Combining RSV and Flu Vaccines Found Safe and Effective, may Potentially Ease Vaccine Burden: Study

UK: A Phase III randomized trial demonstrated that administering the RSV prefusion F protein vaccine (Arexvy) simultaneously with the adjuvanted seasonal quadrivalent influenza vaccine elicited a robust immune response and was safe for older adults. The findings were published online in Clinical Infectious Diseases on August 05, 2024. 

Respiratory syncytial virus
(RSV) is the major cause of acute respiratory illness. Senior citizens,
infants, and individuals with medical conditions such as lung disease, heart
disease, and diabetes are at major risk of developing RSV. It infects the lungs and respiratory tract. In adults and older,
healthy children, respiratory syncytial virus (RSV) symptoms are mild and
typically mimic the common cold. Self-care measures are usually all that’s
needed to relieve any discomfort. Considering this, Rebecca Clark, from Layton
Medical Centre, Blackpool, United Kingdom, et.al conducted a study to evaluate
the co-administration of adjuvanted seasonal quadrivalent influenza vaccine and
respiratory syncytial virus prefusion F protein-based vaccine in ≥65-year-olds.

For this purpose, the
research team conducted a randomized, open-label trial involving 37 centers
from Belgium, Finland, France, Spain, and the United Kingdom. Declaration of
Helsinki from 14 October 2022 to 17 July 2023. Good Clinical Practice and
Regulatory Requirements conducted the study. The protocol of the study was
approved by the relevant ethics committees.

The study included 1045
participants and the per-protocol sets included 471 Co-Ad and 400 Control
participants for the post-vaccination flu analysis and 471 Co-Ad and 374
Control participants for the post-vaccination RSV analysis. Adults with aged ≥65
years and those with chronic stable medical conditions were included in the
study, Individuals with suspected or confirmed immunosuppressive or immunodeficient
conditions resulting from disease or therapy, and individuals who had received
an influenza vaccine within 6 months before FLU-
aQIV
were administered in the study. Individuals who received the individuals who
received RSV vaccine were excluded from the study.

The findings revealed that:

  • In terms of HI titers for the A/Victoria
    (H1N1), B/Victoria, and B/Yamagata influenza strains as well as RSV-A
    neutralization titers, non-inferiority of FLU-aQIV and RSVPreF3 OA
    co-administered with sequential administration was shown, but not for A/Darwin
    (H3N2) HI titers (95%).
  • Using a microneutralization test, the immune
    response to A/Darwin(H3N2) was further evaluated post-hoc. The post-vaccination
    adjusted GMT ratio (Control/Co-Ad) was 1.23 (95%) indicating that the
    immunological response to A/Darwin(H3N2) was sufficient after
    co-administration.
  • 95% of the groups’ RSV-B neutralization titers
    were similar.
  • The majority of solicited adverse events were
    mild to moderate and temporary, but the rates of serious and unsolicited
    adverse events were similar across groups.

“The adjuvanted RSV prefusion
F protein-based vaccine (RSVPreF3 OA, Arexvy, GSK) is effective against
RSV-related lower respiratory tract disease, demonstrates strong
immunogenicity, and has an acceptable safety profile for adults aged 60 and
older”, researchers concluded.

Reference

Clark, R., Davies,
S., Labrador, J., Loubet, P., Natalini Martínez, S., Moza Moríñigo, H.,
Nicolas, J.-F., Pérez Vera, M., Rämet, M., Rebollo-Rodrigo, M. H., Sanz-Muñoz,
I., Dezutter, N., Germain, S., David, M.-P., Jayadev, A., Amare Hailemariam,
H., Kotb, S., & Meyer, N. (2024). Safety and immunogenicity of respiratory
syncytial virus prefusion F protein vaccine when co-administered with
adjuvanted seasonal quadrivalent influenza vaccine in older adults: A phase 3
randomized trial. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae365

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Can we predict who will develop migraine headaches?

A migraine is not just a bad headache. It is a much-dreaded part of a neurologic disorder that has an array of possible symptoms, including pulsating cranial pain, waves of queasiness, bouts of vomiting, and hypersensitivity to light and sound. They frequently materialize unannounced and at the most inopportune of moments.

Pubescent girls with a family history of migraine headaches are especially vulnerable-yet there remain many unknowns regarding the who, when and why of the disorder. Hadas Nahman-Averbuch, PhD, a scientist at Washington University School of Medicine in St. Louis with expertise in pediatric pain and migraine disorder, is trying to change that. She is leading two observational studies: One will examine why some adolescent girls develop migraine headaches and others do not, and the other will explore how puberty plays a role in migraine headaches among boys and girls.

The single-center studies at the School of Medicine are supported by two grants totaling $6 million from the National Institutes of Health (NIH).

