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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.

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U.S. CDC vaccines during pregnancy 2023
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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.

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Irving Texas 2023
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TB cases in US 2022
Tuberculosis vaccines and drugs under development in 2023
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The World Health Organization (WHO) today reported a steady increase in the proportion of SARS-CoV-2 coronavirus variant EG.5 reported, and based on its characteristics, EG.5 may spread globally & cause a surge in COVID-19 cases.

However, as of August 9, 2023, while EG.5 has shown increased prevalence, growth advantage, and immune escape properties, there have been no reported changes in COVID-19 severity to date.

Based on the available evidence, the public health risk posed by EG.5 is evaluated as low globally, aligning with the risk associated with XBB.1.16 and the other currently circulating variants of interest.

During epidemiological week #29 (17 to July 23, 2023), the global prevalence of EG.5 was 17.4%.

This is a notable rise from the data reported four weeks prior (week 25, 19 to June 25, 2023), when the global prevalence was 7.6%, wrote the WHO.

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WHO Aug 9, 2023
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The U.K. Health Security Agency (UKHSA) today announced the Joint Committee on Vaccination and Immunisation (JCVI) published its new advice regarding persons eligible for COVID-19 booster vaccination in autumn 2023.

Announced on August 8, 2023, the JCVI considers it appropriate to offer COVID-19 vaccines to all adults aged 65 years and over.

From autumn 2023, JCVI additionally advises that a primary course COVID-19 vaccination for persons who have not had any COVID-19 vaccines before should consist of a single dose. 

Professor Wei Shen Lim, Chair of COVID-19 immunization on the JCVI, said in a press release, "The autumn booster program will continue to focus on those at greatest risk of getting seriously ill."

"It is important that everyone eligible takes up a booster this autumn – helping to prevent them from hospitalizations and deaths arising from the virus over the winter months."

Specifically, the JCVI published the following sub-groups:

  • residents in a care home for older adults
  • all adults aged 65 years and over
  • persons aged six months to 64 years in a clinical risk group, as laid out in the Immunisation Green Book, COVID-19 chapter (Green Book)
  • frontline health and social care workers
  • persons aged 12 to 64 years who are household contacts (as defined in the Green Book) of people with immunosuppression
  • persons aged 16 to 64 years who are carers (as defined in the Green Book) and staff working in care homes for older adults.

Dr. Mary Ramsay, Director of Public Health Programmes at the UKHSA, commented, #The booster is being offered to those at higher risk of severe illness, and by taking up the booster vaccine this autumn, you will increase your protection ahead of winter, when respiratory viruses are typically at their peak."

To optimize protection over the winter months, the JCVI advises that the autumn program should aim to complete vaccinations by early December 2023, mindful that vaccine protection is highest in the first 3 months following vaccination. 

COVID-19 vaccine effectiveness rates in the U.K. are posted at this link.

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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.

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Local media today reported the People's Republic of Bangladesh's Directorate General of Health Services (DGHS) confirmed the total death toll has reached 293 during the dengue outbreak in 2023.

As of August 8, 2023, this data exceeds the previous record of 281 dengue-related deaths reported in Bangladesh during 2022.

The total dengue cases increased to over 59,000 in early August 3, with around 32,562 cases reported from the capital city of Dhaka.

According to the U.S. Centers for Disease Control and Prevention (CDC), dengue is a vaccine-preventable, vectorborne infectious disease and is endemic in about 125 countries in 2023.

In the U.S., Florida has reported both locally-acquired and travel-related dengue cases in 2023.

As of August 3, 2023, the U.S. States reported 225 dengue cases, and U.S. Territories reported 315 this year.

To alert international travelers, the CDC has recently issued Travel Health Notices regarding dengue outbreaks in the Americas, Africa/Middle East, Costa Rica, and Asia/Pacific Islands. 

Worldwide, two dengue vaccines are in use, but access is limited.

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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.

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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.

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U.S. CDC map of the DRC August 2023
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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.

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