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US Embassy highlights The Bahamas Travel Health Visa
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The U.S. Embassy in Tokyo issued a Health Alert on March 21, 2021, stating the Japanese government had ended the state of emergency covering Tokyo, Kanagawa, Saitama, and Chiba.

The Government of Japan’s national emergency declaration has now been lifted nationwide despite some restrictions, especially those involving the early closure of nightlife establishments (bars, restaurants, and other entertainment outlets) remaining in place.

However, the Government of Japan continues to urge residents to take all possible precautions against the spread of COVID-19, including social distancing, mask-wearing, and avoiding crowded areas.

The U.S. Embassy strongly urges U.S. citizens to comply with all local and national COVID-19 mitigation measures. The U.S. Embassy and consulates are open for routine services, but appointment availability remains limited. To schedule an appointment, visit this website for instructions.

However, the U.S. CDC issued a Travel Alert on March 15, 2021, saying 'travelers at increased risk for severe illness from COVID-19 and should avoid all travel to Japan.'

And, all air passengers coming to the USA, including U.S. citizens, are required to have a negative COVID-19 test result or documentation of recovery from COVID-19 before they board a flight to the United States. See the Frequently Asked Questions for more information.

Furthermore, the CDC says, 'visit your doctor at least a month before your trip to get travel vaccines or medicines you may need.'

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New Jersey-based Merck announced that the U.S. Food and Drug Administration (FDA) had approved KEYTRUDA, an anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.

KEYTRUDA works by increasing the body’s immune system's ability to help detect and fight tumor cells, says Merck.

The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.

For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% and reduced disease progression or death by 35% versus FU and cisplatin alone.

The ORR, an additional efficacy outcome measure, was 45% for patients who received KEYTRUDA plus FU and cisplatin and 29% for those who received FU and cisplatin alone.

Dr. Peter Enzinger, Director, Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center, stated in a press release, “Today’s approval of this indication for KEYTRUDA introduces a new option, which has shown a superior survival benefit compared to FU and cisplatin alone, for newly diagnosed patients with locally advanced or metastatic esophageal or GEJ carcinoma that is not amenable to surgical resection or definitive chemoradiation, regardless of PD-L1 expression status and tumor histology.”

Esophageal cancer begins in the inner layer (mucosa) of the esophagus and grows outward. Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. In the U.S., about 67% of newly diagnosed esophageal cancer cases were adenocarcinoma, and 33% were squamous cell carcinoma. It is estimated there will be approximately 19,260 new cases of esophageal cancer diagnosed and about 15,530 deaths resulting from the disease in the U.S. in 2021.

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives.

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HSV-2 Vaccine (GSK4108771A)

HSV-2 Vaccine (GSK4108771A)

The herpes simplex virus type 2 (HSV-2) vaccine candidate (GSK4108771A) utilizes self-amplifying messenger RNA, "SAM" technology. To develop a SAM-based vaccine, GlaxoSmithKline (GSK) scientists designed a SAM molecule synthetically in a laboratory, using portions of the genetic code of a virus. However, in the SAM molecule, the genes linked to the virus's ability to cause infection are deleted and replaced with genes from target viruses that will produce the antigens for desired vaccines. 

The transport of nascent HSV particles from neuron cell bodies into axons and along axons to axon tips in the periphery is an essential component of this reactivation and reinfection. Two HSV membrane proteins, gE/gI, and US9, play a crucial role in these processes. Tiny balls of fat called lipid nanoparticles or LNPs will deliver the vaccine.

Using the body's cells to produce the vaccine means that GSK would only produce the SAM genetic platform and its delivery systems. Volumes may be much smaller than with traditional vaccines. The production process would be very similar for a wide variety of different vaccines, says GSK, potentially leading to substantial streamlining of the vaccine R&D process.

England-based GSK is the world's largest vaccine company by revenue, delivering vaccines that help protect people at all stages of life. Their R&D focuses on developing vaccines against infectious diseases that combine high-medical needs and strong market potential. The GSK vaccine portfolio has been helping to protect people from serious diseases for well over 100 years, with our Marietta (US) site dedicated to smallpox vaccine production since 1882.  

HSV-2 Vaccine (GSK4108771A) Indication

HSV-2 Vaccine (GSK4108771A) is indicated to prevent HSV.

HSV-2 Vaccine (GSK4108771A) Dosage

HSV-2 Vaccine candidate (GSK4108771A) dosage is being tested in a Phase 1 clinical trial. Four doses of the formulation will be administered intramuscularly on day one and day 57.

HSV-2 Vaccine (GSK4108771A) News

June 28, 2021 - GSK has terminated its phase 1 clinical trial to enable the development of an enhanced vaccine version.

