Zika Breaking News

The U.S. CDC published a health advisory on March 2, 2023, confirming Paraguay's ongoing chikungunya virus outbreak.

Paraguay's Ministry of Health recently reported a total of 71,478 suspect chikungunya cases in Paraguay (Asunción) since an outbreak began in October 2022.

In 2022, the number of chikungunya cases (273,685) reported to the Pan American Health Organization more than doubled the average annual number of cases.

To notify international travelers of potential health risks, the CDC issued a Watch - Level 1 travel alert regarding Paraguay's chikungunya outbreak on February 22, 2023.

Chikungunya virus is a mosquito-borne alphavirus transmitted by infected mosquitoes. The incubation period is typically 3–7 days. 

Unfortuantely, the U.S. FDA has not authorized a chikungunya preventive vaccine as of March 3, 2023.

The CDC's Advisory Committee on Immunization Practices recently reviewed Valneva SE's VLA1553 chikungunya vaccine candidate. 

The good news is VLA1553 has been assigned an FDA Prescription Drug User Fee Act date at the end of August 2023.

Other chikungunya vaccine development news is posted at Vax-Before-Travel.

The U.S. CDC today published Health Alert Network Advisory #CDCHAN-00487, notifying public health authorities and providers there is a substantial increase in chikungunya virus cases in the Republic of Paraguay.

As of February 24, 2023, Paraguay's Ministry of Health reported a total of 71,478 suspect chikungunya cases in Paraguay since an outbreak began in October 2022.

Most of the chikungunya cases have been reported in the capital district of Asunción and the neighboring Central department.

Travelers returning from these areas should seek medical care if they develop fever, joint pain, headache, muscle pain, joint swelling, or rash.  

The CDC warned on March 2, 2023, that Paraguay's virus outbreak could spill over into neighboring countries, such as Argentina, Bolivia, and Uraguay. 

The South American country of Paraguay is a popular tourist destination, welcoming about one million tourists annually.

To notify international travelers of potential health risks, the CDC issued a Watch - Level 1, Practice Usual Precautions alert regarding Paraguay's chikungunya outbreak on February 22, 2023.

The CDC suggests considering chikungunya infection in travelers returning from Paraguay with acute onset of fever and polyarthralgia.

In late 2013, the first local transmission of the chikungunya virus in the Americas was identified in Caribbean countries and territories. 

The virus then spread throughout most of the Americas.

In 2022, the number of chikungunya cases (273,685) reported to the Pan American Health Organization more than doubled the average annual number of cases.

Chikungunya virus is a mosquito-borne alphavirus transmitted by infected mosquitoes, and humans are the primary reservoir during epidemics. 

Most people infected with chikungunya become symptomatic, and the incubation period is typically 3–7 days. 

Unfortunately, chikungunya and dengue viruses cocirculate in Paraguay, are transmitted by the same mosquitoes, and have similar clinical presentations during acute illness. 

Diagnostic testing is available through commercial laboratories, some state health departments, and the CDC. Chikungunya virus disease is a notifiable disease in the U.S.

Moreover, the U.S. FDA has not authorized a chikungunya preventive vaccine as of March 3, 2023.

The CDC's Advisory Committee on Immunization Practices recently met on February 23, 2023, and reviewed Valneva SE's VLA1553 monovalent, single-dose, live-attenuated vaccine candidate. 

VLA1553 has been assigned a Prescription Drug User Fee Act date at the end of August 2023. 

The U.S. Centers for Disease Control and Prevention (CDC) recently added another travel advisory focused on disease outbreaks in the Federal Republic of Nigeria.

On February 24, 2023, the CDC issued its latest advisory focused on an outbreak of diphtheria in several states in Nigeria.

This Alert - Level 2, Practice Enhanced Precautions, says vaccination against diphtheria is essential to protect people against disease.

If traveling to an affected area in Nigeria, you should be updated with diphtheria vaccinations. Furthermore, discuss the need for a booster dose with your healthcare professional before traveling.

CDC recommends vaccinating everyone two months and older to protect against diphtheria.

Diphtheria is a serious infection caused by strains of Corynebacterium diphtheriae bacteria that make a toxin that can cause people to get very sick.

The diphtheria bacteria spread from person to person through respiratory droplets, like from coughing or sneezing; people can also get sick from touching open sores or ulcers of people ill with diphtheria.

Without treatment, up to half of patients can die from the disease, says the CDC.

The CDC previously issued travel advisories for Nigeria's vaccine-preventable diseases, such as yellow fever, polio, measles, and Mpox outbreaks.

These travel vaccines are offered in the U.S. at certified clinics and pharmacies.

