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FDA Grants Emergency Use Authorization for Novavax’s Updated COVID-19 Vaccine

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On Friday, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for an updated version of Novavax’s COVID-19 vaccine.

This new formulation is now approved for individuals aged 12 and older and is specifically designed to target the JN.1 strain of the virus. The announcement comes amid a fluctuating COVID-19 landscape and varying levels of vaccine uptake.

Key Details of the Authorization

The updated Novavax vaccine is tailored to address the ‘parent strain’ of currently circulating variants, with demonstrated strong cross-reactivity against several lineages of the JN.1 variant, including KP.2.3, KP.3, KP.3.1.1, and LB.1.

According to Novavax’s CEO, John Jacobs, this vaccine aims to offer protection against the evolving virus strains that have been circulating.

Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, highlighted the significance of the authorization, stating, “Today’s authorization provides an additional COVID-19 vaccine option.”

This move expands the range of available vaccines, which is crucial as different variants continue to circulate.

Following the FDA’s announcement, Novavax’s shares experienced a notable increase, rising 2.2% in extended trading after a strong closing that saw a gain of 8.6%. This uptick reflects positive investor sentiment regarding the company’s updated vaccine offering.

Novavax has indicated that doses of the new vaccine could be available as early as the end of next week, subject to distribution logistics. This timely release is aimed at addressing the needs of individuals seeking updated protection against current virus strains.

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Comparison with Other COVID-19 Vaccines

Earlier this month, the FDA approved updated COVID-19 vaccines from Pfizer and Moderna, which target the KP.2 variant. JN.1 was the dominant strain in the U.S. earlier in the year but has since decreased in prevalence.

As of August 31, data from the Centers for Disease Control and Prevention (CDC) shows that JN.1 now accounts for approximately 0.2% of COVID-19 cases.

In contrast, the KP.2 subvariant represents about 3.1% of cases, while the KP.3.1.1 subvariant has surged to become the dominant strain at 42.2%.

The evolving nature of the virus has prompted the FDA to request vaccine makers to focus on the KP.2 strain for the 2024-25 vaccine updates.

Vaccine Technology and Public Health Context

Novavax’s vaccine utilizes a traditional protein-based technology, offering an alternative to the messenger RNA (mRNA) vaccines developed by Moderna and Pfizer-BioNTech.

While mRNA vaccines like Moderna’s Spikevax and Pfizer’s Comirnaty have been at the forefront of the pandemic response, Novavax’s approach provides an additional option for those who may prefer or require different technology.

Despite a recent increase in COVID-19-related hospitalizations and deaths in the U.S. over the past three months, the demand for COVID-19 vaccines has significantly declined since the pandemic’s peak.

Novavax has projected that overall vaccine demand will remain consistent with last year’s figures, although it anticipates a better performance for its updated vaccine.

As COVID-19 continues to evolve, the availability of updated vaccines like Novavax’s provides crucial options for maintaining public health protection.

The new EUA for Novavax’s vaccine highlights ongoing efforts to adapt to the changing virus and offer effective solutions to combat it. The coming weeks will be pivotal in assessing the vaccine’s impact and its role in the broader fight against COVID-19.

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Canada Records its First Case on Monkeypox

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The individual sought medical care for mpox (monkeypox) symptoms.

Canada’s Department of Public Health confirmed on Friday that the country’s first mpox (monkeypox) incidence occurred in Manitoba.

According to the Public Health Agency of Canada, this travel-related case is tied to a continuing mpox outbreak in central and eastern Africa.

“The individual sought medical care in Canada for mpox symptoms shortly after their return and is currently isolating,” the agency stated.

The Public Health Agency of Canada works closely with Manitoba’s public health authorities. The National Microbiology Laboratory (NML) informed the province on November 22 that the sample tested positive for mpox (monkeypox),” the agency stated.

The World Health Organization stated earlier in the day that the mpox outbreak remains a public health emergency.

In August, the WHO declared mpox a global public health emergency for the second time in two years, following the spread of a new version of the virus, known as Mpox clade Ib, from the Democratic Republic of Congo to neighboring nations.

MPox is a viral illness that spreads by close contact and causes flu-like symptoms and pus-filled sores. It is typically moderate, but it can be fatal.

The Public Health Agency of Canada said that while the danger to Canada’s general population is low, it constantly monitors the situation. It further stated that a public health investigation, including contact tracing, is underway.

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A Canadian Teenager’s Bird Flu Virus Has Mutations

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HealthDay

(VOR News) – Health experts have warned that the Bird Flu virus identified in Vancouver has undergone alterations that may increase its transmissibility to humans, a circumstance that Canadian officials believe could occur.

“No additional cases have been identified” after monitoring many potential contacts among the adolescent’s friends, family, and healthcare providers; however, there is no indication that the single Canadian teen is the only one infected with this specific mutant H5N1. Brenda Henry, British Columbia’s provincial health officer,

Bird Flu

Dr. Jesse Bloom of the Fred Hutchinson Cancer Center in Seattle told CNN that this is “undoubtedly one of the initial instances where we have observed evidence of such adaptive mutations in H5”.

Bloom observed that the teen’s symptoms began one week before hospitalization, giving the Bird Flu extra time to strengthen its capacity to infiltrate the desired cells.

Significantly, the calf is in critical but stable condition, having contracted a different strain of the virus than the one that affects dairy calves in the United States. An H5N1 strain is circulating throughout Pacific Northwest wild bird populations.

Because there was no documented link with wild birds, Canadian officials are still unsure how the adolescent contracted the illness.

The three discovered alterations in the Canadian example are determined to be at specific regions on the genome, which would improve binding to human cells.

“Numerous influenza virologists, myself included, have observed it due of certain sequences exhibiting indications of mutations that concern us,” he said.

