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Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older.

FLUCELVAX QUADRIVALENT was previously FDA-approved for use in persons four years of age and older.

The expanded age indication is based on absolute efficacy data indicating that FLUCELVAX QUADRIVALENT was effective and produced a sufficient immune response against influenza in children and adolescents between ≥2 to <18 years of age over three influenza seasons in the Southern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator. This represents the first absolute efficacy study of a cell-based influenza vaccine in this population. 

“Young children are at a high risk of complications from influenza, which is why annual vaccination is critical,” commented Gregg Sylvester, M.D., CMO at Seqirus, in a press statement issued on March 4, 2021.

FLUCELVAX QUADRIVALENT will be available as a 0.5ml intramuscular (IM) vaccine per dose for the 2021/22 U.S. influenza season.

Seqirus is part of CSL Limited, one of the largest influenza vaccine providers in the world.

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On International human papillomavirus (HPV) Awareness Day, Tennessee-based St. Jude Children's Research Hospital announced the HPV Cancer Prevention Program's launch. With an investment of $12 million, St. Jude is launching outreach programs to reduce HPV-related cancer deaths by increasing vaccination rates locally, nationally, and eventually, globally.

Heather Brandt, Ph.D., leads the St. Jude HPV Cancer Prevention Program.

"Since 2006, we have had a safe, effective, and durable vaccine to prevent six types of HPV-related cancers in men and women," Brandt stated in a press release.

"However, rates of this cancer-prevention vaccination remain low, especially in areas of the Southeastern and Mid-Southern United States where HPV-related cancer rates are high. We also know there are vast differences in uptake among some populations, so there is an urgent need to address these inequities."

"Far too few have taken advantage of this cancer prevention tool, and I look forward to joining forces with other partners to improve vaccination rates."

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refugee camp in africa
GSK Rotarix is a live, attenuated rotavirus vaccine
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The US Department of State issued its highest level travel advisory on March 1, 2021, for the United Republic of Tanzania, a country in East Africa within the African Great Lakes region.

This Level 4 Advisory says, 'do not travel to Tanzania due to the COVID-19 pandemic. For the pandemic, Tanzania has not implemented stay-at-home orders nor limited transportation options or business operations.

The Centers for Disease Control and Prevention (CDC) has previously issued a Level 4 Travel Health Notice for Tanzania. CDC compliant testing for COVID-19 is either not available, or results are not always available within 3 calendar days of testing. And travelers should expect delays when returning to the USA.

Additionally, the State Department says 'violent crime, such as assault, sexual assault, robberies, mugging, and carjacking, is common. Local police may lack the resources to respond effectively to serious crime. Members of the LGBTI community have been arrested, targeted, harassed, and/or charged with unrelated offenses. Individuals detained under suspicion of same-sex sexual conduct could be subject to forced anal examinations.

Terrorist groups could attack in Tanzania with little or no warning, targeting embassies, police stations, mosques, and other places frequented by Westerners.

If you visit Tanzania, the State Department suggests enrolling in the Smart Traveler Enrollment Program to receive Alerts and make it easier to locate you in an emergency.

The local US Embassy is located at 686 Old Bagamoyo Road, Msasani, Dar es Salaam. Phone: 255-22-229-4000.

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Sweden-based Diamyd Medical announced the upcoming Phase III trial with Diamyd® in new-onset type 1 diabetes based on the first precision medicine approach in the field. The trial is designed to confirm the effect and safety of Diamyd® in individuals recently diagnosed with type 1 diabetes who carry the genetic HLA DR3-DQ2 haplotype.

The Phase III trial is designed to enroll approximately 330 individuals aged 12 to 28, recently diagnosed with type 1 diabetes, who carry the HLA DR3-DQ2 haplotype. This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials. Further stratification for HLA haplotypes will be included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.

”We are breaking new ground and are very excited to advance the first-ever precision medicine approach for type 1 diabetes”, commented Ulf Hannelius, CEO of Diamyd Medical, in a press statement. “We will launch the trial during 2021, and with the support of a partner and institutional investors secure the further required operational and strategic resources to maximize the potential in Diamyd“.

Diamyd Medical is a clinical-stage diabetes company active in the field of pharmaceutical development.

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The U.S. government is funneling travelers from certain African countries into six airports to conduct enhanced Ebola disease screening. These airports are Washington-Dulles International, Atlanta Hartsfield, Chicago O’Hare, Los Angeles International, JFK, and Newark.

