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The U.S. Department of State today confirmed visiting the Republic of Fiji is safe, but people should exercise normal precautions.
The State Department disclosed on August 9, 2023, a higher level of caution is suggested when visiting Colo I Suva Forest Park. Be aware of your surroundings and be extra vigilant along the trails when displaying items like jewelry, bags, and cell phones in public.
In July 2023, a security alert notified U.S. citizen victims of sexual assault are encouraged to contact the U.S. Embassy for assistance at + (679) 331-4466.
Fiji is an island country in Melanesia, part of Oceania in the South Pacific Ocean, where over 200,000 people visit annually.
If you decide to travel to Fiji, the no-cost Smart Traveler Enrollment Program is available to receive security messages and make it easier to locate you in an emergency.
From a health perspective, the U.S. CDC suggests visitors to Fiji speak with a healthcare provider about routine and travel vaccines, including the annual flu shot.
The CDC recently (July 2023) reissued a Travel Health Advisory for the Pacific Islands regarding various dengue outbreaks.
Meissa Vaccines announced positive safety and immunogenicity data for MV-012-968, the company's intranasal live attenuated Respiratory syncytial virus (RSV) vaccine candidate.
Meissa is developing MV-012-968 as a needle-free, adjuvant-free vaccine to protect infants and toddlers from the respiratory syncytial virus (RSV).
The company says RSV is the leading cause of infant hospitalization in the United States and is considered a "missing" pediatric vaccine.
The clinical study in RSV-naïve (seronegative) participants between the ages of six and 36 months enrolled 79 participants at multiple sites in the U.S. to evaluate the safety and immunogenicity of MV-012-968 (NCT04909021).
At the highest dose tested, no serious adverse events related to vaccination were reported with no evidence of any lower respiratory tract symptoms, no Grade 2 or 3 fever observed, and low level, transient vaccine shedding detected.
All RSV-naïve infants and toddlers demonstrated a vaccine response to two doses of 107 PFU.
Serum-neutralizing antibody responses to MV-012-968 were robust and comparable to those seen with previous live attenuated RSV vaccine candidates demonstrating high efficacy against medically-attended RSV disease.
Moreover, MV-012-968 demonstrated significantly greater tolerability to date than these previous candidates.
"With this outstanding safety and robust serum antibody response, we believe Meissa's live attenuated vaccine has the potential to be a best-in-class solution to protect infants and toddlers from RSV, and we are now preparing to advance MV-012-968 into a Phase 2/3 clinical trial next year (2024)," said Martin Moore, Ph.D., co-founder and Chief Scientific Officer, Meissa Vaccines, in a press release on August 8, 2023.
"These data also demonstrate the power of our AttenBlock platform to generate live attenuated vaccines with outstanding safety and immunogenicity – something that we've not seen with other platforms."
As of August 10, 2023, the U.S. FDA has approved RSV vaccines for seniors and antibody therapies for infants.
SK bioscience recently announced that it secured 6.5 million shares of common stock through a private placement investment in Novavax, a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant.
Concurrent with the equity investment announcement, SK bioscience and Novavax have extended their current license agreement, adding Novavax's updated COVID-19 vaccine ((Nuvaxovid, CovoVax, NVX-CoV2373)
The agreement serves as a strategic shift of partnership from the pandemic period to the endemic phase, in which SK bioscience will obtain exclusive rights to Novavax's COVID-19 variant vaccine in South Korea and non-exclusive rights in Thailand and Vietnam to supply and commercialize the vaccine.
Jaeyong Ahn, CEO of SK bioscience said in a press release on August 8, 2023, "We believe that the strategic equity investment and the continuous cooperation between SK bioscience and Novavax, which are among the few companies that focused on developing COVID-19 vaccines during the pandemic, will create a powerful synergy."
Through the enhanced partnership, SK bioscience will explore potential future collaborations with Novavax such as utilizing Novavax's adjuvant, Matrix-M. Novavax also develops COVID-Influenza combination, stand-alone influenza, and high-dose COVID-19 vaccine candidates.
As influenza and respiratory syncytial virus (RSV) seasons approach the U.S., health leaders focus on pregnant women's vaccination needs.
The Centers for Disease Control and Prevention (CDC) will conduct a Clinician Outreach and Communication Activity (COCA) webinar on August 10, 2023, to share updated clinical vaccination guidance for pregnant women.
The CDC and the American College of Obstetrics and Gynecology emphasize the importance of vaccinations for pregnant women and recommend vaccinations against pertussis, flu, and COVID-19 to protect themselves and their babies during the first few months of life.
The CDC says there have been recent declines in vaccination coverage for Tdap (tetanus, diphtheria, and pertussis) and flu shots and low uptake of COVID-19 vaccines among pregnant women.
During Thursday's COCA Call, presenters (Naima T. Joseph MD, MPH, Tara C. Jatlaoui, MD, MPH) will give a comprehensive overview of the timing and promotion of vaccines people should receive during pregnancy and provide an update on RSV vaccine candidates for pregnant women.
This one-hour webinar is scheduled for Thursday, August 10, 2023, 2:00 PM – 3:00 PM ET, at Webinar Link:
https://www.zoomgov.com/j/1604412918; ID: 160 441 2918; Passcode: 650748. Note: Zoom recently modified its privacy policies.
Updated August 10, 2023 - presentation slides.
Dallas County Health and Human Services (DCHHS) today reported the first West Nile Virus (WNV) death in Dallas County, Texas, for the 2023 season.
The patient was a female resident in the City of Irving diagnosed with West Nile Neuroinvasive Disease.
This is the second WNV human death reported in Texas this year.