“During adolescence, we see a significant increase in the prevalence of migraine diagnoses in girls,” said Nahman-Averbuch, who runs the Pain Across the Lifespan lab at the university and is an assistant professor of anesthesiology. “We want to understand the changes that come before migraine headache onset and identify the girls who are at risk of developing them. The hope is that this knowledge leads to new therapies and interventions that, if given early, could prevent, manage or treat migraine headaches in adolescent girls.

“We also want to investigate how puberty affects the severity and incidence of migraine headaches in adolescent girls and boys who already experience them, to better understand the trajectory of the disorder.”

Treatments for young migraine sufferers are limited — newer migraine medications that have hit the market in recent years are limited to those 18 and older — and more research into the often-debilitating condition in adolescents is needed.

Among the issues in getting to the bottom of why migraine headaches occur are the many triggers: among them, stress, certain foods, sleep deprivation, caffeine and fluctuating hormones. On top of that are the wide-ranging and inconsistent time delays between triggers and migraine headache onset, which complicate pinpointing a migraine’s exact cause.

The first study led by Nahman-Averbuch focuses on 200 girls ages 10 to 13. During three visits, study participants undergo magnetic resonance imaging (MRI) to look at brain connectivity between two brain regions – the amygdala and the prefrontal cortex. The amygdala plays a critical role in how we perceive and respond to pain. It communicates and interacts with the prefrontal cortex. Changes in that interaction are found in patients with migraine headaches compared with those without migraine headaches and are linked with changes in headache frequency in adolescents with the disorder, Nahman-Averbuch said.

Girls with a family history of migraine disorder are compared with girls without such history to determine if brain changes can be used to predict who will be diagnosed with the illness. The girls, migraine-free at the start of the study, are monitored for migraine development for two years.

Adolescents who have a first-degree relative with migraine disorder have been found in previous work to have higher sensitivity to pain. Nahman-Averbuch, who was involved in such research, suspects that a heightened response to sensory testing involving heat, cold and pressure stimuli may predict who will be diagnosed with the disorder. The participants rate such experiences as part of the study.

Migraine headache incidence is higher in boys before puberty and in girls during puberty, when fluctuating sex hormones aid in the transition to early adulthood. The researchers seek to figure out if a particular sex hormone-for example, estrogen, testosterone or progesterone – can help predict why adolescent girls are more likely to be affected. The research team is monitoring blood levels of various sex hormones as part of the study.

“There are many changes-biological, psychological and social-happening during puberty,” Nahman-Averbuch said. “Each could impact the pain system and be responsible for this pattern. We want to figure out what those changes are, and if they can predict who is at risk of developing migraine headaches.”

In the second study, the researchers track 180 girls and boys ages 10 to 13 diagnosed with migraine disorder over two years. Migraine-free boys with no family history of migraine disorder and migraine-free girls from the first study are part of the control group. Using the same methods as in the first study, the researchers look at how puberty impacts migraine headaches.

“Understanding the changes that come before migraine headache onset and the changes during puberty that improve migraine disorder in a certain population can help us develop new interventions and preventive strategies,” Nahman-Averbuch said. “Meanwhile, identifying adolescents who are at risk may allow us to start such interventions earlier.”

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Clash between RIMS Junior doctors, security staff; several injured

Ranchi: In a violent clash that erupted between junior doctors and home guards deployed for security at Rajendra Institute of Medical Sciences (RIMS) Ranchi, several junior doctors and home guards of the institute were allegedly brutally attacked resulting in severe injuries and some were also admitted to the emergency department. 

The junior doctors have alleged that the clash occurred because the security staff started a physical confrontation with them over the issue of identification cards to enter a stadium inside their campus. 

A female student alleged that a female security officer behaved inappropriately towards her. Although she showed her ID card, she was refused entry to the stadium and experienced rough treatment.

The incident took place on Tuesday night when a medical student and a female student were trying to enter the stadium. The home guard jawans deployed for security asked them for their ID cards. They told them that the RIMS superintendent had given clear instructions that no student should be allowed to enter the stadium after 7:00 pm. 

As per a regional news report by Punjan Kesari, the female student after this incident informed other students and junior doctors about this. This led to the start of a violent dispute among the doctors and the guards. The medical students alleged that the behaviour of the security guards is often abusive and they do not treat the students properly.

Many videos of the incident that went viral showed doctors asking the home guards if they were intoxicated. In these clips, the doctors claimed that the guards seemed drunk and were allegedly wielding sticks and one person was holding a tube light, implying a potential intent to attack them.

Meanwhile, the guards have claimed that an armoury is located for them in the stadium inside the campus where all their guns are kept. They claimed that at around 11 pm, when some Home Guard jawans were going to the stadium to get their guns, the junior doctors stopped them following which an argument broke out and the junior doctors allegedly attacked them. The situation escalated when a fight erupted between the doctors and the guards. 