The 12th Ebola outbreak has been declared the Democratic Republic of the Congo (DRC).

Air travel has the potential to transport people, some of whom may have been exposed to a communicable disease, anywhere across the globe in less than 24 hours. Therefore, out of an abundance of caution, the U.S. government will institute public health measures for travelers arriving from DRC and Guinea.

Visitors will provide personal health information to the U.S. CDC for public health follow-up and intervention. These travelers can expect verification of data on arrival to ensure completeness and accurateness of contact information. This information will be shared with U.S. state and local health departments to appropriately monitor arrivals in their jurisdiction.

Cumulatively, the DRC reported 11 confirmed cases with four deaths (CFR: 36%) in four health zones. And Guinea has reported 17 cases (13 confirmed and 4 probable) with seven deaths and two recoveries as of March 3, 2021.

 

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Zoonotic Influenza Vaccines 2023

Zoonotic Influenza Vaccines August 2023

Zoonotic influenza infections are caused by harmful germs, bacteria, parasites, and fungi, says the U.S. Centers for Disease Control and Prevention (CDC). These germs cause illnesses in people, birds, and animals, ranging from mild to severe infections, according to the World Health Organization (WHO). As of August 2023, the CDC says annual 'flu shots' do not prevent zoonotic influenza infections such as swine flu (H3N2) or Avian influenza (Bird Flu). In September 2023, the U.S. CDC published Volume 29, Number 9, Research: Interspecies Transmission of Swine Influenza A Viruses and Human Seasonal Vaccine-Mediated Protection Investigated in a Ferret Model - results reaffirm the need for continuous influenza A virus surveillance in pigs and identification of candidate human vaccine viruses.

The WHO's Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted in 2011 as a global approach to pandemic influenza preparedness and response. If a pandemic influenza A virus changes and becomes transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be significant. The CDC says the severity is unpredictable because human immune systems have not established natural defenses. The most recent pandemic occurred in 2009, caused by an influenza A (H1N1) virus. Estimates indicate that the pandemic caused up to 400,000 deaths globally, with about 12,000 people in the U.S. 

Pandemic Influenza Vaccine

In April 2007, the U.S. Food and Drug Administration (FDA) licensed the first inactivated influenza vaccine for people at increased risk of exposure to the H5N1 influenza virus subtype. It was derived from the A/Vietnam/1203/2004 influenza virus a, manufactured by Sanofi Pasteur Inc. Furthermore, four pandemic preparedness vaccines are authorized in Europe, which can be modified into pandemic influenza vaccines. The EMA conditionally Authorized AstraZeneca's Pandemic influenza vaccine H5N1 (P/LAIV) in May 2017 to prevent pandemic influenza in children and adolescents. Companies operating in the global swine flu vaccine market are Novartis AG, CSL Limited, Zydus Cadila, AstraZeneca plc, MedImmune, GlaxoSmithKline, Sanofi SA, Baxter, and Sinovac Biotech Ltd.

Bird Flu Vaccine

Avian influenza vaccine news is published on this webpage.

Swine Influenza (Swine Flu)

When a swine influenza virus (H3N2) is detected in a person, it is called a "variant influenza virus," says the CDC. When animal influenza viruses infect their natural host, they are named for that host, as in avian influenza viruses, swine influenza viruses, equine influenza viruses, etc. In 2005, human infection with the novel flu A virus became nationally notifiable in the United States. The term "swine flu" refers to swine influenza viruses infecting swine. There are different swine influenza virus subtypes and strains, some of which infect other animal species, including (rarely) humans. Most human infections with variant influenza viruses occur following proximity to swine. However, human-to-human transmission can occur, says the CDC. For recommendations on safe trade in animals and related products from countries affected by these influenza viruses, refer to WOAH guidance

The first swine influenza virus was found in pigs in 1918. Since 2005, 512 variant influenza virus infections (of different influenza A virus subtypes), including 37 (human infections with influenza A (H1N2)v viruses, were reported in the U.S. The CDC published an interactive analysis of Novel Influenza A Virus Infections in the U.S. A study (Volume 29, Number 9) published by the CDC in September 2023, results reaffirmed the need for continuous influenza A virus surveillance in pigs and identification of candidate human vaccine viruses.

