar informed the Daily that he was not present at the hospital on the day of the incident. “From February 9 until now, I have been assigned duties as an external examiner at Gandhi Medical College Hyderabad. Secondly, nobody ever made me in charge of the ICU at the Kamareddy Hospital. How can they suspend me when I was not present during the time of the incident?” he added.

Similarly, Dr Kavya said that she was not responsible for the incident as she had morning duty and denied being the ICU in-charge as mentioned in the government release.

Meanwhile, the Indian Medical Association (IMA) also came in support of the protesting doctors and threatened to hold a statewide protest if the government fails to revoke the suspension of the three employees. 

The association in a statement said, “It is the duty of all medical officers to treat the patient till they are discharged, but they have no role in searching for rats in the wards to prevent bites. The ICU is meant to extend treatment to serious patients, to save precious lives. But, not to keep vigil on rats. It is highly irresponsible and unprofessional action taken against the medical officer for rate bite.”

Later, Telangana Vaidhya Vidhana Parishad commissioner Ajay Kumar visited the hospital and inspected with a three-member committee based on the direction of the Health Minister. During the inspection, the committee found several lapses in the hospital and recommended revoking the suspension of the three employees. 

“The hospital has several lapses, including staff crunch, improper upkeep and ongoing construction work. Sightings of rats have been common. The hospital was converted into a medical college last year and is being upgraded from a 100-bed hospital to a 300-bed one. There is sewer network work going on too,” a source told TOI. 

“The government general hospital in Kamareddy has a capacity of 10 ICU beds. The rodent problem is due to dismantling work beside the ICU for renovation of the dialysis unit as well as because of food thrown by patients’ attendants,” a statement issued by the Department of Health, medical and Family Welfare stated. It added that the department was monitoring the situation and “no untoward incident will be tolerated, especially in offering health care to the needy”. As a result, a departmental inquiry has been ordered by the government in this regard. 

Attendants of other patients also complained about the rat menace at the hospital. They demanded hospital authorities to take immediate action to solve the problem.

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New Delhi: The drug major Akum Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate Eq. to Dapagliflozin 5mg/5mg/5mg/5mg plus Glimepiride IP 1mg/2mg/1mg/2mg plus Metformin Hydrochloride IP (As ER) 500mg/500mg/1000mg/1000mg film coated bilayered tablet.

The medical practitioners who are employed in any capacity in West Bengal, those involved in private practice, or the Postgraduate students in any medical college in the State will now mandatorily require registration with the West Bengal Medical Council. This includes the doctors who have registrations in other states and are currently working in the state.

Issuing a notification in this regard on 09.02.2024, the Council further clarified that those who do not have registration with the West Bengal Medical Council will have to obtain the same within the coming three months.

For the full story, check out the link given below:

Registration Mandatory For All Doctors Practising, Studying In Bengal, Medical Council Gives Deadline

The Food and Drug Administration (FDA) has approved EOHILIA (budesonide) oral suspension for treatment of eosinophilic esophagitis among adults and pediatric patients 11 years of age and older.

It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February.

EOHILIA is a corticosteroid indicated for 12 weeks of treatment in patients 11 years and older with EoE.1 Developed specifically for EoE, EOHILIA’s novel formulation of budesonide confers thixotropic properties-flowing more freely when shaken and returning to a more viscous state when swallowed.

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With EOHILIA, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” said Ikuo Hirano, MD, professor of medicine and director of the Kenneth C. Griffin Esophageal Center in the Division of Gastroenterology and Hepatology at Northwestern University Feinberg School of Medicine. “As the treatment needs and goals of patients with EoE can vary, I welcome the flexibility that EOHILIA offers as an oral medication.”

The FDA approval of EOHILIA 2 mg twice daily is based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies (Study 1 and Study 2) in patients (ages 11 to 56 and 11 to 42, respectively) with EoE. In both studies, patients received at least one dose of either EOHILIA 2 mg twice daily or placebo orally twice daily. Efficacy endpoints included histologic remission (peak eosinophil count of ≤6 per high-powered field across all available esophageal levels) and the absolute change from baseline in patient-reported Dysphagia Symptom Questionnaire (DSQ) combined score after 12 weeks of treatment. The DSQ measures how often a patient with EoE has trouble swallowing and the behavioral adaptations they subsequently use, as reported directly by patients.

Significantly more patients receiving EOHILIA achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%). In Study 2, 38% of EOHILIA patients achieved histologic remission vs. 2.4% of those in the placebo group. Absolute change from baseline in DSQ combined score in the EOHILIA vs. placebo groups in Study 1 was -10.2 (1.5) vs. -6.5 (1.8) and in Study 2, -14.5 (1.8) vs. -5.9 (2.1). During the last two weeks of each study, more patients receiving EOHILIA experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” as compared to placebo, as measured by the DSQ. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. The most common adverse reactions (≥2% of patients receiving EOHILIA and at a rate greater than placebo) in Study 1 included: respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%) and erosive esophagitis (2%). The safety profile of EOHILIA in Study 2 was generally similar to Study 1.

“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” said Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda. “With EOHILIA, patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown during two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”

EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus. Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens. The chronic inflammation of EoE can lead to a range of symptoms, which can vary by person and age, and include difficulty swallowing, vomiting and pain. Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus). In fact, EoE is the leading cause of emergency room visits for food impaction.

Takeda is assessing the financial impacts of the approval, including a reversal of impairment loss for intangible assets, on the fiscal year ending on March 31, 2024 (FY2023), but does not anticipate the impact to be material.