To bring the situation under control, the college authorities informed the police. After getting information about the matter, teams from several police stations including Sadar DSP Sanjeev Besra reached the spot and calmed down the situation. 

As per the Daily, the administration said, “A thorough investigation of this matter will be done and strict action will be taken against the culprits.” Meanwhile, the police said that they have recorded the statements of both the parties and action will be taken accordingly in this matter soon. 

Also read- Firing at AMU: MBBS student shot in leg during clash, one arrested

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Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Empagliflozin plus Sitagliptin FDC

New Delhi: Exemed 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 for two strengths, i.e. Empagliflozin 10 mg/25 mg plus Sitagliptin 100 mg/100 mg film-coated tablet.

This came after Exemed Pharmaceutical presented the proposal along with a Phase III clinical trial report for two strengths, i.e. Empagliflozin 10 mg/25 mg plus sitagliptin 100 mg/100 mg film-coated tablet, before the committee.

Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose-dependent increases in insulin and decreases in glucagon to improve control of blood sugar. Sitagliptin was granted FDA approval on October 16, 2006.

Inhibition of DPP-4 by sitagliptin slows DPP-4-mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations. These effects lead to an overall increase in blood glucose control, which is demonstrated by reduced glycosylated hemoglobin (HbA1c).

At the recent SEC meeting for endocrinology and metabolism held on 22nd August 2024, the expert panel reviewed the proposal along with the Phase III clinical trial report for two strengths, i.e. empagliflozin 10mg/25mg plus sitagliptin 100 mg/100 mg film-coated tablet, before the committee.

After detailed deliberation, the committee recommended a grant of permission to the manufacturer and market of the proposed FDC.

Also Read: Dr Reddy’s Laboratories gets CDSCO Panel nod to study Live Attenuated Varicella Vaccine

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What to know about the Oropouche virus, also known as sloth fever

More than 20 people returning to the U.S. from Cuba have been infected with a virus transmitted by bugs in recent months, federal health officials said Tuesday. They all had Oropouche virus disease, also known as sloth fever.

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Shot of confidence: Building trust in vaccination programs

A new paper in the Journal of Public Health finds that highlighting the harms of not getting vaccinated is a more effective message than emphasizing the benefits of vaccination for individual patients or the benefits to public health.

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People with type 2 diabetes at higher risk of certain cancers could be identified by a simple blood test, study suggests

Individuals with type 2 diabetes who are at higher risk of certain cancers could be identified by a simple blood test, this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD) (Madrid, 9–13 September) will hear.

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The next pandemic? How a familiar virus exploits new hosts

Planet Earth—a mere speck in our universe—is home to more viruses than there are stars in the cosmos. They exist at life’s outer limit, performing a delicate dance that has lasted eons but can turn in an instant. Not alive, yet entwined with the living, viruses continue to challenge and surprise us.

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Proof-of-concept study explores massage therapy to help reduce nurse burnout

Even before the coronavirus pandemic, high rates of burnout and staffing shortages plagued the nursing industry, primarily because of the stressful demands of the job. The COVID-19 pandemic only amplified these challenges, and with nearly a third of all Missouri nurses nearing retirement, improving nurse retention is key to avoiding an impending nursing workforce crisis in our state.

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Shilpa Medicare gets USFDA nod for Bortezomib Injection for multiple myeloma

Karnataka: Shilpa Medicare Ltd has announced the U.S. Food and Food Administration (USFDA) has approved the Company’s second NDA [505(b)(2)], injectable product – Bortezomib Injection.

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL).

According to the Company, this is the first “liquid” injection for Bortezomib, approved for both subcutaneous and intravenous administration by the USFDA. The Injection is “ready to use” for subcutaneous administration, offering significant advantages to the health care providers. The Injection has to be diluted for intravenous use.

The reference product Velcade is a lyophilized injection which requires reconstitution prior to administration. Bortezomib Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. This NDA provides for the use of Bortezomib injection for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma.

“This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce patient centric solutions that enhance compliance and ease of administration. I am very pleased to see that our relentless endeavour and self-belief of investing in various value added products across different segments have started paying off with monetization opportunities being created in each of the segments, laying a stronger foundation for the future”, said Vishnukant Bhutada, Managing Director Shilpa Medicare Limited.

Shilpa’s Bortezomib Injection shall be marketed by the Company’s business partner, Amneal Pharmaceutical LLC USA. The current market for the lyophilised Bortezomib in the US is about USD 95 million (MAT Q4 2023).

Read also: Shilpa Medicare successfully completes Phase 3 studies of SMLNUD07 – NorUDCA

Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.

Read also: Shilpa Medicare successfully completes Phase 1 clinical trial for Recombinant Human Albumin 20%

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