On September 2, 2023, the Ministry of Health, Welfare, and Sport of the Netherlands notified the WHO of a laboratory-confirmed human infection with a swine-origin influenza A(H1N1) variant virus. On August 4, 2023, the CDC reported the first two U.S. human infections with swine flu viruses who attended different agricultural fairs in Michigan in 2023 and had exposure to pigs. On June 7, 2023, Brazil notified the WHO of a fatal laboratory-confirmed human case of infection with a swine-origin influenza A(H1N1) variant (v) virus in the inner state of Paraná. It's the third swine flu fatality. Taiwan's CDC reported its third H1N2 variant (H1N2v) influenza virus case in May 2023 involving girls who had contact with pig farms in central Taiwan. India reported 451 cases of H3N2 from January to March 5, 2023.

African Swine Fever

African Swine Fever (ASF) is a highly contagious and deadly viral disease affecting domestic and feral swine of all ages. The U.S. Department of Agriculture and the FDA say ASF cannot be transmitted from domestic and wild pigs to humans.

Langya Henipavirus

Langya henipavirus (LayV), also known as Langya virus, is a species of henipavirus detected in China's Shandong and Henan provinces. Media reports indicated that 35 people were infected from 2018 to August 2022. Hendra virus and Nipah virus from this genus are known to infect humans, with fruit bats as the natural host of both viruses.

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Zoonotic diseases such as swine and bird influenza pandemic in 2023.
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The European Medicines Agency (EMA) announced on March 4, 2021, the latest safety data for the Comirnaty Vaccine (Pfizer-BioNTech) are in line with the known benefit-risk profile, and the outcomes of the related assessments are presented in this update.

The benefits of Comirnaty in preventing COVID19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine, says the EMA.

Safety updates provide the outcomes of the assessment of emerging data since marketing authorization for COVID-19 vaccines. Diarrhea and vomiting after vaccination have been identified as new side effects.

The EMA’s Pharmacovigilance Risk Assessment Committee carries out the assessments based on all available data.

Comirnaty was authorized in the European Union on December 21, 2020, for use in people aged 16 years and older to prevent the development of COVID-19 when infected with the coronavirus SARS-CoV-2. Comirnaty contains a molecule called mRNA, which the body uses to produce the SARS-CoV-2 spike protein temporarily.

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The U.S.Centers for Disease Control and Prevention (CDC) issued a Level 1 Travel Alert for many parts of Central and South America, Mexico, and the Caribbean regarding Dengue virus risks. The CDC published an updated Dengue risk map for the Americas and the Caribbean.

Because mosquito bites spread dengue, all travelers to risk areas should prevent mosquito bites, said the CDC on March 2, 2021. You can find the right insect repellent by using EPA's search tool.

As of February 17, 2021, the CDC had confirmed five travel-related dengue cases in the continental US and 42 dengue cases in Puerto Rico during 2021.

Dengue disease can take up to 2 weeks to develop, with an illness generally lasting less than a week. Health effects from dengue include fever, headache, nausea, vomiting, rash, muscle and joint pain, and minor bleeding.

Dengue can become severe within a few hours. Severe dengue is a medical emergency, usually requiring hospitalization. In severe cases, health effects can include hemorrhage, shock, organ failure, and death says the CDC.

Learn more about dengue how to prevent it on CDC’s dengue page for travelers. An updated dengue vaccine approved list is found on this webpage.

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California-based Sorrento Therapeutics, Inc. announced on March 2, 2021, that it had received clearance from the FDA for its Investigational New Drug application for its Phase 1 study of safety pharmacokinetics of intranasal STI-2099 (COVI-DROPS) in both healthy volunteers and patients with mild COVID-19.

Treatment with STI-2099 has the potential to halt the COVID-19 infection at the earliest stage in the nasal passages before it has a chance to spread to the lungs, and if the infection has already hit the lungs, prevent the development of severe infections.

This small volume IV-push formulation is tested against the dominant strain of the SARS-CoV-2 virus in the USA and the emerging UK variant.

“We plan to use our intranasal formulation technology, which allows administering a drug via simple drops in the nose, for other antibodies we are currently developing with a goal of providing coverage against all variants of the SARS-CoV-2 virus that might evade inhibition from treatment with existing therapies,” commented Dr. Henry Ji, Chairman, and CEO of Sorrento, in a press statement.

Sorrento is a clinical-stage, antibody-centric biopharmaceutical company developing new therapies to treat cancers and COVID-19.

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