For 2023, a total of one hundred and sixty-seven mosquito traps have tested positive for WNV.
Over the last five years, Texas has had 485 WNV cases and 65 related deaths.
“It’s very sad to report the first West Nile Virus death this season,” said Dr. Philip Huang, Director of DCHHS, in a press release on August 9, 2023.
“This again reminds us how important it is to protect against mosquito bites that can carry multiple diseases like WNV. Mosquito activity remains high in Dallas County.”
DCHHS says most people exposed to WNV don’t get sick, but about 20% develop symptoms like headache, fever, muscle and joint aches, nausea, and fatigue. In a small proportion, less than 1%, the virus affects the nervous system, leading to the more severe West Nile neuroinvasive disease that can cause neck stiffness, disorientation, tremors, convulsions, paralysis, and even death.
Aedes albopictus and Aedes aegypti mosquitoes, which transmit WNV, are currently circulating in Texas and remain active in much of Texas into November and December.
As of August 9, 2023, no U.S. FDA-approved WNV vaccines are available.
Novavax, Inc. today announced its operational highlights for the second quarter ended June 30, 2023.
"During the first half of 2023, Novavax has been focused on execution, making significant progress on all three of our key priorities. We have initiated the filing for authorization of our updated XBB COVID vaccine in the U.S., with submissions in the European Union and Canada to follow. We are manufacturing at commercial scale in support of our plan to deliver our vaccine on time for the fall season," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on August 8, 2023.
"We continue to work towards deriving additional value from our pipeline and technology and will be advancing our COVID-Influenza Combination vaccine candidate through the next stage gates and towards late-stage development."
Novavax also received first Full Marketing Authorization in Europe for Nuvaxovid™ as a primary series in individuals aged 12 and older and as a booster in adults aged 18 and older.
Since authorization, Nuvaxovid™, a protein-based vaccine, has been distributed in about 40 markets.
On July 11, 2022, Novavax announced an agreement with the U.S. HHS to secure 3.2 million doses of Novavax's COVID-19 vaccine.
And the company initiated the rolling submission of a U.S. Biologics License Application for full approval of the Novavax COVID-19 Vaccine, Adjuvanted for adults and adolescents aged 12 through 18.
GSK Canada recently announced that Arexvy (respiratory syncytial virus (RSV) vaccine - recombinant, AS01E adjuvanted) was approved in Canada for preventing lower respiratory tract disease caused by RSV in individuals 60 and older.
Arexvy's availability in Canada is expected ahead of the 2023/24 peak RSV season, which is during the winter.
Previous RSV vaccine authorizations have been issued in Europe, the USA, and the U.K.
Marni Freeman, Country Medical Director, GSK, said in a press release on August 4, 2023, "With the approval of Arexvy, we are excited to be able to offer an option to help protect the nearly 10 million Canadians aged 60 and older who are at risk of RSV disease."
"We're hopeful that with a vaccine now available for older Canadians, the virus' burden on our healthcare system will also be dramatically improved."
"We look forward to working with provincial, territorial, and national health authorities to ensure older Canadians at greatest risk of RSV infection can access the vaccine."
RSV is a common, contagious virus that affects the lungs and respiratory airways. The virus can affect all ages, but the impact of RSV in older adults is significant.
RSV is a seasonal respiratory virus generally identified first in Florida each year.
The Democratic Republic of the Congo (DRC) recently confirmed a total of 14 new polio cases.
According to the Global Polio Eradication Initiative (GPEI), there were ten circulating vaccine-derived poliovirus type 1 (cVDPV1) cases reported as of August 2, 2023.
There are now 46 polio cases in the DRC this year. Last year, there were 146 cases.
Furthermore, the DRC reported four new cases involving circulating vaccine-derived poliovirus type 2 (cVDPV2). There are now 61 cases so far this year and 367 cases reported in 2022.
Previously, the DRC launched its first significant immunization campaign in June 2023 using the novel polio vaccine type 2 (nOPV2) to protect children against polio. More than 17 million children under five in 20 provinces were included.
To alert international travelers of this health risk, the U.S. CDC included the DRC in its Level 2 - Practice Enhanced Precautions, Global Polio Travel Health Notice, which was issued on July 28, 2023.
The CDC encourages polio vaccinations for most people visiting Africa.
Previously, the U.S. Department of State issued a Level 3 advisory on July 31, 2023, saying people should reconsider travel to the DRC due to civil unrest and not visit certain providences.
Anixa Biosciences, Inc. today announced that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company's breast cancer vaccine candidate with Keytruda®.
This treatment arm aims to determine if the vaccine/Keytruda combination increases immune response.
Anixa's breast cancer vaccine is designed to generate T cells that target triple-negative breast cancer ("TNBC"). This vaccine takes advantage of endogenously produced proteins that function at certain times in life but then become "retired" and disappear from the body.
Dr. Amit Kumar, Chairman and CEO of Anixa, stated in a press release on August 7, 2023, "Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response–including, we believe, production of T cells that can target TNBC–so we believe that the addition of Keytruda could have a synergistic effect."
"If a vaccine induces the creation of T cells targeting TNBC, and Keytruda generally maintains T cell activity, the combination could be very potent."
Keytruda, a type of immunotherapy known as a checkpoint inhibitor marketed by Merck, is approved for use with chemotherapy before surgery and then alone after surgery to treat high-risk early-stage and advanced TNBC.
The Phase 1a study evaluates the vaccine's safety, identifies the Maximum Tolerated Dose, and monitors the immune response in vaccinated women.
According to the Company, one in eight women in the U.S. will be diagnosed with invasive breast cancer at some point in their lives.