May 5, 2021 - The U.S.-based Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety, and Immune Response of an HSV Vaccine in Healthy (~60) Participants Aged 18-40 Years was last updated. Women of non-childbearing potential may be enrolled in the study. Women with childbearing potential may be enrolled in the study under certain conditions.

March 23, 2021 - GlaxoSmithKline (GSK) launched a limited phase 1 clinical trial for a herpes simplex virus type 2 (HSV-2) candidate known as HSV vaccine (GSK4108771A). This USA-based study will include sixty participants and was last updated on March 18, 2021. This first-time-in-human study intends to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental HSV-2 vaccine administered intramuscularly on a 0, 2-month schedule to healthy participants aged 18-40.

HSV-2 Vaccine (GSK4108771A) Clinical Trial

Clinical Trial NCT04762511: This clinical trial has been terminated. This Phase 1 study aims to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine when administered intramuscularly on a 0, 2-month schedule. 

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Generic: 
GSK4108771A
Clinical Trial: 
https://us.gsk.com/en-us/research-and-development/clinical-trials/
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Wednesday, June 19, 2024 - 05:35
Brand: 
HSV-2 vaccine (GSK4108771A)
Abbreviation: 
HSV-2
Status: 
Manufacturer Country ID: 
FDA First In Class: 
Yes
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 The Bahamas Ministry of Tourism & Aviation (BMTA) announced 'it is thrilled to welcome back longtime partner Royal Caribbean International, as the cruise line revealed that Nassau would be the homeport for Adventure of the Seas, beginning June 2021.

Adventure of the Seas will be visiting additional islands in The Bahamas, including Grand Bahama Island and Perfect Day at CocoCay, stated the BMTA on March 21, 2021.

“We believe starting with cruises for vaccinated adult guests and crew is the right choice. As we move forward, we expect this requirement and other measures will inevitably evolve,” stated Michael Bayley, president, and CEO, Royal Caribbean International, in a press statement issued on March 19, 2021. 

“The opportunity to homeport in The Bahamas is a testament to the tremendous partners the government and the people of the island nation have been to us for more than 50 years. We are grateful for the confidence that they have in us and our commitment to a healthy and happy return to sailing.” 

Full details related to Royal Caribbean's health and safety measures are available online. Simultaneously, testing and entry requirements for The Bahamas, including Bahamas Health Visa application and more, can be found on Bahamas.com.

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The India Ministry of Health and Family Welfare announced on March 22, 2021, 'Given the emerging scientific evidence, the interval between two doses of CoviShield, has been revisited by National Technical Advisory Group on Immunization and subsequently by National Expert Group on Vaccine Administration for COVID-19 in its 20th meeting.

During this meeting, the recommendation has been revised to provide a 2nd dose of CovidShield at 4-8 weeks’ interval after the 1st dose, instead of an earlier practiced interval of 4-6 weeks.

Keeping the existing scientific evidence in view, it appears that protection is enhanced if the second dose of COVISHIELD is administered between 6-8 weeks, but not later than the stipulated period of 8 weeks, stated this group.

Covishield is the Serum Institute of India version of the AstraZeneca COVID-19 vaccine.

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GlaxoSmithKline (GSK) launched a limited phase 1 clinical trial for a herpes simplex virus type 2 (HSV-2) candidate known as HSV vaccine (GSK4108771A). This USA-based study will include sixty participants and was last updated on March 18, 2021.

This first-time-in-human study intends to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental HSV-2 vaccine when administered intramuscularly on a 0, 2-month schedule to healthy participants aged 18-40 years.

The Inclusion Criteria for this study include, but is not limited to the following:

  • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
  • Written informed consent obtained from the participant prior to the performance of any study-specific procedure.
  • Healthy participants as established by medical history and clinical examination before entering into the study.
  • Participants documented to be positive for HIV will not be eligible for study participation.
  • Seronegative for HSV-2 as determined by Western blot.

There are several Exclusion Criteria for this phase 1 study, including a pregnant or lactating woman, and woman planning to become pregnant, or planning to discontinue contraceptive precautions.

The study's Estimated Study Completion Date is August 9, 2022.

GSK's vaccines business has a portfolio of more than 20 vaccines to help protect people from a range of diseases throughout their lives.

Clinical researchers have been developing herpes vaccine candidates and evaluating them in clinical trials to test therapeutic (intended to reduce viral shedding in people who are already infected with HSV) and preventive (designed to prevent infection) vaccine candidates. An updated listing of herpes vaccine candidates is published on this PrecisionVaccinations webpage.

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Gardasil 9 vaccine consists of HPV proteins 6, 11, 16, 18, 31, 33, 45, 52, and 58