Pfizer Inc. announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted during its 179th meeting that available data is adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate ABRYSVO™ (PF-06928316 or RSVpreF).

The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness.

The vaccine candidate is under FDA review to prevent acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 and older.

The FDA's decision on whether or not to approve RSVpreF is expected by the Prescription Drug User Fee Act (PDUFA) goal date in May 2023.

Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, commented in a related press release on February 28, 2023, "We are encouraged by the outcome of today's VRBPAC meeting as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market."

"We look forward to working with the FDA as it completes the review of our application."

Pfizer is currently the only company pursuing regulatory applications for an RSV investigational vaccine candidate for both an indication to help protect older adults, as well as a maternal indication to help protect infants through maternal immunization.

Regarding the maternal indication, earlier this month, Pfizer announced that the FDA had granted priority review to a biologics license application for RSVpreF for the prevention of lower respiratory tract and severe lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant women.

The FDA established a PDUFA action date in August 2023.

The role of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding. 

RSV is a contagious virus and a common cause of respiratory illness.

The virus can affect the lungs and breathing passages of an infected individual. As a result, it can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.

During the initial months of 2023, millions of people were frustrated by the lack of herpes simplex virus (HSV) vaccine development news.

As of February 28, 2023, the U.S. Food and Drug Administration has not authorized any HSV vaccine.

While herpes-candidate vaccines have been conducting clinical research for years, recent messenger RNA (mRNA) technology announcements raised hopes in 2022

These mRNA herpes vaccines are being produced by industry leaders Moderna Inc. and BioNTech SE.

Moderna's herpes simplex virus (HSV) vaccine candidate (mRNA-1608) is an mRNA vaccine targeted against HSV-2 disease, focused on inducing a strong antibody response with neutralizing functionality combined with cell-mediated immunity.

However, mRNA-1608 has yet to launch a human-based phase 1 clinical study.

Based on BioNTech's mRNA platform, the BNT163 candidate vaccine encodes three HSV-2 glycoproteins to help prevent HSV cellular entry and spread and counteract the immunosuppressive properties of HSVs.

BNT163's phase 1 clinical study includes 108 participants and was recently updated on January 5, 2023, and has an Estimated Study Completion Date of June 2025.

Herpes is a sexually transmitted disease (STD), says the FDA. There are two types of HSV that can cause genital herpes: HSV-1 and HSV-2.

Most cases of recurrent genital herpes are caused by HSV-2, and 11.9% of persons aged 14–49 years are estimated to be infected in the U.S.

However, an increasing proportion of anogenital herpetic infections have been attributed to HSV-1, which is prominent among young women.

To increase transparency, the U.S. National Instuties of Health and its partners launched STI Watch, a portal containing updated information on vaccine development status. 

Other herpes vaccine news is posted at PrecisionVaccinations.com/Herpes.

Anixa Biosciences, Inc. today announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance broadening the protection of Anixa's novel breast cancer vaccine technology. 

This technology was invented by the late Dr. Vincent Tuohy and developed at Cleveland Clinic, and Anixa is the exclusive worldwide licensee. 

Anixa's breast cancer vaccine candidate, currently in Phase 1 clinical trials, takes advantage of endogenously produced proteins that have a function at certain times in life but then become "retired" and disappear from the body. 

One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in most triple-negative breast cancers. 

Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. 

The vaccine candidate also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. 

Dr. Amit Kumar, Chairman and CEO of Anixa, commented in a press release on February 27, 2023, "This breast cancer vaccine has the potential to prevent Triple Negative Breast Cancer, the deadliest form of breast cancer, and perhaps other forms of breast cancer that express alpha-lactalbumin."

"In addition, with our partners at Cleveland Clinic, we .... plan to present data from the trial at the annual American Association for Cancer Research meeting in April (2023)."

One in eight women in the U.S. will be diagnosed with invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are Triple-Negative Breast Cancer.

The U.S. Centers for Disease Control and Prevention (CDC) recently concluded that reducing the number of persons traveling while infected with the SARS-CoV-2 virus could reduce associated transmission in airports, aircraft, and destination communities.

This CDC analysis published on February 24, 203, found post-arrival SARS-CoV-2 test results were 52% less likely to be positive when the predeparture COVID-19 testing requirement was in effect.

This finding was factual even when controlling for other factors, such as incidence in the flight’s country of origin and pool size.

Based on observed, real-world traveler data, these findings support the value of predeparture testing as a tool for reducing SARS-CoV-2 transmission associated with travel and were consistent with estimates from previous modeling studies.

The CDC continues to recommend testing before and after international travel.