Following a toddler in Alameda County who was exhibiting minor upper respiratory symptoms, California determined the child may have Bird Flu. According to a news release from the California Department of Public Health (CDPH), the young person is recovering at home following treatment.

Although the patient has had no recorded interaction with an affected animal, the CDPH reports that health officials are investigating possible exposure to wild birds. In addition, they reported, “the positive test indicated a low-level detection of the virus, suggesting the child was unlikely to be infectious to others.”

Four days later, the youngster’s next bird flu test returned negative; further research found that the child tested positive for respiratory infections, which could be causing their Bird Flu and cold symptoms. The US Centers for Disease Control and Prevention will collect test specimens for the next investigation.

California officials emphasized that, despite the reported occurrence, the public health risk remained extremely low.

“We aim to reassure parents, caregivers, and families that, according to our information and data, we do not believe the child was infectious, and no human-to-human transmission of bird flu has been recorded in any country for over 15 years,” stated Dr. Tomás Aragón, head of the CDPH. “It is normal for people to show concern.”

According to the CDC, 53 Americans had confirmed instances of avian flu, with all but one being exposed to contaminated poultry or dairy cows.

In the California example, all of the child’s relatives tested negative, and there is no evidence that the virus moved from person to person.

Dairy cows

The virus first appeared in a pig last month. Seven states have already verified cases of avian influenza, with Oregon reporting the first human case last week. Most incidents have occurred among farmworkers.

California has the state’s largest confirmed human avian influenza infection count, with 27 cases reported (excluding the infant from Alameda County). According to CDC records, there are 11 cases in Washington and 10 in Colorado.

Recent developments have heightened public health experts’ concerns about the prospect of the avian flu virus spreading from person to person.

Since March, the disease has spread to approximately 600 dairy farms in 15 states nationwide. Bird flu has been frequent among domestic and wild birds in the United States for several years.

Dr. James Lawler, co-director of the University of Nebraska’s Global Center for Health Security, recently told the New York Times that “we should be very concerned at this juncture.” “We ought to allocate considerable resources to ascertain the situation, but at this time there is no need for alarm.”

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Pancreatic Cancer Among Young People Is No Longer Alarming.

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Pancreatic Cancer

(VOR News) – Experts have voiced apprehension regarding the increasing incidence of pancreatic cancer among youth; nevertheless, a recent study reveals that this surge in diagnoses has not been paralleled by a commensurate increase in mortality rates attributed to the disease.

What is the reason? Researchers assert that contemporary, more sensitive imaging scans may identify early, non-fatal occurrences of pancreatic cancer in individuals under 40 that were previously undiscovered.

Researchers have noted growing concerns from several registries regarding the rising prevalence of pancreatic cancer among young individuals, especially women, in the United States and worldwide. “While some ascribe this trend to rising obesity rates, others have identified no discernible cause.”

Analyzing the data

The statistics on pancreatic cancer conflate endocrine malignancies and adenocarcinomas, which are two entirely different tumor forms occurring in the same organ.

The first form generally requires years to develop and increase, whereas the second type is characteristically aggressive and spreads rapidly.

The rising prevalence of pancreatic cancer among younger Americans is mostly attributed to an enhanced diagnosis of smaller, early-stage endocrine tumors rather than an escalation in pancreatic adenocarcinoma cases, the researchers noted.

The declining mortality rate of pancreatic cancer, juxtaposed with the rising incidence of new cases, implies that the recent surge in early-onset pancreatic cancer indicates the identification of previously undiagnosed disease rather than an actual rise in cancer prevalence.

Researchers, under the leadership of Dr. Vishal Patel, a surgical resident at Brigham and Women’s Hospital in Boston, acknowledged the increasing incidence of pancreatic cancer among young individuals. Their research, published on Monday in the Annals of Internal Medicine, contains the following information:

Pancreatic cancer operations

Restricting the increase of tumors in their first stages is a significant point to consider. This data indicates a phenomenon termed overdiagnosis, characterized by a rise in mortality that does not correspond with the increase in case numbers.

More dangerous adenocarcinomas are occasionally identified at an earlier stage during abdomen scans conducted for unrelated reasons. Conversely, the study’s authors assert that the prevalence of adenocarcinomas among young individuals has remained constant across all stages of the disease.

Meanwhile, the researchers indicated that CT scans and MRIs, which are increasingly sensitive and utilized for a broader range of applications than before, can identify less malignant endocrine tumors in the pancreas.

Dr. H. Gilbert Welch, a senior researcher at the Center for Surgery and Public Health at Brigham and Women’s Hospital, stated to the New York Times, which published the findings, “The more you are imaged, the more these issues will arise.”

Upon discovery of any issue, both individuals and medical professionals may feel compelled to act.

Dr. Folasade May, a gastroenterologist at the University of California, Los Angeles, stated in an interview with the Times, “Occasionally, we observe anomalies on imaging that necessitate further investigation.” “Ultimately, they may necessitate significant surgical intervention.”

Patients needing surgery

As indicated by the doubling of pancreatic cancer surgical interventions among patients aged 25-34, there has been a substantial increase in surgical interventions for pancreatic cancer among young patients as well.

Dr. Adewole Adamson, a specialist in overdiagnosis at the University of Texas at Austin and a co-author of the paper, stated, “Many patients express a desire for removal.” “Upon receiving a cancer diagnosis, one feels compelled to take action.”

Patients and clinicians should be aware of the following considerations in the future.

The research team states, “Pancreatic cancer may now be subject to overdiagnosis, referring to the identification of disease that is unlikely to result in symptoms or mortality.” “Overdiagnosis is particularly alarming in the context of pancreatic cancer, given that pancreatic surgery carries significant risks of morbidity and mortality.”

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Canadian High School Students Stressing Over Economic Concerns

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